Glimestar - 2 Tablets 2mg

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Glimepiride

Available from:

Mankind Pharma Limited, INDIA

ATC code:

Blood glucose lowering drugs, excl. insulins, Sulf

INN (International Name):

Glimepiride

Dosage:

2mg

Pharmaceutical form:

Tablets

Manufactured by:

Aurochem Pharmaceuticals Pvt. (I) Limited, INDIA

Product summary:

Physical description: White to off white, circular, flat, bevel edged, scored on one side, uncoated tablets; Local technical representative: Phillips Pharmaceuticals (Tanzania) Limited (2404)

Authorization status:

Registered/Compliant

Authorization date:

2020-05-12

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Glimestar-2 tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg of glimepiride.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Tablet.
White to off white, circular, flat, bevel edged, scored on one side,
uncoated tablets
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.
2
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 not adequately controlled with the maximum daily dose of
glimepiride, concomitant
insulin therapy can be initiated if necessary. While maint