Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Glimepiride
Bristol Laboratories Ltd
A10BB12
Glimepiride
4mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06010201; GTIN: 5060013941795
PACKAGE LEAFLET: INFORMATION FOR THE USER GLIMEPIRIDE 1MG, 2MG, 3MG AND 4MG TABLETS 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, please ask your doctor or your pharmacist. • This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their signs of illness are the same as y o u r s . • 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 are and what they are 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 ARE AND WHAT THEY ARE USED FOR • The name of your medicine is Glimepiride 1mg or 2mg or 3mg or 4mg tablets. The active ingredient is Glimepiride • Glimepiride belongs to a group of medicines called oral sulphonylurea, which helps to control blood sugar levels. • Glimepiride works by increasing the amount of insulin released from your pancreas. The insulin then lowers your blood sugar levels. • Glimepiride 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 THESE TABLETS IF YOU: • have ever had an allergic reaction to glimepiride, any of the ingredients (these are listed in Section 6,), other sulphonylureas (e.g. glibenclamide, gliclazide, tolbutamide) or sulphonamides (e.g. sulfamethoxazole). An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue. • have insulin dependant Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Glimepiride 4mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Glimepiride 4mg Excipient with known effect: Also contains lactose monohydrate 146.30mg For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablets. Blue coloured, elongated with notch in center, flat bevelled edged, uncoated tablets with “B” & “L” embossing on either side of breakline on one side & only breakline on other side. The breakline 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 Posology 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 can not compensate if the patient does not keep to the recommended diet. 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 glimepiride per day. In patients not adequately controlled with the maximum daily dose of metformin, concomitant glimepiride therapy can be initiated. While maintaining the metformin dose, glimepiride therapy is started with a low dose, and is then titrated up depending on the desired level of metabolic control up to the maximum dail Przeczytaj cały dokument