Gliclada 60mg Modified-Release Tablets

Land: Malaysia

Språk: engelsk

Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiv ingrediens:

GLICLAZIDE

Tilgjengelig fra:

PAHANG PHARMACY SDN. BHD.

INN (International Name):

GLICLAZIDE

Enheter i pakken:

90 Tablets

Produsert av:

KRKA, d.d., Novo mesto

Informasjon til brukeren

GLICLADA MODIFIED RELEASE TABLETS
Gliclazide 60 mg
_Consumer Medication Information Leaflet (RiMUP)_ _ _
_ _
1
WHAT IS IN THIS LEAFLET
1.
What _Gliclada _is used for
2.
How _Gliclada_ works
3.
Before you use _Gliclada_
4.
How to use _Gliclada_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of _Gliclada_
Product Description
8.
Manufacturer and Product
Registration Holder
9.
Date of revision
WHAT _GLICLADA_ IS USED FOR
_Gliclada_ is used in a certain form of
diabetes (type 2 diabetes mellitus) in
adults, when diet, exercise and weight
loss alone do not have an adequate
effect on keeping blood sugar at the
correct level.
HOW _GLICLADA_ WORKS
_Gliclada_ is a medicine that reduces
blood sugar levels (antidiabetic
medicine taken orally) by stimulating
insulin secretion.
BEFORE YOU USE _GLICLADA _
-
_When you must not use it _
Do not take _Gliclada:_

if you are allergic (hypersensitive)
to gliclazide, to other
sulphonylureas, to sulphonamides or
to any of the other ingredients of
this medicine,

if you have insulin-dependent
(type 1) diabetes,

if you have ketone bodies and sugar
in the urine (this may mean you
have diabetic keto-acidosis),
diabetic pre-coma or coma,

if you have severe kidney or liver
disease,

if you are taking medicines to treat
fungal infections (miconazole),

if you are breast feeding
_ _
_Pregnancy and lactation _
Do not take _Gliclada_ if you are
pregnant, trying to get pregnant or think
you may be pregnant. If you get
pregnant while taking _Gliclada_ stop
taking it immediately and contact your
doctor so he may prescribe you a more
suitable treatment for you.
Do not take _Gliclada_ if you are breast-
feeding. Ask your doctor or pharmacist
for advice before taking any medicine.
_ _
_ _
-
_Before you start use it _
This medicine should be used only if
you are likely to have a regular food
intake (including breakfast). It is
important to have a regular
carbohydrate intake due to the
increased risk of low blood sugar level
(hypoglycaemia) if a meal is delayed or

Preparatomtale

1.3.1
Gliclazide
SPC, Labeling and Package Leaflet
MY
SmPCPIL043814_4
04.11.2013 – Updated: 13.10.2021
Page 1 of 8
GLICLADA
_Gliclazide_
NAME OF THE MEDICINAL PRODUCT
Gliclada 60 mg modified-release tablets
COMPOSITION
Each modified-release tablet contains 60 mg gliclazide.
PRODUCT DESCRIPTION
White to almost white, oval, biconvex tablets.
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.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The daily dose of Gliclada 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 Gliclada 60 mg modified-release tablet corresponds to two Gliclada
30 mg modified-release
tablets.
_Switching from gliclazide (80 mg) tablets (immediate release
formulation) to Gliclada 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
Gliclada 60 mg:_
Gliclada modified-release tablets can be used to replace another oral
antidiabetic medicinal product.
1.3.1
Glicl