국가: 네덜란드
언어: 네덜란드어
출처: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
GLICLAZIDE 60 mg/stuk
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
A10BB09
GLICLAZIDE 60 mg/stuk
Tablet met gereguleerde afgifte
CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; HYPROMELLOSE (Release controlling polymer)(E 464) ; HYPROMELLOSE, type 2208 (Release controlling polymer), K4M (E 464) ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201),
Oraal gebruik
Gliclazide
Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341); HYPROMELLOSE (Release controlling polymer)(E 464); HYPROMELLOSE, type 2208 (Release controlling polymer), K4M (E 464); MAGNESIUMSTEARAAT (E 470b); POVIDON K 30 (E 1201);
1900-01-01
Sandoz B.V. Page 1/8 Gliclazide Sandoz retard 60 mg, tabletten met gereguleerde afgifte RVG 116611 1313-v2 1.3.1.3 Bijsluiter Oktober 2019 PACKAGE LEAFLET: INFORMATION FOR THE USER GLICLAZIDE SANDOZ RETARD 60 MG, TABLETTEN MET GEREGULEERDE AFGIFTE 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 Gliclazide Sandoz is and what it is used for 2. What you need to know before you take Gliclazide Sandoz 3. How to take Gliclazide Sandoz 4. Possible side effects 5. How to store Gliclazide Sandoz 6. Contents of the pack and other information 1. WHAT GLICLAZIDE SANDOZ IS AND WHAT IT IS USED FOR Gliclazide Sandoz is a medicine that reduces blood sugar levels (an oral antidiabetic medicine belonging to the sulphonylurea group). Gliclazide Sandoz 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 GLICLAZIDE SANDOZ DO NOT TAKE GLICLAZIDE SANDOZ: • if you are ALLERGIC to gliclazide or any of the other ingredients of this medicine (listed in section 6), or to other medicines of the same group (sulphonylureas), or to other related medicines (hypoglycaemic sulphonamides), • 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 전체 문서 읽기
Sandoz B.V. Page 1/11 Gliclazide Sandoz retard 60 mg, tabletten met gereguleerde afgifte RVG 116611 1313-v3 1.3.1.1 SmPC Juni 2020 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Gliclazide Sandoz retard 60 mg, tabletten met gereguleerde afgifte _ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each modified-release tablet contains gliclazide 60 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Modified-release tablet. White to off-white oval shape, uncoated tablet, 13.5 mm long, 6.5 mm wide and 4.2 mm thick, with break line on both the surface and debossed '60' on one side of the break line on one surface. 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 osology For adult use only. The daily dose of Gliclazide Sandoz may vary from one half to two 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 Gliclazide Sandoz). 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. Sandoz B.V. Page 2/ 전체 문서 읽기