Diaglycon MR 30mg Modified Release Tablets

Country: Малезија

Језик: Енглески

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

Активни састојак:

GLICLAZIDE

Доступно од:

NOVUGEN PHARMA SDN. BHD.

INN (Међународно име):

GLICLAZIDE

Јединице у пакету:

100x10 Tablets; 50x10 Tablets; 1x10 Tablets; 3x10 Tablets; 6x10 Tablets; 10x10 Tablets; 1x14 Tablets; 2x14 Tablets; 4x14 Tablets; 6x14 Tablets; 8x14 Tablets; 12x14 Tablets

Произведен од:

NOVUGEN PHARMA SDN. BHD.

Информативни летак

_Consumer Medication Information Leaflet (RiMUP) _
DIAGLYCON MODIFIED RELEASE TABLETS
Gliclazide 30mg and 60mg
1
WHAT IS IN THIS LEAFLET
1.
What Diaglycon MR is used for
2.
How Diaglycon MR works
3.
Before you use Diaglycon MR
4.
How to use Diaglycon MR
5.
While you are using Diaglycon
MR
6.
Side effects
7.
Storage
and
Disposal
of
Diaglycon MR
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT DIAGLYCON MR IS USED FOR
Diaglycon MR 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 DIAGLYCON MR WORKS
Diaglycon MR is a medicine that
reduces
blood
sugar
levels
(oral
antidiabetic medicine belonging to
the sulfonylurea group).
BEFORE YOU USE DIAGLYCON MR
−
_When you must not use it _
DO NOT TAKE DIAGLYCON MR:
−
if you are allergic to to gliclazide
or any of the other ingredients of
Diaglycon MR, or to other
medicines of the same group
(sulfonylurea), or to other related
medicines (hypoglycaemic
sulfonamides);
−
if you have insulin-dependent
diabetes (type 1);
−
if you have ketone bodies and
sugar in your urine (this may
mean you have diabetic
ketoacidosis), a diabetic pre-
coma or coma;
−
if you have severe kidney or liver
disease;
−
if you are taking medicines to
treat fungal infections
(miconazole, see Section “Taking
other medicines”);
−
if you are breastfeeding (see
Section “Pregnancy and
breastfeeding”).
−
_Before you start to use it _
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking
Diaglycon MR. 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) is ne

Карактеристике производа

SPECIAL POPULATIONS
ELDERLY
Diaglycon MR should be prescribed using the same dosing regimen
recommended
for patients under 65 years of age.
RENAL IMPAIRMENT
In patients with mild to moderate renal insufficiency, the same dosing
regimen can
be used as in patients with normal renal function with careful patient
monitoring.
PATIENTS AT RISK OF HYPOGLYCAEMIA
•Undernourished or malnourished,
•Severe
or
poorly
compensated
endocrine
disorders
(hypopituitarism,
hypothyroidism, adrenocorticotrophic insufficiency),
•Withdrawal of prolonged and/or high dose corticosteroid therapy,
•Severe vascular disease (severe coronary heart disease, severe
carotid impairment,
diffuse vascular disease);
It is recommended that the minimum daily starting dose of 30mg is
used.
PAEDIATRIC POPULATION
The safety and efficacy of Diaglycon MR in children and adolescents
have not been
established. No data are available.
Note: Diaglycon MR 60mg cannot be divided into two/ cut by half.
4.3 CONTRAINDICATIONS
This medicine is contra-indicated in case of:
•Hypersensitivity to gliclazide or to any of the excipients as
listed under section List
of Excipients, other sulfonylurea, sulfonamides,
•Type 1 diabetes,
•Diabetic pre-coma and coma, diabetic keto-acidosis,
•Severe
renal
or
hepatic
insufficiency:
in
these
cases
the
use
of
insulin
is
recommended,
•Treatment with miconazole (see section Interaction with other
medicinal products
and other forms of interaction),
•Lactation (see section Fertility, pregnancy and lactation).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
HYPOGLYCAEMIA:
This treatment should be prescribed only if the patient is likely to
have a regular food
intake (including breakfast). It is important to have a regular
carbohydrate intake due
to the increased risk of hypoglycaemia if a meal is taken late, if an
inadequate
amount of food is consumed or if the food is low in carbohydrate.
Hypoglycaemia is
more likely to occur during low-calorie diets, following prolonged or
strenuous
exercise, alcohol intake or if a combin