Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
GLICLAZIDE
SERVIER MALAYSIA SDN BHD
GLICLAZIDE
60Tablet Tablets
LES LABS SERVIER INDUSTRIE
_Consumer Medication Information Leaflet (RIMUP) _ 1 DIAMICRON ® MR MODIFIED RELEASE TABLET_ _ Gliclazide 30mg WHAT IS IN THIS LEAFLET 1. What DIAMICRON MR 30 mg is used for 2. How DIAMICRON MR 30 mg works 3. Before you use DIAMICRON MR 30 mg 4. How to use DIAMICRON MR 30 mg 5. While you are using DIAMICRON MR 30 mg 6. Side effects 7. Storage and Disposal of DIAMICRON MR 30 mg 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revisión 11. Serial number WHAT DIAMICRON MR 30MG IS USED FOR DIAMICRON MR 30 mg 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. HOW DIAMICRON MR 30MG WORKS DIAMICRON MR 30 mg is a medicine that reduces blood sugar levels (oral antidiabetic medicine belonging to the sulfonylurea group). BEFORE YOU USE DIAMICRON MR 30 MG - _When you must not use it _ _ _ DO NOT TAKE DIAMICRON MR 30 MG: - if you are allergic (hypersensitive) to gliclazide or any of the other ingredients of DIAMICRON MR 30 mg, 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), a diabetic pre-coma or coma; - if you have severe kidney or liver disease; - if you are taking medicines to treat fungal infections (miconazole, see Section “Taking other medicines”); - if you are breastfeeding (see Section “Pregnancy and breastfeeding”). - _Before you start to use it _ _WARNINGS AND PRECAUTIONS _ Talk to your doctor before taking Diamicron MR 30 mg. You should observe the treatment plan prescribed by your doctor to achieve proper blood sugar levels. This means, apart from regular tablet intake, to observe the dietary regimen, have physical exercise and, where necessary, reduce weight. During gliclazide treatment regular monitoring of your Baca dokumen lengkap
Final PI_Diamicron MR 30mg_Gidy_17.05.2022 1 DIAMICRON MR MODIFIED RELEASE TABLET 1. NAME OF THE MEDICINAL PRODUCT DIAMICRON 30 MG , modified release tablet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains gliclazide 30 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Modified release tablet. White, oblong tablet engraved on both faces, ‘DIA 30’ on one face and on the other. 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 may vary from 1 to 4 tablets per day, _i.e_ . from 30 to 120 mg taken orally in a single intake at breakfast time. It is recommended that the tablet(s) be swallowed whole. 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. 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. • Switching from Diamicron 80 mg tablets to Diamicron 30 mg modified release tablets: 1 tablet of Diamicron 80 mg is comparable to 1 tablet of Diamicron 30 mg. Consequently the switch can be performed provided a careful blood monitoring. Final PI_Diamicron MR 30mg_Gidy_17.05.2022 2 • Switching from another oral antidiabetic agent to Diamicron 30 mg: Diamicron 30 mg can be used to repl Baca dokumen lengkap