Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
GLIBENCLAMIDE
Chanelle Medical
A10BB01
GLIBENCLAMIDE
2.5 Milligram
Tablets
Product subject to prescription which may be renewed (B)
glibenclamide
Not Marketed
2008-12-12
ID: PL 109 IE VERSION: 07 EFFECTIVE DATE: PACKAGE LEAFLET: INFORMATION FOR THE USER GLIBENCLAMIDE 2.5 MG TABLETS Glibenclamide IN THIS LEAFLET: 1. What Glibenclamide is and what it is used for. 2. What you need to know before you take Glibenclamide. 3. How to take Glibenclamide. 4. Possible side effects. 5. How to store Glibenclamide. 6. Contents of the pack and other information. The name of your medicine is Glibenclamide 5 mg Tablets Glibenclamide is a medicine taken by mouth to help lower blood sugar. It belongs to a group of medicines called sulfonylureas. Glibenclamide works by increasing the amount of insulin released from your pancreas. The insulin then lowers your blood sugar levels. WHAT GLIBENCLAMIDE IS USED FOR Glibenclamide is used to treat a certain form of diabetes (type 2 diabetes mellitus), when diet, physical exercise and weight reduction alone have not been able to control your blood sugar levels. DO NOT TAKE GLIBENCLAMIDE TABLETS IF: You are allergic (hypersensitive) to glibenclamide, sulphonamides (medicines for bacterial infection) or any of the other ingredients of Glibenclamide. You have insulin dependent diabetes (type 1 diabetes mellitus) You have diabetic ketoacidosis (a complication of diabetes with some of the following signs: fatigue, nausea (feeling sick), frequent urination and muscular stiffness) You are in diabetic coma You are pregnant You are breast-feeding You have severe problems with your kidneys You have a severe liver disease You are receiving a medicine called bosentan used to treat high blood pressure. 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 Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Glibenclamide 2.5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Glibenclamide 2.5 mg. Excipient(s) with known effect: lactose 51.5 mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. A plain, round, flat bevelled edge, 6.5mm white tablet, with a breakline on one side. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Glibenclamide is a sulphonylurea hypoglycaemic agent indicated for the oral treatment of patients with non-insulin dependent diabetes who respond inadequately to dietary measures alone_._ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dosage of glibenclamide is governed by the desired blood glucose level. The dosage of glibenclamide must be the lowest possible dose which is effective. Mistakes, e.g. forgetting to take a dose, must never be corrected by subsequently taking a larger dose. The usual total daily dosage is 2.5 to 15 mg daily with a usual initial dose of 5 mg daily. Weekly adjustments can be made to increase the dosage to the optimal level. Doses of 10 mg or less may be taken as a single dose immediately before/after breakfast, but should the daily dose exceed 10 mg, the remainder should be taken immediately before/after the evening meal. PATIENTS AGED 65 YEARS AND OLDER: starting and maintenance doses of glibenclamide must be carefully adjusted to reduce the risk of hypoglycaemia. Treatment should be started with the lowest available dose and increased gradually if necessary (see section 4.4). PAEDIATRIC POPULATION The safety of Glibenclamide in the paediatric population has not been established. Currently avaible data are described in sections 4.8 but no recommendations on a posolgy can be made. DOSE OMISSION A physician should be consulted in the event that a dose has not been taken at the prescribed time, a meal has been skipped or an extra dose has been taken. It is very important not to skip meals after the tablets have been taken. SE Lugege kogu dokumenti