hovid-Famotidine Film-Coated Tablet 20 mg

Country: Malaysia

Language: English

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

Active ingredient:

FAMOTIDINE

Available from:

HOVID BERHAD

INN (International Name):

FAMOTIDINE

Units in package:

100Tablet Tablets

Manufactured by:

HOVID BERHAD

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
HOVID-FAMOTIDINE TABLET
Famotidine (20mg; 40mg)
1
WHAT IS IN THIS LEAFLET
1.
What hovid-Famotidine Tablet
is
used for
2.
How
hovid-Famotidine
Tablet
works
3.
Before you use hovid-Famotidine
Tablet
4.
How
to
use
hovid-Famotidine
Tablet
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
hovid-
Famotidine Tablet
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT
HOVID-FAMOTIDINE
TABLET
IS
USED FOR
Famotidine is used for the short-term
treatment of:
-
Duodenal ulcer
-
Gastric (stomach) ulcer
-
Overproduction
of
gastric
acid
such
as
Zollinger-Ellison
syndrome
Famotidine
is
also
used
for
the
following:
-
Prevent reoccurrence of duodenal
ulcer
-
Relief
of
heartburn
caused
by
stomach acid leaking up into the
gullet
-
Healing of erosions or ulceration in
the food pipe
HOW HOVID-FAMOTIDINE TABLET WORKS
Famotidine
belongs
to
a
group
of
medicines
called
H
2
-antagonists
or
H
2
-blockers.
It
works
by
reducing
the
amount
of
acid
in
the
stomach
thereby
reducing
the
pain
and
allowing the ulcer to heal.
BEFORE
YOU
USE
HOVID-FAMOTIDINE
TABLET
_- When you must not use it _
Do
not
take
this
medicine
if
you
have
had
an
allergic
reaction
to
famotidine, any other similar medicines,
or to any of the ingredients listed at the
end of this leaflet.
If
you
are
not
sure
whether
you
should
start
taking
famotidine,
talk
to your doctor or pharmacist.
_ _
_- Before you start to use it _
Tell your doctor if:
1.
You have allergies to:
-
any other medicines
-
any
other
substances,
such
as
foods, preservatives or dyes.
2.
You
have
or
have
had
any
medical conditions, especially the
following:
-
kidney disease
-
gastric ulcer (doctor may arrange
additional
tests
to
diagnose
stomach
cancer
before
starting
medication because famotidine can
mask the symptoms and delay the
diagnosis.)
-
any other health problems
3.
You are pregnant or breastfeeding,
or
plan
to
become
pregnant
or
breast-feed. Famotidine should not
be used dur

Summary of Product characteristics

HOVID-FAMOTIDINE TABLET
VIFAMxx-0 (MY)
DESCRIPTION
Famotidine 20 mg and 40 mg Tablet: Square, light orange
film-coated tablet, bevel-edged with shallow convex faces.
COMPOSITION
Each tablet contains:
Famotidine 20 mg/tablet
Famotidine 40 mg/tablet
PHARMACODYNAMICS
Famotidine is a H
2
-receptor antagonist. It inhibits basal and
nocturnal gastric acid secretion by competitive inhibition of
the action of histamine at the histamine H
2
-receptors of the
parietal cells. It also inhibits gastric acid secretion stimulated
by
food,
betazole,
pentagastrin,
caffeine,
insulin
and
physiological vagal reflex.
PHARMACOKINETICS
ABSORPTION:
It is rapidly but incompletely absorbed from the gastro-
intestinal tract.
BIOAVAILABILITY:
The bioavailability of famotidine following oral administration
is about 40% and is not significantly affected by the presence
of food.
METABOLIC REACTIONS:
A small proportion of famotidine is metabolized in the liver to
famotidine S-oxide.
HALF-LIFE:
The
elimination
half-life
from
plasma
is
reported
to
be
between 2.5 to 4 hours and is prolonged in renal impairment.
EXCRETION:
Most is excreted unchanged in urine.
INDICATIONS
Famotidine
is
indicated
in
the
short
term
treatment
of
duodenal
ulcer,
benign
gastric
ulcer
and
hypersecretory
conditions such as Zollinger-Ellison syndrome. It is also used
in
the
prevention
of
relapses
of
duodenal
ulceration,
symptomatic relief of gastro-oesophageal reflux disease and
healing of oesophageal erosions or ulceration associated with
gastro-oesophageal reflux disease.
CONTRAINDICATIONS
Risk-benefit should be considered when the following medical
problems exist:
•
Cirrhosis
•
Hepatic and renal function impairment
•
Sensitivity to any of the histamine H
2
-receptor antagonists
WARNINGS AND PRECAUTIONS
PATIENTS WITH MODERATE OR SEVERE RENAL INSUFFICIENCY:
Since CNS adverse effects have been reported in patients
with moderate and severe renal insufficiency, longer intervals
between doses or lower doses may need to be used in
patients with moderate (creatinine cleara