מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Glimepiride
Accord-UK Ltd
A10BB12
Glimepiride
3mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06010201; GTIN: 5060149311615
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. WHAT IS IN THIS LEAFLET 1. What Glimepiride Tablets is and what it is used for 2. What you need to know before you take Glimepiride Tablets 3. How to take Glimepiride Tablets 4. Possible side effects 5. How to store Glimepiride Tablets 6. Contents of the pack and other information 1. WHAT GLIMEPIRIDE TABLETS IS AND WHAT IT IS USED FOR Glimepiride is an orally active blood sugar lowering drug. This drug belongs to a blood sugar lowering group of medicines called sulfonylureas. Glimepiride works by increasing the amount of insulin released from your pancreas. The insulin then lowers your blood sugar levels. WHAT GLIMEPIRIDE TABLETS IS USED FOR: Glimepiride Tablets 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GLIMEPIRIDE TABLETS DO NOT TAKE GLIMEPIRIDE TABLETS AND TELL YOUR DOCTOR IF: • You are allergic (hypersensitive) to Glimepiride or other sulfonylureas (medicines used to lower your blood sugar such as glibenclamide) or sulfonamides (medicines for bacterial infections such as sulfamethoxazole) or any of the other ingredients of this medicine (listed in section 6 what Glimepiride tablets contains). • You have insulin dependent diabetes (type 1 diabetes mellitus) • You have diabetic ketoacidosis ( a complication of diabetes when your acid level is raised in your body and you may have some of קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Glimepiride 3 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 3 mg of glimepiride. Each tablet contains 155.70 mg of lactose monohydrate. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablet. GLIMEPIRIDE TABLETS 1 MG: Pink coloured round, flat uncoated tablets with bevelled edges and score line one side & plain on other side. GLIMEPIRIDE TABLETS 2 MG: Light pink coloured oval shaped, uncoated tablets with score line on one side & plain on other side. GLIMEPIRIDE TABLETS 3 MG: Pale yellow, oval shaped uncoated tablets with score line one side & plain on other side. GLIMEPIRIDE TABLETS 4 MG: White coloured oval shaped, uncoated tablet with score line on one side & plain on other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Glimepiride is indicated for the treatment of type 2 diabetes mellitus, when diet, physical exercise and weight reduction alone are not adequate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. The basis for successful treatment of diabetes is a good diet, regular physical activity, as well as routine checks of blood and urine. Tablets or insulin cannot compensate if the patient does not keep to the recommended diet. Posology The dosage is determined by the results of blood and urinary glucose determinations. The starting dose is 1 mg glimepiride per day. If good control is achieved, this dosage should be used for maintenance therapy. For the different dosage regimens appropriate strengths are available. If control is unsatisfactory, the dosage should be increased, based on the glycaemic control, in a stepwise manner with an interval of about 1 to 2 weeks between each step, to 2, 3, or 4 mg glimepiride per day. A dosage of more than 4 mg glimepiride per day gives better results only in exceptional cases. The maximum recommended dose is 6 mg glim קרא את המסמך השלם