Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Gliclazide
Actavis Group PTC ehf
A10BB; A10BB09
Gliclazide
30 milligram(s)
Modified-release tablet
Oral use
Blisters: 10, 14, 28, 30, 56, 60, 90, 120, 180
Product subject to prescription which may be renewed (B)
Actavis ehf, Balkanpharma-Dupnitsa AD
Blood glucose lowering drugs, excl. insulins: Sulfonylureas
Sulfonamides, urea derivatives; gliclazide
Non insulin-dependent diabetes (type 2) in adults when dietary measures, physical exercise and weight loss alone are not sufficient to control blood glucose.
Marketed
2015-05-22
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VITILE MR 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 Vitile MR is and what it is used for 2. What you need to know before you take Vitile MR 3. How to take Vitile MR 4. Possible side effects 5. How to store Vitile MR 6. Contents of the pack and other information 1. WHAT VITILE MR IS AND WHAT IT IS USED FOR Vitile MR is a medicine that reduces blood sugar levels (oral anti-diabetic medicine belonging to the sulphonylurea group). Vitile MR 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 VITILE MR DO NOT TAKE VITILE MR: - 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 taking medicines to treat fungal infections (miconazole, see section ‘Other medicines and Vitile MR’) - if you are breastfeeding (see Section ‘Pregnancy and breastfeeding’). WARNINGS AND PRECAUTIONS Talk to your doctor or pha Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vitile MR 30 mg Modified Release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each modified-release tablet contains 30 mg gliclazide. Excipient with known effect: Each modified-release tablet contains 54 mg lactose (as the monohydrate) (see section 4.4). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Modified-release tablet. Vitile MR 30 mg modified-release tablets are white, oval, biconvex 5 x 11 mm tablets marked “G” on one side. 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. 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 gliclazide 80 mg tablets to Vitile MR 30mg modified-release tablets_ 1 tablet of gliclazide 80 mg is comparable to 1 tablet of Vitile MR 30 mg modified-release. Consequently, the switch can be performed provided careful blood monitoring is undertaken. _Switching from another oral anti-diabetic agent to Vitile MR_ Vitile Aqra d-dokument sħiħ