Country: Մալթա
language: անգլերեն
source: Medicines Authority
GLICLAZIDE
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
A10BB09
GLICLAZIDE 30 mg
MODIFIED-RELEASE TABLET
GLICLAZIDE 30 mg
POM
DRUGS USED IN DIABETES
Withdrawn
2015-05-14
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AZILDOR 30 MG MODIFIED-RELEASE TABLETS AZILDOR 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 Azildor is and what it is used for 2. What you need to know before you take Azildor 3. How to take Azildor 4. Possible side effects 5. How to store Azildor 6. Contents of the pack and other information 1. WHAT AZILDOR IS AND WHAT IT IS USED FOR Azildor is a medicine that reduces blood sugar levels (oral anti-diabetic medicine belonging to the sulphonylurea group). Azildor 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 AZILDOR DO NOT TAKE AZILDOR: - 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 Azildor’) - if you are breastfeeding (see Section ‘Pregnancy and breastfeeding’). WARNINGS AND PRECAUTIONS Talk to your doct read_full_document
Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 12 1. NAME OF THE MEDICINAL PRODUCT Azildor 30 mg modified-release tablets Azildor 60 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). Each modified-release tablet contains 60 mg gliclazide. Excipient with known effect: Each modified-release tablet contains 108 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. Azildor 30 mg modified-release tablets are white, oval, biconvex 5 x 11 mm tablets marked “G” on one side. Azildor 60 mg modified-release tablets are white, oval, biconvex 7 x 15 mm tablets scored on both sides, marked with “G” on one side of the score and “60” on the other side of the score. 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 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. The daily dose 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. 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). Page 3 of 12 _Initial dose _ The recommended starting dose is 30 mg daily. The recommended starting dose is 30 mg daily (half a 60 mg tablet). If blood glucose is effectively controlled, this dose may be used for maintenance treatment. If blood glucose is not adequately controlled read_full_document