GLIMSURE 4 Uncoated Tablets

Country: Tanzania

Bahasa: Inggeris

Sumber: Tanzania Medicinces & Medical Devices Authority

Bahan aktif:

Glimepiride

Boleh didapati daripada:

Aurobindo Pharma Limited, INDIA

Kod ATC:

Blood glucose lowering drugs, excl. insulins, Sul

INN (Nama Antarabangsa):

Glimepiride

Dos:

4

Borang farmaseutikal:

Uncoated Tablets

Dikeluarkan oleh:

Aurobindo Pharma Limited, Unit-XV, INDIA

Ringkasan produk:

Physical description: 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; Local technical representative: GENERICS & SPECIALITIES LIMITED (9801)

Status kebenaran:

Registered/Compliant

Tarikh kebenaran:

2022-07-19

Ciri produk

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