Carbosylane for bloating & flatulences, 48 doses of 2 capsules, Charcoal 140mg/Simeticone 45mg

1. NAME OF DRUG CARBOSYLANE, capsule. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active charcoal: 140 mg Simeticone: 45 mg Per blue or red capsule. To see a complete list of dilutants, see section 6.1. 3. PHARMACEUTICAL FORM Capsule. 4. CLINICAL DATA 4.1. Therapeutic Indications Symptomatic treatment for dyspeptic and meteorism states. 4.2. Dosage and how to use Orally. Suitable for adults and, children over the age of 6 years old. Take the blue stomach-dissolvable capsule with the red stomach-resistant capsule. The normal dose is 3 doses per day (one blue and one red capsule 3 times per day before or after the main meals). 4.3. Contraindications · allergy to one of its components, · children younger than 6 years (risk of choking on the capsule). 4.4. Special warnings and side effects In case of treatment with Cardiac glycosides, take CARBOSYLANE with a 2 hour gap. 4.5. Interactions with other drugs Due to the properties of the charcoal, the potential reduction in the absorption of the drugs leads to the administration of any other medication at a distance (more than 2 hours, if possible) of the CARBOSYLANE. Combinations to be aware of: + Cardiac glycosides Decrease in the digestive absorption of Cardiac glycosides. Take CARBOSYLANE 2 hours apart from Cardiac glycosides. 4.6. Pregnancy and breast feeding Pregnancy: There is no clear evidence of malformations detected in animals. The use of charcoal has no deformative or foetotoxic effect. However epidemiological studies are necessary to check the risk. Given the data, the use of charcoal is not recommended during pregnancy unless necessary. Breast feeding: This medication can be prescribed during breast-feeding. 4.7. Effects on the ability to drive and operate machinery Not applicable. 4.8. Side effects The use of this at high doses can cause a discolouration of faeces. After commercialisation rare cases or skin reactions were reported (urticaria, anaphylactoid reaction). 4.9. Overdose No case of an overdose has been reported, however high doses can cause a discolouration of faeces. 5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmaco-dynamic properties Pharmaco-therapeutic class: ANTI-FLATULENT/INTESTINE ABSORBANT. (A: digestive and metabolism). Carbosylane has two main active ingredients: - charcoal which has absorbent properties - simeticone the physiologically inert substance, simeticone, which has no pharmacological activity and acts by modifying the surface tension of the gas bubbles, thus causing them to coalesce. 5.2. Pharmacokinetics properties The two capsules should be taken at the same time and contain the same two main ingredients. This medication acts in two ways: the blue capsule releases the active ingredients in the stomach where as the red capsule releases the ingredients in the intestine. The two main active ingredients are not absorbed in the gastro-intestinal mucous membrane. 5.3. Preclinical safety data Not known. 6. PHARMACEUTICAL DATA 6.1. List of dilutants Sorbitan oleate, polysorbate 80. Coating of the blue capsule: gelatine, indigotine (E132), titanium dioxide (E171). Coating of the red capsule: gelatine, erythrosin (E127), titanium dioxide (E171), indigotine (E132). Coating of the red stomach-resistant capsule: cellulose phtalate acetate, diethyl phtalate. 6.2. Incompatibilities Not applicable. 6.3. Shelf life 4 years. 6.4. Storage precautions No specific storage precautions. 6.5. Nature and contents of outside packaging 48 blue capsules + 48 red capsules in blister packs (PVC/Aluminium). 6.6. Precautions for handling and disposal No specific requirements. 7. THE MARKETING AUTHORISATION HOLDER Laboratoires GRIMBERG 19, rue Poliveau 75005 PARIS 8. NUMBER OF THE MARKETING AUTHORSATION HOLDER · 327 244-3 or 34009 327 244 3 7: 48 blue capsules + 48 red capsules in blister packs (PVC/Aluminium). 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.