VADEMECUM Lek OTC Division 1995 LEK OTC Division Sometimes all your patient needs is advice CONTENTS Introduction: The culture of selfmedication in Slovenia and world-wide Analgesics, antipyretics and non-steroidal anti-inflammatory drugs Fortalgin C, effervescent flu and cold tablets Lekadol, analgesic and antipyretic tablets and syrup Fenalgin, pain relieving tablets Diverin, coated tablets for rheumatic and muscular pain relief Diverin, gel for rheumatic and muscular pain relief Miospray, topical analgesic Expectorants, rhinolytics and other products for the treatment of acute respiratory tract infections Mentoklar, inhalation set Mentoklar, drops for inhalation Mentoklar, gel against cold and rheumatism Mentoklar, pocket inhaler Mentosana, antiseptic tablets for mouth and throat Lekonil, Lekonil P, nasal drops Timi, expectorant syrup for children Fluimukan, dispersible tablets, granules Immunostimulants Immunal, immunostimulant drops Psychophytotherapeutic drugs Persen, tranquilizing coated tablets, Persen forte, tranquilizing capsules Deprim, mood improving herbal tablets Sanosan, herbal tablets against insomnia Lipid regulating agents Trienyl, capsules, dietary supplement for prevention of cardiovascular diseases Antidiarrheals and oral rehydration salt Linex, antidiarrheal and antiflatulent capsules Nelit N, oral rehydration salt Hepatoprotectives Syromin forte, tablets for protection of the liver Digestants Altalex, drops Plantex, instant tea for infants and small children Drugs against travel-sickness Tralan, herbal capsules for prevention and relief of travel-sickness Local venotonics Venitan, cream for swollen and painful legs Hemorrhoidal products Modolex, ointment and suppositories for hemorrhoids Drugs for alleviation of gynecological disorders Altalex, drops Klimaktin, herbal tablets for alleviation of climacteric disorders Drugs for prostatic diseases Trianol, capsules for troubles caused by prostatic hyperplasia Vitamin and mineral products Lekovit multi, effervescent tablets Lekovit multi, vitamin lozenges Lekovit C-Ca, effervescent tablets with calcium and vitamin C Lekovit amino, capsules Dermatological products Antopar, anti acne gel LMK, medical liquid soap, LMK, medical cream Lice-killing agents Milinor, lice-killing shampoo Oral health products Lekofluor, dental lotion for children, dental lotion for adults THE CULTURE OF SELFMEDICATION IN SLOVENIA AND WORLD-WIDE Lek OTC Division is an independent unit of the company Lek. It is composed of an interdisciplinary group of pharmacists, doctors, biologists, and others who are engaged in research and development work, production technology, quality control and product marketing. Among the products of Lek OTC Division, in addition to the well-known and proven therapeutic agents derived from natural sources, there are also OTC drugs - hence we have a complete range of drug products for selfmedication. The rapid increase in the costs of medical care, and likewise of drugs, is a process which the developed countries actively promote, despite the fact that these countries are richer than Slovenia. In this activity, however, they do not - above all - limit the consumption of drugs, nor do they reduce the prices, since drugs represent only a relatively small part of the overall costs of medical care, but they do especially transform medical practice. The health care policy supports medical treatment at out-patient clinics as a substitute for hospital treatment. A higher level of education and of health culture, the awareness of the modern individual that he or she no longer wishes to be an "object" in medical treatment, but rather to be an active participant in the prevention and cure of illness - all these are factors which influence further validation of self-medication. Here the possibilities are indeed great for a more rational use of funds for medical care and for their reduction. In particular, we doctors and pharmacists (in medical service and in industry) are acquiring new tasks in health education and in the shaping of health culture. Hence, the role of the medical and pharmaceutical professions involves satisfying people's need for health, for a healthy manner of living and for a higher quality of life, and here health means the individual's physical, mental and social well-being. The role of Lek OTC Division in these processes is primarily to provide quality pharmaceuticals intended for selfmedication, together with information on it designed for both, the professional and the lay public. In the future, we expect to see in Slovenia, too, a further expansion in the choice of drugs which can be dispensed without prescription, and further affirmation of therapeutic agents derived from natural sources . The two prime qualities of products intended for selftreatment (OTC - over the counter drugs) must be, above all, safety and efficiency. The relation between the two is of particular importance when approving drugs derived from natural sources because, in addition to the medical standards, sociological and phychological criteria must also be taken into account, which also includes the recognition of tradition and empirical knowledge. In order to make responsible and safe use of selfmedication drugs, patients need advice, which is most often obtained from a doctor or a pharmacist. The influence of the media is relatively small. Fear of the indiscriminate use of drugs during selfmedication is not entirely justified. Considerable number of research studies in many different countries have indicated that, generally, patients use the drugs carefully and responsibly, and not just at the appearance of the most trivial symptoms; this, however, depends mainly on the quality of health education, and not on the various restrictions. Advantages of selfmedication it encourages self-education, creativity, self-confidence, and personal responsibility; it is a more convenient form of treatment; it allows for great saving of time and resources for the individual, society, and the profession. Deficiencies and risks polypragmasy, the treatment of all, even the slightest symptoms harmful side effects drug interactions deferral of consultation with the doctor. In Lek OTC Division we, too, would like to contribute towards the new, advisory role of doctors and pharmacists. With this catalogue of Lek OTC drugs, adjuvant therapeutic agents and dietetic products, we would like to pass on to you the information which is needed above all by the general practitioner (family doctor), who is the most often consultant, or the pharmacist working in a pharmacy, who frequently influences the choice of self-medication products. We would also welcome your suggestions or questions, to which we will gladly respond. Lek d.d. Lek OTC Division Verovškova 57, POB 100 61107 Ljubljana Slovenia ANALGESICS, ANTIPYRETICS AND NON-STEROIDAL ANTI-INFLAMMATORY DRUGS FORTALGIN(r) C, effervescent flu and cold tablets COMPOSITION Each tablet contains 400 mg of acetylsalicylic acid and 240 mg of ascorbic acid (vitamin C). ACTION Fortalgin C effervescent tablets possess analgesic, antipyretic, anti-inflammatory and anticoagulant effects. Ascorbic acid is a substitute for enhanced vitamin C requirements in infections. The analgesic effect is either central or peripheral. Acetylsalicylic acid inhibits prostaglandin synthesis, thus alleviating inflammation and pain. It also inhibits the platelet aggregation. The antipyretic effect is the result of its action on the body temperature regulation centre in the hypothalamus. Vitamin C plays an important role in biological oxidation-reduction processes and in cell respiration. INDICATIONS - pain and increased body temperature in influenza; - headache, toothache, pain caused by inflammation of the muscles and joints; - painful menstruation; - febrile conditions. CONTRAINDICATIONS Hypersensitivity to non-steroidal anti-inflammatory drugs, frequent bleeding, gout, acute phase of peptic ulcer, iron metabolism diseases. PRECAUTIONS Caution is necessary in: - patients with allergic diseases, such as asthma and urticaria; - patients with severe renal disorders or hepatic impairment; - patients with chronic or recurrent gastric and duodenal disorders; - patients with a reduced enzyme system of glucose-6-phosphate dehydrogenase; - gouty patients. WARNING Acetylsalicylic acid should not be given to children with increased body temperature caused by a virus disease; the administration of acetylsalicylic acid in children with chickenpox and influenza increases the risk of development of Reye's syndrome. Pregnancy and lactation Acetylsalicylic acid should not be taken by pregnant women and nursing mothers, unless advised by the doctor. In the last trimester of pregnancy, self-medication with acetylsalicylic acid is to be particularly avoided. SIDE EFFECTS Acetylsalicylic acid may cause nausea and gastric pain. Less frequently observed side effects are hypersensitivity reactions, e.g. skin rash, pruritus and respiratory disorders (bronchospasm). Gastric bleeding may occur very rarely with the excessive use of acetylsalicylic acid; its signs are dark stools or blood vomiting. DRUG INTERACTIONS Acetylsalicylic acid may potentiate the activity and side effects of other non-steroidal anti-inflammatory drugs, oral antidiabetics, barbiturates, digoxin, lithium, anticoagulant drugs, and cytostatic methotrexate. When concomitantly administered with corticosteroids, it increases the risk of gastrointestinal bleeding. Acetylsalicylic acid may diminish the effect of diuretics, antihypertensives and uricosurics (sulfinpyrazone). DOSAGE AND ADMINISTRATION Adults and children above 15 years of age take 1 to 2 effervescent tablets for 10 days, at the most, up to three times daily. Maximum daily dosage of acetylsalicylic acid is 4 g. The Fortalgin C effervescent tablet should be dissolved in a glass of water. The solution should be drunk freshly-prepared. In long-term treatment with higher doses, the freshly-prepared solution, containing a large amount of liquid, should be taken after meals. OVERDOSAGE Signs of mild overdosage include nausea, upper abdominal pain, dizziness, tinnitus and perspiration. Withdrawal of the drug is usually sufficient in such cases. When larger amounts of effervescent tablets are taken, disturbances of consciousness, coma, hypotension, respiratory depression, convulsions, severe metabolic acidosis, gastrointestinal haemorrhage, hypoglycemia, excessive perspiration with dehydration and fever may also occur. The measures to be taken in case of accidental overdosage are: gastric lavage, administration of activated charcoal and symptomatic therapy. The elimination of salicylates from the body may be greatly accelerated by forced alkaline diuresis and by hemolysis in severer cases, upon a preliminary determination of salicylate serum levels. Registration status The drug may also be dispensed without prescription. FORTALGIN C, effervescent flu and cold tablets acetylsalicylic acid, ascorbic acid analgesic, antipyretic, anti-inflammatory drug reduction of increased body temperature and alleviation of pain in influenza, cold and other viral infections the formulation of the active component in the effervescent tablet reduces the direct effect of acetylsalicylic acid on gastric mucosa LEKADOL(r), analgesic and antipyretic tablets and syrup COMPOSITION Each tablet contains 500 mg of paracetamol. Each 5 ml of syrup contains 120 mg of paracetamol. ACTION Paracetamol has analgesic and antipyretic effects in cases of acute inflammation. It is promptly absorbed from the upper gastrointestinal tract after peroral application. The important site of paracetamol absorption is the small intestine. After the regular peroral doses it achieves peak plasma levels from 15 