Երկիր: Տանզանիա
Լեզու: անգլերեն
Աղբյուրը: Tanzania Medicinces & Medical Devices Authority
Glimepiride
Aurobindo Pharma Limited, INDIA
Glimepiride
3 mg
Tablets
Aurobindo Pharma Limited, INDIA
Physical description: Light yellow colored, flat-faced, oblong uncoated tablets with notched sides at double bisect, debossed with "Y" and "33" on either side of the bisect on one face and plain on other face.; Local technical representative: GENERICS & SPECIALITIES LIMITED
Registered/Compliant
2018-03-03
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Glimsure 3 (Glimepiride 3mg) tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 3 mg of glimepiride. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablet. GLIMEPIRIDE TABLETS 3 MG: Light yellow flat faced oblong uncoated tablets with notched sides at double bisect, debossed with ‘Y’ and “33” on either side of bisect on one face and plain on the other face. 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 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, the 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 combination therapy should be initiated under close medical supervision. In patients n Կարդացեք ամբողջական փաստաթուղթը