מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ferrous sulfate dried
NorthStar Healthcare Unlimited Company
B03AA07
Ferrous sulfate dried
200mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 09010101; GTIN: 5051089990107 5051089990091 5051089990381
PACKAGE LEAFLET: INFORMATION FOR THE USER FERROUS SULFATE TABLETS 200 MG ferrous sulfate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take/use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. • 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. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Ferrous Sulfate Tablets are and what they are used for 2. What you need to know before you take Ferrous Sulfate Tablets 3. How to take Ferrous Sulfate Tablets 4. Possible side effects 5. How to store Ferrous Sulfate Tablets 6. Contents of the pack and other information Ferrous Sulfate tablets belong to a group of medicines called iron supplements. These medicines work by replacing body iron. Iron is a mineral that the body needs to produce red blood cells. When the body does not get enough iron, it cannot produce the number of normal red blood cells needed to keep you in good health. This condition is called irondeficiency anaemia. Ferrous Sulfate tablets are used for the prevention and treatment of iron-deficiency anaemia. DO NOT TAKE Ferrous Sulfate Tablets and tell your doctor if you: • are ALLERGIC to the active substance, iron salts, or any of the other ingredients of this medicine (listed in section 6). • are receiving repeated BLOOD TRANSFUSIONS. • are receiving IRON INTRAVENOUSLY. • have a disorder in which there is EXCESSIVE ABSORPTION and STORAGE of IRON such as haemochromatosis. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR OR PHARMACIST before taking Ferrous Sulfate tablets if you have: • HAEMOLYTIC ANAEMIA • a BLOOD disease (haemoglobinopathy) • an IRON STORAGE or ABSORPTION disease • GASTROINTESTIN קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ferrous Sulfate Tablets 200mg. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ferrous sulfate 200mg equivalent to 65 mg ferrous iron. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Coated tablets 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Iron-deficiency anaemia 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: Prophylactic dose - one tablet daily. Therapeutic dose - one tablet 2-3 times daily. Elderly: The usual adult dose can be administered (see section 4.4). Children 6-12 years: Treatment: Children weighing > 22kg – one tablet daily. Children weighing > 44kg – one tablet twice daily. Children weighing > 66kg – one tablet three times daily. A liquid preparation maybe more appropriate for children. Children under 6 years or weighing less than 22kg:_ _ This medicine is not recommended. Method of administration: For oral 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 any ingredients in the formulation; patients receiving repeated blood transfusions; concomitant parenteral iron; haemochromatosis and other iron overload syndromes. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Administer with caution in patients with haemolytic anaemia, haemoglobinopathies, iron storage or iron absorption diseases, existing gastrointestinal disease. The label will state ‘Important warning: Contains iron. Keep out of the sight and reach 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. Patients with rare hereditary problems of galactose intolerance or fructose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product. Before starti קרא את המסמך השלם