Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Gliclazide
KRKA, d.d., Novo mesto
A10BB; A10BB09
Gliclazide
60 milligram(s)
Modified-release tablet
Product subject to prescription which may be renewed (B)
Sulfonamides, urea derivatives; gliclazide
Marketed
2013-02-22
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DIACRONAL MR 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 Diacronal MR is and what it is used for 2. What you need to know before you take Diacronal MR 3. How to take Diacronal MR 4. Possible side effects 5. How to store Diacronal MR 6. Contents of the pack and other information 1. WHAT DIACRONAL MR IS AND WHAT IT IS USED FOR Diacronal MR is a medicine that reduces blood sugar levels (antidiabetic medicine taken orally, belonging to the sulphonylurea group). Diacronal 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 DIACRONAL MR DO NOT TAKE DIACRONAL 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 substance group (sulphonylureas) or to other related medicines (hypoglycaemic sulphonamides); - if you have insulin-dependent diabetes (type I); - if you have ketone bodies and sugar in your urine (this may mean that you have diabetic ketoacidosis), a diabetic precoma or coma; - if you have severe kidney or liver disease; - if you are taking medicines to treat fungal infections (miconazole, see section "Taking Diacronal MR with other medicines"); - if you are breast feeding (see section "Pregnancy and breast-feeding"). WARNINGS AND PRE Přečtěte si celý dokument
Health Products Regulatory Authority 08 January 2021 CRN009ZHX Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diacronal MR 60 mg modified-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each modified‑release tablet contains 60 mg gliclazide. Excipient(s) with known effect Each modified‑release tablet contains 88.7 mg lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Modified-release tablet. White to almost white, oval, biconvex tablet, 13mm long and with a thickness of 3.5 mm to 4.9 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Non‑insulin dependent Diabetes mellitus (Type II) 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 OF DIACRONAL MR MAY VARY 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 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 initial 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. ONE DIACRONAL MR 60 MG MODIFIED‑RELEASE TABLET CORRESPONDS TO TWO DIACRONAL MR 30 MG MODIFIED‑RELEASE TABLETS. Health Products Regulatory Authority 08 January 2021 CRN009ZHX Page 2 of 9 SWITCHING FROM GLICLAZIDE (80 MG) TABLETS (IMMEDIATE RELEASE FORMULATION) TO DIACRONAL MR 60 MG TABLETS WITH MODIFIED RELEASE One Přečtěte si celý dokument