Country: Малта
Језик: Енглески
Извор: Medicines Authority
GLICLAZIDE
Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France
A10BB09
GLICLAZIDE 30 mg
MODIFIED-RELEASE TABLET
GLICLAZIDE 30 mg
POM
DRUGS USED IN DIABETES
Licence number in the source country: NOT APPLICAPABLE
Authorised
2021-03-23
1 PACKAGE LEAFLET Page 2 of 8 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DIAMICRON ® 30 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 30 mg is and what it is used for 2. What you need to know before you take Diamicron 30 mg 3. How to take Diamicron 30 mg 4. Possible side effects 5. How to store Diamicron 30 mg 6. Contents of the pack and other information 1. WHAT DIAMICRON 30 MG IS AND WHAT IT IS USED FOR Diamicron 30 mg is a medicine that reduces blood sugar levels (oral antidiabetic medicine belonging to the sulfonylurea group). Diamicron 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIAMICRON 30 MG DO NOT TAKE DIAMICRON 30 MG - if you are allergic to gliclazide or any of the other ingredients of Diamicron 30 mg (listed in section 6), or to other medicines of the same group (sulfonylureas), 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 “Other medicines and Diamicron 30 mg”); - if you are breastfeeding (see section Прочитајте комплетан документ
1 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 10 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. • Switching from another oral antidiabetic agent to Diamicron 30 mg: Diamicron 30 mg can be used to replace other oral antidiabetic agents. The dosage and the half-life of the previ Прочитајте комплетан документ