BioWell Famotac Film-Coated Tablets 40mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

FAMOTIDINE

Boleh didapati daripada:

Hovid Nutriworld Sdn Bhd

INN (Nama Antarabangsa):

FAMOTIDINE

Unit dalam pakej:

100 Tablets

Dikeluarkan oleh:

HOVID BERHAD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
BIOWELL FAMOTAC FILM-COATED
TABLETS 40 MG
FAMOTIDINE 40 MG
1
WHAT IS IN THIS LEAFLET
1.
What
BioWell
Famotac
Film-
Coated Tablets 40mg is used for
2.
How
BioWell
Famotac
Film-
Coated Tablets 40mg works
3.
Before you use BioWell Famotac
Film-Coated Tablets 40mg
4.
How
to
use
BioWell
Famotac
Film-Coated Tablets 40mg
5.
While
you
are
using
BioWell
Famotac
Film-Coated
Tablets
40mg
6.
Side effects
7.
Storage and Disposal of BioWell
Famotac
Film-Coated
Tablets
40mg
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT BIOWELL FAMOTAC FILM-COATED
TABLETS 40MG 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 BIOWELL FAMOTAC FILM-COATED
TABLETS 40MG WORKS
Famotidine
belongs
to
a
group
of
medicines called H2-antagonists or H2-
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
BIOWELL
FAMOTAC
FILM-COATED TABLETS 40MG
_- 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
mas

Ciri produk

DESCRIPTION
Famotidine 40 mg Tablet: Square, light orange film-coated tablet,
bevel-edged with shallow convex faces.
COMPOSITION
Each Film-Coated Tablet contains: Famotidine U.S.P. 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
clearance < 50mL/min) or severe (creatinine clearance < 10mL