Country: Tanzania
Language: English
Source: Tanzania Medicinces & Medical Devices Authority
Glimepiride
Aurobindo Pharma Limited, INDIA
Blood glucose lowering drugs, excl. insulins, Sul
Glimepiride
2
Uncoated Tablets
Aurobindo Pharma Limited, Unit-XV, INDIA
Physical description: White to off-white coloured, flat-faced, oblong uncoated tablets with notched sides at double bisect, debossed with Y and 32 on either side of the bisect on one face, and plain on the other face; Local technical representative: GENERICS & SPECIALITIES LIMITED (9801)
Registered/Compliant
2022-07-19
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Glimepiride Tablets 1 mg, 2 mg, 3 mg & 4 mg. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg, 2 mg, 3 mg, 4 mg of glimepiride Ph.Eur. Excipients with known effect: 1 mg, 2 mg, 3 mg and 4 mg tablets also contain 158.45 mg, 157.50 mg, 156.45 mg and 155.35 mg lactose monohydrate per tablet respectively. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. GLIMEPIRIDE TABLETS 1 MG: Pink coloured, flat faced, oblong uncoated tablets with notched sides at double bisect, debossed with “X” and “76” on either side of the bisect on one face, and plain on the other face. The tablet can be divided into equal doses. GLIMEPIRIDE TABLETS 2 MG: White to off white coloured, flat faced, oblong uncoated tablets with notched sides at double bisect, debossed with “Y” and “32” on either side of the bisect on one face, and plain on the other face. The tablet can be divided into equal doses. GLIMEPIRIDE TABLETS 3 MG: Light yellow coloured, 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 the other face. The tablet can be divided into equal doses. GLIMEPIRIDE TABLETS 4 MG: Light blue to blue coloured, flat faced, oblong uncoated tablets with notched sides at double bisect, debossed with “Y” and “34” on either side of the bisect on one face, and plain on the other face. The tablet can be divided 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 recommend Read the complete document