Glimepirid Sandoz Tablets 4

Země: Tanzanie

Jazyk: angličtina

Zdroj: Tanzania Medicinces & Medical Devices Authority

Aktivní složka:

Glimepiride

Dostupné s:

Sandoz GmbH, Kundl, AUSTRIA

ATC kód:

Blood glucose lowering drugs, excl. insulins, Sulf

INN (Mezinárodní Name):

Glimepiride

Dávkování:

4

Léková forma:

Tablets

Výrobce:

LEK S.A., POLAND

Přehled produktů:

Physical description: Blue slightly mottled, oblong, flat, bevelled edge tablet scored on both sides, with the embossment “G4” on one side.; Local technical representative: Phillips Pharmaceuticals (Tanzania) Limited (2404)

Stav Autorizace:

Registered/Compliant

Datum autorizace:

2021-07-24

Charakteristika produktu

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Glimepiride 4 mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg of glimepiride.
Each tablet contains 142.22 mg of lactose monohydrate.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Tablet.
GLIMEPIRIDE TABLETS 4 MG: Blue, slightly mottled, oblong, flat,
bevelled edge tablet scored
on both sides with the embossment “G4” on one side.
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
con