País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Glimepiride
Sandoz Ltd
A10BB12
Glimepiride
4mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06010201
Glimepiride is an orally active blood sugar lowering medicine. This medicine belongs to a blood sugar lowering group of medicines called sulphonylureas. Glimepiride works by increasing the amount of insulin released from your pancreas. The insulin then lowers your blood sugar levels. WHAT GLIMEPIRIDE IS USED FOR • 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 DO NOT TAKE GLIMEPIRIDE AND TELL YOUR DOCTOR IF • you are allergic to glimepiride or other sulphonylureas (medicines used to lower your blood sugar such as glibenclamide) or sulphonamides (medicines for bacterial infections such as sulphamethoxazole) or any of the other ingredients of this medicine (listed in section 6), • you have diabetes mellitus type 1, • you have diabetic ketoacidosis (a complication of diabetes when your acid level is raised in your body and you may have some of the following signs: fatigue, feeling sick (nausea), frequent urination and muscular stiffness) • you are in a diabetic coma • you have severe kidney disease • you have a severe liver disease, Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking glimepiride. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING GLIMEPIRIDE IF • You are recovering from an injury, operation, infections with fever, or from other forms of stress, inform your doctor as temporary change of treatment may be necessary • You have a severe liver or kidney disorder If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking glimepiride. Lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur in patients missing the enzyme glucose-6-phosphate dehydrogenase. The information available on the use of glimepiride in people under 18 years of age is limited. Therefore, its use Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Glimepiride 4 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 4 mg of glimepiride. Excipient with known effect Each tablet contains 135.1 mg of lactose (as monohydrate).For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Blue, slightly mottled, oblong, flat, bevelled edge tablet scored on both sides with the embossment ‘G4’ on one side The tablet can be divided into equal doses. Where a lower tablet strength is available this should be used instead. 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 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. Dose 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 dose should be used for maintenance therapy. For the different dose regimens appropriate strengths are available. If control is unsatisfactory the dose 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 dose 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 daily dose. The combinati Leer el documento completo