Effizinc Zinc 15mg, 30 capsules, Expanscience

1. NAME OF DRUG EFFIZINC 15mg capsule. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Zinc: 15.00 mg Under the form of zinc gluconate: 104.55 mg Per capsule. To see a complete list of dilutants, see section 6.1. 3. PHARMACEUTICAL FORM Capsule. 4. CLINICAL DATA 4.1. Therapeutic Indications Treatment for minor to moderate inflamed acne. Treatment for acrodermatitis enteropathica. 4.2. Dosage and how to use Acne: The daily dose is 2 capsules (30mg of zinc) in one dose in the morning on an empty stomach with a glass of water. This dosage of 2 capsules per day should be taken for 3 months then reduced down to 1 capsule per day. Acrodermatitis enteropathica: The daily dose to at least the age of puberty is 1 capsule: treatment should be continued to avoid relapses. At the time of puberty, increase the dosage to 2 capsules per day. After this growth stage you can take 1 capsule per day. 4.3. Contraindications Not applicable. 4.4. Special warnings and side effects To achieve maximum absorption, take this medication outside of mealtimes. 4.5. Interactions with other drugs Combinations to be aware of: + Iron and Calcium Decrease in zinc absorption by iron and calcium. Take iron salts and calcium at different time to zinc (2 hour gap). + Cyclines, Fluoroquinolones Decrease in cyclines and fluoroquinolone absorption by zinc. Take zinc salts at different time to cyclines and fluoroquinolone (2 hour gap). + Strontium Decrease in strontium absorption by zinc. Take strontium at a different time to zinc salts (2 hour gap). 4.6. Pregnancy and breast feeding Pregnancy: For acrodermatitis enteropathica, taking zinc is essential and must be continued during pregnancy. For acne during the 1st trimester and given the available data, it is not recommended to take EFFIZINC. The clinical data is encouraging but is still limited and the animal data does not allow us to have a clear answer. During the 2nd and 3rd trimester, taking EFFIZINC is possible but the dosage must take into account other zinc supplements (poly-vitamins or oligo-elements). Breast feeding: For acrodermatitis enteropathica, taking zinc is essential and must be continued during breast-feeding. For acne during the 1st trimester and given the available data, it is not recommended to take EFFIZINC. There has been no reported cases of side effects among children when the mothers zinc level was less or equal to 20mg during breast-feeding. 4.7. Effects on the ability to drive and operate machinery Not applicable. 4.8. Side effects Gastro-intestinal problems have been reported. They are temporary and not serious. 4.9. Overdose There is a very low chance of acute intoxication; treatment of salts and phytic acid are only used for the memory. 5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmaco-dynamic properties OTHER MEDICATION WITH SYSTEMATIC USE, code ATC: D10BX (D: Dermatology) The zinc gluconate acts as an inflammatory on acne. Sun exposure: it has been studied that zinc gluconate does not lead to any photo toxic or photo allergy reactions. Treatment with zinc gluconate does not react with sun exposure. 5.2. Pharmacokinetics properties The zinc gluconate is absorbed in the intestine. The seric peak is achieved between the second and third hour. The absorption is lower if the medication is taking during mealtimes. Pharmacological studies have shown that zinc is found in the skin. The elimination of zinc is faecal. 5.3. Preclinical safety data No pertinent study has been carried out on animals to evaluate the toxicity of zinc gluconate vis-a-vis reproduction functions. 6. PHARMACEUTICAL DATA 6.1. List of dilutants Potato starch, mannitol, anhydrous colloidal silica, magnesium stearate. Composition of the coating: gelatine, titanium dioxide (E171). 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 14, 15, 28, 30, 56 or 60 tablets in blister packs (PVC/PVDC/Alu). 6.6. Precautions for handling and disposal Not applicable. 7. THE MARKETING AUTHORISATION HOLDER Laboratoires EXPANSCIENCE 10, avenue de l'Arche 92419 Courbevoie Cedex 8. NUMBER OF THE MARKETING AUTHORSATION HOLDER 367,892-6: 14 tablets in blister packs (PVC/PVDC/Alu). 367,893-2: 15 tablets in blister packs (PVC/PVDC/Alu). 367,894-9: 28 tablets in blister packs (PVC/PVDC/Alu). 367,895-5: 30 tablets in blister packs (PVC/PVDC/Alu). 367,896-1: 56 tablets in blister packs (PVC/PVDC/Alu). 367,897-8: 60 tablets in blister packs (PVC/PVDC/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.