País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Ferrous sulphate
Teofarma S.R.L.
B03AA; B03AA07
Ferrous sulphate
325 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 325 MG PROLONGED-RELEASE TABLETS DRIED FERROUS SULPHATE 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 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 Tablets are and what they are used for 2. Before you take Ferrograd Tablets 3. How to take Ferrograd Tablets 4. Possible side effects 5. How to store Ferrograd Tablets 6. Further information 1. WHAT FERROGRAD TABLETS ARE AND WHAT THEY ARE USED FOR The name of your tablets is Ferrograd Prolonged-Release Tablets. Ferrograd are prolonged release, film coated tablets which contain the active ingredient dried Ferrous Sulphate. Ferrograd is an iron supplement. Its use is described below. WHAT IS FERROGRAD USED FOR? Ferrograd is an iron supplement used to prevent and treat iron-deficiency anaemia. Ferrograd 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 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 several hours and reduces the likelihood of stomach irritation. The controlled-release system consists of a harmless plastic honeycomb with thousands of narrow passages containing iron. As the tablet passes through the stomach and gut the iron is released and the empty honeycomb is passed out in the stools. 2. BEFORE YOU TAKE FERROGRAD TABLETS DO NOT T Leia o documento completo
Health Products Regulatory Authority 22 May 2023 CRN00DKC4 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ferrograd 325mg Prolonged release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Dried Ferrous Sulphate 325mg (elemental iron 105mg) Excipients with known effect: Each tablet contains 19.4mg lactose monohydrate and sunset yellow FCF (E110). For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Prolonged release tablet. Circular, biconvex, red film-coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prevention and treatment of iron deficiency anaemias. 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. 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. Health Products Regulatory Authority 22 May 2023 CRN00DKC4 Page 2 of 5 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. Use in patients with haemochromatosis and iron overload syndromes. Use in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. 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 no other information. As with all iron preparations, this product should be u Leia o documento completo