Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Dried ferrous sulphate; Vitamin c
Imbat Limited
B03AA; B03AA07
Dried ferrous sulphate; Vitamin c
325/500 milligram(s)
Prolonged-release tablet
Product not subject to medical prescription
Iron bivalent, oral preparations; ferrous sulfate
Authorised
2010-12-17
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER FERROGRAD ® C 325MG/500MG PROLONGED RELEASE TABLETS dried ferrous sulphate/vitamin C Your medicine is available using the above name, but will be referred to as ‘Ferrograd C’ throughout this leaflet. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to take Ferrograd C carefully to get the best results from it. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. You must contact a doctor if your symptoms worsen or do not improve after 4 weeks. If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. WHAT IS IN THIS LEAFLET: 1. What Ferrograd C are and what they are used for 2. Before you take Ferrograd C 3. How to take Ferrograd C 4. Possible side effects 5. How to store Ferrograd C 6. Contents of the pack and other information 1. WHAT FERROGRAD C ARE AND WHAT THEY ARE USED FOR The name of your tablets is Ferrograd C Prolonged-release Tablets. Ferrograd C are prolonged release, film coated tablets. The active ingredients in Ferrograd C are: Dried Ferrous Sulphate and Vitamin C (Ascorbic Acid), as sodium ascorbate. Ferrograd C is a combined iron and vitamin C supplement. Its use is described below. WHAT IS FERROGRAD C USED FOR? Ferrograd C is an iron supplement used to prevent and treat iron-deficiency anaemia and vitamin C deficiency when the two are present together. Ferrograd C should only be used for the prevention and treatment of iron-deficiency anaemia diagnosed by laboratory testing under the supervision of a medical doctor. Ferrograd C should only be taken by pregnant women after the first 13 weeks of pregnancy. The added vitamin C helps the body to absorb the iron. A controlled- release system in the tablet allows release of the iron over seve Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ferrograd C 325mg/500mg Prolonged release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Dried Ferrous Sulphate 325 mg (elemental iron 105 mg) Vitamin C 500 mg (as sodium ascorbate) Excipient(s) with known effect Dye Red Ponceau 4R Lake (E124) For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Prolonged release tablet. _Product imported from the UK_ Ovoid, biconvex, red film-coated tablets. 4 CLINICAL PARTICULARS As per PA1235/002/001 5 PHARMACOLOGICAL PROPERTIES As per PA1235/002/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Methylacrylate methylmethacrylate copolymer Magnesium stearate Povidone Macrogol 400 Macrogol 8000 Maize starch Purified talc Ethylcellulose Hypromellose Titanium Dioxide (E171) Dye Red Ponceau 4R Lake (E124) 6.2 INCOMPATIBILITIES Not applicable. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _3_ _/_ _0_ _5_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _2_ _0_ _3_ _5_ _7_ _5_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.3 SHELF LIFE The shelf life expiry date of this product is the date shown on the blister strips and outer carton of the product as marketed in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25°C. Store in the original package in order to protect from light and moisture. 6.5 NATURE AND CONTENTS OF CONTAINER Overlabelled cardboard outer containing blister strips. Each blister strip Прочетете целия документ