to 20 µg/ml within 30 to 90 minutes, depending on dosage form. It is quickly distributed throughout the body. It is mainly metabolised in the liver and excreted via the kidney. The elimination half-life of 1 g of perorally administered paracetamol is about two hours. Pracetamol crosses the placenta and penetrates into breast milk. INDICATIONS - relieves mild to moderate pain; - reduces symptoms of minor inflammations and transient febrile conditions; - symptomatic and supplementary treatment in cold, certain viroses and influenza. CONTRAINDICATIONS Hypersensitivity to paracetamol. PRECAUTIONS Care is necessary in patients with severe renal diseases or liver failure. WARNING Pregnancy and lactation Epidemiological data reveal that the use of paracetamol does not present a risk in pregnancy. Nevertheless, pregnant women and nursing mothers should avoid taking it, unless otherwise advised by the doctor. SIDE EFFECTS Paracetamol is usually well tolerated. Allergic reactions, such as skin rash, urticaria and pruritus are very rare. DRUG INTERACTIONS No important clinical interactions of the drug have been reported. DOSAGE AND ADMINISTRATION The drug should be taken with water. Adults Single dose: 1 to 2 Lekadol tablets (0.5 g to 1 g of paracetamol). Interval between individual doses: 4 to 6 hours. Maximum daily dose: 3 g of paracetamol. Children 6 to 12 years: single dose: 1/2 tablet to 1 Lekadol tablet (250 to 500 mg of paracetamol) or 2 to 4 teaspoonfuls of syrup; 1 to 6 years: single dose: 1 to 2 teaspoonfuls of syrup; infants from three months to one year: single dose: 1/2 to 1 teaspoonful of syrup. There should be at least a 4 to 6-hour interval between individual Lekadol doses. It is recommended not to take Lekadol more than four times within 24 hours. OVERDOSAGE Nausea and vomiting occur after moderate overdosage (less than 15 g) and within the first 12 to 24 hours after major overdosage (more than 15 g). Symptoms and signs of major overdosage are visible on the third day as inappetence, growing confusion, progressing jaundice and gastrointestinal bleeding. Hepatic failure may result in coma and death. The intravenous use of N-acetylcysteine within 12 hours after the overdosage may prevent hepatotoxicity from paracetamol; the administration of N-acetylcysteine within 36 hours after the overdose may significantly increase the likelihood of survival. Methionine may also be given by mouth, but its effect is less reliable ( as it is absorbed from the gastrointestinal tract). In case of hepatic failure, standard measures need to be taken. Patients taking drugs which have an impact upon enzymes (e.g. barbiturates) and chronic alcoholics without cirrhosis may be more sensitive to toxic effects of paracetamol overdosage. Registration status The drug may also be dispensed without medical prescription. LEKADOL, tablets, syrup paracetamol analgesic and antipyretic suitable and safe for infants and young children (in the form of syrup, it has been an OTC drug in the USA already since 1960 ) first-choice analgesic and antipyiretic in patients with ulcer disease and those in whom the use of acetylsalicylic acid and of non-steroidal anti-inflammatory drugs is contraindicated due to gastrointestinal adverse effects suitable and safe analgesic and antipyretic for asthmatics since it does not inhibit prostaglandin synthesis and very rarely provokes bronchospasm analgesic and antipyretic with minimal side effects when administered in therapeutic doses - also in alcoholics and other endangered persons who are starving (drug addicts, deprived people) FENALGIN(r), pain relieving tablets COMPOSITION Each tablet contains 200 mg of acetylsalicylic acid, 300 mg of paracetamol and 60 mg of caffeine. ACTION Fenalgin relieves pain and reduces inflammation and increased body temperature. Acetylsalicylic acid combines analgesic, anti-inflammatory and antipyretic actions. The analgesic effect is both peripheral and central. The antipyretic effect results from action on the heat-regulating centre in the hypothalamus. Paracetamol combines analgesic and antipyretic activities. Caffeine exerts a stimulating effect on the central nervous system and prevents fatigue and somnolence. INDICATIONS - headache, toothache, painful menstruation (dysmenorrhea); - pains in myositis and arthritis; - febrile conditions. CONTRAINDICATIONS The drug should not be taken by persons hypersensitive to its ingredients, those with porphyria, hepatic and renal failure, gastric and duodenal mucosal lesions and gastrointestinal bleeding, persons hypersensitive to non-steroidal anti-inflammatory drugs, and those prone to bleeding. PRECAUTIONS Caution is necessary in: - patients with allergic diseases, such as asthma and uticaria; - patients with major renal disorders or hepatic failure; - patients with chronic or recurrent gastric and duodenal disorders; - patients with reduced enzyme system of glucose-6-phosphate dehydrogenase; - patients suffering from severe heart failure, cardiac arrhythmia, or coronary disease; - alcoholics. WARNING The drug should not be given to children with increased body temperature caused by virus disease; the administration of acetylsalicylic acid in children with chickenpox or influenza may increase the risk of development of Reye's syndrome. Pregnancy and lactation The drug should not be taken by pregnant women and nursing mothers except when advised by the doctor. In the last trimester of pregnancy, self-medication should be particularly avoided. The possibility of development of side-effects is higher in elderly persons. SIDE EFFECTS If the prescribed dosage is observed, side effects are rare. The most frequent are nausea and gastric pain, while hypersensitivity reactions, such as skin rash, pruritus and respiratory disorders occur less frequently. Very rarely gastric haemorrhage may arise, the signs of which are dark stools or blood vomiting. DRUG INTERACTIONS Concomitant administration of this drug with non-steroidal anti-inflammatory agents, anti-coagulant drugs, corticosteroids, oral antidiabetics and the cytostatic methotrexate, barbiturates, digoxin and lithium is not advised, since it potentiates their effects. Concurrent use with antihypertensives, diuretics and uricosurics is not recommended either, since it diminishes their activity. Simultaneous consumption of alcohol increases the risk of gastrointestinal bleeding and hepatic failure. Concomitant administration with aminoglycoside antibiotics increases the possibility of damage to the hearing. DOSAGE AND ADMINISTRATION Adults and children above 15 years of age take 1 to 2 tablets for 10 days at the most up to three times daily. OVERDOSAGE Long-term administration of large doses of the drug may cause nausea, vomiting, tinnitus and dizziness. Rapid ingestion of excessive doses at one time may provoke gastrointestinal haemorrhage and hepatic failure. Medical assistance should be sought in such cases in order to remove the ingested drug by inducing vomiting, with gastric lavage, administration of activated charcoal, laxatives and with rehydration. It is also recommended that a regional toxicological centre be consulted in this event. Registration status The drug may also be dispensed without prescription. FENALGIN, tablets acetylsalicylic acid, paracetamol, caffeine combined analgesic and antipyretic agent suitable combined analgesic/antipyretic according to the critera of both, the German and the American drug legislation, which allows for the combination of caffeine with acetylsalicylic acid and paracetamol without pyrazolone derivatives (e. g. propyphenazone), which may cause severe side effects even with therapeutic doses (e. g. agranulocytosis) does not contain codeine, as this incurs a great risk of the development of dependence DIVERIN(r), coated tablets for rheumatic and muscular pain relief COMPOSITION Each coated tablet contains 200 mg of ibuprofen. ACTION Diverin has analgesic, antipyretic, and anti-inflammatory properties. Ibuprofen inhibits prostaglandin synthesis. Diverin is prompty resorbed and distributed throughout the body after peroral application. Its elimination via the kidney is quick and complete. When taken on an empty stomach, it achieves maximum plasma levels within 45 minutes of ingestion. When administered with food, it obtains peak plasma concentrations two hours upon ingestion, depending on dosage form. Its half-life of elimination is about two hours. Some studies have revealed very low ibuprofen concentrations in breast milk. INDICATIONS - Alleviation of mild to moderate pain; - Relief of symptoms in minor inflammations and transient febrile conditions; - Symptomatic and supplementary treatment in common cold, some viroses and influenza. CONTRAINDICATIONS Hypersensitivity to acetylsalicylic acid and ibuprofen, patients with gastric or duodenal ulceration. PRECAUTIONS Care is necessary in: - patients with allergic diseases, e.g. with asthma or urticaria; - elderly people with severe renal disease; - patients with chronic or recurrent gastric and duodenal disorders. Ibuprofen is not used in children except if advised by the doctor. WARNING Pregnancy and lactation Pregnant women and breast feeding mothers should not take ibuprofen except if advised by the doctor. In the last trimester of pregnancy, self-medication with ibuprofen should be particularly avoided. SIDE EFFECTS Ibuprofen may induce gastrointestinal irritation, dyspepsia or nausea. In rare cases, large ibuprofen doses may cause gastric bleeding. Less frequently observed side effects are hypersensitivity reactions, e.g. bronchospasm, skin rash and pruritus. DRUG INTERACTIONS Ibuprofen may potentiate the activity and side effects of other non-steroidal anti-inflammatory drugs. Ibuprofen may diminish the effect of diuretics. DOSAGE AND ADMINISTRATION The drug should be taken with water. Adults Single dose: 1 do 2 Diverin coated tablets; the intervals between individual doses: 4 to 6 hours. Maximum daily dosage: 1200 mg (6 Diverin coated tablets), divided into several doses. Children Up to 2 years: only following medical instructions. Up to 12 years: 20 mg/kg body weight daily, divided into several doses. Over 12 years: as for adults. OVERDOSAGE Signs and symptoms of overdosage include: nausea, vomiting, epigastric pain, dizziness, somnolence, ataxia and coma in very rare cases. There does not exist a specific antidote for this drug. Therapeutic measures involve gastric lavage and complementary steps. Registration status The drug may also be dispensed without prescription. DIVERIN, coated tablets ibuprofen analgesic and antipyretic, particularly suitable for alleviating pain in muscles and joints and menstrual pain the analgesic effect of ibuprofen is significantly higher than that of acetylsalicylic acid an OTC drug in the USA since 1984 and in Great Britain since 1983 gastrointestinal side effects of ibuprofen occur more rarely than those with acetylsalicylic acid DIVERIN(r), gel for rheumatic and muscular pain relief COMPOSITION 100 g of Diverin gel contain 5 g of ibuprofen. ACTION Diverin gel possesses local anti-inflammatory and analgesic actions. It is non-sticky and colourless, it is readily absorbed, and exerts a prompt effect on the affected area. INDICATIONS Diverin gel is used in the local treatment of non-rheumatoid arthritis (tendinitis, tendovaginitis, bursitis, periarthritis, fibrositis syndrome), degenerative rheumatic disorders, sports injuries and other forms of damage to joints, periarthritic regions and soft tissue. CONTRAINDICATIONS Diverin gel should not be used by persons hypersensitive to ibuprofen and other non-steroidal anti-inflammatory drugs, or by those with an allergic predisposition. Diverin gel should not be applied to the damaged skin. PRECAUTIONS The