Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
glimepiride, Quantity: 2 mg
Sanofi-Aventis Australia Pty Ltd
Tablet, uncoated
Excipient Ingredients: indigo carmine; sodium starch glycollate; lactose monohydrate; povidone; iron oxide yellow; magnesium stearate; microcrystalline cellulose
Oral
100 tablets, 10 tablets, 30 tablets, 50 tablets
(S4) Prescription Only Medicine
Amaryl is indicated as an adjunct to diet, exercise and weight loss, to lower the blood glucose in patients with non-insulin-dependent (type 2) diabetes mellitus.
Visual Identification: Green oblong, bi-planar scored tablets debossed with "NMM" and the Hoechst logo on both sides: 10 x 5mm.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1996-09-24
AMARYL ® _(AM-A(R)-RILL)_ _glimepiride (glim-epi-RIDE)_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Amaryl. 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 risks and benefits. Your doctor has weighed the risks of you taking Amaryl 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 AMARYL IS USED FOR Amaryl is used to control blood glucose in patients with type 2 diabetes mellitus. Amaryl is used when healthy eating and increased physical activity are not enough to control your blood glucose. Amaryl can be used alone, or together with insulin or other medicines for treating diabetes. _HOW IT WORKS_ Amaryl lowers high blood glucose by increasing the amount of insulin produced by your pancreas. Amaryl belongs to a group of medicines called sulfonylureas. If your blood glucose in not controlled properly, you may experience hypoglycaemia (low blood glucose - a "hypo") or hyperglycaemia (high blood glucose). Low blood glucose can occur suddenly. Signs may include: • weakness, trembling or shaking • sweating • lightheadedness, dizziness, headache or lack of concentration • tearfulness or crying • irritability • hunger • numbness around the lips and tongue If not treated promptly, these may progress to: • loss of co-ordination • slurred speech • confusion • loss of consciousness or seizures High blood glucose usually occurs more slowly than low blood glucose. Signs of high blood glucose may include: • lethargy or tiredness • headache • thirst • passing large amounts of urine • blurred vision High blood glucose can lead to serious problems with your heart, eyes, circulation or kidneys. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN P Read the complete document
amaryl-ccdsv14-piv12-23jun20 Page 1 of 15 AUSTRALIAN PRODUCT INFORMATION AMARYL (GLIMEPIRIDE) TABLET 1 NAME OF THE MEDICINE Glimepiride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Amaryl tablets contain 1 mg, 2 mg, 3 mg or 4 mg of glimepiride. Excipients with known effect: lactose monohydrate. For the full list of excipients, see Section 6.1, List of Excipients. 3 PHARMACEUTICAL FORM Tablet, uncoated 1 mg: Pink, oblong, scored tablets debossed with “NMK” and the Hoechst logo on both sides. 2 mg: Green, oblong, scored tablets debossed with “NMM” and the Hoechst logo on both sides. 3 mg: Pale yellow, oblong, scored tablets debossed with “NMN” and the Hoechst logo on both sides. 4 mg: Light blue, oblong, scored tablets debossed with “NMO” and the Hoechst logo on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amaryl is indicated as an adjunct to diet, exercise and weight loss, to lower the blood glucose in patients with non-insulin-dependent (type 2) diabetes mellitus. 4.2 DOSE AND METHOD OF ADMINISTRATION In the management of type 2 diabetes mellitus, administration of an oral antidiabetic agent is not a substitute for appropriate dietary control. In initiating treatment for type 2 diabetes mellitus, diet should be emphasised as the primary form of treatment. Caloric restriction and weight loss are essential in the obese diabetic patient. Proper dietary management alone may be effective in controlling the blood glucose and symptoms of hyperglycaemia. The importance of regular physical activity should also be amaryl-ccdsv14-piv12-23jun20 Page 2 of 15 stressed, and cardiovascular risk factors should be identified and corrective measures taken where possible. If this treatment program fails to reduce symptoms and/or blood glucose, the use of an oral sulfonylurea should be considered. Use of Amaryl must be viewed by both the physician and patient as a treatment in addition to diet, and not as a substitute for diet or as a convenient mechanism for avoiding dietary restraint. Furthermore, lo Read the complete document