País: Malásia
Língua: inglês
Origem: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
METFORMIN HYDROCHLORIDE
APEX PHARMACY MARKETING SDN. BHD.
METFORMIN HYDROCHLORIDE
100Tablet Tablets
DELORBIS PHARMACEUTICALS LTD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ GLUCON TABLET _ _ Metformin (500mg & 850mg) 1 WHAT IS IN THIS LEAFLET 1. What Glucon is used for 2. How it works 3. Before you use Glucon 4. How to use Glucon 5. While you are using it 6. Side Effects 7. Storage and Disposal of Glucon 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of Revision WHAT GLUCON IS USED FOR GLUCON belongs to a group of medicines called biguanides. It is indicated for treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. GLUCON may be used: - In adults, as monotherapy or in combination with other oral anti-diabetic agents or with insulin. - In children from 10 years of age and adolescents, as monotherapy or in combination with insulin. Ask your doctor why you have to take this medicine. HOW GLUCON WORKS In type 2 diabetes, there is too much sugar (glucose) in your blood. This is because your body does not make enough insulin or because it makes insulin that does not work properly. Insulin is a hormone that allows your body tissue to take glucose from the blood and use it for energy or for storage for future use. Metformin works by improving the sensitivity of your body to insulin. It helps your body to use glucose in the normal way again. BEFORE YOU USE GLUCON _- When you must not use it _ DO NOT TAKE GLUCON In case of: Hypersensitivity to metformin hydrochloride or to any of the excipients Serious problems with your diabetes in the past called diabetic ketoacidosis. When you have this you lose weight quickly, feel sick (nausea) or are sick (vomiting) Liver or kidney problems Recently had a severe infection, injury or trauma (shock) Dehydrated Going to have an X-ray where you will be injected with a dye Recently had a heart attack or any heart problems Severe circulation problems or difficulty in breathing Heavy drinker of alcohol Pregnancy or Leia o documento completo
_GLUCON TABLET 500MG_ _GLUCON TABLET 850MG_ COMPOSITION _GLUCON TABLET 500MG_ contains Metformin HCI 500mg _GLUCON TABLET 850MG_ contains Metformin HCI 850mg DESCRIPTION _GLUCON TABLET 500MG:_ White coloured, film-coated, round, biconvex tablets, 11.0 mm diameter, with breakline on one side. _GLUCON TABLET 850MG: _ White, round, biconvex, film-coated tablets, 13.5mm diameter. PHARMACODYNAMICS Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose. It does not stimulate insulin secretion and therefore does not produce hypoglycaemia. Metformin may act via 3 mechanisms: (1) reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis (2) in muscle, by increasing insulin sensitivity, improving peripheral glucose, uptake and utilisation (3) and delay of intestinal glucose absorption. Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase. Metformin increases the transport capacity of all types of membrane glucose transporters (GLUT). In humans, independently of its action on glycaemia, metformin has favourable effects on lipid metabolism. This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: metformin reduces total cholesterol, LDL cholesterol and triglyceride levels. PHARMACOKINETICS _Absorption:_ After an oral dose of metformin, Tmax is reached in 2.5 hours. Absolute bioavailability of a 500mg or 850mg metformin tablet is approximately 50-60% in healthy subjects. After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%. After oral administration, metfomin absorption is saturable and incomplete. It is assumed that the pharmacokinetics of metformin absorption is non-linear. At the usual metformin doses and dosing schedules, steady state plasma concentrations are reached within 24 to 48 hours and are generally less than 1 μg/ml. In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 4 μg/ml, even at maximum doses Leia o documento completo