AXCEL CIMETIDINE-400 TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CIMETIDINE

Boleh didapati daripada:

KOTRA PHARMA (M) SDN. BHD.

INN (Nama Antarabangsa):

CIMETIDINE

Unit dalam pakej:

1000 Tablets; 100 Tablets; 1000 Tablets

Dikeluarkan oleh:

KOTRA PHARMA (M) SDN. BHD.

Risalah maklumat

AXCEL CIMETIDINE TABLET
Cimetidine (200mg, 400mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Axcel Cimetidine Tablet is
used for.
2.
How
Axcel
Cimetidine
Tablet
works.
3.
Before
you
use
Axcel
Cimetidine Tablet.
4.
How to take Axcel Cimetidine
Tablet.
5.
While you are using it.
6.
Side effects.
7.
Storage
and
disposal
of
Axcel
Cimetidine Tablet.
8.
Product description.
9.
Manufacturer
and
Product
Registration Holder.
10.
Date of revision.
WHAT AXCEL CIMETIDINE TABLET IS
USED FOR
Axcel Cimetidine Tablet is used for
the following treatment:

Active ulcers in the stomach and
intestine
and
recurrent
ulceration.

Persistent indigestion symptoms.

Nonsteroidal
anti-inflammatory
drug (NSAIDs) - induced lesions
(ulcers, erosions) and symptoms.

Gastro-esophageal reflux disease
(content of the stomach comes
up
into
the
esophagus
(food
pipe)).

Zollinger-Ellison syndrome and
other
cases
of
high
gastric
secretion.

To
be
used
with
enzyme
supplements
in
people
with
pancreatic problems.
HOW
AXCEL
CIMETIDINE
TABLET
WORKS
Cimetidine
belongs
to
a
group
of
medicines
called
H2-receptor
antagonists. Cimetidine inhibits both
the
secretion
of
gastric
acid
and
reduces
pepsin
enzyme
output.
It
also
has
a
beneficial
effect
in
maintaining
the
integrity
of
the
gastric lining barrier.
BEFORE YOU USE
AXCEL CIMETIDINE
TABLET

_When you must not use it _
Do not take Axcel Cimetidine Tablet
if:

You
are
allergic
or
hypersensitive to Cimetidine or
other ingredients.

You
are
pregnant
or
nursing
mother unless essential.

_Before you start to use it _
Tell your doctor if:

You have a history of digestive
ulcer, particularly the elderly.

You
have
severely
impaired
kidney function.

You have medication treatment
or with illness that could cause
falls in blood cell count.
Cimetidine treatment can mask the
symptoms
and
allow
transient
healing
of
gastric
cancer.
Your
doctor
may
plan
some
tests
to
exclude gastric cancer.

_Taking other medicines _
You should tell your do

Ciri produk

CIMETIDINE-400
COMPOSITION:
Each tablet contains
Cimetidine
400mg
Contains Quinoline Yellow Dye and Brilliant
Blue as colourant.
PRESENTATION:
Light green, elongated tablets, 18.8mm in
length.
INDICATIONS:
Treatment of active duodenal, benign gastric,
stomal and recurrent ulceration, persistent
dyspeptic
symptoms
with
or
without
ulceration. NSAID - induced lesions (ulcers,
erosions) and symptoms, gastroesophageal
reflux disease (including conditions ranging
from
heartburn
to
peptic
esophagitis),
Zollinger-Ellison syndrome and other cases of
high
gastric
secretion,
in
pancreatic
insufficiency
as
an
adjunct
to
enzyme
supplement therapy.
PHARMACOLOGY:
Mechanism of Action:
Cimetidine inhibits both the stimulated and
basal secretion of gastric acid and reduces
pepsin output. It competitively inhibits the
action
of
histamine
at
the
histamine
H
2
-receptor of the parietal cells and thus is a
histamine H
2
antagonist. In addition to its
antisecretory
effects,
cimetidine
also
has
cytoprotective properties and therefore has a
beneficial effect in maintaining the integrity of
the gastric mucosal barrier.
Pharmacokinetics:
Cimetidine
is
rapidly
absorbed
after
oral
administration. Its half-life is approximately 2
hours and the principal route of excretion is
through the urine.
DOSAGE AND ADMINISTRATION:
For oral administration.
a) Active
ulcer:
in
active
duodenal
benign
gastric and stomal ulceration, 800mg as a
single dose at bedtime or 400mg twice daily
with
breakfast
and
at
bedtime.
Treatment
should be continued for at least 4 weeks, even
TABLET
if symptomatic relief has been achieved in shorter time.
b)
Prevention
of
recurrent
ulcer:
In
patients
with
recurrent
duodenal
and
benign
gastric
ulceration,
maintenance dose of 400mg at bedtime for as long as
the physician deems necessary to prevent a relapse.
c)
Persistent
dyspeptic
symptoms
with
or
without
ulceration: 200mg twice daily after breakfast and at
bedtime. Individual courses of treatment should not
exceed 4 weeks. If there is no clinical response or if
symptoms reoccur