Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
METFORMIN HYDROCHLORIDE; GLIBENCLAMIDE
MERCK SDN. BHD.
METFORMIN HYDROCHLORIDE; GLIBENCLAMIDE
120Tablet Tablets; 120 Tablets
MERCK SANTE S.A.S.
_Consumer Medication Information Leaflet (RiMUP) _ 1 GLUCOVANCE FILM COATED TABLET Metformin Hydrochloride/Glibenclamide ( 500/2.5mg, 500/5mg) WHAT IS IN THIS LEAFLET 1. What Glucovance is used for 2. How Glucovance works 3. Before you use Glucovance 4. How to take Glucovance 5. While you are using Glucovance 6. Side effects 7. Storage and disposable of Glucovance 8. Product description 9. Manufacturer and Product registration holder 10. Date of revision WHAT IS GLUCOVANCE USED FOR Glucovance is made up of two antidiabetic medicines, which belong to the groups of medicines called biguanide (metformin hydrochloride) and sulphonylurea (glibenclamide). Glucovance is taken orally for the treatment of type 2 diabetes mellitus in adult patients. It is used to replace the combination of the two active substances, metformin hydrochloride and glibenclamide given separately in patients previously treated with this combination. HOW GLUCOVANCE WORKS Insulin is a hormone that enables body tissues to take up glucose (sugar) from the blood and to use it for producing energy or to store it for future use. Patients with type 2 diabetes mellitus (i.e. non-insulin dependent diabetes) do not produce enough insulin in their pancreas or their body does not respond properly to the insulin it produces. This causes an increased level of glucose in the blood. Glucovance helps to reduce their blood sugar towards a normal level. BEFORE YOU USE GLUCOVANCE _When you must not use it _ Do not take Glucovance • if you are allergic (hypersensitive) to metformin hydrochloride, glibenclamide or other sulphonamides or any of the other ingredients of Glucovance • if you have kidney or liver function problems • if you have a severe infection (for example an infection of the air passages or an urinary tract infection) • if you suffer from type 1 diabetes mellitus (i.e. insulin-dependent) or if you have severe loss of diabetes control with either pre-coma or ketosis (a condition caused by substances called ‘ketone bodies’ accumulating in the Baca dokumen lengkap
NAME OF THE MEDICINAL PRODUCT GLUCOVANCE 500 mg/2.5 mg, film-coated tablets GLUCOVANCE 500 mg/5 mg, film-coated tablets Metformin hydrochloride and Glibenclamide QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 500 mg metformin hydrochloride, equivalent to 390 mg metformin, and 2.5 mg glibenclamide. Each film-coated tablet contains 500 mg metformin hydrochloride, equivalent to 390 mg metformin, and 5 mg glibenclamide. Excipients: Contains lactose, see Special warnings and precautions for use. For a full list of excipients, see List of excipients. PHARMACEUTICAL FORM Film-coated tablets are orange capsule-shaped, biconvex, with '2.5' engraved on one side. Film-coated tablets are yellow capsule-shaped, biconvex, with '5' engraved on one side. ROUTE OF ADMINISTRATION Oral CLINICAL PARTICULARS Therapeutic indications Glucovance is indicated as second-line therapy when diet, exercise, and initial treatment with a sulphonylurea or metformin do not result in adequate glycaemic control in patients with type 2 diabetes. Posology and method of administration General Consideration Dosage of Glucovance must be individualized on the basis of both effectiveness and tolerance while not exceeding the maximum recommended daily dose of 2000 mg metformin/20 mg glibenclamide. Glucovance should be given with meals with a sufficiently high carbohydrate content to prevent the onset of hypoglycaemic episode. Glucovance should be initiated at a low dose, with gradual dose escalation as described below, in order to avoid hypoglycaemia (largely due to glibenclamide), to reduce GI side effects (largely due to metformin), and to permit determination of the minimum effective dose for adequate control of blood glucose for the individual patient. With initial treatment and during dose titration, appropriate blood glucose monitoring should be used to determine the therapeutic response to Glucovance and to identify the minimum effective dose for the patient. Thereafter, HbA 1c (glycosylated haemoglobin) should be measured Baca dokumen lengkap