use of Diverin gel is not recommended in children of up to 14 years of age. Pregnant women and nursing mothers should apply the gel only for shorter periods of time on limited skin areas. When applying Diverin gel, care should be taken to avoid contact with the eyes. After use, the hands should be thoroughly washed. SIDE EFFECTS Only rarely there may occur redness of the skin and skin rash, itching and a burning sensation. In such cases the treatment should be interrupted. DOSAGE AND ADMINISTRATION Diverin gel is to be applied to the skin three to four times daily. Apply a thin layer of gel to the painful area and rub it thoroughly into the skin. Diverin gel can be used as a complement to the treatment with Diverin coated tablets. Registration status The drug may also be dispensed without prescription. DIVERIN, gel ibuprofen local antirheumatic appropriate complement to therapy with Diverin coated tablets alternative to peroral treatment with non-steroidal anti-inflammatory drugs when the latter is not possible it does not irritate the skin MIOSPRAY(r), topical analgesic COMPOSITION The aerosol spray contains 0.18 g of benzyl nicotinate, 0.18 g of nicotinamide and 0.16 g of menthol. ACTION Benzyl nicotinate dilates blood vessels and improves blood supply, while menthol exercises a pleasant cooling effect on the skin and relieves pain. Sprayed on the skin, Miospray produces hyperemia and a sensation of warmth. The pain decreases very rapidly and, consequently, functional mobility for everyday tasks is restored quickly, and sportsmen are able to continue training or competing. INDICATIONS Contusions, sprains, myalgia, muscular cramps, muscular fatigue. CONTRAINDICATIONS Miospray should not be applied to injured skin, the eyes or the body orifices. WARNING When the condition deteriorates, when the signs last longer than seven days, or when the condition worsens again after a few days, it is recommended that selfmedication be discontinued. Miospray should not be applied to children younger than two years. SIDE EFFECTS Very rarely hypersensitivity to menthol may arise. In such cases the use of the preparation is to be discontinued. DOSAGE AND ADMINISTRATION Miospray is used above all in minor injuries and in conditions of muscle and joint pain, such as: contusion, sprain, myositis and myalgia (inflammation and pain in muscles), in muscular fatigue and cramps, particularly in sport injuries. Miospray is sprayed on the affected areas of the skin from a distance of 10 to 15 cm until it forms a thick moist layer. Massage it gently (until the skin reddens slightly), thus strenghtening and accelerating the activity of the drug. If Miospray is sprayed near the joints, gentle physiological movements are recommended instead of massage. Miospray can be applied several times a day. NOTE Miospray is presented in an aerosol spray container under high pressure and must, therefore, be protected against heat and fire. Registration status: OTC drug. MIOSPRAY benzyl nicotinate, nicotinamide, menthol local analgesic suitable for relieving pain in sport injuries and other muscle and joint pains EXPECTORANTS, RHINOLYTICS AND OTHER PRODUCTS FOR THE TREATMENT OF ACUTE RESPIRATORY TRACT INFECTIONS MENTOKLAR(r), inhalation set The plastic inhaler is used for the preparation of vapour inhalations. It consists of a basin for inhalation solution and an anatomically designed adapter. Vapour inhalations have a beneficial effect in acute respiratory tract infections. PREPARATION OF INHALATION Pour half a litre of hot water (approximately 65C) into the inhalation basin. Put 2.5 to 5 ml (1/2 to 1 teaspoonful) of Mentoklar drops, or 5 to 10 cm of Mentoklar gel, into the water. Place the basin on a firm, even basis, and cover it with the adapter. Inhale in a sitting position, bent over the adapter. Inhale the rising vapours deeply for about 5 minutes through the mouth or through the nose. Prepare two to three inhalations a day. Wash the basin with hot water and with washing-powder and dry. Disinfect the dried inhaler with 70-percent alcohol. The inhaler may also be sterilized by saturated water vapour at an increased pressure and at a temperature of 120 C for 20 minutes. MENTOKLAR(r), drops for inhalation COMPOSITION 50 ml of the solution contain 4.52 g of a mixture of essential oils of eucalyptus (Oleum Eucalypti) and turpentine (Oleum Terebinthinae) and of essential oils of peppermint (Oleum Menthae Piperitae), thyme (Oleum Thymi) and cedar (Oleum Cedri), and 1.0 g of menthol (Mentholum). ACTION AND PROPERTIES The hot water vapours humidify the mucosa in respiratory tract infections. They soothe cough provoked by irritation of the larynx, trachea and bronchi. The essential oils increase bronchial mucus secretion by liquefying the thick and tough secretion and facilitating expectoration. The essential oils and menthol also exert antiseptic, anti-inflammatory and spasmolytic actions. INDICATIONS Acute infections of the respiratory tract (common cold, rhinitis, sinusitis, bronchitis), chronic bronchitis, influenza. CONTRAINDICATIONS Inhalations of Mentoklar drops should not be used in patients with hypersensitivity to essential oils, bronchial asthma and pertussis. PRECAUTIONS Infants and small children should not be administered Mentoklar drops in the form of inhalations. Solutions containing menthol may induce, when inhaled, a reflex respiratory depression in infants and small children. DOSAGE AND ADMINISTRATION Pour half a litre of hot water (65 C) in the inhalation basin and instil 2.5 to 5 ml (1/2 to 1 teaspoonful) of Mentoklar drops into it. Cover the basin with the adapter and inhale the rising vapours deeply for 5-10 minutes with the mouth open or through the nose. Repeat the procedure two to three times a day. Registration status: OTC drug MENTOKLAR, drops a mixture of essential oils of eucalyptus, turpentine, peppermint, thyme, and cedar and of menthol expectorant, antimicrobial and spasmolytic action supplementary treatment in acute respiratory tract infections and in chronic bronchitis MENTOKLAR(r), gel against cold and rheumatism COMPOSITION The hydrophilic base contains a 6 % mixture of essential oils of eucalyptus (Oleum Eucalypti), turpentine (Oleum Terebinthinae), peppermint (Oleum Menthae Piperitae), thyme (Oleum Thymi) and cedar (Oleum Cedri), 3 % of camphor (Camphora) and 2 % of menthol (Mentholum). ACTION AND PROPERTIES Mentoklar dilates blood vessels at the site of application, thereby accelerating blood circulation and providing a feeling of warmness. Due to irritation of nerve endings in the skin, blood vessels in deep located tissues are dilated reflexively, as well. A favourable effect of the increased blood supply is an accelerated reversal of the inflammatory process and increased immune response of the body. The essential oils also possess an antiseptic action. INDICATIONS - acute respiratory tract infections, influenza, chronic bronchitis; - pains in muscles and joints. CONTRAINDICATIONS Mentoklar gel must not be applied to the damaged skin or used in patients hypersensitive to essential oils, in bronchial asthma and pertussis. PRECAUTIONS In infants and young children, the gel should not be administered to the face (or around the nose), nor applied in the form of inhalations. Ointments containing menthol may induce reflexive respiratory depression in infants and young children, when administered to the nose or around it. DOSAGE AND ADMINISTRATION For treatment of the common cold Mentoklar is applied to the chest and back in the evening. It should be well rubbed into the skin, after which the affected area should be warmed. Moreover, the inhalation is prepared twice daily: 1 teaspoonful of gel is placed in a basin with hot water (65 C), and the vapours are inhaled deeply for five minutes. When the upper respiratory pathways are obstructed, however, a small amount of gel is also applied under the nostrils several times a day. In rheumatic and muscle pain Mentoklar should be massaged into the skin above the painful sites several times a day. Registration status: OTC drug MENTOKLAR, gel a mixture of the essential oils of eucalyptus, turpentine, peppermint, thyme and cedar, as well as camphor and menthol, in a hydrophilic base rubefacient - improves local blood supply, produces a feeling of warmness and relieves pain in muscles and joints expectorant inhalation MENTOKLAR(r), pocket inhaler COMPOSITION 0.6 g of Ventilan(r) (a mixture of essential oils), 0.2 g of menthol (Mentholum) and 0.3 g of camphor (Camphora). ADMINISTRATION Unscrew the cap of the inhaler, bring it close to the nostrils and inhale deeply. Repeat this procedure several times a day, if needed. Close the inhaler well after use and store it at a temperature of up to 25 C. Registration status: OTC drug MENTOKLAR, pocket inhaler a mixture of essential oils of Ventilan, menthol, camphor inhalation rhinolytic symptomatic treatment of common cold MENTOSANA(r), antiseptic tablets for mouth and throat COMPOSITION Each tablet contains 30 mg of dry sage leaves extract (Extr. Salviae folium sicc.), 0.3 mg of essential sage oil (Salviae aetheroleum) and 1.5 mg of menthol. The tablets are aromatised with the addition of anise and fennel essential oils. ACTION AND PROPERTIES Sage leaves contain essential oil, tannins, bitter substances and flavonoids. The essential oil acts as an anti-inflammatory and antiseptic agent. Tannins acting as astringents also contribute to the anti-inflammatory effects of sage. They change the surface of the mucous membranes which become less permeable and more resistant. Menthol has a mild cooling effect; it reduces the sensitivity of the mucous membranes and gives a refreshing taste. INDICATIONS - symptomatic treatment of virus inflammations of the mucous membrane of the oral cavity and throat; - supplement to antibiotic therapy of bacterial infections of the throat. CONTRAINDICATIONS Pregnancy (The Monography of the E Commission of the German Ministry of Health does not advise the use of pure sage volatile oil and of sage alcohol extracts during pregnancy. Sage volatile oil contains up to 40 % of thujone, which has a fetotoxic effect.) WARNING Prolonged use of the tablets in amounts exceeding maximum recommended doses is not advisable. DOSAGE AND ADMINISTRATION In mild inflammations of the oral cavity and throat, 1 to 2 tablets should be dissolved in the mouth every two hours. For prevention of infections, 1 tablet is to be taken several times daily. Registration status: OTC drug MENTOSANA, tablets dry sage leaves extract, essential sage oil and menthol symptomatic treatment in virus infections of the mouth mucosa and throat complement antibiotic therapy of bacterial infections of the throat do not contain saccharose LEKONIL, LEKONIL(r) P, nasal drops COMPOSITION Each millilitre of 0.05% Lekonil solution contains 0.5 mg of oxymetazoline hydrochloride. Each millilitre of 0.025% Lekonil P solution contains 0.25 mg of oxymetazoline hydrochloride. ACTION Oxymetazoline is a sympathicomimetic agent used as a nasal decongestant. It reduces swelling of nasal passages and nasal discharge by causing vasoconstriction of arterioles. It facilitates breathing through the nose and relieves the accompanying symptoms of nasal congestion. It acts within 15 minutes and its effect lasts for 6 to 8 hours. INDICATIONS Acute nasal congestion due to common cold, sinusitis, inflammation of the eustachian tube, hay fever and nasal congestion due to other upper respiratory allergies. CONTRAINDICATIONS Known hypersensitivity to any of the components of the drug, rhinitis sicca. PRECAUTIONS The drug should not be used for self-treatment by pregnant women and nursing mothers, by patients with narrow angle glaucoma, prostatic hypertrophy, porphyria, chronic