GANATON TABLET 50MG

Country: Malaysia

Language: English

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

Active ingredient:

ITOPRIDE HYDROCHLORIDE

Available from:

ABBOTT LABORATORIES (M) SDN. BHD.

INN (International Name):

ITOPRIDE HYDROCHLORIDE

Units in package:

, 0 30 TabletOthers Tablets

Manufactured by:

Mylan EPD G.K.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
GANATON® TABLET
Itopride hydrochloride (50mg)
1
WHAT IS IN THIS LEAFLET
1. What Ganaton® is used for
2. How Ganaton® works
3. Before you use Ganaton®
4. How to use Ganaton®
5. While you are using it
6. Side effects
7. Storage and disposal of Ganaton®
8. Product description
9. Manufacturer and product
registration holder
10. Date of revision
WHAT GANATON®
IS USED FOR
Ganaton® is used to treat symptoms
caused by impaired bowel movement
and delayed gastric emptying, such as
gastric fullness, discomfort or painful
pressure in the upper abdomen, loss
of appetite, heartburn, nausea and
vomiting, indigestion (not due to
ulcer) or long-term gastric
inflammation.
HOW GANATON® WORKS
Ganaton® contains itopride that
improves gastric movement and
blocks the center inside your brain
which initiate nausea and vomiting.
BEFORE YOU USE GANATON®
_- When you must not use it_
•
If you are allergic to itopride
hydrochloride or any of the
ingredients listed at the end
of this leaflet
•
If you have gastrointestinal
bleeding, obstruction or
perforation.
_- Before you start to use it_
Discuss with your doctor or
pharmacist before taking your
medicine if:
-
you are lactose intolerant
_- Taking other medicines_
It is particularly important to tell your
doctor or pharmacist if you are
taking, have recently taken or might
take any other medicines. This also
concerns medicines obtained without
a prescription including herbal
medicines.
Tell your doctor or
pharmacist if you are taking any of
the following medicines:
•
anticholinergic agents
(medicine commonly used to
treat asthma and Parkinson’s
Disease)
HOW TO USE GANATON®
_- How much to use_
Always take Ganaton® exactly as
your doctor has told you. You should
check with your doctor or pharmacist
if you are not sure.
The recommended dosage is 1 tablet
three times a day.
Safety of this product in children
under the age of 16 has not been
established.
_- When to use it_
Take the tablets with a glass of water
before meal.

Summary of Product characteristics

GANATON®
ITOPRIDE HYDROCHLORIDE
PRODUCT NAME
Itopride Hydrochloride
BRAND NAME
Ganaton®
QUALITATIVE AND QUANTITATIVE COMPOSITION
One coated tablet contains 50mg Itopride hydrochloride.
For full list of excipients, see section list of excipients.
PHARMACEUTICAL FORM
Itopride hydrochloride is a white to pale yellowish white crystal or
crystalline powder. It is odorless and
has a bitter taste. It is very soluble in water, freely soluble in
methanol or in glacial acetic acid, sparingly
soluble in ethanol and practically insoluble in acetic anhydride or in
ether. The pH of the solution is 4.0 to
5.0. The melting point is 193 to 198°C.
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.
DOSAGE AND ADMINISTRATION
_Adults _
The recommended dose of itopride hydrochloride for adult patients is
150 mg daily [one tablet (50 mg)
taken orally three times a day before meals]. The dose may be reduced
according to the patient’s age
symptoms (see PRECAUTIONS).
_Duration of Treatment _
In clinical studies, itopride hydrochloride has been administered up
to 8 weeks.
CONTRAINDICATIONS
Itopride hydrochloride is contraindicated in patients with known
hypersensitivity to itopride hydrochloride
or any of the excipients.
Itopride hydrochloride should not be used in patients in whom an
increase in gastrointestinal motility could
be harmful, eg: gastrointestinal hemorrhage, mechanical obstruction or
perforation.
PRECAUTIONS
GENERAL
Itopride hydrochloride enhances the action of acetylcholine and may
produce cholinergic side effects. Data
on long-term use are not available.
USAGE IN SPECIAL POPULATIONS
_PEDIATRIC 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
administrat