Gliclada Modified Release Tablet 30 mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

GLICLAZIDE

Boleh didapati daripada:

PAHANG PHARMACY SDN. BHD.

INN (Nama Antarabangsa):

GLICLAZIDE

Unit dalam pakej:

90 Tablets

Dikeluarkan oleh:

KRKA

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
GLICLADA MODIFIED RELEASE TABLETS
Gliclazide (30 mg)
_ _
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
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT GLICLADA IS USED FOR
Gliclada is a medicine that reduces
blood sugar levels (oral antidiabetic
medicine belonging to the sulfonylurea
group).
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 reduces blood glucose levels
by stimulating the secretion of a
hormone, called insulin, from the
pancreatic gland.
BEFORE YOU USE GLICLADA
-
_When you must not use it _

if you are allergic to gliclazide or
to any of the other ingredients of
this medicine or to other
medicines of the same group
(sulfonylureas) or to other related
medicines (hypoglycaemic
sulfonamides),

if you have insulin-dependent
diabetes (type 1),

if you have ketone bodies and
sugar in the urine (this may mean
you have diabetic ketoacidosis), a
diabetic precoma or coma,

if you have severe kidney or liver
disease,

if you are taking medicines to treat
fungal infections (miconazole, see
section "Taking with other
medicines"),

if you are breast feeding (see
section ‘Pregnancy and breast-
feeding’).
-
_Before you start use it _
Talk to your doctor or pharmacist
before taking Gliclada.
You should observe the treatment plan
prescribed by your doctor to achieve
proper blood sugar levels. This means,
apart from regular tablet intake, to
observe the dietary regimen, have
physical exercise and, where necessary,
reduce weight.
During gliclazide treatment regular
monitoring of your blood (and possibly
urine) sugar level and also your
glycated haemoglobin (HbA1c

Ciri produk

1.3.1
Gliclazide
SPC, Labeling and Package Leaflet
MY
SmPCPIL125734_6
24.01.2019 – Updated: 08.04.2021
Page 1 of 9
1.
NAME OF THE MEDICINAL PRODUCT
Gliclada 30 mg modified-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified-release tablet contains 30 mg gliclazide.
Excipient(s) with known effect
Each modified-release tablet contains 73.5 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified-release tablet.
The modified-release tablets are white to almost white, oval, slightly
biconvex tablets with bevelled
edges.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Non insulin-dependent diabetes (type 2) 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 may vary from 1 to 4 tablets per day, i.e. from 30 to
120 mg taken orally in a single
intake at breakfast time.
It is recommended that the tablet(s) be swallowed whole.
If a dose is forgotten, there must be no increase in the dose taken
the next day.
As with any hypoglycaemic agent, the dose should be adjusted according
to the individual patient's
metabolic response (blood glucose, HbA1c).

Initial dose
The recommended starting 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.

Switching from gliclazide 80 mg tablets (immediate release
formulation) to Gliclada 30 mg
modified-release tablets
1.3.1
Gliclazide
SPC, Labeling and Package Leaflet
MY
SmPCPIL125734_6
24.01.2019 – Updated: 08.04.2021