Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Glibenclamide
Mawdsley-Brooks & Company Ltd
A10BB01
Glibenclamide
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06010201
PACKAGE LEAFLET: INFORMATION FOR THE USER GLIBENCLAMIDE 2.5MG TABLETS/ GLIBENCLAMIDE 5MG TABLETS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE THIS MEDICINE. - Keep this leaflet. You may need to read it again while you are receiving your treatment. - If you have any further questions, please 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Glibenclamide Tablets are and what they are used for 2. Before you take Glibenclamide Tablets 3. How to take Glibenclamide Tablets 4. Possible side effects 5. How to store Glibenclamide Tablets 6. Further information 1. What Glibenclamide Tablets are and what they are used for The name of your medicine is Glibenclamide Tablets. These tablets belong to a group of medicines called sulphonylureas. Glibenclamide Tablets are used to lower blood sugar levels and are used in the treatment of late-onset diabetes (type II diabetes mellitus) in patients whose blood sugar is not controlled by diet alone and who are not suitable for insulin injections. 2. Before you take Glibenclamide Tablets YOU SHOULD NOT TAKE GLIBENCLAMIDE TABLETS IF YOU: are allergic (hypersensitive) to glibenclamide, other sulphonylureas or any of the other ingredients in Glibenclamide Tablets (see section 6, Further information) suffer from early onset or type I diabetes (requiring insulin) suffer from severe kidney disease suffer from liver problems are suffering from ketoacidosis (caused by excessively high blood sugars in diabetics) are suffering from a severe infection are suffering from stress are suffering from any condition likely to make controlling your blood sugar difficult are due to undergo surgery are pregnant have reduced consciousness or coma resulting from your Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Glibenclamide 5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Glibenclamide 5mg For excipients, see 6.1 3 PHARMACEUTICAL FORM Tablet for oral use Glibenclamide 5mg Tablets are white, dragee shaped tablets marked ‘GL’ and ‘5’ on either side of a break-line on one face and plain on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Glibenclamide is a hypoglycaemic agent indicated in the treatment of noninsulin dependent diabetes in patients who respond inadequately to dietary measures alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Treatment of previously untreated diabetes: _ Stabilisation can be started with one 5mg tablet daily with or immediately after breakfast or the first main meal. If control is satisfactory one tablet is continued as the maintenance dose. If control is unsatisfactory, the dose can be adjusted by increments of 2.5 or 5mg at weekly intervals. The total daily dosage rarely exceeds 15mg and increasing the daily dosage above this does not generally produce any additional effect. The total daily requirement should normally be given as a single dose at breakfast, or with the first main meal. The patient’s diet and activity should be taken into account. Children: Glibenclamide is not recommenced for use in children. Elderly: In debilitated patients or aged patients who may be more liable to hypoglycaemia, treatment should be initiated with one 2.5mg tablet daily. _Changeover from other sulphonylureas: _ The changeover to glibenclamide from other drugs with similar mode of action can be carried out without any break in therapy. Treatment is commenced with the equivalent dose of glibenclamide without exceeding an initial dose of 10mg. If response is inadequate, the dose can be raised in a stepwise fashion to 15mg daily. One 5mg tablet of glibenclamide is approximately equivalent to 1g tolbutamine or glymidine, 250mg chlorpropamide or tolazamide, 500mg acetohexamide, 25mg glibornuride or 5mg glipizide. Les hele dokumentet