País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ferrous fumarate
Advanz Pharma
B03AA02
Ferrous fumarate
322mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 09010101; GTIN: 5021691140016
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - 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. Fersaday 322mg Tablets was previously known as Fersaday 100mg Tablets. The product has been renamed to reflect the amount of ferrous fumarate instead of elemental iron content. The name of your medicine is Fersaday 322mg Tablets. It will be referred to as Fersaday Tablets for ease hereafter. WHAT IS IN THIS LEAFLET 1. What Fersaday Tablets are and what they are used for 2. What you need to know before you take Fersaday Tablets 3. How to take Fersaday Tablets 4. Possible side effects 5. How to store Fersaday Tablets 6. Contents of the pack and other information 1. WHAT FERSADAY TABLETS ARE AND WHAT THEY ARE USED FOR Fersaday Tablets contain a form of iron called ferrous fumarate. Iron is usually found in foods and is necessary for the normal development of red blood cells. A lack of iron affects the development of the red blood cells and causes iron deficiency anaemia. Fersaday Tablets are used to prevent or treat iron deficiency anaemia. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FERSADAY TABLETS DO NOT TAKE FERSADAY TABLETS IF: • You are allergic to Ferrous fumarate or any of the other ingredients of this medicine (listed in section 6), or to any other medicine containing iron • You have noticed blood in your urine • You suffer from any form of anaemia, other than iron deficiency anaemia, or from any other condition where your body’s iron is affected (your doctor will be able to advise you) • You have bronze markings on your skin or you have been told that you have incre Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fersaday 322mg Tablets Ferrous Fumarate 322mg Film-Coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 322.0mg Ferrous Fumarate BP (equivalent to approximately 100 mg ferrous iron) For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated Tablets Each film coated tablet is brown ochre in colour and engraved ‘FE’ on one face and ‘322’ on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis and treatment of iron deficiency states. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults and the elderly: One tablet daily (the foil enclosing the tablet is printed with days of the week in sequence). In severe or refractory iron deficiency, one tablet may be given twice a day. _Paediatric population:_ Ferrous Fumarate tablets are not intended for the treatment of children. Method of administration: Oral 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Paroxysmal nocturnal haemoglobinuria, haemosiderosis, haemochromatosis, active peptic ulcer, repeated blood transfusions, regional enteritis, and ulcerative colitis. Ferasday tablets must not be used in anaemias other than those due to iron deficiency. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Some post gastrectomy patients show poor absorption of iron. Care is needed when treating patients with iron deficiency anaemia in patients with treated or controlled peptic ulceration. Duration of treatment of uncomplicated iron deficiency anaemia should not usually exceed 6 months (or 3 months after reversal of the anaemia has been achieved). Since anaemia due to combined iron and vitamin B12 or folate deficiencies may be microcytic in type, patients with microytic anaemia resistant to therapy with iron alone should be screened for vitamin B12 or folate deficiency. Paediatric Population Ferrous Fumarate tablets should be kept out of the sight and reach of children. T Leer el documento completo