Χώρα: Νέα Ζηλανδία
Γλώσσα: Αγγλικά
Πηγή: Medsafe (Medicines Safety Authority)
Metformin hydrochloride 850mg; ; ; Metformin hydrochloride 850mg
Viatris Limited
Metformin hydrochloride 850 mg
850 mg
Film coated tablet
Active: Metformin hydrochloride 850mg Excipient: Dri-Klear Magnesium stearate Povidone Active: Metformin hydrochloride 850mg Excipient: Magnesium stearate Opadry clear 20C59060 Povidone
Prescription
Exemed Pharmaceuticals
· 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 · Metformin may be used as initial treatment or in sulfonylurea failures either alone or in combination with a sulfonylurea and other oral agents. · Adjuvant therapy in insulin dependent diabetes especially if overweight.
Package - Contents - Shelf Life: Bottle, plastic, , HDPE with Polyproplyene screw caps - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, , HDPE with Polyproplyene screw caps - 100 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, , HDPE with Polyproplyene screw caps - 250 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, , HDPE with Polyproplyene screw caps - 500 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, , HDPE with Polyproplyene screw caps - 1000 tablets - 36 months from date of manufacture stored at or below 25°C
2013-06-10
Page 1 of 5 NEW ZEALAND CONSUMER MEDICINE INFORMATION METFORMIN VIATRIS _METFORMIN HYDROCHLORIDE, FILM COATED TABLETS, 500 & 850 MG_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Metformin Viatris. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Metformin Viatris against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT METFORMIN VIATRIS IS USED FOR Metformin Viatris is used to control blood glucose (the amount of sugar in the blood) in people with type 2 diabetes mellitus. This type of diabetes is also known as non-insulin-dependent diabetes mellitus (NIDDM) or maturity onset diabetes. Metformin Viatris is used when diet and exercise are not enough to control your blood glucose. It can be used alone, or together with other medicines for treating diabetes. Metformin Viatris contains the active ingredient metformin hydrochloride. It belongs to a group of medicines called biguanides. It works by reducing liver glucose (sugar) production, increasing insulin sensitivity in the muscles and delaying the absorption of glucose from the intestinal tract. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor’s prescription. This medicine does not cause hypoglycaemia (low blood sugar) and is not expected to affect your ability to drive a car or operate machinery. However there is a risk of hypoglycaemia when Metformin Viatris is used in combination with other antidiabetic medicines (see Taking other medicines). Metformin Viatris is not recommended for use in children. BEFORE YOU TAKE METFORMIN VIATRIS _WHEN YOU MUST NOT TAKE _ _IT_ DO NOT TAKE METFOR Διαβάστε το πλήρες έγγραφο
Page 1 of 12 NEW ZEALAND DATA SHEET METFORMIN VIATRIS 1. PRODUCT NAME Metformin Viatris, 500 mg, 850 mg & 1000 mg, film coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 500 mg, 850 mg or 1000 mg of metformin hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Metformin Viatris 500 mg: White, round, normal convex, film coated tablet, plain on both sides. Metformin Viatris 850 mg: White, round, normal convex, film coated tablet, plain on both sides. Metformin Viatris 1000 mg: White, oval, film coated tablet, debossed “MF” and “3” on either side of the break line on one side and “G” on the other side. Do not halve the 500 mg and 850 mg tablets. Dose equivalence when the tablet is divided has not been established. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS_ • 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. • Metformin may be used as initial treatment or in sulfonylurea failures either alone or in combination with a sulfonylurea and other oral agents. • Adjuvant therapy in insulin dependent diabetes especially if overweight. _4.2_ _DOSE AND METHOD OF ADMINISTRATION_ LIFE THREATENING LACTIC ACIDOSIS CAN OCCUR DUE TO ACCUMULATION OF METFORMIN. RISK FACTORS INCLUDE RENAL IMPAIRMENT, OLD AGE AND DOSES OF METFORMIN ABOVE 2 G PER DAY (SEE SECTION 4.4). DOSE _MONOTHERAPY AND COMBINATION WITH OTHER ORAL ANTIDIABETIC AGENTS IN ADULTS WITH NORMAL RENAL _ _FUNCTION_ Initially 500 mg should be taken once or twice a day and, if necessary, increased over a few weeks up to a maximum of 1 g three times per day. The dose should be titrated with gradual dose increments until the desired effect is obtained. 500 mg three times a day is often sufficient to obtain diabetic control. Control may be attained within a few days but occasionally requires up to two weeks. Once control has been obtained, the dosage Διαβάστε το πλήρες έγγραφο