Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
gliclazide, Quantity: 60 mg
Servier Laboratories (Aust) Pty Ltd
Gliclazide
Tablet, modified release
Excipient Ingredients: magnesium stearate; lactose monohydrate; colloidal anhydrous silica; maltodextrin; hypromellose
Oral
60, 20
(S4) Prescription Only Medicine
Type II Diabetes in association with dietary measures when dietary measures alone are inadequate to control blood glucose. During controlled clinical trials in patients with type II diabetes, a modified release formulation of gliclazide (30 mg-120 mg), taken as a single daily dose, was shown to be effective long term in controlling blood glucose levels, based on monitoring of HbA1c.
Visual Identification: White oblong tablets. Break bar. DIA 60 on both faces; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2009-11-11
ARDIX ® GLICLAZIDE 60 MG MR _Modified Release tablets containing gliclazide (pronounced gli-cla-zide)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ARDIX GLICLAZIDE 60 mg MR. It does not contain all the available information Reading this leaflet 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 ARDIX GLICLAZIDE 60 mg MR against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR, PHARMACIST, OR DIABETES EDUCATOR. KEEP THIS LEAFLET WITH THE MEDICINE. YOU MAY NEED TO READ IT AGAIN. WHAT ARDIX GLICLAZIDE 60 MG MR IS The name of your medicine is ARDIX GLICLAZIDE 60 mg MR. ARDIX GLICLAZIDE 60 mg MR contains the active ingredient 'gliclazide'. Gliclazide belongs to a group of medicines called sulphonylureas. The medicine releases the active ingredient gliclazide progressively over 24 hours. WHAT ARDIX GLICLAZIDE 60 MG MR IS USED FOR ARDIX GLICLAZIDE 60 mg MR is used to control blood glucose (sugar) in patients with Type II diabetes mellitus. This type of diabetes is also known as non-insulin-dependent diabetes (NIDDM), or maturity-onset diabetes). _WHY ARDIX GLICLAZIDE 60_ _MG MR IS USED FOR TYPE II_ _DIABETES MELLITUS_ ARDIX GLICLAZIDE 60 mg MR is used when diet and exercise are not enough to control your blood glucose. ARDIX GLICLAZIDE 60 mg MR can be used alone or together with insulin or other medicines for treating diabetes. _HOW IT WORKS_ Glucose is used by the body as fuel, and all people have glucose circulating in their blood. In diabetes, levels of blood glucose are higher than is needed, which is also known as hyperglycaemia. If your blood glucose is not properly controlled, you may experience hypoglycaemia (low blood glucose) or hyperglycaemia (high blood glucose). High blood glucose can lead to serious problems with our heart, circulation and/or kidneys. It is very Lesen Sie das vollständige Dokument
AUSTRALIAN PRODUCT INFORMATION ARDIX ® GLICLAZIDE 60 MG MR TABLET, MODIFIED RELEASE Version: 8 1/14 AUSTRALIAN PRODUCT INFORMATION ARDIX ® GLICLAZIDE 60 MG MR 1 NAME OF THE MEDICINE Gliclazide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ARDIX GLICLAZIDE 60 mg MR tablet contains 60 mg of gliclazide. Gliclazide is an oral hypoglycaemic sulphonylurea which differs from other related compounds by an N-containing heterocyclic ring with an endocyclic bond. Excipient with known effect: each tablet contains 71.36 mg of lactose monohydrate. For the full list of excipients, see _section 6.1 - List of excipients_. 3 PHARMACEUTICAL FORM Tablet, modified release: white, oblong, scored with a break bar on both sides with an engraving of "DIA 60" on both faces. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Type II diabetes in association with dietary measures when dietary measures alone are inadequate to control blood glucose. During controlled clinical trials in patients with type II diabetes, a modified release formulation of gliclazide (30 mg - 120 mg), taken as a single daily dose, was shown to be effective long term in controlling blood glucose levels, based on monitoring of HbA1c. 4.2 D OSE AND METHOD OF ADMINISTRATION For adult use only. ARDIX GLICLAZIDE 60 mg MR tablets have a break bar and may be administered as whole or as half tablets (see _section 5.2 – Pharmacokinetic properties_). So that the modified release properties of the product can be maintained, tablets should not be chewed or crushed. Whole or half tablets of ARDIX GLICLAZIDE 60 mg MR should be taken with food because there is an increased risk of hypoglycaemia if a meal is taken late, if an inadequate amount of food is consumed or if the food is low in carbohydrate. It is recommended that the medication be taken at breakfast time. If a dose is forgotten, the dose taken on the next day should not be increased. A single daily dose provides an effective blood glucose control. The daily dose may vary from half a tablet to two tablets per day i. Lesen Sie das vollständige Dokument