Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
metformin hydrochloride, Quantity: 1000 mg
Cipla Australia Pty Ltd
Tablet, film coated
Excipient Ingredients: maize starch; povidone; colloidal anhydrous silica; magnesium stearate; hypromellose; titanium dioxide; propylene glycol; macrogol 6000; purified talc; sodium starch glycollate type A
Oral
20, 28, 30, 56, 60, 100, 10, 14, 90
(S4) Prescription Only Medicine
Metformin is indicated in the treatment of type 2 diabetes mellitus in adults, children from 10 years of age and adolescents, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. For adult patients, metformin may be used as initial treatment or in sulfonylurea failures either alone or in combination with a sulfonylurea and other oral agents or as adjuvant therapy in insulin requiring type 2 diabetes.
Visual Identification: White to off white, oval shaped, biconvex tablets debossed with '10' and '00' on either side of deep notch on one side and breakline on other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2019-03-29
APO METFORMIN _contains the active ingredient metformin hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about medicine. It does not contain all the available Information. It does not take the place of talking to your doctor, pharmacist or diabetes educator. All medicines have benefits and risks. Your doctor has weighed the risks of you taking this medicine against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR, PHARMACIST OR DIABETES EDUCATOR. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT IT IS USED FOR It is used to control blood glucose (the amount of sugar in the blood) in people with diabetes mellitus. It can be used in type 2 diabetes in adults and children over 10 years of age. It is especially useful in those who are overweight, when diet and exercise are not enough to lower high blood glucose levels. (hyperglycaemia). For adult patients, APO Metformin be used alone, or in combination with other oral diabetic medicines or in combination with insulin in insulin requiring type 2 diabetes. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. It is available only with a doctor's prescription. There is no evidence it is addictive. _ _ _HOW IT WORKS _ _ _ It belongs to a group of medicines called biguanides. It lowers high blood glucose (hyperglycaemia) by helping your body make better use of the insulin produced by your pancreas. People with type 2 diabetes are unable to make enough insulin or their body does not respond properly to the insulin it does make. This causes a build up of glucose in the blood, which can lead to serious medical problems. Long-term hyperglycaemia can lead to heart disease, blindness, kidney damage, poor blood circulation and gangrene. Signs of hyperglycaemia may include: • tiredness or lack of energy • headache • thirst • passing large amounts of Lue koko asiakirja
PRODUCT INFORMATION-AUSTRALIA APO METFORMIN (REV-01/03-2020) 1 AUSTRALIAN PRODUCT INFORMATION - APO-METFORMIN 500, 850 & 1000 (METFORMIN HYDROCHLORIDE) 1 NAME OF THE MEDICINE Metformin hydrochloride. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Metformin Hydrochloride 500 mg tablet contains 500 mg of metformin hydrochloride. Each Metformin Hydrochloride 850 mg contains 850 mg of metformin hydrochloride. Each Metformin Hydrochloride 1000 mg contains 1000 mg of metformin hydrochloride. The tablets are gluten free. For full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM METFORMIN 500 MG, 850 MG AND 1000 MG 500 MG: Metformin hydrochloride 500 mg tablet: White coloured film coated round biconvex tablets with “500” debossing. 850 MG: Metformin hydrochloride 850 mg tablet: White coloured film coated round biconvex tablets with “850” debossing. 1000 MG: Metformin hydrochloride 1000 mg tablet: White to off white film coated, oval shaped, biconvex tablets debossed with ‘C’ and ‘36’ on either side of deep notch on one side and breakline on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Metformin is indicated in the treatment of type 2 diabetes mellitus in adults, children from 10 years of age and adolescents, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. For adult patients, metformin may be used as initial treatment or in sulfonylurea failures either alone or in combination with a sulfonylurea and other oral agents or as adjuvant therapy in insulin requiring type 2 diabetes. 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 THE USE OF HIGH DOSES OF METFORMIN ABOVE 2 G PER DAY. PRODUCT INFORMATION-AUSTRALIA APO METFORMIN (REV-01/03-2020) 2 It is important that the tablets are taken in divided doses with meals. Half tablet doses of the 1000 mg tablet may be administer Lue koko asiakirja