Maa: Malesia
Kieli: englanti
Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Mecobalamin
IDAMAN PHARMA MANUFACTURING SDN BHD
Mecobalamin
500 Tablets
IDAMAN PHARMA MANUFACTURING SDN BHD
_Consumer Medication Information Leaflet (RiMUP)_ CITREX MECOLAMIN 500MCG TABLET Mecobalamin 1 WHAT IS IN THIS LEAFLET: 1. What Citrex Mecolamin 500mcg Tablet is used for? 2. How Citrex Mecolamin 500mcg Tablet works 3. Before you use Citrex Mecolamin 500mcg Tablet 4. How to use Citrex Mecolamin 500mcg Tablet 5. While you are using Citrex Mecolamin 500mcg Tablet 6. Side Effects 7. Storage and Disposal of Citrex Mecolamin 500mcg Tablet 8. Product Description 9. Product Registration Holder and Manufacturer 10. Date of Revision WHAT CITREX MECOLAMIN 500MCG TABLET IS USED FOR? Citrex Mecolamin 500mcg Tablet contains the active ingredient Mecobalamin. Citrex Mecolamin 500mcg Tablet is used in the treatment of peripheral neuropathies (damage to peripheral nerves). HOW CITREX MECOLAMIN 500MCG TABLET WORKS? Mecobalamin is a coenzyme of Vitamin B12. It plays an important role in assisting the restoration process of damaged nerve cells and also in maintaining proper functioning of nerve cells. BEFORE YOU USE CITREX MECOLAMIN 500MCG TABLET _Do not take if you_ • Have ever had a reaction or been told that you are allergic to Mecobalamin or any of the other ingredient in this preparation. _Before you start to take it_ Tell your doctor if you have allergies to any other medicines, foods, preservative or dyes. Tell your doctor if: • Your occupation required you to handle mercury or its compound. If you are not sure whether you should start taking this medicine, talk to your doctor. _ _ _ _ _ _ _ _ _Taking other medicines _ Inform your doctor or pharmacist if you are taking or if you have recently taken any other medicines, including medicines obtained without a prescription. Some medicines and Citrex Mecolamin 500mcg Tablet may interfere with each other. It is important to tell your doctor or pharmacist if you are taking: • Antibiotics e.g. chloramphenicol _, _ neomycin, aminosalicylic _ _ acid and aminoglycosides group e.g. gentamicin. • Medicine for gastric ulcers e.g. cimetidine, ranitidine. • Medicine for epilepsy Lue koko asiakirja
IDAMAN PHARMA MANUFACTURING SDN BHD CITREX MECOLAMIN 500MCG TABLET PRODUCT DESCRIPTION Round,film coated tablet and plain on both sides. Colour: Pink Each tablet contains Mecobalamin 500 mcg Source of Lactose: Bovine ROUTE OF ADMINISTRATION Oral PHARMACODYNAMICS Vitamin B12 in the form of Mecobalamin is a cofactor in the methionine synthase reaction. The enzyme converts homocysteine to methionine. Methionine is a precursor of S- adenosylmethionine (SAMe). SAMe is the principal transmethylating agent and involved in among many other things, the synthesis of myelin basic protein. Abnormal myelin basic protein resulting in defective myelination, is thought to be responsible for many of the neurological effects of B12 deficiency. B12 deficiency results in decreased formation of thymidylic acid and purine nucleotides, precursors of DNA synthesis and which are necessary for normal cell division. Mecobalamin acts to repair damaged nerve tissue in nerve disorder e.g., axonal degeneration and demyelination and it is involved in erythroblast maturation, promotion of erythroblast division, and heme synthesis, thus acting to improve the status of the blood in megaloblastic anemia. PHARMACOKINETICS Single Dose Administration: After oral administration of single dose of 500 mcg and 1500 mcg of Mecobalamin to healthy adult subjects, dose related peak plasma concentrations were both achieved after 3 hours. From 40- 80% of the cumulative amount of total B12 recovered in the urine by 24 hours after oral administrations were excreted within the first 8 hours. Repeated-Dose Administration: The percentage increase in the plasma concentration of total B12 were determined in healthy subjects given an oral daily dose of 1500 mcg of Mecobalamin for 12 consecutive weeks. The changes in the plasma level were also measured in the same patients for a period of the first 4 weeks after the last administration. The plasma concentration increased for the first 4 weeks after administration, reaching twice as high as the initial concentration. The Lue koko asiakirja