Land: Malta
Språk: engelsk
Kilde: Medicines Authority
Galenica S.A. 4 Εleftherias Str., 14564, Kifissia, Greece
R05CB03
CARBOCISTEINE 750 mg/5ml
SYRUP
CARBOCISTEINE 750 mg/5ml
POM
COUGH AND COLD PREPARATIONS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2021-06-23
PAGE 1 OF 5 PACKAGE LEAFLET PAGE 2 OF 5 PACKAGE LEAFLET: INFORMATION FOR THE USER Pulmoclase «sugar free» 750mg/5ml syrup Carbocisteine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take 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. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to your doctor if you do not feel better or if you feel worse after 5 days. Keep out of the reach of children WHAT IS IN THIS LEAFLET 1. What Pulmoclase «sugar-free» 750mg/5ml syrup is and what it is used for 2. What you need to know before you take Pulmoclase «sugar-free» 750mg/5ml syrup 3. How to take Pulmoclase «sugar-free» 750mg/5ml syrup 4. Possible side effects 5. How to store Pulmoclase «sugar-free» 750mg/5ml syrup 6. Contents of the pack and other information 1. WHAT PULMOCLASE «SUGAR-FREE» 750MG/5ML SYRUP IS AND WHAT IT IS USED FOR This medicine thins bronchial secretions (mucus) and makes them easier to cough up (expectorate). This medicine is for adults and adolescents aged over 15 years only. It is used for patients with recent productive cough who have difficulty expectorating. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PULMOCLASE «SUGAR-FREE» 750MG/5ML SYRUP DO NOT TAKE PULMOCLASE «SUGAR-FREE» 750MG/5ML SYRUP: • If you are allergic (hypersensitive) to carbocisteine or any of the other ingredients of this medicine (especially methyl parahydroxybenzoate) listed in section 6. WARNINGS AND PRECAUTIONS You must not use medicines which suppress the cough (cough suppressants) or which dry out bronchial secretions when taking Pulmoclase «sugar-free» 750mg/5ml syrup. This is because Pulmoclase «sugar-free» 750mg/5ml syrup thins secretions, making them e Les hele dokumentet
PAGE 1 OF 6 SUMMARY OF PRODUCT CHARACTERISTICS PAGE 2 OF 6 1. NAME OF THE MEDICINAL PRODUCT Pulmoclase «sugar free» 750 mg/5 ml syrup 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml of syrup contains 750 mg of carbocisteine. Excipients with known effect Each 5 ml of syrup contains 96.1 mg (4.2 mmol) of sodium. Each 5 ml of syrup contains 7.5 mg of sodium methyl parahydroxybenzoate. Each 5 ml of syrup contains 250.0 mg of glycerol. Each 5 ml of syrup contains 4.05 mg of propylene glycol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Syrup Clear, amber-coloured liquid, with raspberry odour. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medication is indicated in adults and adolescents aged over 15 years for the treatment of recent respiratory disease involving difficulty in expectorating (i.e. difficulty in expelling bronchial secretions in sputum). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral route FOR ADULTS AND ADOLESCENTS OVER 15 YEARS OF AGE ONLY. This product is suitable for patients following low-carbohydrate or low-calorie diets. One dose of 5 ml three times daily initially; if symptoms improve, the dose may be lowered to 2 times a day, i.e. total 10 ml/day. The maximum daily dose is 15 ml. Do not exceed the stated dose. A smaller volume of this product is needed, compared to other carbocisteine products, to achieve the same recommended dose. 4.3 CONTRAINDICATIONS Hypersensitivity to carbocisteine or to any of the excipients listed in section 6.1. PAGE 3 OF 6 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Special warnings Productive coughs is a fundamental defense mechanism of the bronchopulmonary system, and as such should not be suppressed. Combining drugs that affect bronchial secretions with cough suppressants and/or substances that dry up secretions (atropine-like agents) is not recommended. Precautions for Use Caution is recommended in the elderly, in patients with a history of gastroduodenal ulcers, and in those taking concomitant medications which may cau Les hele dokumentet