Страна: Малайзия
Язык: английский
Источник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
IRON
ZUELLIG PHARMA SDN BHD
IRON
30 Tablets
Corden Pharma Fribourg SA
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 MALTOFER _® _ CHEWABLE TABLET Iron (100mg) WHAT IS IN THIS LEAFLET 1. What Maltofer® Chewable Tablet is used for 2. How Maltofer® Chewable Tablet works 3. Before you use Maltofer® Chewable Tablet 4. How to use Maltofer® Chewable Tablet 5. While you are using it 6. Side Effects 7. Storage and Disposal 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT MALTOFER® CHEWABLE TABLET IS USED FOR Maltofer® Chewable Tablet is used to treat iron deficiency without or with anemia(lack of red blood cells). It is also used as prevention therapy during pregnancy to avoid iron deficiency HOW MALTOFER® CHEWABLE TABLET WORKS Maltofer® Chewable Tablet contains iron which is used to help in the formation and function of red blood cells. BEFORE YOU USE MALTOFER® CHEWABLE TABLET - _Do not take this medicine if you: _ _ _ • are allergic to iron or to any of the other ingredients (listed in product description) _ _ • have iron overload in the body • have iron utilisation disorders • have anaemia which is not caused by iron deficiency because Maltofer® Chewable Tablet will not be effective. _ _ _Before you start to use it _ • Your doctor will want to monitor the progress of your treatment with periodic follow- up examinations and may even carry out blood tests. This is normal and should not alarm you. • Tell your doctor or pharmacist before taking Maltofer® Chewable Tablet if you have an infection or a tumour. _ _ _ _ _Pregnancy and lactation _ • Please consult your doctor or pharmacist if you are pregnant, planning for pregnancy or breast-feeding before using any medicine. - _Taking other medicine _ • Tell your doctor or pharmacist if you have recently been treated with injectable iron preparations or might be treated with these. Using such iron preparations at the same time as Maltofer® Chewable Tablet is not recommended. • Tell your doctor if you are taking any other medicines, including any that you buy wi Прочитать полный документ
PRODUCT Maltofer Chewable tablets COUNTRY Malaysia MANUFACTURER VIF SAP NUMBER 3005247-04S MIN. VER.: 02 MANUFACTURER IDENTIFICATION NUMBER n/a FONTS Helvetica (min. 9 pt) DIMENSIONS 180 x 320 mm COLOURS/FLATS Black NON-PRINTED COLOURS Dye Cut ID: 2304-040 3005247-04 Chewable tablets Pharmaceutical form: chewable tablets, chocolate flavour Qualitative and quantitative composition Each chewable tablet contains 100 mg of iron as iron(III)-hydrox- ide polymaltose complex (IPC). Excipients: microcrystalline cellulose, cocoa, sodium cyclamate, polyethylene glycol 6000, talc, vanillin, dextrates, chocolate essence. Properties Pharmacotherapeutical group: iron preparation. ATC Code: B03AB05 In the iron(III)-hydroxide polymaltose complex, the polynuclear iron(III)-hydroxide core is superficially surrounded by a number of non-covalently bound polymaltose molecules resulting in an over- all average molecular weight of approximately 50 kDa. The polynu- clear core of IPC has a structure similar to that of the physiological iron storage protein, ferritin. IPC is a stable complex and does not release large amounts of iron under physiological conditions. Because of its size, the extent of diffusion of IPC through the mem- brane of the mucosa is about 40 times less than that of the hexa- quo-iron(II) complex. Iron from IPC is taken up in the gut via an active mechanism. Therapeutic Indications Treatment of iron deficiency without anaemia and iron deficiency anaemia. Prophylactic therapy of iron deficiency during pregnancy. Posology Dosage and duration of therapy are dependent upon the extent of iron deficiency. Treatment of iron deficiency anaemia in children over 12 years and adults: 100 mg to 300 mg iron (1–3 chewable tablets) daily for 3–5 months until normalisation of the haemoglobin value is achieved. After- wards, the therapy should be continued for several weeks with 1 chewable tablet daily to replen- ish the iron stores. Treatment of iron deficiency anaemia in pregnancy: 200 mg to 300 mg iron (2–3 tablets) daily un Прочитать полный документ