heart failure, cardiac arrhythmias, hypertension, hyperthyroidism and diabetes mellitus. Do not use this drug for children under 1 year of age. WARNINGS Keep the drug out of the reach of children. In case of accidental ingestion, seek medical assistance immediately. Prolonged use of the drug may result in hyperemia of the nasal mucosa. SIDE EFFECTS Lekonil and Lekonil P are well tolerated. Occasionally, transient dryness and burning of the nasal mucosa, dry mouth and throat, and sneezing may occur. Very rarely systemic sympathicomimetic side effects - such as hypertension, nervousness, nausea, dizziness, headache, insomnia, palpitations - have been observed. DRUG INTERACTIONS In patients receiving tricyclic antidepressants or maprotiline, co-administration of oxymetazoline, because of its absorption, may potentiate its effect on the blood pressure. In patients who are at the same time receiving MAO inhibitors, oxymetazoline may produce a hypertensive crisis. DOSAGE AND ADMINISTRATION Adults and school children: Insert 1 to 2 drops of Lekonil solution into each nostril two to three times daily. Children aged 1 to 7 years: Insert 1 to 2 drops of Lekonil P solution into each nostril two to three times daily. For self-medication Lekonil and Lekonil P solutions may be used only in the recommended dosage, and not for longer than 3 days. Prolongation of the treatment for more than 3 days is at the physician's discretion. Registration status The drug may also be dispensed without medical prescription. LEKONIL, drops oxymetazoline hydrochloride local rhinolytic symptomatic treatment in common cold TIMI(r), expectorant syrup for children COMPOSITION 5 ml of the syrup contain 0.33 g of Pimpinella root extract (Extr. Pimpinellae radix), 0.325 g of Primula root extract (Extr. Primulae radix), 0.39 g of Thyme extract (Extr. Thymi herba) and 2.25 g of honey. ACTION AND PROPERTIES The Pimpinella and Primula roots contain saponins which increase the secretion of bronchial mucus. Thus the thick and viscous mucus irritating the mucosa and provoking cough, is thinned and liquefied, which makes expectoration easier. Thyme volatile oil soothes cough and alleviates expectoration, relieving at the same time contractions of smooth muscle fibers in the respiratory tract. It contains thymol, which exerts an antibacterial effect on the mucous membranes of the respiratory system. Honey has long been recognized as a valuable natural medicine. With its ingredients it additionally facilitates expectoration. INDICATIONS Acute respiratory tract infections accompanied by coughing. CONTRAINDICATIONS Are not known. SIDE EFFECTS Have not been reported. DOSAGE AND ADMINISTRATION The syrup, which contains active ingredients with mild effects and honey giving it a pleasant taste, is intended for children to order to ease expectoration and soothe cough in common cold. Children older than six years are administered two teaspoonfuls of syrup three times a day, children from 2 to 6 years of age one teaspoonful three times a day, and infants up to two years half a teaspoon of syrup two to three times a day. Registration status: OTC drug TIMI, syrup Pimpinella and Primula root extracts, thyme extract and honey herbal expectorant also suitable for young children FLUIMUKAN(r), dispersible tablets, granules COMPOSITION Each dispersible tablet contains 200 mg of N-acetylcysteine. Each sachet contains 100 mg or 200 mg of N-acetylcysteine in the form of granules. ACTION As a mucolytic agent, Fluimukan reduces the viscosity of bronchial mucus secretions, facilitates expectoration and alleviates the respiratory tract obstruction provoked by large amounts of mucus in it. In some diseases of the respiratory system, the production of neutral and acid silfomucin glycopeptides in the body, which increase the viscosity of sputum, is enhanced. The action of N-acetylcysteine is to liquefy the mucus and to make its secretion easier. It also influences the structure of mucus, since lower amounts of viscous sialomucins are secreted, the result of which is less thick mucus. INDICATIONS Fluimukan is used in the acute form of common cold, when mucus production in the respiratory system (particularly in the bronchi) is increased, thus making expectoration more difficult. CONTRAINDICATIONS Hypersensitivity to N-acetylcysteine. PRECAUTIONS Particular caution during Fluimukan administration is required in asthmatic patients. When respiration is obstructed by bronchospasm, treatment must be interrupted at once. Caution is also necessary in patients with active peptic ulcer and in older patients with respiratory insufficiency. WARNINGS Pregnancy and lactation Although there are no data available on harmful effects of Fluimukan on the fetus, the use of this drug is not advised during pregnancy and lactation. Infants under two years Fluimukan should not be given as self-medication to infants under two years of age. Diabetics Diabetics should be well aware that each sachet of Fluimukan granules contains approximately 4.3 g of saccharose or 0.36 bread units. Older patients with reduced cough reflex In older patients with diminished cough reflex, the administration of the drug may provoke hypersecretion of bronchial mucus and deterioration of respiratory insufficiency. Ability to drive a motor vehicle or to operate a machine Fluimukan administration does not affect the ability to drive a motor vehicle or to operate a machine. SIDE EFFECTS Fluimukan is generally very well tolerated. Side effects, which do not occur frequently, are gastrointestinal disorders (dry mouth, nausea, vomiting, dyspepsia, colic pains, diarrhea), headache, fatigue, allergic reactions, somnolence, nasal discharge, blood-stained sputum (hemoptysis), inflammation of nasal mucosa, chills and bronchospasm. DRUG INTERACTIONS Patients should not take Fluimukan concomitantly with tetracyclines, amphotericin, erytromycin and ampicillin. There should be a two-hour interval betweeen the ingestion of these drugs and Fluimukan administraiton. DOSAGE AND ADMINISTRATION The usual dosage for adults is one dispersible tablet or one sachet of granules with 200 mg of N-acetylcysteine three times daily. Children from 2 to 6 years take one sachet of granules with 100 mg of N-acetylcysteine two to three times daily. Children from 6 to 14 years receive one dispersible tablet or one sachet of granules with 200 mg of N-acetylcysteine two times a day. Patients may swallow the tablet whole with plenty of liquid, or put it in at least 100 ml of water or tea, and stir until dissolved. Granules are dissolved in half a glass of water or tea. OVERDOSAGE N-acetylcysteine is a low toxicity substance. Only large doses of Fluimukan might cause irritation of the gastrointestinal tract. Registration status The drug may also be dispensed without medical prescription. FLUIMUKAN, dispersible tablets, granules N-acetylcysteine the first synthetic mucolytic agent in Slovenia which may also be dispensed without prescription IMMUNOSTIMULANTS IMMUNAL(r), immunostimulant drops COMPOSITION 100 ml of the solution contains 80 ml of juice obtained from the flowering, freshly harvested echinacea herb (Echinacea purpurea L.). The solution contains 20 % of ethanol. ACTION AND PROPERTIES The purple cone flower or Echinacea purpurea contains active ingredients that enhance the defense capacity of the body as nonspecific stimulant agents. By increasing the number of leukocytes (granulocytes, lymphocytes T) and activating their phagocytosis ability, they inhibit the penetration of microorganisms in the body, and accelerate their extirpation. The antiviral activity of the purple cone flower against viruses of influenza and herpes has also been proven. INDICATIONS - prevention of common cold and influenza; - adjuvant agent in antibiotic management of microbial infections (otitis, sinusitis, sore throat, bronchitis, bacterial skin infections). CONTRAINDICATIONS Drops should not be taken in progressive systemic diseases, such as: tuberculosis, leukoses, collagenoses and multiple sclerosis, as well as in cases of known hypersensitivity to the drug. WARNING The drug may become turbid if it has not been in use for some time, or else there may occur flocculi composed of active polysaccharides. Therefore, the bottle should be well shaken prior to use. DOSAGE AND ADMINISTRATION: 20 Immunal drops are administered three times daily with some liquid. In the acute stage of the disease the initial dosage is 40 drops. Later on, 20 drops should be administered every one to two hours during the first two days, followed by the usual dose. Children from 1 to 6 years of age are administered 5 to 10 drops three times daily, while children from 6 to 12 years are given 10 to 15 drops three times daily. Immunal drops should be taken for at least one week in order to obtain a satisfactory effect. They should not be taken without interruption for a period longer than eight weeks. Registration status: OTC drug IMMUNAL, drops solution with extracted juice obtained from the flowering freshly harvested echinacea herb natural immunostimulant prevention of viral respiratory tract infections and influenza supplementary agent to antibiotic management of bacterial infections also suitable for young children PSYCHOPHYTOTHERAPEUTIC DRUGS PERSEN(r), tranquilizing coated tablets PERSEN(r) forte, tranquilizing capsules COMPOSITION Each coated tablet contains 50 mg of valerian extract (Extr. Valerianae Radix), 25 mg of peppermint extract (Extr. Menthae Piperitae) and 25 mg of melissa extract (Extr. Melissae Officinalis). Each capsule contains 125 mg of valerian extract (Extr. Valerianae Radix), 25 mg of peppermint extract (Extr. Menthae Piperitae) and 25 mg of melissa extract (Extr. Melissae Officinalis). ACTION AND PROPERTIES Valerian, with its well-known active ingredients valepotriates and sesquiterpenes, exerts a tranquilizing effect on the central and vegetative nervous system. It relieves neurasthenic disorders, reduces agitation, irritability and tension due to mental strain. It insomnia, it restores normal sleep. Peppermint helps in mild manifestations of insomnia. Melissa has an additional tranquilizing activity. Moreover, it stimulates the appetite, which is diminished in many subjects by neurasthenic disorders. INDICATIONS Neurasthenic and dystonic symptoms, such as: - tiredness occurring immediately after getting up or after the slightest effort; - irritability; - emotional tensions and anxiety; - difficulty in concentration and memory disorders; - insomnia; - perspiration of palms and trembling of hands. CONTRAINDICATIONS Have not been known. DOSAGE AND ADMINISTRATION Adults In psychomotor lability, conditions of fear, tension, agitation and nervousness, adults are recommended to take two coated tablets two to three times daily, or one capsule two to three times daily. In insomnia, adults take two coated tablets or one capsule one hour before sleep. Older children are given one coated tablet once to three times daily. Registration status: OTC drug PERSEN, coated tablets, capsules valerian, peppermint and melissa extracts it is a natural tranquilizer it is devoid of side effects it does not diminish the psychomotor functions it does not cause dependence and tolerance it is particularly suitable as the first-choice agent in mild psychic disorders when the administration of a more potent drug (benzodiazepine) is not reasonable it is particularly suitable for elderly people, and for children as well DEPRIM(r), mood improving herbal tablets COMPOSITION Each tablet contains standardized St. John's Wort extract (Extr. Hyperici herba) with minimum 0.3 mg of total hypericin. ACTION AND PROPERTIES St. John's Wort, especially its principal active ingredient hypericin, has a harmonizing action on the