Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)
Gliclazide
Lexon (UK) Ltd
A10BB09
Gliclazide
30mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06010201
PATIENT INFORMATION 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. Your medicine is called Diaprel MR 30mg Tablets but will be referred to as Diaprel throughout this leaflet. WHAT IS IN THIS LEAFLET: What Diaprel is and what it is used for What you need to know before you take Diaprel How to take Diaprel Possible side effects How to store Diaprel Contents of the pack and other information WHAT DIAPREL IS AND WHAT IT IS USED FOR Diaprel is a medicine that reduces blood sugar levels (oral antidiabetic medicine belonging to the sulfonylurea group). Diaprel 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIAPREL DO NOT TAKE DIAPREL * if you are allergic to gliclazide or any of the other ingredients of Diaprel (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 Diaprel”); * if you are breast-feeding (See section “Pregnancy and breast-feeding”). WARNINGS AND PRECAUTIONS Talk to your doctor before taking Diaprel. You should o Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diamicron 30mg MR Tablets 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 MR Tablets. Consequently the switch can be performed provided a careful blood monitoring. • Switching from another oral antidiabetic agent to Diamicron 30 mg MR Tablets: Diamicron 30 mg MR Tablets can be used to replace other oral antidiabetic agents. The dosage and the half-life of the previous Perskaitykite visą dokumentą