AXCEL CIMETIDINE-200 SUSPENSION

País: Malàisia

Idioma: anglès

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

ingredients actius:

CIMETIDINE

Disponible des:

KOTRA PHARMA (M) SDN. BHD.

Designació comuna internacional (DCI):

CIMETIDINE

Unidades en paquete:

100 ml mL; 60 ml mL

Fabricat per:

KOTRA PHARMA (M) SDN. BHD.

Informació per a l'usuari

AXCEL CIMETIDINE-200 SUSPENSION
Cimetidine (200mg/5ml)
_ _
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
WHAT IS IN THIS LEAFLET
1.
What
Axcel
Cimetidine-200
Suspension is used for.
2.
How
Axcel
Cimetidine-200
Suspension works.
3.
Before
you
use
Axcel
Cimetidine-200 Suspension.
4.
How to use Axcel Cimetidine-
200 Suspension.
5.
While you are using it.
6.
Side effects.
7.
Storage
and
disposal
of
Axcel
Cimetidine-200 Suspension.
8.
Product description.
9.
Manufacturer
and
Product
Registration Holder.
10.
Date of revision.
WHAT
AXCEL
CIMETIDINE-200
SUSPENSION IS USED FOR
Axcel Cimetidine-200 Suspension is
used to treat:
•
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-200
SUSPENSION 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-
200 SUSPENSION
_-When you must not use it _
Do
not
take
Axcel
Cimetidine-200
Suspension 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:
•
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

Fitxa tècnica

MAL 19940271A
should particularly be borne in mind in patients of middle
age and over with new or recently changed dyspeptic
symptoms. Care should be taken for patient with a history of
peptic ulcer, particularly the elderly, being treated with
cimetidine and non-steroidal anti-inflammatory agent are
observed regularly. It should be avoided during lactation
unless essential. In patients in drug treatment or with illness
that could cause falls in blood cell count, the possibility that
H2 receptor antagonism could potentiate this effect should
be borne in mind. Exclude malignancy in gastric ulcer. Use
in pregnancy should be avoided unless essential for benefit.
Dosage to be reduced in patients with severely impaired
renal function.
SIDE EFFECTS:
Agranulocytosis,
headache,
myalgia,
arthralgia,
sinus
bradycardia,
tachycardia,
heart
block
and
reversible
impotence. Diarrhoea, tiredness, dizziness, rash in small
number
of
patients.
Gynaecomastia,
rarely.
Decreased
white blood cell counts including agranulocytosis mostly in
patients also receiving drug known to reduce blood counts.
Very rare cases of thrombocytopenia and aplastic anaemia.
A few cases of reversible confusion, mostly in elderly and/or
severely ill patients. Rare cases of hepatitis, pancreatitis
and interstitial nephritis.
DRUG INTERACTIONS:
Cimetidine
apparently
through
an
effect
on
certain
microsomal enzymes system, has been reported to reduce
the
hepatic
metabolism
of
warfarin-type
anticoagulant,
phenytoin,
propranolol,
nifedipine,
chlordiazepoxide,
diazepam,
certain
tricyclic
antidepressant,
lidocaine,
theophylline
and
metronidazole,
thereby
delaying
elimination and increasing blood levels of these drugs.
Clinically significant effects have been reported with the
warfarin
anticoagulants;
therefore,
close
monitoring
of
prothrombin time is recommended, and adjustment of the
anticoagulant dose may be necessary when cimetidine is
administered
concomitantly.
Interaction
with
phenytoin,
lidocaine
and
theophylline
has
also
been
reported
to
produce adverse clin