central and vegetative nervous system. Deprim relieves depression, low-spiritedness, apathy and the accompanying symptoms (general indisposition, lack of appetite, insomnia), thereby improving mood, increasing mental and physical ability and interest in work. INDICATIONS - mild manifestations of neurotic depression (depression, low-spiritedness, apathy) - emotional disturbances during menopause, and in - hypersensitivity to weather changes. CONTRAINDICATIONS Hypersensitivity of the skin to sunlight. WARNING Hypericin may cause skin hypersensitivity to ultraviolet light (photosensitization). Direct exposure to sunshine or UV light is therefore not recommended during Deprim administration. DOSAGE AND ADMINISTRATION In adults one tablet is recommended three times daily; in children above 7 years one or at the most two tablets a day should be administered in the morning or at noon. Tablets should be taken before meals. The best effect of Deprim is achieved by taking it regularly for several weeks or months. Registration status: OTC drug DEPRIM, tablets standardized St. John's Wort extract with minimum 0.3 mg of total hypericin natural antidepressant suitable for management of mild depressive conditions has no side effects there are no interactions with other drugs suitable for elderly people with initial signs of depression, women in menopause, children and adolescents SANOSAN(r), herbal tablets against insomnia COMPOSITION Each tablet contains 60 mg of valerian extract (Extr. Valerianae Radix) and 100 mg of hops extract (Extr. Humuli Lupuli). ACTION AND PROPERTIES The active ingredients of valerian (valepotriates and sesquiterpenes) have a tranquilizing effect on the central and the vegetative nervous system and promote sleep. The active ingredients contained in hops (bitter acids lupulone and humulone) exert a soporific and a sedative action. The combination of valerian and hops in Sanosan tablets helps to establish psychic balance, relaxation, rest and normal sleep. INDICATIONS Insomnia (sleep disturbances, wakening at night, wakening early in the morning) due to restlessness, fear, tension and irritation. CONTRAINDICATIONS Have not been noted. DOSAGE AND ADMINISTRATION In adults 2 to 3 tablets are recommended one hour prior to sleep. Children over 6 years of age should be given 1 to 2 tablets. Registration status: OTC drug SANOSAN, tablets valerian and hops extracts natural soporific without contraindications or side effects an evening dose does not cause a morning residual sedation does not induce dependence and tolerance particularly suitable as the first-choice agent in mild manifestations of insomnia appropriate for children, and for adolescents as well LIPID REGULATING AGENTS TRIENYL(r), capsules, dietary supplement for prevention of cardiovascular diseases COMPOSITION Each capsule contains 500 mg of the North Sea fish oil concentrate with minimum (out of total) 30 % unsaturated omega-3 fatty acids: 18 % of eicosapentaenoic acid and 12 % of docosahexaenoic acid, and 15 mg of vitamin E. ACTION AND PROPERTIES The unsaturated omega-3 fatty acids are indispensable for the human body. The body cannot produce them by itself, but obtains them only through food. They are present, however, only in very low quantities in our nutrition. Omega-3 fatty acids regulate blood lipid levels and platelet aggregation, and influence blood pressure regulation, thereby reducing the risk of atherosclerotic changes and of their consequences. INDICATIONS Primary and secondary prevention of atherosclerosis, particularly in subjects with atherosclerotic risk factors. CONTRAINDICATIONS Have not been reported. PRECAUTIONS Omega-3 fatty acids exert a mild inhibitory effect on blood platelet reactivity. The bleeding time is prolonged upon the intake of omega-3 fatty acids (in proportion to the dosage). In patients receiving anticoagulant and antiaggregation drugs, or manifesting disturbances in platelet aggregation, the dosage should be adjusted during administration of TRIENYL capsules. DOSAGE AND ADMINISTRATION Daily dose: 3 to 6 capsules (1 to 2 capsules three times daily before meals with some liquid). Registration status: OTC drug TRIENYL, capsules polyunsaturated omega-3 fatty acids, vitamin E are of natural origin regulate blood lipid levels reduce platelet aggregation exert a mild hypotensive effect are devoid of major side effects ANTIDIARRHEALS AND ORAL REHYDRATION SALT LINEX(r), antidiarrheal and antiflatulent capsules COMPOSITION Each capsule contains not less than 1.2 x 107 of lyophilized viable lactic acid bacteria: - Lactobacillus acidophilus - Bifidobacterium infantis v. liberorum - Streptococcus faecium, which are resistant to antibiotics and chemotherapeutics. ACTION AND PROPERTIES Lactic acid bacteria can be found in the small and large intestine where they maintain the acid-base balance, necessary for the normal activity of digestive enzymes. In the absence of sufficient amounts of lactic acid bacteria, the environment becomes more alkaline, which inhibits the activity of digestive enzymes and allows for the excessive growth of harmful bacteria, the result of which are various gastrointestinal disorders. Linex capsules contain lyophilized lactic acid bacteria, which regulate the physiological balance of the intestinal flora. INDICATIONS - diarrhea in infants, children and adults; - flatulence; - diarrhea and other gastrointestinal disorders during treatment with broad-spectrum antibiotics and chemotherapeutics. CONTRAINDICATIONS Have not been encountered. WARNING Linex should not be taken by those who are hypersensitive to milk products. DOSAGE AND ADMINISTRATION Infants and children up to two years are administered the content of 1 capsule three times daily with tea. Children aged 2 to 12 years are given the content of 1 to 2 capsules three times daily with tea. The dosage in adults is 2 capsules three times daily with some liquid. Registration status: OTC drug LINEX, capsules lyophilized viable lactic acid bacteria (Lactobacillus acidophilus, Bifidobacterium infantis v. liberorum, Streptococcus faecium) they are of natural origin they reduce flatulence they reduce the frequency of defecation and diminish the volume of stools they are also suitable for infants and young children. NELIT(r) N, oral rehydration salt COMPOSITION Each 100 g of powder contains 12.1 g of sodium chloride, 5.2 g of potassium chloride, 10.0 g of sodium citrate, 69.2 g of glucose and other auxiliary substances. ACTION Dissolved in water, Nelit N replaces the electrolytes and glucose which have been lost, thereby effectively and rapidly rehydrating the dehydrated patient. INDICATIONS - Dehydration; - Acute diarrheal diseases of various etiology. CONTRAINDICATIONS Have not been reported. WARNING If the child vomits after the intake of Nelit N, the solution can be readministered after five to ten minutes. Only small amounts of the solution can be administered each time. A fresh solution is to be prepared every day and stored in a cool place. SIDE EFFECTS Puffiness of the eyelids may occur with prolonged administration, but it spontaneously disappears upon discontinuation of treatment. DOSAGE AND ADMINISTRATION Dissolve the contents of one sachet (28.9 g of powder) in 1 litre of boiled and cooled water, and the contents of one sachet of 7.2 g in 250 ml of water. Nelit N solution is used for treatment of mild to moderate dehydration. Dosage (ml) Body weight in the first 4 hours maintenance (kg) mild moderate dose up to 6 150-300 200-400 50 6-9 300-450 400-600 50 9-12 450-600 600-800 100 12-15 600-750 800-1000 150 15-30 750-1500 1000-2000 200 more than 30, and adults 1500-3000 2000-4000 400 After the first four hours of administration of the Nelit N solution, the degree of dehydration is determined and the appropriate treatment is given: if dehydration is reduced, a maintenance dose is to be given until the dehydration symptoms disappear; if the degree of dehydration remains unchanged, the treatment is to be prolonged for 4 to 6 hours; if dehydration deteriorates, pareteral rehydration therapy should be undertaken. Registration status The drug may also be dispensed without medical prescription. NELIT N, salt sodium chloride, potassium chloride, sodium citrate and glucose peroral rehydration is the most convenient treatment for mild to moderate dehydration also suitable for young children HEPATOPROTECTIVES SYROMIN(r) forte, tablets for protection of the liver COMPOSITION The tablets contain 200 mg of standardized extract from milk thistle fruit (Cardui mariae fructus), containing 100 mg of silymarin, calculated as silybin. ACTION AND PROPERTIES The liver is a vital organ due to its metabolism of carbohydrates, protein and fat. It produces and secretes bile which is needed for digestion, and detoxifies harmful substances. Any damage to the liver, including the damage caused by different toxins, can disturb its normal functioning. In experiments on animals the protective effect of silymarin against numerous toxins harmful to the liver has been proven, i.e. tetrachlorocarbohydrates, green toadstool toxins faloidine and alpha amanitine, galactosamine and others. The protective action of silymarin is dual: it changes the structure of the cell membrane in the liver in such a way that toxins cannot penetrate into the liver cell, and at the same time stimulates the regeneration of damaged cells and growth of new cells. Silymarin promotes the recovery of the liver after intoxication by different poisons, alcohol and mushrooms. In chronic liver diseases and cirrhosis, patients' general condition is improved, the digestive troubles are reduced, and the pressure in the upper right part of the abdomen is relieved. Patients' appetite is improved and they gradually gain weight. INDICATIONS - Prevention of liver disorders due to poisons from the working environment and from alcohol; - Additional treatment of chronic hepatitis and cirrhosis. CONTRAINDICATIONS Are not known. SIDE EFFECTS Syromin forte tablets can very rarely have mild purgative effects. DOSAGE AND ADMINISTRATION At the beginning of treatment and in severe cases, four tablets of SYROMIN forte (400 mg of silymarin) are recommended daily in two doses with some water. In the continuation of treatment and in moderately severe cases, the dose is reduced to two to three Syromin forte tablets daily. Registration status: OTC drug SYROMIN forte, tablets standardized extract from milk thistle fruit prevention of liver impairment due to poisons from the working environment, and from alcohol additional treatment in chronic hepatitis and cirrhosis DIGESTANTS ALTALEX(r), drops COMPOSITION The product is a 2.5% mixture of the essential oils of melissa (Ol. Melissae), peppermint (Ol. Menthae piperitae), fennel (Ol. Foeniculi), cloves (Ol. Caryophylli), thyme (Ol. Thymi), pine needles (Ol. Pini), anise (Ol. Anisi), eucalyptus (Ol. Eucalypti), sage (Ol. Salviae), cinnamon (Ol. Cinnamomi) and lavender (Ol. Lavandulae) in diluted ethanol. ACTION AND PROPERTIES Altalex is a home-style product for the soothing of various common health problems. It is produced according to a recipe based on hundred years' experience of monastery pharmacies. It contains the essential oils of eleven medicinal herbs which have spasmolytic, carminative, choleretic, sedative and antiseptic effects. Altalex relieves spasms of smooth muscles, reduces flatulence, stimulates bile secretion and appetite, alleviates menstrual disorders, aids in nausea and insomnia, calms the nerves, alleviates pain, soothes cough and facilitates expectoration, relieves inflammation and exerts an antiseptic action. INDICATIONS For internal use: - gastric pain and flatulence; - menstrual disorders; - nervousness, indisposition, insomnia; - nausea, inappetence; - headache. For