1. NAME OF DRUG Tanganil Ge ACETYLLEUCINE, 500g, tablet
2. QUALITATIVE AND QUANTITATIVE COMPOSITION Acetylleucine .............................................. 500,00 mg Per tablet.
Dilutant: wheat starch (gluten). To see a complete list of dilutants, see section6.1.
3. PHARMACEUTICAL FORM: Tablet. White and oblong.
4. CLINICAL DATA
4.1. Therapeutic Indications Symptomatic treatment of vertigo.
4.2. Posologie et mode d'administration 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 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 Wheat starch, pregelatinised maize starch, calcium carbonate, magnesium stearate
6.2. Incompatibilities Not applicable 6.3. Shelf life 3 years.
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 PIERRE FABRE MEDICAMENT 45, PLACE ABEL GANCE 92100 BOULOGNE
8. NUMBER OF THE MARKETING AUTHORISATION HOLDER · 274 002-0 or 34009 274 002 09 :30 tablets in blister packs (PVC/Aluminium).