Država: Velika Britanija
Jezik: engleski
Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)
Gliclazide
IVAX Pharmaceuticals UK Ltd
A10BB09
Gliclazide
80mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06010201
1 PACKAGE LEAFLET: INFORMATION FOR THE USER GLICLAZIDE 80MG TABLETS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4. IN THIS LEAFLET: 1. What Gliclazide Tablets are and what they are used for 2. Before you take Gliclazide Tablets 3. How to take Gliclazide Tablets 4. Possible side effects 5. How to store Gliclazide Tablets 6. Further information 1. WHAT GLICLAZIDE TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Gliclazide Tablets. Gliclazide Tablets contain a medicine called gliclazide. This belongs to a group of medicines called ‘sulphonylureas’. It works by controlling sugar (glucose) levels in the blood. Gliclazide Tablets are used for the sort of diabetes called ‘Type 2 diabetes’. This is when insulin is not needed, but diet and exercise alone do not lower sugar levels in the blood. People usually need treatment for diabetes for the rest of their life. 2. BEFORE YOU TAKE GLICLAZIDE TABLETS DO NOT TAKE GLICLAZIDE TABLETS IF: • you are allergic to gliclazide or any of the other ingredients in Gliclazide Tablets (listed in section 6) • you are allergic to ‘sulphonylureas’, ‘sulphonamides’ or any other similar medicines • you have used ‘sulphonylureas’ before, but they have stopped working for you • you have ‘Type 1 diabetes’ (this is when you need to use insulin to control your diabetes) • you have a very high blood sugar which is life threatening (‘diabetic ketoacidosis’) • you are going to have an operation, have recently had a serious accident or been very stressed • you have a serious infection • you have Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gliclazide 80 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 80 mg of gliclazide. Excipient(s) with known effect: This product contains lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, flat, round tablets marked with a double score line on one side and ‘3G5’ on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Gliclazide tablets are indicated for the treatment of non insulin dependent diabetes mellitus. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. _Adults _ The total daily dose may vary from 40 to 320 mg taken orally. The dose should be adjusted according to the individual patient’s response, commencing with 40-80 mg daily (½-1 tablets) and increasing until adequate control is achieved. A single dose should not exceed 160 mg (2 tablets). When higher doses are required, gliclazide should be taken twice daily and according to the main meals of the day. In obese patients or those not showing adequate response to gliclazide alone, additional therapy may be required. _Children _ Gliclazide, as with other sulphonylureas, is not indicated for the treatment of juvenile onset diabetes mellitus. _Older people _ Plasma clearance of gliclazide is not altered in the older people and steady state plasma levels can therefore be expected to be similar to those in adults under 65 years. Clinical experience in the older people to date shows that gliclazide is effective and well tolerated. Care should be exercised, however, when prescribing sulphonylureas in the older people due to a possible age- related risk of hypoglycaemia. In patients with mild to moderate renal impairment In these patients, the same dosing regimen can be used as in patients with normal renal function with careful patient monitoring. These data have been confirmed in clinical trials. In patients at risk of hypoglycaemia Higher risk of hypoglycaemia exists in follo Pročitajte cijeli dokument