external use: - headache, nausea, tiredness; - muscle and joint pains. For gargling: - common cold. CONTRAINDICATIONS Altalex drops are contraindicated in patients with liver diseases, gastric or duodenal ulcers and in children under 6 years of age. PRECAUTIONS Altalex contains alcohol. Caution in the use of Altalex drops is advised in alcoholics, persons suffering from epilepsy or head injury, pregnant women and nursing mothers, and in children. DRUG INTERACTIONS Are not known. SPECIAL WARNING An unpleasant burning sensation can appear if the drops come into contact with eyes or due to excessive use of Altalex drops on the face. If necessary, rinse the eyes abundantly with water and the troubles will soon disappear. SIDE EFFECTS Have not been reported. DOSAGE AND ADMINISTRATION Internal use: Drink 10-20 Altalex drops in hot tea, water or dripped onto a sugar cube up to five times daily (during meals). External use: Rub the undiluted Altalex drops lightly into the skin above the painful areas several times a day. At the same time, vapour can be inhaled deeply in headache, nausea or common cold. To prepare the gargling solution, add 10-20 drops into a glass of warm water and gargle. Children above 6 years: 1/3 to 1/2 of adult dose. Registration status: OTC drug ALTALEX, drops a mixture of the essential oils of melissa, peppermint, fennel, cloves, thyme, pine needles, anise, eucalyptus, sage, cinnamon and lavender traditional tried and tested agent for relief of gastrointestinal disorders its composition is based on hundreds years of experience PLANTEX(r), instant tea for infants and children COMPOSITION 100 g of instant tea contain an extract of 55 g of fennel fruit (Extr. Fruct. Foeniculi), 0.3 g of fennel aroma with 16 % of volatile oil (Ol. Foeniculi), 50 g of glucose and 44.7 g of lactose. The energy value of 100 g of tea is 1584 KJ (379 kcal). ACTION AND PROPERTIES Fennel fruit and fennel volatile oil possess a stomachic and a carminative action. They increase gastric secretion and stimulate peristalsis, thereby improving digestion. The food is, consequently, more readily decomposed and more quickly absorbed. The active ingredients also inhibit gas production in the intestine and promote flatus passing. In this way they soothe the intestinal spasms. INDICATIONS Relief of gastrointestinal disorders in infants and young children. CONTRAINDICATIONS Are not known. DOSAGE AND ADMINISTRATION Infants: Empty the contents of one sachet (5 g) into the feeding bottle, pour over it 100 ml of freshly boiled water or milk, and shake until the instant tea has dissolved. Cool to appropriate temperature and give the tea to infants as a food supplement after a meal or as a wholesome drink. Young children: Empty the contents of one to two sachets (5 to 10 g) into a bowl and pour over it 100 ml to 150 ml of boiled warm or cold water. Then stir the tea until dissolved. Do not sweeten it. Registration status: OTC drug PLANTEX, instant tea extract of fennel fruit, fennel aroma and volatile oil, glucose and lactose relieves meteorism and intestinal spasms in infants and young children simple preparation DRUGS AGAINST TRAVEL-SICKNESS TRALAN(r), herbal capsules against travel-sickness COMPOSITION Each capsule contains 250 mg of ground rhizome of ginger (Zingiberis rhizoma). ACTION AND PROPERTIES Ginger (Zingiber officinale R.) is a tropical perennial with a tuberous thickened rhizome. It contains the essential oil with zingiberone and resinous substances (gingerole) which give it an acrid, burning taste and a pleasant odour. Ginger, which is usually known as flavouring agent is used in medicine as an appetite stimulant and digestant agent. Its active ingredients promote gastric secretion and strengthen the peristalsis. In recent time scientists have found out, through the experience of Caribbean fishermen, that ginger powder inhibits the development of the signs of kinetosis: paleness, cold sweat, nausea, vomiting and headache. It is believed that ginger inhibits the reaction of the digestive tract to excessive stimulation of sensory cells of the vestibulocochlear organ. INDICATIONS Prevention of travel-sickness. CONTRAINDICATIONS The administration of Tralan capsules is not advised in pregnant women and children under 6 years of age. SPECIAL WARNING In persons suffering from gallstones, Tralan may induce a bilious attack due to its cholagogic activity. DOSAGE AND ADMINISTRATION Adults and children over 6 years take 2 capsules half an hour before setting out on journey, and 2 capsules every 4 hours during the journey. Registration status: OTC drug TRALAN, capsules ground rhizome of ginger they are of natural origin they do not possess any side effects they do not affect the psychomotor functions as synthetic drugs (antihistamines) may do LOCAL VENOTONICS VENITAN(r), cream for swollen and painful legs COMPOSITION 100 g of cream contain 5 g of horse chestnut extract with 20 % of escin in a hydrophilic base. ACTION AND PROPERTIES The principal active ingredient is extract of horse chestnut seed (Aesculus hippocastanum L.). The horse chestnut seed contains a number of active ingredients, such as: flavone glycosides, acid saponin escin, coumarin derivatives and catechins. These active substances strengthen the tonus of vein walls and reduce capillary fragility and permeability. Thus they reduce the development of oedema, accelerate blood flow and improve metabolism in the affected tissue. INDICATIONS Disorders of venous blood circulation, surface inflammatory and varicose vein diseases, sensation of heaviness in legs due to prolonged standing or pregnancy. Venitan cream is also a suitable complement to compression therapy (compress footwear or compression bandage). It is also used for reduction of oedema and more rapid resorption of hematomas caused by blows, or following infusions and injections. CONTRAINDICATIONS Have not been reported. ADMINISTRATION Apply the cream to affected sites several times a day. Registration status: OTC drug VENITAN, cream horse chestnut extract with 20% of escin in a hydrophilic base it is of natural origin it strengthens the tonus of vein walls it reduces capillary fragility and permeability active substances are contained in an ointment base which allows for prompt absorption HEMORRHOIDAL PRODUCTS MODOLEX(r), ointment and suppositories for hemorrhoids COMPOSITION The suppository contains 250 mg of calcium dobesilate monohydrate and 40 mg of lidocaine hydrochloride monohydrate. The ointment contains 4% of calcium dobesilate monohydrate and 2% of lidocaine hydrochloride monohydrate. ACTION Calcium dobesilate exerts an effect above all on the venous and capillary walls. It reduces the increased permeability of the capillaries and their fragility, thereby reducing oedema and having a protective effect on blood vessels. Lidocaine is a local anesthetic with a good superficial activity. It penetrates in depth through the mucous membranes and reduces the sensation of pain. The combination of both ingredients in the preparation has a beneficial effect in the treatment of hemorrhoids. It alleviates oedema, inflammation and bleeding from hemorrhoids - as well as local moistening - quickly and efficiently. INDICATIONS Internal and external hemorrhoids, itching of the anus, acute thrombosis of hemorrhoids, anal fissures, hemorrhoids during pregnancy, treatment before and after surgical operation on hemorrhoids. CONTRAINDICATIONS The drug must not be used in the first three months of pregnancy or in cases of hypersensitivity to its ingredients. SPECIAL WARNING Keep the drug out of the reach of children. DOSAGE AND ADMINISTRATION Insert one suppository into the rectum in the morning and one in the evening, preferably after defecation and washing. Patients with internal hemorrhoids should press the ointment out from the tube as deep into the rectum as possible using the enclosed accessory. In external hemorrhoids and itching in the anal region, patients should apply a thin film of the ointment on the affected area several times a day. It is not advisable to use the ointment for more than 14 days. SIDE EFFECTS The suppositories and ointment are well tolerated by patients. Registration status The drug may also be dispensed without medical prescription. MODOLEX, ointment and suppositories calcium dobesilate monohydrate, lidocaine hydrochloride monohydrate two formulations of the active substance enable the treatment of internal and external hemorrhoids DRUGS FOR ALLEVIATION OF GYNECOLOGICAL DISORDERS ALTALEX(r), drops COMPOSITION The product is a 2.5% mixture of the essential oils of melissa (Ol. Melissae), peppermint (Ol. Menthae piperitae), fennel (Ol. Foeniculi), cloves (Ol. Caryophylli), thyme (Ol. Thymi), pine needles (Ol. Pini), anise (Ol. Anisi), eucalyptus (Ol. Eucalypti), sage (Ol. Salviae), cinnamon (Ol. Cinnamomi) and lavender (Ol. Lavandulae) in diluted ethanol. ACTION AND PROPERTIES Altalex is a home-style product for soothing of various everyday health problems. It is produced according to a recipe based on hundred years of experience in monastery pharmacies. It contains the essential oils of eleven medicinal herbs which have spasmolytic, carminative, choleretic, sedative and antiseptic effects. Altalex relieves spasms of smooth muscles, alleviates flatulence, stimulates bile secretion and appetite, alleviates menstrual disorders, aids in nausea and insomnia, calms the nerves, alleviates pain, soothes cough and facilitates expectoration, relieves inflammation and disinfects. INDICATIONS For internal use: - menstrual disorders; - gastric pain and flatulence; - nervousness, indisposition, insomnia; - nausea, inappetence; - headache. For external use: - headache, nausea, tiredness; - muscle and joint pains. For gargling: - common cold. CONTRAINDICATIONS Altalex drops are contraindicated in patients with liver diseases, gastric or duodenal ulcers and in children under 6 years of age. PRECAUTIONS Altalex contains alcohol. Caution in the use of Altalex drops is advised in alcoholics, persons suffering from epilepsy or head injury, pregnant women and nursing mothers, and in children. SPECIAL WARNING An unpleasant burning sensation can appear if the drops come into contact with eyes or due to excessive use of Altalex drops on the face. If necessary, rinse the eyes with a large amount of water and the troubles will disappear soon. DRUG INTERACTIONS Are not known. DOSAGE AND ADMINISTRATION Internal use: Drink 10-20 Altalex drops in hot tea, in water or dripped onto a sugar cube up to five times daily (during meals). External use: Rub the undiluted Altalex drops lightly into the skin above the painful areas several times a day. At the same time, vapours can be inhaled deeply in headache, nausea or common cold. To prepare the gargling solution, add 10-20 drops to a glass of warm water and gargle. Children above 6 years: 1/3 to 1/2 of adult dose. SIDE EFFECTS Have not been reported. Registration status: OTC drug ALTALEX, drops a mixture of the essential oils of melissa, peppermint, fennel, cloves, thyme, pine needles, anise, eucalyptus, sage, cinnamon and lavender traditional tried and tested agent for relief of menstrual disorders its composition is based upon centuries-long experience KLIMAKTIN(r), herbal tablets for alleviation of climacteric disorders COMPOSITION Each tablet contains 3.33 mg of standardized root-stock extract of Cimicifuga racemosa (L.) with minimum 0.5% of triterpeneglycosides. ACTION AND PROPERTIES Secretion of hormones is normally reduced in the premenopausal and menopausal periods and stops in the postmenopause. This period can be accompanied by climacteric signs, such as: hot flushes, sweating, headache, dizziness, sleep disorders, sudden mood changes, irritability, apathy