Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Gliclazide
Les Laboratoires Servier
A10BB; A10BB09
Gliclazide
60 milligram(s)
Modified-release tablet
Product subject to prescription which may be renewed (B)
Sulfonamides, urea derivatives; gliclazide
Marketed
2009-12-18
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DIAMICRON MR 60 MG MODIFIED RELEASE TABLETS_ _ _Gliclazide _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What DIAMICRON MR 60 mg, modified release tablet is and what it is used for 2. What you need to know before you take DIAMICRON MR 60 mg, modified release tablet 3. How to take DIAMICRON MR 60 mg, modified release tablet 4. Possible side effects 5. How to store DIAMICRON MR 60 mg, modified release tablet 6. Contents of the pack and other information 1. WHAT DIAMICRON MR 60MG, MODIFIED RELEASE TABLET IS AND WHAT IT IS USED FOR DIAMICRON MR 60 mg, modified release tablet is a medicine that reduces blood sugar levels (oral antidiabetic medicine belonging to the sulfonylurea group). DIAMICRON MR 60 mg, modified release tablet is used in a certain form of diabetes (type 2 diabetes mellitus) in adults, when diet, exercise and weight loss alone do not have an adequate effect on keeping blood sugar at the correct level. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIAMICRON MR 60 MG, MODIFIED RELEASE TABLET DO NOT TAKE DIAMICRON MR 60 MG, MODIFIED RELEASE TABLET: - if you are allergic to gliclazide or any of the other ingredients of DIAMICRON MR 60 mg, modified release tablet (listed in section 6), or to other medicines of the same group (sulfonylurea), or to other related medicines (hypoglycaemic sulfonamides); - if you have insulin-dependent diabetes (type 1); - if you have ketone bodies and sugar in your urine (this may mean you have diabetic keto- acidosis Lugege kogu dokumenti
Health Products Regulatory Authority 03 March 2020 CRN008YXF Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT DIAMICRON MR 60 mg modified-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One modified release tablet contains gliclazide 60 mg Excipients with known effect: lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Modified release tablet. White, oblong, tablet, scored and engraved, with ‘DIA 60’ on both faces. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Non insulin-dependent diabetes (type 2) in adults when dietary measures, physical exercise and weight loss alone are not sufficient to control blood glucose. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The daily dose of DIAMICRON MR 60 mg may vary from one half to 2 tablets per day, _i.e_.from 30 to 120 mg taken orally in a single intake at breakfast time. It is recommended to swallow the dose without crushing or chewing. If a dose is forgotten, there must be no increase in the dose taken the next day. As with any hypoglycaemic agent, the dose should be adjusted according to the individual patient's metabolic response (blood glucose, HbAlc). Initial dose The recommended starting dose is 30 mg daily (half a tablet of DIAMICRON MR 60 mg). If blood glucose is effectively controlled, this dose may be used for maintenance treatment. If blood glucose is not adequately controlled, the dose may be increased to 60, 90 or 120 mg daily, in successive steps. The interval between each dose increment should be at least 1 month except in patients whose blood glucose has not reduced after two weeks of treatment. In such cases, the dose may be increased at the end of the second week of treatment. The maximum recommended daily dose is 120 mg. One DIAMICRON MR 60 mg modified release tablet is equivalent to two DIAMICRON MR 30 mg modified release tablets. The breakability of the DIAMICRON MR 60 mg modified release tablet enables flex Lugege kogu dokumenti