LIBEXIN for dry cough without secretion 100 mg x 20 tablets.

LIBEXIN / LIBEXIN TABLET. indications: Acute and chronic cough of various origins, catarrh of the upper respiratory tract, acute and chronic bronchitis, bronchopneumonia, pulmonary emphysema, preparation of patients for bronchoscopy or bronchography, dry and exudative pleurisy, pulmonary infarction, spontaneous pneumothorax. Dosage and administration: Adults - 1 tablet 3 times a day. Children - 1/2 - 1/4 tablet in three or four doses a day. In preparation for bronchoscopy, the preparation is taken 60 minutes before the manipulation in a dose of 0.9 - 3.8 mg / kg in combination with atropine 0.5 - 1 mg.
Ingredients: The active substance is: prenoxdiazine hydrochloride 100 mg; The other ingredients are: glycerol, magnesium stearate, talc, povidone, corn starch, lactose monohydrate (38.0 mg). 
PACKAGE LEAFLET: INFORMATION FOR THE USER LIBEXIN 100 mg tablets LIBEXIN 100 mg tablets prenoxdiazine hydrochloride Read all of this leaflet carefully before you start using this medicine because it contains important information for you. This medicine is available without a prescription. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Keep this leaflet. You may need to read it again. If you need further information or advice, ask your pharmacist. If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not listed in this leaflet. You should seek medical advice if your symptoms get worse or do not improve. In this leaflet: 1. What Libexin is and what it is used for 2. What you need to know before you take Libexin 3. How to take Libexin 4. Possible side effects 5. How to store Libexin 6. Further information 1. WHAT Libexin is and what it is used for The medicinal product is used for acute and chronic, mainly dry cough (one in which no secretions are produced). For preparation when conducting bronchoscopy and bronchographic examination to suppress cough. 2. BEFORE YOU TAKE Libexin Do not take Libexin: if you are hypersensitive to the excipients of the medicinal product, if you have diseases associated with significant secretion of bronchial secretions, in postoperative conditions (after inhalation anesthesia) Warnings and precautions In the presence of lactose intolerance, it should be borne in mind that one tablet contains 38.0 mg of lactose. When taken according to the dosage recommendations, each dose provides up to 114 mg of lactose. The product is not suitable for people with lactase deficiency, galactosemia or glucose/galactose malabsorption syndrome. Glycerol is harmful at high doses. It may cause headache, stomach irritation and diarrhoea. Other medicines and Libexin Please tell your doctor and/or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding Although it does not affect the fetus, its use during pregnancy and breast-feeding should only be done after consulting a doctor. Driving and using machines At higher doses, the medicinal product may impair alertness, therefore the use of Libexin is only done after an individual assessment of the condition. Important information about some of the ingredients of Libexin If your doctor has told you that you have an intolerance to some sugars, consult him before taking this product. If you are lactose intolerant, please note that one tablet contains 38 mg of lactose. Glycerol may cause headache, stomach irritation and diarrhoea. 3. HOW TO TAKE LIBEXIN Always take this medicine exactly as described in this leaflet or as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Unless otherwise prescribed, the recommended dose is: Adults: The usual dose is 3-4 times a day, 1 tablet (3 times x 100 mg). In more severe cases, the dose is increased to 3-4 times a day x 2 tablets, or 3 times x 3 tablets (3-4 times x 200 mg, or 3 times x 300 mg). Children (1 to 14 years of age); In accordance with the patient's age and body weight, the usual dose is proportionally lower: U* to Ug tablet 3-4 times daily (3-4 times x 25 mg to 50 mg). In children aged 1 to 6 years or weighing 10 kg to 20 kg: HL tablet 3 times daily (3 times x 50 mg). In children aged 6 to 14 years or weighing over 20 kg: Ug tablet 3-4 times daily (3-4 times x 50 mg). It is used in children over 1 year of age. In preparation for bronchoscopy: It is used only after consultation with a doctor in the dose prescribed by him. In case of difficulty in clearing thick bronchial secretions, the use of expectorants and mucolytics may be necessary. The tablet is swallowed whole without chewing, because it can cause temporary numbness of the oral mucosa. The maximum single dose for children over 1 year of age is 1/2 tablet, for adults 3 tablets. The maximum daily dose for children is 1.5 to 2 tablets, for adults 9 tablets. If you take more Libexin than you should When using higher doses, a sedative effect and fatigue are observed a few hours after taking it. In case of overdose, consult a doctor immediately. If you forget to take Libexin Do not take a double dose to make up for the missed dose. If you have any further questions on the use of this product, please ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur: - rarely: dry mouth or throat, allergic reactions. – with unknown frequency: bronchospasm, gastrointestinal complaints (stomach pain, constipation) may occur (in less than 10 % of cases), which disappear when following a diet. If you experience any side effects, tell your doctor or pharmacist. This includes any possible side effects not described in this leaflet. 5. HOW TO STORE LIBEXIN Keep out of the reach of children. Store at room temperature below 25°C, in the original packaging. Do not use after the date stated on the packaging. Do not throw away medicines in the sewer or in the household waste container. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. FURTHER INFORMATION What Libexin contains The active substance is: prenoxdiazine hydrochloride 100 mg (prenoxdiazine hydrochloride); The other ingredients are: glycerol, magnesium stearate, talc, povidone, corn starch, lactose monohydrate (38.0 mg). What Libexin looks like and contents of the pack One pack contains 20 tablets in a PVC/aluminium blister. Marketing Authorisation Holder Sanofi-Aventis Bulgaria EOOD, Sofia 1303, Blvd. Al. Stamboliyski 103 Bulgaria Manufacturer CHINOIN Pharmaceutical and Chemical Works Co.Ltd. H-2112 Veresegyhaz, Levai u. 5, Hungary