DIAMICRON MR 60 Modified release tablets

País: Tanzânia

Língua: inglês

Origem: Tanzania Medicinces & Medical Devices Authority

Ingredientes ativos:

Gliclazide

Disponível em:

LES LABORATOIRES SERVIER, FRANCE

Código ATC:

Sulfonylureas

DCI (Denominação Comum Internacional):

Gliclazide

Dosagem:

60

Forma farmacêutica:

Modified release tablets

Fabricado por:

Les Laboratoires Servier Industrie (LSI), FRANCE

Resumo do produto:

Physical description: White,oblong tablet,scored and engraved with 'DIA 60' on both faces; Local technical representative: Harleys (T) Limited (4194)

Status de autorização:

Registered/Compliant

Data de autorização:

2020-07-09

Características técnicas

1. Name of the medicinal product
Diamicron MR 60 mg modifies release scored tablet
2. Qualitative and quantitative composition
Each modified-release tablet contains 60 mg gliclazide.
Excipient(s) with known effect:
Lactose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Modified-release tablet
White to almost white, oval, biconvex tablets with a length 13 mm and a thickness 3.5 mm - 4.9
mm.
4. Clinical particulars
4.1 Therapeutic indications
Non-insulin dependent Diabetes mellitus (Type II) in adults when dietary measures, physical
exercise and weight loss alone are not sufficient to control blood glucose.
4.2 Posology and method of administration
Posology
The daily dose of Gliclazide Krka may vary from 30 to 120 mg taken orally in a single intake at
breakfast time.
If a dose is forgotten, there must be no increase in the dose taken next day.
As with any hypoglycaemic agent, the dose should be adjusted according to the individual
patient's metabolic response (blood glucose, HbAlc).
Initial dose
The recommended initial dose is 30 mg daily.
If blood glucose is effectively controlled, this dose may be used for maintenance treatment.
If blood glucose is not adequately controlled, the dose may be increased to 60, 90 or 120 mg
daily, in successive steps. The interval between each dose increment should be at least 1
month except in patients whose blood glucose has not reduced after two weeks of treatment. In
such cases, the dose may be increased at the end of the second week of treatment. The maximum
recommended daily dose is 120 mg.
One Gliclazide Krka 60 mg modified-release tablet corresponds to two Gliclazide Krka 30 mg
modified-release tablets.
Switching from gliclazide (80 mg) tablets (immediate release formulation) to Gliclazide Krka 60
mg tablets with modified release
One tablet of gliclazide (80 mg) is comparable to one modified-release tablet 30 mg.
Consequently, the switch can be performed with careful blood monitoring.
Switchover from another oral antidiabetic medicinal product to Gl