Asketon 50mg film-coated tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ITOPRIDE HYDROCHLORIDE

Boleh didapati daripada:

KOMEDIC SDN BHD

INN (Nama Antarabangsa):

ITOPRIDE HYDROCHLORIDE

Unit dalam pakej:

10x10 Tablets; 3x10 Tablets

Dikeluarkan oleh:

MEDOCHEMIE LTD (CENTRAL FACTORY)

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
ASKETON FILM-COATED TABLET
_Itopride hydrochloride 50mg _
WHAT IS IN THIS LEAFLET
1.
What ASKETON is used for
2.
How it works
3.
Before you use ASKETON
4.
How to use ASKETON
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
ASKETON
8.
Product description
9.
Manufacturer
and
Product
registration holder
10.
Date of revision
WHAT ASKETON IS USED FOR
Asketon is used in adults to treat:
-
Symptoms of gastric dysmotility
and delayed gastric emptying such
as
bloating,
early
satiety,
postprandial
fullness,
upper
abdominal pain or discomfort
-
Loss of appetite
-
Heartburn
-
Nausea and vomiting
-
Non-ulcer indigestion
-
Chronic gastric inflammation
HOW ASKETON WORKS
Asketon contains the active substance
itopride.
Asketon
activates
stomach
motility,
antiemetic
action
and
accelerates gastric emptying.
BEFORE YOU USE ASKETON
_- When you must not use it _
Do not take Asketon if you:
-
are allergic to itopride or any of the
other ingredients of this medicine
-
could
be
harmful
if
you
have
increased
stomach
motility
eg.
gastric bleeding, gastric obstruction
or perforation
_- Before you start to use it _
Talk
to
your
doctor
before
taking
Asketon if you:
-
are an elderly
-
are
galactose
intolerance,
Lapp
lactase
deficiency
or
glucose-
galactose malabsorption
-
are under age 16
-
have liver impairment
-
have kidney impairment
PREGNANCY AND BREAST-FEEDING
Tell
your
doctor
if
you
become
pregnant, or you are trying to become
pregnant,
while
you
are
taking
Asketon. You should use Asketon only
after discussing the potential benefits
and any potential risks to your unborn
child with your doctor.
There is possibility of adverse effect to
the
infant,
therefore,
speak
to
your
doctor or pharmacist whether to take
Asketon or discontinue breast-feeding.
_- Taking other medicines _
Tell your doctor or pharmacist if you
are taking, have recently taken or might
take
any
other
medicines,
including
medicines
obtained
without
a
prescription.
-
Medicine with narrow therapeutic
inde

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Asketon 50mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains itopride hydrochloride 50 mg.
Excipient with known effect: lactose. Each film-coated tablet contains
58.7 mg of lactose (as lactose monohydrate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
White, round, biconvex, film-coated tablets with diameter 7mm.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of gastrointestinal symptoms caused by gastric dysmotility
and delayed gastric emptying, like sensation of bloating,
early satiety, postprandial fullness, upper abdominal pain or
discomfort, anorexia, heartburn, nausea and vomiting; functional
(non-ulcer) dyspepsia or chronic gastritis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
The recommended dose of itopride hydrochloride for adult patients is
150mg daily [one tablet (50mg) taken orally three times
a day before meals]. The dose may be reduced according to the
patient’s age and symptoms. (see section 4.4).
Duration of treatment
In clinical studies, itopride hydrochloride has been administered up
to 8 weeks.
Method of administration
Oral use. The tablets should be taken before meals.
4.3 CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
•
Asketon should not be administered to patients in whom increased
gastrointestinal motility could be harmful, e.g., in
patients with gastro-intestinal bleeding, mechanical obstruction or
perforation.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
General
Itopride hydrochloride enhances the action of acetylcholine and may
produce cholinergic side effects. Data on long-term use
are not available.
Paediatric Use
Safety of this product in children under the age of 16 has not been
established.
Geriatric Use
In general, appropriate caution should be exercised in the
administration and monitoring of itopride hydrochloride