RANITIDINE AN ranitidine (as hydrochloride) 300mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ranitidine hydrochloride

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

Ranitidine hydrochloride

Authorization status:

Registered

Patient Information leaflet

_Ranitidine AN tablets – Consumer Medicine Information _
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_Doc ID: 95.AN.M.1.0 _
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_Page 1 _
RANITIDINE AN TABLETS
_Ranitidine hydrochloride tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Ranitidine 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 Ranitidine
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 RANITIDINE AN IS
USED FOR
The name of your medicine is
Ranitidine
AN.
It
contains
the
active
ingredient
ranitidine
hydrochloride.
It
belongs
to
a
group
of
medicines called H
2
-antagonists
or H2-blockers.
Ranitidine works by reducing the
amount of acid produced by your
stomach.
Ranitidine
is
used
for
the
following:

To treat and prevent peptic
ulcers.
Peptic
ulcers
are
ulcers
that
occur
in
the
stomach or duodenum.

To treat reflux or heartburn

Zollinger-Ellison Syndrome

Scleroderma oesophagitis
By reducing the amount of acid
produced
by
the
stomach,
Ranitidine AN reduces the pain
associated
with
the
above
conditions, helps ulcers to heal
and helps heal oesphagitis.
Your
doctor
may
have
prescribed
Ranitidine
AN
for
another reason. Ask your doctor
if you have any questions about
why
Ranitidine
AN
has
been
prescribed for you.
Ranitidine AN is available only
with a doctor’s prescription.
Ranitidine AN is not addictive.
BEFORE YOU TAKE
RANITIDINE AN
_WHEN YOU MUST NOT TAKE _
_IT _
DO NOT TAKE RANITIDINE AN IF
YOU
HAVE
AN
ALLERGY
TO
RANITIDINE
OR
ANY
OF
THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Symptoms of an allergic reaction
may include asthma, wheezing,
shortness of breath, swelling of
the face, lips or tongue which
may
cause
difficulty
in
swallowing or breathing, hives,
itching or ski

Summary of Product characteristics

_Ranitidine AN tablets Product Information _
_ Amneal Pharma Australia Pty Ltd _
Ranitidine AN PI v2.0
Page 1
RANITIDINE AN
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_(RANITIDINE (AS HYDROCHLORIDE) TABLETS) _
_ _
PRODUCT INFORMATION
NAME OF THE MEDICINE
The name of the medicine is ranitidine hydrochloride
CHEMICAL NAME:
_N_-[2-[[[5-[(dimethylamino)methyl]furan-2-yl]methyl]-thio]ethyl]-_N’-_
methyl-2-nitroethene-1,1-diamine hydrochloride
MOLECULAR FORMULA: C
13
H
22
N
4
O
3
S.HCl
MOLECULAR WEIGHT: 350.87
CAS REGISTRY NUMBER: _[66357-59-3] _
DESCRIPTION
Ranitidine hydrochloride is an aminoalkyl substituted furan and is
structurally different from
cimetidine, lacking the imidazole ring and the cyanoguanidine group.
Each Ranitidine AN tablet contains ranitidine hydrochloride equivalent
to 150 mg or 300 mg
of ranitidine respectively. Each tablet also contains the following
excipients: microcrystalline
cellulose,
croscarmellose
sodium,
colloidal
anhydrous silica,
purified
talc, purified water,
magnesium
stearate,
hypromellose,
castor
oil,
iron
oxide
yellow,
titanium
dioxide,
OPACODE monogramming ink S-1-27794 BLACK.
PHARMACOLOGY
Ranitidine hydrochloride is a histamine H
2
-receptor antagonist.
Animal experiments both _ in vitro _ and _ in vivo _ have established
that ranitidine is a selective,
competitive
antagonist
of
histamine at H
2
-receptor sites.
Ranitidine has no significant
interaction at histamine H
1
-receptors, muscarinic receptors
or β-adrenoceptors. Ranitidine is a
potent inhibitor of gastric secretion in the rat and dog.
All the evidence from human studies is compatible with a selective,
competitive antagonism of
histamine H
2
-receptors
by
ranitidine
in
humans. Oral
or
intravenous
administration
of
ranitidine inhibits both basal gastric secretions and gastric acid
secretion induced by histamine,
pentagastrin and other secretagogues. On a weight basis ranitidine is
between 4 and 9 times
more potent than cimetidine.
After oral administration of ranitidine, the plasma concentrations of
ranitidine achieved are
directly related to the dose
adm