SW METOCLOPRAMIDE TABLET 10MG

Land: Maleisië

Taal: Engels

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

Werkstoffen:

METOCLOPRAMIDE HYDROCHLORIDE

Beschikbaar vanaf:

SUNWARD PHARMACEUTICAL SDN. BHD.

INN (Algemene Internationale Benaming):

METOCLOPRAMIDE HYDROCHLORIDE

Eenheden in pakket:

100 Tablets; 1000 Tablets; 500 Tablets; 1000 Tablets

Geproduceerd door:

SUNWARD PHARMACEUTICAL SDN. BHD.

Bijsluiter

SW METOCLOPRAMIDE TABLET
Metoclopramide hydrochloride (10mg)
1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET
1. What SW Metoclopramide Tablet is used for
2. How SW Metoclopramide Tablet works
3. Before you use SW Metoclopramide Tablet
4. How to use SW Metoclopramide Tablet
5. While you are using it
6. Side effects
7. Storage and disposal of SW Metoclopramide
Tablet
8. Product description
9. Manufacturer and Product Registration
Holder
10.Date of revision
WHAT SW METOCLOPRAMIDE TABLET IS USED
FOR
For adults, SW Metoclopramide tablet is used
for;

treatment of nausea and vomiting, including
acute migraine.

prevention nausea and vomiting induced by
radiation and chemotherapy.
In
children
age
1
to
18
years
old,
SW
Metoclopramide
Tablet
is
used
as
second
option to prevent nausea and vomiting
induced from chemotheraphy.
HOW SW METOCLOPRAMIDE TABLET WORKS
The
active
ingredient
in
this
medicine
is
Metoclopramide hydrochloride. It blocks the
triggers in the brain which cause nausea and
vomiting.
BEFORE YOU USE SW METOCLOPRAMIDE TABLET
_- When you must not use it _
Do not take this medicine if you:

are
allergic
to
Metoclopramide
hydrochloride or any other ingredients of
this
medicine
(listed
in
Product
Description)

have
gastrointestinal
tract
bleeding,
obstruction or perforation.

are
confirmed
or
suspect
with
pheochromocytoma
(rare
type
of
tumor
which releases hormones that may cause
high blood pressure).

have
history
of
uncontrolled
body
movement induced by metoclopramide or
neuroleptic medications.

have epilepsy.

have parkinson disease or using levodopa or
dopamine
agonists
(medicine
to
treat
parkinson disease).

have history of excessive methemoglobin in
the blood which could be due to NADH-
cytochrome
b5
reductase
enzyme
deficiency.
_ _
_ _
_Children _
Should not be used in for children below age
one year old.
_- Before you start to use it _
Tell your doctor before taking SW Metoclo-
pramide Tablet if you have:

kidney or liver problem.

neurological

Productkenmerken

PROPOSED PACKAGE INSERT
METOCLOPRAMIDE TABLET / SYRUP
PHARMACOLOGY:
Metoclopramide increases the tone and amplitude of gastric (especially
antral) contractions, relaxes the pyloric sphincter and duodenal bulb,
and
increases peristalsis of the duodenum and jejunum resulting in
accelerated gastric emptying and intestinal transit. It increases the
resting tone of
the lower esophageal sphincter. It has little, if any, effect on the
motility of the colon or gallbladder. Like the phenothiazines and
related drugs,
which are also dopamine antagonists, metoclopramide produces sedation
and may produce extrapyramidal reactions, although comparatively
rare. Metoclopramide inhibits the central and peripheral effects of
apomorphine, induces release of prolactin and causes a transient
increase in
circulating aldosterone levels, which may be associated with transient
fluid retention. The onset of pharmacology action of metoclopramide in
30
to 60 minutes following an oral dose; pharmacological effects persist
for 1 to 2 hours. Approximately 85% of the radioactivity of an orally
administered radioactive dose appears in the urine within 72 hours. Of
the 85% eliminated in the urine, about half is present as free or
conjugated
metoclopramide.
INDICATIONS:
_ADULT POPULATION_
Metoclopramide is indicated in adults for:
- Prevention of delayed chemotherapy induced nausea and vomiting
(CINV).
- Prevention of radiotherapy induced nausea and vomiting (RINV).
- Symptomatic treatment of nausea and vomiting, including acute
migraine induced nausea and vomiting.
_PAEDIATRIC POPULATION_
Metoclopramide is indicated in children (aged 1-18 years) for:
- Prevention of delayed chemotherapy induced nausea and vomiting
(CINV) as a second line option.
SIDE EFFECTS/ ADVERSE REACTIONS:
The most frequent adverse reactions of metoclopramide are
restlessness, drowsiness, fatigue and lassitude that occur in
approximately 10% of
patients. Less frequently, insomia, headache, dizziness, nausea, bowel
disturbance or extrapyramidal symptoms may occur. Rarely depre