Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Iron (III) Hydroxide polymaltose complex
UNIMED SDN BHD
Iron (III) Hydroxide polymaltose complex
30 Capsules
XL Laboratories Pvt. Ltd.
_Consumer Medication Information Leaflet (RiMUP) _ 1 HAEMO XL CAPSULE (IRON (III) HYDROXIDE POLYMALTOSE COMPLEX 370MG EQ. TO ELEMENTAL IRON 100MG) WHAT IS IN THIS LEAFLET 1. What _Haemo XL Capsule _ is used for 2. How _Haemo XL Capsule _ works _3._ _ _ Before you use _Haemo XL _ _Capsule _ _4._ _ _ How to use _Haemo XL Capsule _ 5. While you are using it 6. Side effects _7._ _ _ Storage and Disposal of _Haemo _ _XL Capsule _ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT IS _HAEMO XL CAPSULE _USED FOR _Haemo XL Capsule _ contains Iron (III) Hydroxide Polymaltose Complex. It is used for treatment & prevention of Iron deficiency in pregnancy (after first 13 weeks) and Iron deficiency anaemia. HOW _HAEMO XL CAPSULE _WORKS _Haemo XL Capsule _ is involved in the formation and functioning of red blood cells. BEFORE YOU USE _HAEMO XL CAPSULE _ - _When you must not use it _ • If you are allergic to iron or any of the ingredients in _Haemo XL _ _Capsule. _ • If you are having hemosiderosis, hemochromatosis, thalassemia, sideroachresticanaemia, or lead- induced anaemia. • If you are having anaemia not caused by iron deficiency (haemolyticanaemia or megaloblastic anaemia due to vitamin B12 deficiency Do not use this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using _Haemo XL _ _Capsule_ . - _Before you start to use it _ Please make sure you have understood the explanation given by your doctor or pharmacist before taking this medicine. Speak to your doctor/pharmacist if you have one of following conditions: • If you have hemosiderosis, hemochromatosis, thalassemia, sideroblastic anaemia, chronic haemolysis, or lead-induced anaemia. - _Taking other medications _ Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription, herbal medicines, dietary supplements or vitamins. This is especially Soma hati kamili
PL00000-00 Size: 165x120 mm 165.00 mm 120.00 mm COMPOSITION: Each hard gelatin capsule contains: Iron (III) Hydroxide Polymaltose Complex Eq. to elemental Iron 100mg PHARMACODYNAMICS: The polynuclear iron (III)-hydroxide cores are supercially surrounded by a number of non-covalently bound polymaltose molecules resulting in an overall complex molecular mass (Mw) of approximately 50 kD, which is so large that diffusion through the membrane of mucosa is about 40 times smaller than that of the hexaqua-iron(II) units. The complex is stable and does not release ionic iron under physiological conditions. The iron in the poly-nuclear cores is bound in a similar structure as in the case of physiologically occurring ferritin. Due to this similarity, only the iron (III) of the complex is absorbed by an active absorption process. By means of competitive ligand exchange, any iron binding protein in the gastro- intestinal uid and on the surface of the epithelium, take up iron (III). The absorbed iron is stored mainly in the liver, where it is bound to ferritin. Later in the bone marrow, it is incorporated into haemoglobin. Iron (III)-Hydroxide Polymaltose Complex has no pro-oxidative properties such as there are in iron II) salts. The susceptibility of lipoproteins such as Very Low Density Lipoprotein (VLDL) + Low Density Lipoprotein (LDL) to oxidation is reduced. Iron (III) Hydroxide Polymaltose Complex does not cause teeth staining. PHARMACOKINETICS: Studies using the twin-isotope technique (55Fe and 59Fe) show that absorption of iron measured as haemoglobin in erythrocytes is inversely proportional to the dose given (the higher the dose, the lower the absorption). There is a statistically negative correlation between the extent of iron deciency and the amount of iron absorbed (the higher the iron deciency, the better the absorption). The highest absorption of iron is in the duodenum and jejunum. Iron which is not absorbed is excreted via the faeces. Excretion via the exfoliation of the epithelial cells of the ga Soma hati kamili