Cystine Vitamin B6 500mg/50mg, delicate hair and nails, box of 120 tablets, Biogaran Conseil

1. NAME OF DRUG CYSTINE / VITAMIN B6 BIOGARA CONSEIL 500mg/50mg coated tablet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION L-cystine: 500.00 mg Pyridoxine hydrochloride (vitamin B6): 50.00 mg Per coated tablet. To see a complete list of dilutants, see section 6.1. 3. PHARMACEUTICAL FORM Round, biconvex coated tablet. 4. CLINICAL DATA 4.1. Therapeutic Indications This medication contains cystine, amino acid and vitamin B6. It is treatment for phaneria disorders (delicate hair and nails). 4.2. Dosage and how to use ONLY TO BE TAKEN BY ADULTS. Dosage 4 tablets per day in two doses during mealtimes for 1 month. If there is no improvement after one month of treatment, consult your doctor. 4.3. Contraindications - Cystinuria - Combined with levodopa (see section 4.5), 4.4. Special warnings and side effects Treatment with this medication does not preclude any specific treatment. 4.5. Interactions with other drugs Linked to the vitamin B6 content: Inadvisable combinations + Levodopa Inhibition of the activity of levodopa when used without a peripheral dopadecarboxylase inhibitor. Avoid any intake of pyridoxine in the absence of dopadecarboxylase inhibitor. 4.6. Pregnancy and breast feeding Not applicable. 4.7. Effects on the ability to drive and operate machinery Not applicable. 4.8. Side effects Declaration of suspected side effects The declaration of suspected side effects after drug authorisation is important. It allows continuous observation into the benefits/risks of the drug. Health professionals declare all suspected side effects via the national system of declaration: The ANSM and the network of Regional Centres of Pharmacovigilance- website www.ansm.sante.fr. 4.9. Overdose Not applicable. 5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmaco-dynamic properties Pharmaco-therapeutic class: OTHER DERMATOLOGICAL PRODUCTS Pharmaco-therapeutic class: VITAMINS, OTHER COMBINATIONS Code ATC: D11 Code ATC: A11JC (D. Dermatology) Supply of cystine, sulfur-containing amino acid contained in keratin of the integuments, and of vitamin B6, factor of use of the cystine. A cystine study in the bulb and hair shaft in healthy volunteers showed the incorporation of cystine into the hair bulb. These results were not correlated with a possible clinical improvement. 5.2. Pharmacokinetics properties Not applicable. 5.3. Preclinical safety data Not applicable. 6. PHARMACEUTICAL DATA 6.1. List of dilutants Microcrystalline cellulose, talc, magnesium stearate. Coating: Opadry II yellow*, macrogol 6000. *Composition of opadry II yellow: polyvinylic alcohol, talc, macrogol 4000, titanium dioxide (E171), soya lecithin, yellow quinoleine aluminium lacquer, yellow iron oxide (E172). 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 120 coated tablets in blister packs (PVC/Alu). Not all pack sizes will be available. 6.6. Precautions for handling and disposal No specific requirements. 7. THE MARKETING AUTHORISATION HOLDER biogaran 15 boulevard charles gaulle 92700 colombes 8. NUMBER OF THE MARKETING AUTHORSATION HOLDER · 216 748-3 or 34009 216 748 3 5: Box of 120 coated 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.