Motigut Suspension 1mgml

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
15-04-2021
Ciri produk Ciri produk (SPC)
15-04-2021

Bahan aktif:

DOMPERIDONE

Boleh didapati daripada:

MEDISPEC (M) SDN.BHD

INN (Nama Antarabangsa):

DOMPERIDONE

Unit dalam pakej:

60ml1Units mL

Dikeluarkan oleh:

SQUARE PHARMACEUTICALS LTD

Risalah maklumat

                                MOTIGUT SUSPENSION
Domperidone (1 mg/ml)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Motigut Suspension_
is used for
2.
How
_Motigut Suspension_
works
3.
Before you use
_Motigut Suspension_
4.
How to use
_Motigut Suspension_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Motigut _
_Suspension_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _MOTIGUT SUSPENSION_
IS USED FOR
Motigut
is
used
for
the
relief
of
symptoms of nausea and vomiting.
This includes:
•
Nausea and vomiting of functional,
organic, infectious or dietary origin.
•
Nausea and vomiting induced by:
-
Radiotherapy or drug therapy
-
Dopamine agonists (such as L-dopa
and
bromocriptine)
used
in
the
treatment of Parkinson’s disease.
HOW _MOTIGUT SUSPENSION_ WORKS
_Motigut _
_suspension _
contains
_ _
domperidone
with
anti-emetic
(stop
vomiting) properties. It also increases the
gastric emptying.
BEFORE YOU USE _MOTIGUT SUSPENSION_
-
_When you must not use it _
Do not use
_Motigut suspension_
if:
•
You are allergic to domperidone or
any
of
the
ingredients
in
this
medication.
•
You
suffer
from
a
tumor
of
the
pituitary gland called prolactinoma
•
You
have
or
had
heart
problems
including
heart
failure
or
heart
rhythm disorders including a slow or
irregular heartbeat
•
You are taking QT-prolonging drugs
•
You
are
taking
potent
CYP3A4
inhibitors
•
• have bleeding, obstruction and hole
in the stomach and bowel (e.g. severe
stomach cramps or persistent black
stools).
•
You have moderate to severe liver
disease
Do not take
_Motigut Suspension_
if you
are taking any of the following medicine:
Clarithromycin (antibiotic)
_Pregnancy and lactation _
Do not take
_Motigut Suspension_
if you
are pregnant, trying to get pregnant or
think you may be pregnant.
Do not take
_Motigut Suspension_
if you
are breast-feeding. Ask your doctor or
pharmacist for advice before taking any
medicine.
_ _
-
_Before you start to use it _
Tell your doctor or
                                
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Ciri produk

                                160 mm X 210 mm
Motigut
®
Suspension 1 mg/ml
®
1. NAME OF THE MEDICINAL PRODUCT: Motigut
®
Suspension 1 mg/ml
2. QUALITATIVE AND QUANTITATIVE COMPOSITION: Each ml oral suspension
contains domperidone 1 mg.
3. PHARMACEUTICAL FORM: Suspension
Product Description: A white raspberry-banana flavored suspension
having sweet taste, filled and sealed in amber color PET bottle with
white color SQUARE printed cap.
4. PHARMACOLOGICAL PROPERTIES
4.1 PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: Propulsive
ATC Code: A03F A 03
Domperidone is a dopamine antagonist with anti-emetic properties,
Domperidone does not readily cross the blood-brain barrier. In
domperidone users, especially adults, extrapyramidal
side effects are very rare, but domperidone promotes the release of
prolactin from the pituitary. Its anti-emetic effect may be due to a
combination of peripheral (gastrokinetic) effects and
antagonism of dopamine receptors in the chemoreceptor trigger zone,
which lies outside the blood-brain barrier in the area postrema.
Animal studies, together with the low
concentrations found in the brain, indicate a predominantly peripheral
effect of domperidone on dopamine receptors. Studies in man have shown
oral domperidone to increase lower
oesophageal pressure, improve antroduodenal motility and accelerate
gastric emptying. There is no effect on gastric secretion.
4.2 PHARMACOKINETIC PROPERTIES
Absorption
In fasting subjects, domperidone is rapidly absorbed after oral
administration, with peak plasma concentrations at 30 to 60 minutes.
The low absolute bioavailability of oral domperidone
(approximately 15%) is due to an extensive first-pass metabolism in
the gut wall and liver. Although domperidone's bioavailability is
enhanced in normal subjects when taken after a meal,
patients with gastro-intestinal complaints should take domperidone
15-30 minutes before a meal. Reduced gastric acidity does not impair
the absorption of domperidone. Oral
bioavailability is not decreased by prior concomitant administration
of cimetidine 
                                
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Risalah maklumat Risalah maklumat Bahasa Melayu 15-04-2021

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