AlfaAmylase 3000U, 18 coated tablets, Sore Throat for adults, Biogaran Conseil

1. NAME OF DRUG ALFAAMYLASE BIOGARAN CONSEIL 3000U, CEIP, coated tablet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Alfa-amylase: 3000 U.CEIP* Per coated tablet. *2142.9 units Dilutants: yellow orange S (E110), saccharose, sorbitol. To see a complete list of dilutants, see section 6.1. 3. PHARMACEUTICAL FORM Coated tablet. 4. CLINICAL DATA 4.1. Therapeutic Indications Treatment for congestion in the oropharynx. NB: Given the general clinical signs of bacterial infection, general antibiotic therapy should be considered. 4.2. Dosage and how to use Only to be used by adults. There is a syrup for children. Dosage 1 tablet 3 times per day during mealtimes. How to use Swallow the tablet with a glass of water. if there is no improvement after 5 days of treatment, consult your doctor. 4.3. Contraindications Sensitive to alfa-amylase or one of the other ingredients. 4.4. Special warnings and side effects Special warnings: This drug contains saccharose. This medication is not recommended for patients with a fructose intolerance, glucose/galactose malabsorption syndrome or sucrase/isomaltase deficiency. This drug contains sorbitol. This drug is not recommended for patients with a sugar intolerance (rare hereditary illness). This drug contains an azoic dye agent (E110) and can cause allergic reactions. Precautions for use If other symptoms appear (sore throat, headaches, nausea, vomiting...) or fever, treatment must be reevaluated. This medication must not be used for a prolonged period of time (no more than 5 days). 4.5. Interactions with other drugs No study has been carried out. 4.6. Fertility, Pregnancy and Breast-feeding Pregnancy: There is no clear evidence of malformations detected in animals. In clinical studies there are no particular malformative or fetotoxic effects appeared to date. However monitoring pregnancies exposed to this drug is not enough to rule out any risk. For precautionary measures, it is advisable not to take this drug during pregnancy. Breast feeding: In the absence of data on the passage of alfa-amylase in breast milk, the use of ALFA-AMYLASE BIOGARAN CONSEIL should be avoided during breast-feeding. 4.7. Effects on the ability to drive and operate machinery ALFA-AMYLASE BIOGARAN CONSEIL has no effects on the ability to drive and operate machinery 4.8. Side effects due to the alfa-amylase content rare cases of allergic reactions have been reported such as urticaria and angioedema. 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 No case of an overdose has been reported. 5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmaco-dynamic properties Pharmaco-therapeutic class: Enzyme for anti-inflammatory, code ATC: R02A. 5.2. Pharmacokinetics properties Not applicable. 5.3. Preclinical safety data Not applicable. 6. PHARMACEUTICAL DATA 6.1. List of dilutants Magnesium stearate, sorbitol, lacquer gum, copolymer of butyl methacrylate of (2-dimethylaminoethyl) metacrylate and methyl methacrylate 1: 2: 1 (eudragit E100), talc, gelatine, sucrose, gum Arabic, titanium dioxide, orange yellow S (E110), carnauba wax. 6.2. Incompatibilities Not applicable. 6.3. Shelf life 18 months. 6.4. Storage precautions Store in a place below 25°C. 6.5. Nature and contents of outside packaging 18 coated tablets in blister pack (PVC/Alu). 18 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 LABORATOIRE TOP PHARM DOMAINE DE MONTCAUSSON BP 50 31250 REVEL 8. NUMBER OF THE MARKETING AUTHORSATION HOLDER · 34009 354 644 9 1: 24 coated tablets in blister packs (PVC/Alu). · 34009 496 440 4 9: 18 coated tablets in blister pack (PVC/Alu). · 34009 496 441 0 0: 18 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.