1. NAME OF THE MEDICINAL PRODUCT
BELLOC COAL 125 mg, soft capsule
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Activated charcoal ..................................................... 125.0 mg For one soft capsule. For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Softgel capsule.
4. CLINICAL DATA
4.1 Therapeutic indications Symptomatic treatment of functional digestive disorders, particularly with meteorism.
4.2. Dosage and administration Only for adults and adolescents over 15 years of age. 2 capsules, 2 to 3 times daily.
4.3. Contraindications Hypersensitivity to any of the constituents.
4.4 Special warnings and precautions for use In the event of associated diarrhoea, the need for rehydration should be assessed, particularly in children. The extent of rehydration by oral or intravenous rehydration solution must be adapted according to the intensity of the diarrhoea, the age and the particular characteristics of the patient (associated illnesses, etc.).
4.5. Interactions with other medicinal products and other forms of interaction Due to the properties of charcoal, the potential reduction in the absorption of medicinal products means that any other medication should be administered at a distance (more than 2 hours, if possible) from the intake of this medicinal product.
4.6. Pregnancy and breast-feeding Pregnancy There are no teratogenicity studies available in animals. In clinical trials, the use of charcoal in limited numbers has apparently not revealed any malformative or foetotoxic effects to date. However, epidemiological studies are required to verify the absence of risk. Consequently, and given the lack of resorption of charcoal, this medicine should only be used during pregnancy if necessary. Breast-feeding This medicinal product may be taken during breast-feeding.
4.7. Effects on ability to drive vehicles and use machines Not applicable.
4.8. Undesirable effects Use of this medicinal product in high doses may cause darker stools.
4.9. Overdosage Not applicable.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties INTESTINAL ADSORBANT (A: digestive system and metabolism)
5.2. Pharmacokinetic properties Not applicable
5.3. Preclinical safety data Not applicable
6. PHARMACEUTICAL DATA
6.1. List of excipients Soya oil, yellow beeswax, soya lecithin, glycerol, gelatin.
6.2 Incompatibilities Not applicable.
6.3. Shelf life 3 years.
6.4. Special precautions for storage No special precautions for storage.
6.5. Nature and contents of the pack - Box of 60 capsules in blister packs (PVC/PVDC/Aluminium).
6.6. Special precautions for disposal and handling No special requirements.
7. MARKETING AUTHORISATION HOLDER
LABORATOIRES SUPER DIET 8, RUE CHRISTOPHE COLOMB 75008 PARIS 8. MARKETING AUTHORISATION NUMBER(S) - 363 844-7: 60 soft capsules in blister packs (PVC/PVDC/Alu). 9. DATE OF FIRST AUTHORISATION / RENEWAL OF AUTHORISATION [to be completed by the holder] 10. DATE OF UPDATE OF TEXT [to be completed by the holder] 11. DOSIMETRY Not applicable. 12 INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS Not applicable. CONDITIONS OF PRESCRIPTION AND DELIVERY Medicinal product not subject to medical prescription.
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