Land: Malta
Språk: engelska
Källa: Medicines Authority
JED Pharma Limited Questum Business Park, South Ballingarrane Clonmel, Co Tipperary, E91 V329 , Ireland
R05CB03
CARBOCISTEINE 750 mg
ORAL SOLUTION
CARBOCISTEINE 750 mg
POM
COUGH AND COLD PREPARATIONS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2022-09-14
PAGE 1 OF 6 PACKAGE LEAFLET PAGE 2 OF 6 PACKAGE LEAFLET: INFORMATION FOR THE USER Carbocisteine Labomed S.A. «sugar free» 750mg/5ml oral solution 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. - If you have any further questions, ask your doctor or pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Carbocisteine «sugar-free» 750mg/5ml oral solution is and what it is used for 2. What you need to know before you take Carbocisteine «sugar-free» 750mg/5ml oral solution 3. How to take Carbocisteine «sugar-free» 750mg/5ml oral solution 4. Possible side effects 5. How to store Carbocisteine «sugar-free» 750mg/5ml oral solution 6. Contents of the pack and other information 1. WHAT CARBOCISTEINE «SUGAR-FREE» 750MG/5ML ORAL SOLUTION IS AND WHAT IT IS USED FOR This medicine thins bronchial secretions (mucus) and makes them easier to cough up. This medicine is for adults and adolescents aged over 15 years only. It is used for patients with the breathing passages (respiratory tract). These problems happen when too much mucus is made or the mucus is too sticky. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARBOCISTEINE «SUGAR-FREE» 750MG/5ML ORAL SOLUTION DO NOT TAKE CARBOCISTEINE «SUGAR-FREE» 750MG/5ML ORAL SOLUTION: • If you are allergic (hypersensitive) to carbocisteine or any of the other ingredients of this medicine (especially methyl parahydroxybenzoate) listed in section 6. • If you suffer from peptic ulcers (stomach or gut ulcers). WARNINGS AND PRECAU Läs hela dokumentet
PAGE 1 OF 6 SUMMARY OF PRODUCT CHARACTERISTICS PAGE 2 OF 6 1. NAME OF THE MEDICINAL PRODUCT Carbocisteine Labomed S.A. «sugar free» 750mg/5ml oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml of oral solution contains 750mg of carbocisteine. Excipients with known effect Each 5ml of oral solution contain 96.1mg (4.2mmol) of sodium. Each 5ml of oral solution contain 7.5mg of sodium methyl parahydroxybenzoate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution Clear, amber-coloured liquid, with raspberry odour. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Carbocisteine «sugar free» 750mg/5ml oral solution is a mucolytic agent for the adjunctive therapy of respiratory tract disorders characterised by excessive and viscous mucus in adults and adolescents aged over 15 years. 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 5ml three times daily initially; if symptoms improve, the dose may be lowered to 2 times a day, i.e. total 10ml/day. The maximum daily dose is 15ml. 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. Use in patients with known active peptic ulceration. 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. PAGE 3 OF 6 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 cause gastroin Läs hela dokumentet