1. NAME OF THE MEDICINAL PRODUCT
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
Tablet White, oblong tablet.
4. CLINICAL PARTICULARS
4.1. Therapeutic indications Symptomatic treatment of the vertiginous crisis.
4.2. Posology and method of administration In adults 1.5 to 2 g per day, ie 3 to 4 tablets in two doses in the morning and evening. The duration of treatment varies according to the clinical course (between 10 days and 5 to 6 weeks); at the start of treatment or in the event 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 medicine is contraindicated in patients with an allergy to wheat (other than celiac disease).
4.4. Special warnings and precautions for use This medication can be administered in cases 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 drugs and other forms of interaction Not applicable.
4.6. Pregnancy and breast-feeding In view of the available data, 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. In the absence of available data, it is best not to use acetylleucine during breast-feeding.
4.7. Effects on ability to drive and use machines Not applicable.
4.8. Undesirable effects Very rarely: skin rashes (sometimes associated with pruritus), urticaria Reporting of suspected side effects Reporting of suspected side effects after authorization of the medicinal product is important. It allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals report any suspected adverse reactions via the national reporting system: National Agency for Medicines and Health Products Safety (ANSM) and network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.