1. NAME OF THE MEDICINE
TANGANILPRO 500 mg, tablet
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Acetylleucine .............................................. ........................................... 500 mg For one tablet. Excipients with known effect: wheat starch (gluten). For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
White, oblong tablet.
4. CLINICAL DATA
4.1. Therapeutic indications Symptomatic treatment of vertiginous crisis.
4.2. Dosage and method of administration In adults 1.5 to 2 g per day, ie 3 to 4 tablets in two doses, morning and evening. The duration of the treatment is variable according to the clinical evolution (between 10 days and 5 to 6 weeks); at the beginning of the treatment or in case of failure, the dosage can be increased without inconvenience up to 3 g and even 4 g per day.
4.3. Contraindications hypersensitivity to acetylleucine or to any of the excipients listed in section 6.1. This medication is contraindicated in patients with wheat allergy (other than celiac disease).
4.4. Special warnings and precautions for use This medicine can be administered in case of celiac disease. Wheat starch may contain gluten, but only in trace amounts, and is therefore considered safe for people with celiac disease.
4.5. Interactions with other medicinal products and other forms of interaction Not applicable.
4.6. Pregnancy and lactation Considering the data available, it is preferable, as a precaution, not to use acetylleucine during pregnancy, whatever the term. Indeed, the clinical data are reassuring but still limited and the animal data do not allow a conclusion to be drawn. In the absence of available data, it is preferable not to use acetylleucine during breast-feeding.
4.7. Effects on ability to drive and use machines Not applicable.
4.8. Adverse effects Very rarely: skin rashes (sometimes associated with pruritus), urticaria Reporting of suspected adverse reactions Reporting of suspected adverse reactions after authorization of the medicinal product is important. It allows continuous monitoring of the benefit/risk ratio of the medicinal product. Health professionals report any suspected adverse effects via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Pharmacovigilance Centers
4.9. Overdose Not applicable.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties ANTIVERTIGINOUS. Antivertiginous with unknown mechanism of action.
5.2. Pharmacokinetic properties After oral administration, peak plasma acetylleucine concentration is reached after approximately 2 hours.
5.3. Preclinical safety data Not applicable.
6. PHARMACEUTICAL DATA
6.1. List of excipients Wheat starch, pregelatinized corn starch, calcium carbonate, magnesium stearate.
6.2. Incompatibilities Not applicable.
6.3. Shelf life 3 years for blister packaging (PVC/aluminium).
6.4. Special precautions for storage No special precautions for storage.
6.5. Nature and contents of container 30 tablets in blister packs (PVC/Alu).
6.6. Special precautions for disposal and other handling No special requirements.
7. MARKETING AUTHORIZATION HOLDER
Pierre FABRE MEDICAMENT 45, place Abel Gance 92100 BOULOGNE
8. MARKETING AUTHORIZATION NUMBER(S) 338 457-3 or 3400933845735: 30 tablets in blister packs (PVC/Alu).
9. DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION [to be completed by the holder] 10. DATE OF TEXT UPDATE [to be completed by the holder]
11. DOSIMETRY Not applicable.
12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS Not applicable. CONDITIONS OF PRESCRIPTION AND DELIVERY Medicine not subject to medical prescription.
100% secure payment, Customer Satisfaction
Order shipped within 24 hours from Monday to Friday*
