Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Calcium Pantothenate; Cyanocobalamin; PYRIDOXINE HCL/VITAMIN B6; RIBOFLAVINE; THIAMINE MONONITRATE; Nicotinamide
ZONTRON PHARMACEUTICALS SDN. BHD.
Calcium Pantothenate; Cyanocobalamin; PYRIDOXINE HCL/VITAMIN B6; RIBOFLAVINE; THIAMINE MONONITRATE; Nicotinamide
100Tablet Tablets; 30Tablet Tablets
TERAPUTICS SDN BHD
_ _ _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ SATISPLEX TABLET Nicotinamide/Thiamine Mononitrate/Riboflavine/Calcium Panthothenate/Pyridoxine Hydrochloride/Cyanocobalamine_ _ (50mg/10mg/5mg/3mg/1mg/1mcg)_ _ ____________________________________________________________________________________________________________ __________________________________________________________________________________________________ 1 WHAT IS IN THIS LEAFLET 1. What Satisplex Tablet is used for 2. How Satisplex Tablet works 3. Before you use Satisplex Tablet 4. How to use Satisplex Tablet 5. While you are using it 6. Side Effects 7. Storage and Disposal of Satisplex Tablet 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT SATISPLEX TABLET IS USED FOR It is used for prevention and treatment of vitamin deficiency. HOW SATISPLEX TABLET WORKS Satisplex Tablet contains six types of Vitamin B which are Cyanocobalamin (B12), Riboflavin (B2), Thiamine Mononitrate (B1), Calcium Pantothenate (B5), Nicotinamide (B3) and Pyridoxine Hydrochloride (B6). These will replenish the deficiency of Vitamin B in the body. BEFORE YOU USE SATISPLEX TABLET _-When you must not use it _ Do not use Satisplex Tablet: if you are hypersensitive to thiamine, pyridoxine, cyanocobalamin, niacin / niacinamide, or any of the ingredients contained in Satisplex Tablet. if you have Wernicke's encephalopathy (a nervous system disease due to lack of vitamin B1 deficiency) If you have following medical conditions, please consult your doctor or pharmacist before taking this medication: Diabetes Gout Liver disease or a history of liver disease such as jaundice Bleeding disorders or glaucoma Low blood pressure Stomach or intestinal ulcer Kidney problems _ _ _- Before you start to use it _ Tell your doctor or pharmacist if you: are pregnant, planning to get pregnant, or breastfeeding. _ _ _-Taking other medicines _ Inform your doctor or pharmacist before taking this medicine, includin Прочетете целия документ
PRODUCT LITERATURE SATISPLEX TABLET EACH TABLET CONTAINS Nicotinamide 50.00mg Thiamine Mononitrate 10.00mg Riboflavine 5.00mg Calcium Panthothenate 3.00mg Pyridoxine HCl 1.00mg Cyanocobalamine 1.00mcg PRODUCT DESCRIPTION Round yellow-coloured sugar-coated tablet INDICATION For prevention and/or treatment of vitamin deficiency. RECOMMENDED DOSE Adult : 1 tablet, 2 or 3 times daily after meals ROUTE OF ADMINISTRATION Oral CONTRAINDICATION _Risk-benefit should be considered when the following medical problems exist: _ _ _ Thiamine Sensitivity to thiamine Wernicke's encephalopathy (intravenous glucose loading may precipitate or worsen this condition in thiamine-deficient patients; thiamine should be administered prior to glucose) Pyridoxine Sensitivity to pyridoxine Cyanocobalamin Sensitivity to cyanocobalamin Nicotinamide Arterial bleeding or hemorrhage or Glaucoma (these conditions may be exacerbated) Diabetes mellitus (large doses of niacin may cause impaired glucose tolerance; adjustment of diet and/or hypoglycemic therapy may be necessary) Gout (large doses may cause hyperuricemia) Hepatic disease (large doses may cause hepatic damage) Hepatobiliary disease, history of or Jaundice, history of (patients with a past history of these medical problems should be closely observed during niacin extended- release therapy; frequent monitoring of liver function tests and blood glucose is recommended) Hypotension (may worsen due to vasodilating effects of niacin) Peptic ulcer (large doses may activate peptic ulcer) Renal dysfunction (caution is advised when niacin extended-release is used in patients with renal dysfunction; increased drug exposure may result due to decreased renal elimination of niacin and metabolites) _ _ _Except under special circumstances, this medication should not be used when _ _the following medical problems exists: _ _ _ NOTE: These medical problems are contraindications for niacin extended-release due to the higher doses used to treat hyperli Прочетете целия документ