and anxiety. It has been established that the root-stock extract of the North American medicinal herb Cimicifuga racemosa (L.) has a favourable effect on these signs and symptoms. Its active ingredients gently regulate the decreasing secretion of hormones and considerably improve or cure the characteristic climacteric disorders. INDICATIONS Neurovegetative climacteric disorders: hot flushes, perspiration, sleep disorders, headache, dizziness, sudden mood changes, palpitations, irritability or depression, anxiety. CONTRAINDICATIONS Are not known. SIDE EFFECTS Rarely, transitory gastric disorders or indigestion may occur. DOSAGE AND ADMINISTRATION Take one Klimaktin tablet with a little liquid in the morning and one in the evening. The effects of Klimaktin do not appear immediately; the first effects occur only after two weeks of regular use of the tablets. A complete effect is achieved after a few months of administration of Klimaktin. Registration status: OTC drug KLIMAKTIN, tablets standardized root-stock extract of Cimicifuga racemosa (L.) with triterpeneglycosides is of natural origin alleviates neurovegetative climacteric disorders has no side effects has no contraindications is also suitable for women who prefer not to have hormonal therapy and for those in whom such therapy is contraindicated DRUGS FOR PROSTATIC DISEASES TRIANOL(r), capsules for troubles caused by prostatic hyperplasia COMPOSITION Each capsule contains 25 mg of biologically active lipido-sterol complex, extracted from the bark of the tree Pygeum africanum Hook. ACTION AND PROPERTIES Trianol has an anti-inflammatory effect, it regenerates the prostatic glandular cells and stimulates their secretory activity. Trianol capsules relieve pain and troubles caused by enlargement of the prostate: trouble with the initial micturition, increased frequency of micturition, nocturia, and incomplete bladder discharge. Regular use of Trianol capsules in the initial stage of a disease may help to slow down its progress. Trianol has no hormonal activity. INDICATIONS Micturition disorders due to prostate enlargement (benign prostatic hyperplasia). CONTRAINDICATIONS TRIANOL should not be taken by men who are hypersensitive to any of the drug components. SIDE EFFECTS The drug is well tolerated. Side effects, e.g. gastric disorders or minor skin changes only rarely occur. DOSAGE AND ADMINISTRATION The usual dosage is 4 Trianol capsules daily, i.e. 2 capsules twice a day before meals. The capsules should be taken for at least four to six weeks. Registration status The drug may also be dispensed without medical prescription. TRIANOL, capsules lipido-sterol complex, extracted from the bark of the tree Pygeum africanum Hook anti-inflammatory activity regeneration of prostatic glandular cells relief of pain and troubles accompanying benign prostatic hyperplasia VITAMIN AND MINERAL PRODUCTS LEKOVIT(r) multi, effervescent tablets COMPOSITION Each tablet (4g) contains 2 mg of thiamine monohydrate (vitamin B1), 2.5 mg of riboflavin sodium phosphate (vitamin B2), 4 mg of pyridoxine hydrochloride (vitamin B6), 20 mg of nicotinamide, 100 mg of ascorbic acid (vitamin C), 2.5 mg of tocopheryl acetate (vitamin E), 30 g of biotin, 2 g of cyanocobalamin (vitamin B12), 3 000 I.U. of vitamin A, 8 mg of calcium pantothenate and sodium hydrogen carbonate, tartaric acid, sodium saccharinate, saccharose and orange and mandarin flavours. The energy value of one tablet is 34.8 kJ (8.3 kcal). ACTION Lekovit contains all the essential vitamins in appropriate ratios and in amounts sufficient for the daily needs of an adult in normal physiological conditions. Lekovit is recommended in: - unbalanced and vitamin-deficient diet; - periods of increased vitamin requirements during growth, pregnancy and lactation; - considerable psysical and mental efforts; - smokers and alcohol consumers; - women taking oral contraceptives; - convalescence following a disease, a surgical operation or an injury. DOSAGE AND ADMINISTRATION Adults and children should take one effervescent tablet dissolved in half a glass (100 ml) of water once to twice daily. The drink should be consumed after the tablet has completely dissolved. There is no risk of hypervitaminosis with the recommended dose. Registration status: dietetic product LEKOVIT multi, effervescent tablets thiamine, riboflavin, pyridoxine, nicotinamide, ascorbinic acid, tocopherol, biotin, cyanocobalamin, vitamin A, calcium pantothenate dietary supplement in pregnancy, lactation and convalescence for women taking oral contraceptives for smokers and alcohol consumers LEKOVIT(r) multi, lozenges COMPOSITION Each tablet (1.2 g) contains 9.0 mg of vitamin C (ascorbic acid), 0.2 mg of vitamin B1 (thiamine mononitrate), 0.24 mg of vitamin B2 ( riboflavin), 0.28 mg of vitamin B6 (pyridoxine hydrochloride), 2.6 mg of mg of vitamin PP (nicotinamide) and auxiliary substances: aspartame, sorbitol, mannitol, other ingredients, artificial colour (E 104) and nature-based flavour. The energy value of one tablet is 0.84 kJ (0.2 kcal). DOSAGE AND ADMINISTRATION Eight tablets for adults, and five for children are sufficient for the daily vitamin requirements. LEKOVIT tablets do not cause tooth decay as they do not contain sugar. Therefore, they are particularly suitable for children and diabetics. Registration status: dietetic product LEKOVIT(r) multi, lozenges ascorbic acid, thiamine, riboflavin, pyridoxine, nicotinamide do not contain saccharose - suitable also for those who avoid taking sugar LEKOVIT(r)C-Ca, effervescent tablets with calcium and vitamin C COMPOSITION Each effervescent tablet contains 600 mg of calcium carbonate (240 mg of calcium ions) and 500 mg of vitamin C. ACTION Calcium is the most important mineral in the human body. The greatest portion (99%) of all calcium is found in the bones and teeth, giving them firmness (supportive calcium). The remaining calcium is found in soft tissue cells (muscular system, nervous system, other cells) and in blood. Hormones regulate calcium exchange from bones and teeth into the remaining tissues and vice versa. Due to dietary calcium deficiency, the absorption of calcium from the intestine into the blood is reduced - the result is the depletion of calcium from bones (demineralization of bones), disorders in neuromuscular transmission (disorders in cardiac rhythm, muscular spasms) and disorders in blood coagulation. Vitamin C is a significant factor in the defence mechanism of the organism against infections (cold and influenza). It stimulates the immune system to produce immune substances (immunoglobulins, interferons). Vitamin C is associated with the formation of connective tissue (collagen) and intercellular material, and is therefore indispensable in the healing of wounds and bone fractures. It binds harmful substances within the body (free radicals) and thus protects cells from ageing. The combination of vitamin C and calcium protects the organism against infections (stimulates the production of antibodies) and accelerates the formation of extracellular material. The drug is presented in a form which permits good absorption of both substances from the intestine into the blood. INDICATIONS • cold and influenza; • vitamin C and calcium-deficient diet; • period of growth and development; • pregnancy and lactation; • considerable physical and mental efforts; • bone fractures, wounds and osteoporosis (as adjunct therapy); • photosensitivity. CONTRAINDICATIONS LEKOVIT C-Ca is not suitable for people suffering from kidney stones, an excess of calcium in the blood (hypercalcemia) or in the urine (hypercalciuria). WARNING When taking iron products, antibiotics of the tetracycline group or products containing sodium fluoride, at least two hours' interval between the application of the above drugs and the ingestion of Lekovit C-Ca should be respected. SIDE EFFECTS LEKOVIT C-Ca is well tolerated if the recommended dosage is adhered to. Very rarely mild gastrointestinal disorders may occur. DOSAGE AND ADMINISTRATION Dissolve the effervescent tablet in half a glass of water (1 dl of water). Adults are advised to take 1-2 tablets daily and children under 12 one tablet daily. Take the dissolved tablet with meals. Registration status The drug may also be dispensed without prescription. Lekovit C-Ca, effervescent tablets calcium carbonate, ascorbic acid (vitamin C) supply of sufficient daily amount of calcium - prevention of osteoporosis supplementary treatment in wounds and bone fractures LEKOVIT(r) amino, capsules COMPOSITION Lekovit amino capsules contain vitamins, minerals and amino acids. In brackets are indicated percentages of the recommended daily dosage administered with one Lekovit amino capsule. Each capsule contains: vitamins - 100.16 mg in total: 0.8 mg of vit. A (100 %), 5 (g of vit. D (100 %), 10.0 mg of vit. E (100 %), 1.4 mg of vit. B1 (100 %), 1.6 mg of vit. B2 (100 %), 2.0 mg of vit. B6 (100 %), 1.0 (g of vit. B12 (100 %), 0.15 mg of biotin (100 %), 0.2 mg of folic acid (100 %), 18.0 mg of nicotinamide (100 %), 60.0 mg of vit. C (100 %), 6.0 mg of panthenol (100 %); amino acids - 91.30 mg in total: 8.9 mg of asparagine, 6.3 mg of threonine, 4.2 mg of serine, 13.8 mg of glutamine, 6.1 mg of proline, 1.3 mg of glycine, 4.4 mg of alanine, 5.6 mg of valine, 3.2 mg of methionine, 6.0 mg of isoleucine, 8.5 mg of leucine, 2.8 mg of tyrosine, 3.4 mg of phenylalanine, 1.9 mg of histidine, 9.5 mg of lysine, 2.5 mg of arginine, 2.9 mg of cysteine; minerals (in the form of salts) - 98.00 mg in total: 0.15 mg of iodine (100 %), 2.5 mg of copper (100 %), 3.5 mg of manganese (100 %), 0,15 mg molybdenum (100 %), 15.0 mg of zinc (100 %), 2.5 mg of fluorine (100 %), 0.07 mg of selenium (100 %), 0.125 mg of chromium (100 %), 14.0 mg of iron (100 %), 60.0 mg of magnesium (20 %); other ingredients: 7.0 mg of silicon dioxide, 125 mg of calcium hydrogen phosphate,10.0 mg of inositol, 10.0 mg of choline bitartrate, 10 mg of lecithin, rape-oil, saturated triglycerides, ethyl vanillin, arachis oil, gelatin, lactose, glycerol and artificial colours. ACTION Lekovit amino is a harmonious combination of all the essential and indispensable vitamins, minerals and amino acids. It is intended to be used as a dietary supplement; it is above all recommended to people with an insufficient diet (unbalanced nutritional intake, weight reducing diet, institutional food) and to those with increased requirements for vitamins, minerals and amino acids due to mental and physical strain. Vitamins should be well-balanced in the body. The latter does not get all the necessary vitamins with food (especially in winter time). Due to consumption of alcoholic drinks the need for vitamins from group B is augmented, especially that of thiamine (vitamin B1) and pyridoxine (vitamin B6). Smoking enhances the vitamin C requirement. The organism needs higher amounts of vitamins also during pregnancy, lactation and in the period of growth. Lekovit amino also contains minerals and trace elements, which play an important role in the metabolism and must be continuously introduced into the organism with food or drinking water. The requirement for vitamins, minerals and trace elements is greater in alcohol consumers (e.g. for magnesium, zinc and vitamins of group B ), in the period of growth, during pregnancy and lactation. Drinking water and mineral waters contain only a part of the minerals required. Lekovit amino is a complement to minerals, vitamins and amino acids, which are important for stimulation of mineral salts absorption. DOSAGE AND ADMINISTRATION Lekovit amino capsules are a dietary supplement when the nutrition does not contain sufficient amounts of vitamins and minerals, namely in: - weight reducing diets; - unbalanced or inadequate diet, or when