Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Glimepiride
Zentiva Pharma UK Ltd
A10BB12
Glimepiride
4mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06010201; GTIN: 5000283651888
PATIENT INFORMATION LEAFLET GLIMEPIRIDE 1MG, 2MG, 3MG AND 4MG TABLETS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. ! Keep this leaflet. You may need to read it again. ! If you have 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 symptoms are the same as yours. ! If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Glimepiride Tablets are and what they are used for 2. Before you take Glimepiride Tablets 3. How to take Glimepiride Tablets 4. Possible side effects 5. Storing Glimepiride Tablets 6. Further Information Glimepiride is one of a group of medicines called sulphonylurea hypoglycaemics, which are used for the treatment of diabetes by helping to control blood sugar levels (glucose). Diabetes is a condition where the body does not produce enough insulin to control the level of blood glucose. Glimepiride Tablets are used to treat non-insulin dependent (Type II) diabetes mellitus, in addition to a recommended diet, regular physical exercise and weight reduction when these have not worked on their own. DO NOT TAKE GLIMEPIRIDE TABLETS IF YOU: ! are allergic (hypersensitive) to glimepiride, any of the other ingredients (listed in Section 6) or to other oral sulphonylurea anti-diabetics or sulphonamide antibiotics ! have type I insulin-dependent diabetes ! have suffered from confusion, fainting or coma as a result of your diabetes ! have been told by your doctor you have 'ketoacidosis' (your breath may smell of pear drops) ! have severe kidney or liver disease, as your diabetes will need to be treated with insulin ! are pregnant or breastfeeding. TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING THE TABLETS IF: ! you are suffering from an infection with or without fever ! you have had a recent accident, are to have an operation or other Đọc toàn bộ tài liệu
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 Đọc toàn bộ tài liệu