GLILUPI MR TABLET 60MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Gliclazide

Available from:

GOLDPLUS UNIVERSAL PTE LTD

ATC code:

A10BB09

Pharmaceutical form:

TABLET, EXTENDED RELEASE

Composition:

Gliclazide 60 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

LUPIN LIMITED

Authorization status:

ACTIVE

Authorization date:

2023-12-29

Summary of Product characteristics

1

NAME OF THE MEDICINAL PRODUCT
Glilupi MR Tablet 60 mg
2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified-release tablet contains 60 mg of gliclazide.
For the full list of excipients, see section 6.1.
3. DESCRIPTION OF THE APPEARANCE OF THE PRODUCT
White to of f-white oval shape, uncoated tablets with breakline on
both the surface
and debossed '60' on one side of the break line on one surface.
4.

PHARMACEUTICAL FORM
Modified release (MR) Tablets
5.

CLINICAL PARTICULARS
5.1

THERAPEUTIC INDICATIONS
Gliclazide modified release tablets are indicated for the treatment of
type II diabetes
in association with dietary measures and with, physical exercise when
these
measures alone are inadequate to control blood glucose.
During controlled clinical trials in patients with type II diabetes, a
modified release
formulation of gliclazide (30mg - 120mg), taken as a single daily
dose, was shown to
be effective long term in controlling blood glucose levels, based on
monitoring of
HbA1c.
5.2

POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
The daily dose of Gliclazide 60 mg MR Tablets may vary from one half
to 2 tablets per
day, i.e., from 30 to 120 mg taken orally in a single intake at
breakfast time.
It is recommended to swallow the dose without crushing or chewing.
If a dose is forgotten, there must be no increase in the dose taken
the next day.
These products should be taken with food because there is an increased
risk of
hypoglycemia if a meal is taken late, if an inadequate amount of food
is consumed or
if the food is low in carbohydrate. It is recommended that the
medication be taken at
breakfast time.
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 starting dose is 30 mg daily (half a tablet of
Gliclazide 60 mg MR
Tablets).
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