Țară: Regatul Unit
Limbă: engleză
Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)
Glibenclamide
Viatris UK Healthcare Ltd
A10BB01
Glibenclamide
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06010201; GTIN: 5016695330129
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 Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Glibenclamide 5mg Tablets BP Liamid 5mg Tablets, Gliken 5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Glibenclamide 5.0mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM TABLET FOR ORAL USE Glibenclamide 5mg Tablets are white, dragee shaped tablets marked, ‘GL’ and ‘5’ either side of a breakline 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 non- insulindependent diabetes in patients who respond inadequately to dietary measures alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY_ _ Glibenclamide should be taken with or immediately after food. There were no changes to the reference product information in the report period. The total daily dosage is preferably given as a single dose at breakfast or with the first main meal, but due consideration should be given to the patients meal habits and daily activity when apportioning dosage. _ _ Adults:_ _ _New diabetes: _ In maturity-onset of mild to moderate severity, treatment should be started at 5mg daily, or 2.5mg in debilitated or elderly patients. If this dosage is not sufficient for proper control it should be increased by 2.5mg at intervals of one week, or as directed by the clinician. The total daily dosage rarely exceeds 15mg and increasing the daily dosage above this does not generally produce any additional effect. Paediatric population: Glibenclamide is not recommended for use in children. _Transfer from other oral 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 tolbut Citiți documentul complet