Carbocisteine 5% Loose Cough Syrup for Adults, 200ml, sugar-free, for bronchial congestion

1. NAME OF DRUG CARBOCISTEINE BIOGARAN 5% SUGAR-FREE drinkable solution sweetened with saccharin sodium 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Carbocisteine ................................................................................................................................... 5.00 g Per 100ml of drinkable solution. 15 ml corresponds to 750mg of carbocisteine and 96mg of sodium. To see a complete list of dilutants, see section 6.1. 3. PHARMACEUTICAL FORM Drinkable solution. 4. CLINICAL DATA 4.1. Therapeutic Indications Treatment for bronchial secretion disorders, particularly in acute bronchial conditions: acute bronchitis and acute episode of chronic broncho-pneumonia. Orally. ONLY TO BE TAKEN BY ADULTS. This medication has been adapted to patients on a hypoglucidic or hypocaloric diet. 15 ml of this syrup corresponds to 750mg of carbocisteine. The recommended daily dose is: 750 mg 3 times per day (3 15ml measures, 3 times per day). The length of treatment should not be more than 8-10 days. 4.3. Contraindications: - Previous sensitivity (allergy) to active ingredient or one of its components (see section 6.1). 4.4. Special warnings and side effects Special warnings: Productive coughs (which are a fundamental element to broncho-pulmonary defence) must be respected. The combination of bronchial muco-modulators and antitussives and/or substances that dry out secretions (atropinic) is not advisable. Due to the saccharose, fructose and glucose content in this medication it is not suitable for those with a fructose intolerance, glucose/galactose malabsorption syndrome or sucrase-isomaltase insufficiency. Precautions for use: Take precaution for patients with peptic ulcers. This medication contains 96mg of sodium per 15ml measure: patients on a strict low-salt diet should take precaution. 4.5. Interactions with other drugs Not applicable. 4.6. Pregnancy and breast feeding Pregnancy: Studies in animals have not shown a teratogen effect. In the absence of a teratogenic effect in animals, a malformative effect on the human species is not expected. To date the substances responsible for malformations in the human species have been shown to be teratogenic in animals during well-conducted studies on two species. In clinical studies there are no particular malformative or fetotoxic effects appeared to date. However monitoring pregnancies exposed to this drug is not enough to rule out any risk. Given the data, the use of carbocisteine is not recommended during pregnancy unless necessary. Breast feeding: No data concerning the passing of carbocisteine into human milk. Given the low toxicity level, the potential risks to the child are low when taking this medication. Therefore you can breast feed during treatment. 4.7. Effects on the ability to drive and operate machinery Not applicable. 4.8. Side effects Possible digestion problems (stomach ache, nausea, diarrhoea). It is therefore advised to reduce the dosage. Possible skin reactions due to the parahydroxybenzoate content (esters). 4.9. Overdose Not applicable. 5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmaco-dynamic properties Pharmaco-therapeutic class: MUCOLYTIC Code ATC: R05CB03, (R: Respiratory system). Carbocisteine is a mucolytic mucous-former. It works during the gel phase of the mucous by breaking down the disulphide components making coughing easier. 5.2. Pharmacokinetics properties After oral application of the carbocisteine, it is quickly absorbed; the peak of the plasma concentration is reached after 2 hours. The bioavailability is low, less than 10% of the administered dose, presumably by intraluminal metabolism and significant first-pass hepatic effect. The half-life is approximately 2 hours. Its disposal and that of the metabolites is done through the kidneys. 5.3. Preclinical safety data Not applicable. 6. PHARMACEUTICAL DATA 6.1. List of dilutants Hydroxyethyl cellulose, sodium saccharine, sodium methyl parahydroxybenzoate, caramel / vanilla flavouring*, sodium hydroxide, purified water. *Composition of the caramel/vanilla flavouring (code 31G139): cocoa alcoholate and tincture, grape alcoholate and tincture, vanilla extract, coffee extract, anisic aldehyde, propylene glycol, ethyl alcohol. 6.2. Incompatibilities Not applicable. 6.3. Shelf life 2 years. 6.4. Storage precautions Store in a place below 25°C. 6.5. Nature and contents of outside packaging 200 ml bottle (type III brown glass) with a VISTOP lid and metal cap with a seal and a measuring cup (clear PP). 6.6. Precautions for handling and disposal No specific requirements. 7. THE MARKETING AUTHORISATION HOLDER BIOGARAN 15 BOULEVARD CHARLES DE GAULLE 92700 COLOMBES 8. NUMBER OF THE MARKETING AUTHORSATION HOLDER · 381 344-2: 200ml bottle (type III brown glass) with a measuring cup (clear PP). 9. START/RENEWEL DATE OF AUTHORISATION [To be completed by holder] 10. DATE OF UPDATE OF TEXT [To be completed by holder] 11. DOSIMETRY Not applicable. 12. INSTRUCTIONS FOR RADIOPHARMACEUTICAL PREPARATION Not applicable. PRESCRIPTION AND DELIVERY CONDITIONS Drug not subjected to prescription.