Țară: Malta
Limbă: engleză
Sursă: Medicines Authority
CARBOCISTEINE
Sanofi Malta Limited
R05CB03
CARBOCISTEINE
SYRUP
CARBOCISTEINE 20 mg/ml
OTC
COUGH AND COLD PREPARATIONS
Authorised
2006-12-12
RHINATHIOL Expectorant _CARBOCISTEINE 2% FOR CHILDREN _ syrup for children 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 a doctor if you do not feel better or if you feel worse. Keep out of the reach of children. What is in this leaflet 1. What Rhinathiol Expectorant Carbocisteine is and what it is used for 2. What you need to know before you take Rhinathiol Expectorant Carbocisteine 3. How to use Rhinathiol Expectorant Carbocisteine 4. Possible side effects 5. How to store Rhinathiol Expectorant Carbocisteine 6. Contents of the pack and other information 1. WHAT RHINATHIOL EXPECTORANT CARBOCISTEINE 2 % SYRUP FOR CHILDREN IS AND WHAT IT IS USED FOR Pharmacotherapeutic group: MUCOLYTICS - ATC code: R05CB03 (R: respiratory system) This medicine thins bronchial secretions (mucus) and makes them easier to cough up (expectorate). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RHINATHIOL EXPECTORANT CARBOCISTEINE 2 % SYRUP FOR CHILDREN DO NOT TAKE RHINATHIOL EXPECTORANT CARBOCISTEINE 2 % SYRUP FOR CHILDREN: • if you are allergic (hypersensitive) to the active substance or any of the other ingredients of this medicine listed in section 6. • if your child is under 2 years of age, as bronchial congestion may become worse. WARNINGS AND PRECAUTIONS You (or your child) must not use medicines which suppress cough (cough suppressants) or which dry out bronchial secretions when taking Rhinathiol Expectorant Carbocisteine. This is because Rhinathiol Expectorant Carbocisteine thins secretions, making them easier to cough up. Coughing is a useful mechanism for expe Citiți documentul complet
Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT RHINATHIOL 2 PER CENT CHILDREN, SYRUP 2. QUALITATIVE AND QUANTITATIVE COMPOSITION CARBOCISTEINE ………………………...………………….…... 2.000 G For 100 ml of syrup One 5 ml measuring spoon contains 100 mg of carbocisteine. Excipient(s) with known effect: 3.5 g of sucrose and 13 mg of sodium per 5 ml measuring spoon. Methyl parahydroxybenzoate (E218). Ponceau 4R (E124). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Syrup. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of bronchial secretion disorders, notably during the course of acute bronchial disease: acute bronchitis and acute episodes of chronic pulmonary disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION One 5-ml measuring spoon contains 100 mg of carbocisteine. Children aged 2 to 5 years: 200 mg per day, in 2 divided doses, i.e. one 5-ml measuring spoon 2 times per day. Children aged over 5 years: 300 mg per day, in 3 divided doses, i.e. one 5-ml measuring spoon 3 times per day. Treatment duration should be short and not exceed 8 to 10 days. 4.3 CONTRAINDICATIONS • History of hypersensitivity to any of the ingredients (particularly methyl parahydroxybenzoate and other parahydroxybenzoate salts). • Infants (under two years of age) (see section 4.4). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE SPECIAL WARNINGS In patients with thick and purulent sputum, fever or chronic bronchial and pulmonary disease, the clinical situation should be reassessed. Productive cough, which is a fundamental bronchopulmonary defense mechanism, should not be Page 2 of 4 suppressed. Combining drugs that affect bronchial secretions with cough suppressants and/or substances that dry up secretions (atropine-like agents) is irrational. Mucolytic agents may induce severe bronchial congestion in infants. Infant bronchial mucus drainage capacities are limited due to the physiological characteristics of their bronchial tree. Mucolytics should ther Citiți documentul complet