1. NAME OF DRUG ACETYLLEUCINE BIOGARAN 500 mg, comprimé 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Acetylleucine .............................................. 500.00 mg Per tablet. To see a complete list of dilutants, see section 6.1. 3. PHARMACEUTICAL FORM: Tablet. White tablet, biconvex and elongated. 4. CLINICAL DATA 4.1. Therapeutic Indications Symptomatic treatment of vertigo. 4.2. Dosage and how to use Use for adults 1.5g - 2g per day, 3 or 4 tablets taken twice a day morning and evening. The duration of treatment is variable according to clinical advice (between 10 days and 5-6 weeks); from the beginning of the treatment or if unsuccessful, the dose may be increased up to 3g or even 4g per day. How to use Orally. 4.3. Contraindications: Over-sensitivity to acetylleucine or one of its dilutants. 4.4. Special warnings and side effects Not applicable. 4.5. Interactions with other drugs Not applicable. 4.6. Pregnancy and breast feeding: Pregnancy: Taking into account the available data it is not advisable to take acetylleucine any time during pregnancy. The clinical data is encouraging but is still limited and the animal data does not allow us to have a clear answer. Breast feeding: Due to the lack of available information, it is not advisable to take acetylleucine during breast feeding. 4.7. Effects on the ability to drive and operate machinery Not applicable. 4.8. Side effects Very rare: rashes (sometimes associated with itchiness), urticaria. 4.9. Overdose Not applicable. 5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmaco-dynamic properties Pharmaco-therapeutic class: ANTIVERTIGO WITH UNKNOWN MECHANISM OF ACTION Code ATC: N07CA04. 5.2. Pharmacokinetics properties After an oral dose, peak plasma concentration occurs with 2 hours. 5.3. Preclinical safety data Not applicable. 6. Pharmaceutical data 6.1. List of dilutants Pregelatinised maize starch, calcium carbonate, magnesium stearate 6.2. Incompatibilities Not applicable. 6.3. Shelf life 30 months. 6.4. Storage precautions No specific storage precautions. 6.5. Nature and contents of outside packaging Box of 30 tablets in blister packs (PVC/Alu). 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 · 418 255-8 ou 34009 418 255 8 3: Box of 30 tablets in blister packs (PVC/Alu). 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.
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