Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
gliclazide, Quantity: 60 mg
Lupin Australia Pty Limited
Tablet, modified release
Excipient Ingredients: povidone; calcium hydrogen phosphate dihydrate; hypromellose; magnesium stearate
Oral
20 tablets, 60 tablets
(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 to off-white oval shaped, bioconvex, uncoated tablet with a break line on both sides and debossed wtih 60 on one side of the break line on one surface.and plain on the other side; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2022-11-14
Gliclazide Lupin MR V1 1 GLICLAZIDE LUPIN MR CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING GLICLAZIDE LUPIN MR? Gliclazide Lupin MR contains the active ingredient gliclazide. Gliclazide Lupin MR is used to control blood glucose (sugar) in patients with type II diabetes mellitus when diet and exercise are not enough to control your blood glucose. For more information, see Section 1. Why am I using Gliclazide Lupin MR? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE GLICLAZIDE LUPIN MR? Do not use if you have ever had an allergic reaction to gliclazide or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Gliclazide Lupin MR? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Gliclazide Lupin MR and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE GLICLAZIDE LUPIN MR? Swallow the tablet(s) as prescribed by your physician with a glass of water at the same time-usually with breakfast. More instructions can be found in Section 4. How do I use Gliclazide Lupin MR? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING GLICLAZIDE LUPIN MR? THINGS YOU SHOULD DO • Remind any doctor, dentist, pharmacist, or diabetes educator you visit that you are using gliclazide. • Check your blood glucose levels regularly to know if your diabetes is being controlled properly. THINGS YOU SHOULD NOT DO • Do not stop using this medicine or change the dosage, without checking with your doctor. • Do not skip meals while taking Gliclazide Lupin MR. DRIVING OR USING MACHINES • Gliclazide Lupin MR may cause dizziness and drowsiness in some people. Przeczytaj cały dokument
AUSTRALIAN PRODUCT INFORMATION – GLICLAZIDE LUPIN MR (GLICLAZIDE) MODIFIED RELEASE TABLET 1 NAME OF THE MEDICINE Gliclazide. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Gliclazide Lupin MR tablet contains 60 mg gliclazide. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Modified release tablet: Gliclazide Lupin MR 60 mg tablets: White to off white, oval shaped, biconvex, uncoated tablet with a breakline on both sides and debossed with ’60’ on one side of the breakline on one surface and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC 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 DOSE AND METHOD OF ADMINISTRATION For adult use only. Gliclazide Lupin MR 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 Gliclazide Lupin 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. Gliclazide Lupin MR v1 Page 2 of 14 (gliclazide) modified release tablet A single daily dose provides an effective blood glucose control. The daily dose may vary from half a tablet to two tablets per day, ie. 30 mg to 120 mg taken orally. The initial recommended dose is half a tablet (30 mg), even in elderly patients (≥65 years). The daily dose should Przeczytaj cały dokument