Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Gliclazide
Key Pharmaceuticals Ltd
A10BB09
Gliclazide
60 milligram(s)
Prolonged-release tablet
gliclazide
Marketed
2019-04-05
PACKAGE LEAFLET KEY PHARMACEUTICALS LTD. LAMZARIN 60MG PROLONGED-RELEASE TABLETS PL 34424/0038 PA 0343/006/002 VERSION NO.: 07 (MARCH 2021) Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER LAMZARIN 60MG PROLONGED-RELEASE TABLETS gliclazide Your medicine is called Lamzarin 60mg Prolonged-release Tablets, but it will be referred to as Lamzarin Prolonged-release Tablets throughout this leaflet. 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 LAMZARIN PROLONGED-RELEASE TABLETS ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LAMZARIN PROLONGED-RELEASE TABLETS 3. HOW TO TAKE LAMZARIN PROLONGED-RELEASE TABLETS 4. POSSIBLE SIDE-EFFECTS 5. HOW TO STORE LAMZARIN PROLONGED-RELEASE TABLETS 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. W h AT LAMZARIN PROLONGED-RELEASE TABLETS A r E A n D wh AT the Y A r E u S e D f OR Lamzarin Prolonged-release Tablets is a medicine that reduces blood sugar levels (oral anti-diabetic medicine belonging to the sulphonylurea group). Lamzarin Prolonged-release Tablets 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 LAMZARIN PROLONGED-RELEASE TABLETS DO NOT TAKE LAMZARIN PROLONGED-RELEASE TABLETS IF YOU: • are allergic (hypersensitive) to gliclazide or to any of the other ingredients (see section 6 for list of ingredients), or to other medicine of the Lees het volledige document
Health Products Regulatory Authority 20 April 2020 CRN009NQY Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lamzarin 60 mg prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Prolonged-release Tablet contains 60 mg gliclazide. Excipient with known effect: Each Prolonged-release Tablet contains 163.8 mg lactose (as the monohydrate) (see section 4.4) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release Tablet. Lamzarin 60mg Prolonged-release Tablets are White biconvex oval shaped tablet with a deep breakline on both sides and engraved 'GLI' and '60' on either side of the breakline on both sides. Having dimensions Length 15.00 mm ± 0.15 mm, Breadth: 7.00 mm ± 0.15 mm and Thickness: 3.65 mm ± 0.15 mm. The 60 mg 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 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. 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 treatm Lees het volledige document