FAMOTIDINE AN famotidine 20mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

famotidine

Available from:

Arrow Pharma Pty Ltd

INN (International Name):

Famotidine

Authorization status:

Registered

Patient Information leaflet

_Famotidine AN tablets – Consumer Medicine Information _
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_Famotidine AN CMI v2.0 _
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_Page 1 _
FAMOTIDINE AN TABLETS
_Famotidine _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Famotidine AN.
It
does
not
contain
all
of
the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed
the
risks
of
you
taking
Famotidine
AN
against
the
benefits they expect it will have
for you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
TAKING
THIS
MEDICINE,
TALK
TO
YOUR
DOCTOR
OR
PHARMACIST.
Keep
this
leaflet
with
your
medicine.
You may need to read it again.
WHAT FAMOTIDINE AN
IS USED FOR
Famotidine AN tablets belong to
a group of medicines called H
2
-
antagonists. They are used for:

Treat stomach and duodenal
ulcer
disease
(also
known
as
peptic
ulcer)
and
stop
ulcers coming back.

Treat
Zollinger-Ellison
Syndrome
(rare
condition
caused
by
too
much
acid
production in the stomach).
Famotidine AN works by reducing
the amount of acid in the stomach
thereby reducing the pain and
allowing the ulcer to heal.
Your
doctor
may
have
prescribed
Famotidine
AN
for
another reason. Ask your doctor
if you have any questions as to
why
this
medicine
has
been
prescribed for you.
DO NOT TAKE FAMOTIDINE AN TO
TREAT
ANY
OTHER
COMPLAINTS
UNLESS
YOUR
DOCTOR
HAS
INSTRUCTED YOU TO DO SO.
Famotidine AN is only available
with a doctor’s prescription.
Famotidine
AN
should
not
be
given to children under 18 years
of
age
as
there
is
limited
experience
with
the
use
of
famotidine in children.
There
is
no
evidence
that
Famotidine
AN
tablets
are
addictive.
BEFORE YOU TAKE
FAMOTIDINE AN
_DO NOT TAKE FAMOTIDINE _
_AN IF: _

YOU
HAVE
AN
ALLERGY
TO
FAMOTIDINE OR TO ANY OF THE
INGREDIENTS
LISTED
AT
THE
END
OF
THIS
LEAFLET.
SYMPTOMS
OF
AN
ALLERGIC
REACTION
MAY
INCLUDE,
SHORTNESS
OF
BREATH,
SWELLING OF THE TONGUE OR
FACE,
SKIN
RASH
AND
ITCHINESS.

YOU ARE BREAST-FEEDING OR
PLAN
TO
BREAST-FEED.
FAMOTIDINE
AN
PAS

Summary of Product characteristics

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_Famotidine AN tablets Product Information _
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_ Amneal Pharma Australia Pty Ltd _
Famotidine AN PI v2.0
Page 1
FAMOTIDINE AN
_(FAMOTIDINE TABLETS) _
PRODUCT INFORMATION
NAME OF THE MEDICINE
The name of this medicine is famotidine.
Chemical Name: 3-
[[[2-[(aminoiminomethyl)amino]-4-thiazolyl]methyl]thio]-N-
(aminosulfonyl)propanimidamide. It is a guanylthiazole derivative.
Empirical Formula: C
8
H
15
N
7
O
2
S
3
Molecular Weight: 337.45
Structural Formula:
CAS registry number: 76824-35-6
DESCRIPTION
Famotidine is a white to pale-yellow nonhygroscopic crystalline
substance. Very slightly soluble in
water, freely soluble in glacial acetic acid, very slightly soluble in
anhydrous ethanol, practically
insoluble in ethyl acetate. It dissolves in dilute mineral acids. It
shows polymorphism.
FAMOTIDINE AN 20 mg Tablets also contain: Pregelatinised maize starch,
microcrystalline
cellulose, magnesium stearate, purified talc and Opadry Buff OY-3690.
FAMOTIDINE AN 40 mg Tablets also contain: Pregelatinised maize starch,
microcrystalline
cellulose, magnesium stearate, purified talc and Opadry Buff OY-3682.
PHARMACOLOGY
_Gastrointestinal effects. _Famotidine is a competitive inhibitor of
histamine H
2
-receptors. The primary
clinically important pharmacological activity of famotidine is
inhibition of gastric secretion. Both the
acid concentration and volume of basal, nocturnal and stimulated
gastric secretion are suppressed by
famotidine, while changes in pepsin secretion are proportional to
volume output. In normal volunteers
and hypersecretors, famotidine inhibited basal and nocturnal gastric
secretion, as well as secretion
stimulated by food and pentagastrin. After oral administration, the
onset of the antisecretory effect
occurred within one hour; the maximum effect was dose dependent,
occurring within one to three
hours. Duration of inhibition of secretion by doses of 20 and 40 mg
was ten to twelve hours.
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_Famotidine AN tablets Product Information _
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_ Amneal Pharma Australia Pty Ltd _
Famotidine AN