País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Ferrous sulphate; Folic acid
Teofarma S.R.L.
B03AD; B03AD03
Ferrous sulphate; Folic acid
325 mg/0.35 milligram(s)
Prolonged-release tablet
Product not subject to medical prescription
Iron in combination with folic acid; ferrous sulfate
Marketed
1980-04-01
PACKAGE LEAFLET: INFORM ATION FOR THE USER FERROGRAD FOLIC 325 MG/0.35 MG PROLONGED-RELEASE TABLETS DRIED FERROUS SULPHATE/FOLIC ACID 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 Folic Tablets 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. W hat Ferrograd Folic Tablets are and what they are used for 2. Before you take Ferrograd Folic Tablets 3. How to take Ferrograd Folic Tablets 4. Possible side effects 5. How to store Ferrograd Folic Tablets 6. Further information 1. WHAT FERROGRAD FOLIC TABLETS ARE AND WHAT THEY ARE USED FOR The name of your tablets is Ferrograd Folic Prolonged-Release Tablets. Ferrograd Folic are prolonged release, film coated tablets. The active ingredients in Ferrograd Folic are: Dried Ferrous Sulphate and Folic Acid. Ferrograd Folic is a combined iron and folic acid supplement. Its use is described below. WHAT IS FERROGRAD FOLIC USED FOR? Ferrograd Folic is an iron and folic acid supplement used to prevent and treat iron-deficiency anaemia and to prevent anaemia due to folic acid deficiency. Ferrograd Folic 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 Folic can be used by pregnant women, but only after the first thirteen weeks of pregnancy. A controlled-release system in the tablet allows release of the iron over a number of hours and reduces the likelihood of stomach irritation. The controlled-release system consists of a harmless plastic hon Leia o documento completo
Health Products Regulatory Authority 28 January 2019 CRN008LVN Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ferrograd Folic 325mg/0.35mg Prolonged release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Dried Ferrous Sulphate 325 mg (elemental iron 105 mg) Folic Acid 0.35mg (350 micrograms) Excipients with known effect: Each tablet contains 2 mg Dye Red Ponceau 4R Lake (E124), 30 mg sucrose and 257 mg lactose monohydrate. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Prolonged release tablet. Circular biconvex, 2 layered, red and yellow film-coated tablet 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prophylaxis and treatment of iron and folic acid deficiencies and if used in pregnancy should be used after the first 13 weeks of pregnancy only. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS: The recommended dosage is one tablet daily before food. CHILDREN: Not applicable. ELDERLY: As for adults. The sustained release tablet and its inert plastic matrix may cause a safety hazard in some elderly or other patients suffering from delayed intestinal transit. * Medical advice should be sought if symptoms do not improve after four weeks of use of this product as these symptoms may reflect on underlying disease process. METHOD OF ADMINISTRATION: Health Products Regulatory Authority 28 January 2019 CRN008LVN Page 2 of 7 The tablets should not be sucked, chewed or kept in the mouth, but swallowed whole with water. Tablets should be taken before meals or during meals, depending on gastrointestinal tolerance. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Ferrograd Folic should not be used in the presence of megablastic anaemia due to primary vitamin B12 deficiency or any undiagnosed anaemia. Use in patients with intestinal diverticular or any intestinal obstruction. • Individuals with haemochromatosis and iron overload syndromes. Patients with rare hereditary Leia o documento completo