the need of the organism for these substances is increased, e.g. in: - pregnancy - fatigue or convalescence - lactation - growth - physical effort, e.g. in sporting activities. Adults and children over 8 years should take 1 capsule with some water once daily during the principal meal. PRECAUTIONS The product contains phenylalanine, which should be taken into account by those with phenylketonuria. Lekovit amino does not contain sugar and is therefore suitable for diabetics as well. Registration status: dietetic product Lekovit amino, capsules vitamins: A, D, E, B1, B2, B6, B12, C, biotin, folic acid, nicotinamide, panthenol, essential and non essential amino acids minerals: iodine, copper, manganese, molybdenum, zinc, fluorine, selenium, chromium, iron, magnesium dietary supplement during pregnancy, lactation, convalescence following diseases, surgical operations and injuries for women taking oral contraceptives for smokers and alcohol consumers DERMATOLOGICAL PRODUCTS ANTOPAR(r), anti acne gel COMPOSITION The gel contains stabilized benzoyl peroxide 5% or 10%. ACTION Benzoyl peroxide regulates the function of the sebaceous glands, dries the skin and causes slight peeling . It also has antibacterial properties. It is a potent oxidizing agent which, in contact with the tissue, slowly but steadily releases active oxygen. The degree of drying and peeling caused by benzoyl peroxide depends on the type of skin, the frequency and duration of use of the drug, and on concentration of the active substance in the product. INDICATIONS Acne vulgaris. CONTRAINDICATIONS History of hypersensitivity to benzoyl peroxide. PRECAUTIONS Antopar gel should not be applied to the eyelids, mucous membranes, severely inflamed or very thin and sensitive skin, to the neck and lips. Avoid contact of the drug with the eyes. If the gel accidentally comes into contact with the eyes, the eyelids, lips or mucous membranes, they should be immediately rinsed with water. During therapy sunbathing - whether natural or with ultraviolet lamps - must be avoided. If irritation of the skin persists despite the interruption of treatment, a doctor should be consulted. WARNING The drug may cause discoloration in contact with coloured matter (hair, clothes). SIDE EFFECTS Allergic reaction to benzoyl peroxide is rare. If it occurs, stop the treatment. At the beginning of therapy with Antopar gel, a burning sensation, erythema - and more rarely - a swelling may develop. In such cases the drug should be rinsed off. If irritation of the skin still persists, use of the gel should be discontinued for a day or two to give the skin a rest, then the therapy can be reinstituted. Side effects are mainly transient and do not necessitate interruption of the therapy. Occasionally, excessive drying and marked peeling of the skin occur during the treatment. In such cases the best thing is to apply a non-greasy cream to previously cleaned skin. DOSAGE AND ADMINISTRATION Therapy is generally initiated with Antopar gel 5% and continued with Antopar gel 10% after three to four weeks. Normally, the sensitive skin on the face or on the affected area is washed with lukewarm water. It is covered with a thin layer of 5% gel, applied with the fingertips once daily (in the afternoon or evening), during the first two days. Allow the gel to act for two hours and then rinse it off with lukewarm water. On the third and fourth day, rinse the gel off after four hours; and from the fifth to eleventh day leave it to act overnight. From days twelve to twenty-one the gel is used twice a day (in the morning and evening). If no visible improvement occurs, the 10 % gel should be used. With sensitive skin the beginning of treatment should be even more progressive, and the time of action of the Antopar gel should be shortened. To improve the therapeutic effect, Antopar gel 5% should be applied overnight two to three times a week. Registration status The drug may also be dispensed without prescription. ANTOPAR, gel benzoyl peroxide treatment of acne vulgaris on the face and back LMK(r), medical liquid soap LMK(r), medical cream COMPOSITION LMK medical liquid soap contains 1 % of undecylenepolydiethanolamide and 0.1 % of allantoin in surfactants. LMK medical cream contains 0.2 % of allantoin, 0.1 % of vitamin complex AEF, and 0.2 % of triclosan in an ointment base. ACTION AND PROPERTIES LMK medical liquid soap is intended for washing the hands, face and body. It also penetrates deep into the pores and cleanses them. It has a pH between 5 and 7, which helps to protect the natural acid coat of the skin. It does not dry the skin. It possesses a deodorizing effect due to its bacteriostatic compounds, and thus prevents the development of unpleasant body odour. LMK medical cream protects, nourishes and regenerates the skin. It has a pH from 5 to 7. It stabilizes the protective biological acidity of the skin, and has an astringent and antiseptic action. INDICATIONS Medical skin care in periods during therapy of seborrheic dermatoses, rosacea, acne, eczema, occupational diseases, profuse sweating between the fingers and toes or after it, and in saprophyte dermatomycoses. CONTRAINDICATIONS Have not been reported. ADMINISTRATION LMK medical liquid soap and cream are used in washing and skin care cosmetics of both healthy and sensitive skin. LMK medical liquid soap is particularly suitable for persons who may not tolerate hard soaps well or should not use them. LMK medical liquid soap and LMK medical cream should be used several times a day. Registration status: OTC drug LMK, medical liquid soap undecylenepolydiethanolamide and allantoin in surface-active agents LMK, medical cream allantoin, vitamin complex AEF in triclosan in an ointment base suitable for sensitive skin medical skin care in periods during therapy of dermatoses LICE-KILLING AGENTS MILINOR(r), lice-killing shampoo COMPOSITION 100 g of shampoo contains 1 g of lindane (gamma benzene hexachloride). ACTION Milinor shampoo contains lindane, which kills lice. If not used properly, it can be poisonous for people too, because it is absorbed through the skin. INDICATIONS Pubic (crab) lice and head lice. CONTRAINDICATIONS Milinor shampoo should not be used if the skin of the scalp or of the pubic region is injured, scratched, festered or inflamed. It should not be used either by epileptics or persons in whom lindane causes skin irritation and hypersensitivity reactions. Its use is not allowed in prematurely born babies and in newborn infants. PRECAUTIONS Milinor shampoo should be used with particular caution in children under three years of age, in pregnant women and nursing mothers. Pregnant women should not use it more often than twice during pregnancy. When applying the shampoo, the eyes and sensitive parts of the face (mouth, nose) and of the body should be protected. Use gloves, if skin on the hands is damaged. If Milinor shampoo comes into contact with the eyes or with any other sensitive part of the body, wash them immediately with a strong jet of water. In case of skin irritation or hypersensitivity reactions, stop using the shampoo at once and consult the doctor. If accidental swallowing occurs, urgent medical attention must be sought. SIDE EFFECTS Incorrect or excessive use may have toxic effects on the central nervous system, causing dizziness, vertigo or muscular spasms. It can irritate the eyes, skin or mucous membranes, or provoke skin rash. DOSAGE AND ADMINISTRATION Wet the hair with warm water. Shake Milinor shampoo well before use. Administer 15 ml of the shampoo (one table spoonful) to younger children, and 30 ml (two table spoonfuls) to older children and adults. Allow the shampoo to remain on area for 4 minutes, the scalp being covered totally (especially behind the ears). The hair should be thoroughly washed with water and dried with a fresh, dry towel. After that comb the hair with a fine toothcomb to remove the remaining nits. Second shampooing is rarely needed. It should be repeated according to the previously described procedure, but not before 24 hours. If new lice hatch from the remaining nits, the procedure can be repeated, but not earlier than seven to eight days after the last shampooing. The shampoo should not be applied more than twice a week. The same procedure is used for removing pubic lice. First wet the pubic region or any other hairy part of the body with warm water, and after that apply 10 to 15 ml of the shampoo (two to three teaspoonfuls). Allow Milinor shampoo to remain on the hairy parts for 4 minutes, then wash it off with water and allow it to dry. Comb the hair after that with a fine toothcomb. Be careful to allow as little as possible of the shampoo to come into contact with mucous membranes of the sexual organs. The spoon used for portioning out the shampoo should be thoroughly rinsed with water. Combs, brushes and other toilet requisites may be washed with the shampoo. Underwear and clothes, which were in contact with the infected persons, should be washed or dry-cleaned. Registration status: OTC drug MILINOR, shampoo lindane (gamma benzene hexachloride) efficiently removes head and crab lice ORAL HEALTH PRODUCTS LEKOFLUOR(r), dental lotion for children, dental lotion for adults COMPOSITION Lekofluor dental lotion is a green solution containing 0.05 % of sodium fluoride (=223 ppm F). Lekofluor dental lotion for children is a red solution containing 0.05 % of sodium fluoride (=223 ppm F), but it does not contain ethanol. ACTION Fluorine protects teeth against caries when they are still being formed, and later when they are fully formed. Fluorine in the enamel replaces the hydroxyl group in the apatite crystal and forms fluoroapatite; consequently the enamel becomes even firmer. Fluorine inhibits the growth of bacteria which accumulate in dental plaques causing the development of tooth decay. In this way it also reduces acid formation in the oral cavity. The enamel is protected against caries when its surface contains at least one promil of fluorine by surface area. INDICATIONS Regular washing of mouth and teeth with Lekofluor dental lotion provides an efficient additional dental and mouth care. It also protects teeth against caries. It is intended above all for children over 6 years and for adolescents up to 16 years of age. The latter particularly need fluorine for healthy teeth growth and protection against caries. Lekofluor dental lotion for adults with menthol flavour is also a mouthwash, which helps to keep the breath fresh and pleasant. CONTRAINDICATIONS Have not been known. SIDE EFFECTS Have not been registered. ADMINISTRATION Rinse your teeth once a day with 10 ml of undiluted dental lotion for one minute after having brushed them with a toothbrush. With the mouth closed, roll the dental lotion over the teeth and through the interdental spaces. Spit out the liquid after rinsing. The dental lotion will be even more effective when the oral cavity is not rinsed with water for at least half an hour after its use and when no food and drink is taken. Registration status: OTC drug LEKOFLUOR, dental lotion sodium fluoride solution prophylaxis of dental caries pleasant and easy to use, for children as well Published by: LEK, Pharmaceutical and Chemical Company d.d., Ljubljana, OTC Division - Editor-in-Chief: Darja Temlin-Miheli~ - Editorial Board: Gorazd Hladnik, Darja Hlede, Janez Jelnikar, Dragana Miliki~, Davorin Poherc, Branka Soto{ek-Lekovac - Texts by: Gorazd Hladnik, †Nata{a Kapelj, Jo`e Kopa~, Darja Temlin-Miheli~ - Translation: Milena Kotnik - Text editor: Alan McConnell Duff - Cover photograph: Dragan Arrigler - Photographs by: Jani [por~i~ - Design and Setting: Virgo - Photolithographs: Intermarketing - Printed by: Tiskarna Ljubljana - Impression: 10,000 copies - Publication date: 1996 7