GLIMSURE 2 Uncoated Tablets

국가: 탄자니아

언어: 영어

출처: Tanzania Medicinces & Medical Devices Authority

유효 성분:

Glimepiride

제공처:

Aurobindo Pharma Limited, INDIA

ATC 코드:

Blood glucose lowering drugs, excl. insulins, Sul

INN (International Name):

Glimepiride

복용량:

2

약제 형태:

Uncoated Tablets

Manufactured by:

Aurobindo Pharma Limited, Unit-XV, INDIA

제품 요약:

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)

승인 상태:

Registered/Compliant

승인 날짜:

2022-07-19

제품 특성 요약

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