RANTAC TABLET 150MG

Country: Malaysia

Language: English

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

Active ingredient:

RANITIDINE

Available from:

UNIMED SDN BHD

INN (International Name):

RANITIDINE

Units in package:

10Tablet Tablets; 20 Tablet Tablets

Manufactured by:

UNIQUE PHARMACEUTICAL LABORATORIES

Patient Information leaflet

RANTAC TABLETS 150MG, 300MG
Ranitidine HCl (150mg, 300mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What RANTAC is used for
2.
How RANTAC works
3.
Before you use RANTAC
4.
How to use RANTAC
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of RANTAC
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT RANTAC IS USED FOR
RANTAC
belong
to
a
group
of
medicines called "H2-antagonists". They
reduce
the
amount
of
acid
in
your
stomach and are used to treat:

Duodenal ulcer

Benign gastric ulcer

Post-operative ulcer

Zollinger-Ellison syndrome

Systemic mastocytosis

Reflux esophagitis

Chronic episodic dyspepsia.
HOW RANTAC WORKS
RANTAC is a specific and rapidly acting
histamine H
2
-antagonist. RANTAC
inhibits basal and stimulated secretion of
gastric acid, reducing both the volume
and the acid and pepsin content of the
secretion. RANTAC has a relatively long
duration of action.
BEFORE YOU USE RANTAC
-
When you must not use it
HYPERSENSITIVITY
Do not take RANTAC if you are allergic
(hypersensitive) to RANTAC or any of
the other ingredients in the product.
-
Before you start use it
Check with your doctor of pharmacist
before taking RANTAC if:

you have stomach cancer

kidney problems. You may need
different dose of RANTAC.

you have had stomach ulcer and
you
are
taking
non-steriodal
anti-inflammatory
medicines
(NSAID)
such
as
aspirin
or
ibuprofen

you
have
rare
disease
called
porphyria

you are over 65 years old

you have lung disease

you are diabetic

you
have
any
problems
with
you immune system
If you are not sure if any of the above
apply
to
you,
talk
to
your
doctor
or
pharmacist before taking this medicine.
PREGNANCY
AND
BREAST-FEEDING
Pregnancy
Like other drugs, RANTAC should only
be used during pregnancy if considered
essential.
RANTAC
crosses
the
placenta
but
therapeutic
doses
administered
to
patients
in
labour
or
undergoing
caesarean section have been without any
adverse

Summary of Product characteristics

For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory only
.
RANTAC* 1 5 0
_I _
300
(RANITIDINE TABLETS USP 150 MG _I _300 MG)
COMPOSITION:
Each film coated tablet contains:
Ranitidine Hydrochloride USP equivalent to Ranitidine 150mg /300 mg.
DESCRIPTION:
150MG & 300MG
Orange coloured round, biconvex, film-coated tablet. packed in blister
of 10 tablets, 20 such blisters are
packed in a printed carton
.
PHARMACOLOGY:
Histamine H 2-receptor Antagonist, Rantac is a competitive reversible
inhibitor of the action of Histamine
at the Histamine H 2-receptor including receptors on the gastric
cells.
Ranitidine inhibits daytime and nocturnal basal gastric acid
secretion, as well as gastric acid secretion
stimulated by food, histamine and pentagastrin. Basal and nocturnal
secretions are most sensitive to
inhibit by ranitidine, responding almost completely to doses of 100 mg
or less. Ranitidine does not affect
pepsin secretion or pantagastrin stimulated intrinsic factor secretion
and has little or no effect on fasting
or postprandial serum gastrin.
Rantac is a highly effective, rapidly acting histamine H 2 antagonist.
It inhibits basal and stimulated
secretion of gastric acid, reducing both the volumes of secretion, the
acid and pepsin content.
Absorption of the oral Ranitidine is not significantly impaired by the
administration of food. Concomitant
administration of antacids may reduce its absorption. Propantheline
slightly delays and increases peak
blood levels, probably by delaying gastric emptying and transit time.
Serum protein binding averages
15%
Hepatic metabolism results in three metabolites. Elimination half-life
is 2 to 3 hours and duration of
action is 8 to 12 hours. The principal route of excretion is the urine
and active tubular excretion.
Accumulation of the drug occurs in renal impairment; elimination
half-life increases to 8 to 10hours.
Ranitidine is removed by hemodialysis and peritoneal dialysis.
MECHANISM OFACTION:
Rantac is a highly effective, rapidly acting histamine H2 Antagon