Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Ferrous sulfate; Sodium ascorbate
Teofarma S.R.L.
B03AA; B03AA07
Ferrous sulfate; Sodium ascorbate
325 mg/500 milligram(s)
Prolonged-release tablet
Product not subject to medical prescription
Iron bivalent, oral preparations; ferrous sulfate
Marketed
1980-04-01
PACKAGE LEAFLET: INFORMATION FOR THE USER FERROGRAD C 325 MG/500 MG PROLONGED-RELEASE TABLETS DRIED FERROUS SULPHATE/VITAMIN C 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 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. What Ferrograd C Tablets are and what they are used for 2. Before you take Ferrograd C Tablets 3. How to take Ferrograd C Tablets 4. Possible side effects 5. How to store Ferrograd C Tablets 6. Further information 1. WHAT FERROGRAD C TABLETS 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 several hours and reduces the likelihood of stomach irritation. The controlled release system consists of a harmless plas Aqra d-dokument sħiħ
Health Products Regulatory Authority 22 May 2023 CRN00DKC4 Page 1 of 5 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 325.0 mg (elemental iron 105 mg) Sodium ascorbate 562.4 mg (ascorbic acid/Vitamin C 500 mg) Excipients with known effect: Each tablet contains 23.4mg Dye Red Ponceau 4R Lake (E124) For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Prolonged release tablet. Ovoid, biconvex, two layered, red film-coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prevention and treatment of iron deficiency anaemia and for the simultaneous treatment of vitamin C deficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS: The recommended dosage is one tablet daily before food. CHILDREN: Not recommended for children under 12 years. Above this age, as for adults. ELDERLY: As for adults. The sustained release tablet and its plastic inert 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 an underlying disease process. METHOD OF ADMINISTRATION: 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. Use in patients with intestinal diverticular disease or any intestinal obstruction. • Individuals with haemochromatosis and iron overload syndromes. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The label will state "Important warning: Contains iron. Keep out of reach and sight of children, as overdose may be fatal". This will appear on the front of the pack within a rectangle in which there is n Aqra d-dokument sħiħ