RANITIDINE GH ranitidine (as hydrochloride) 300 mg film-coated tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
27-06-2019
Summary of Product characteristics
(SPC)
27-06-2019
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
ranitidine hydrochloride
Available from:
Sandoz Pty Ltd
INN (International Name):
Ranitidine hydrochloride
Authorization status:
Registered
Patient Information leaflet
CONSUMER MEDICINE INFORMATION
RANITIDINE GH
(RANITIDINE HYDROCHLORIDE) FILM-COATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Ranitidine GH.
It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risk of you taking
this medicine against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST. KEEP THIS LEAFLET
WITH THE MEDICINE.
You may need to read it again.
WHAT RANITIDINE GH IS
USED FOR
This medicine is used to treat:
•
PEPTIC ULCERS. Depending on
the position of the ulcer it is
called a gastric or duodenal
ulcer. A gastric ulcer occurs
in the stomach. A duodenal
ulcer occurs in the duodenum
which is the tube leading out
of the stomach. These can
be caused in part by too
much acid being produced in
the stomach. Ranitidine GH
is also used to help stop
these ulcers from coming
back.
•
REFLUX OESOPHAGITIS OR
REFLUX DISEASE. This can be
caused by “washing back”
(reflux) of food and acid from
the stomach into the food
pipe, also known as the
oesophagus. Reflux can
cause a burning sensation in
the chest rising up to the
throat, also known as
heartburn.
•
ZOLLINGER-ELLISON
SYNDROME, a rare condition
where the stomach produces
very large amounts of acid,
much more than in ulcers
and reflux disease.
•
SCLERODERMA OESOPHAGITIS.
Scleroderma is a rare
condition, and in scleroderma
oesophagitis the food pipe is
abnormal and reflux occurs.
It contains the active ingredient
ranitidine hydrochloride.
Ranitidine hydrochloride belongs
to a group of medicines called
H
2
antagonists or H
2
blockers.
It works by decreasing the
amount of acid made by the
stomach. This helps to reduce
the pain and also allows the
ulcer and/or reflux disease to
heal in most people.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have
presc
Read the complete document
Summary of Product characteristics
AUSTRALIAN PRODUCT INFORMATION – RANITIDINE GH
(RANITIDINE HYDROCHLORIDE) FILM-COATED TABLET
1
NAME OF THE MEDICINE
Ranitidine hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg or 300 mg ranitidine (as
hydrochloride).
List of excipients with known effects: Lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Ranitidine GH 150 mg tablets: Yellow, round, film-coated tablets,
scored on one side.
Ranitidine GH 300 mg tablets: Yellow, oblong, film-coated tablets,
scored on one side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1.
Short-term treatment of proven duodenal ulcer and gastric ulcer.
2.
Maintenance treatment to reduce the risk of relapse in duodenal ulcer.
3.
Maintenance treatment for periods up to one year to reduce the risk of
relapse in patients with
documented healing of benign gastric ulcer.
4.
Treatment of gastrinoma (Zollinger-Ellison syndrome).
5.
Short-term symptomatic treatment of reflux oesophagitis unresponsive
to conservative antireflux
measures and simple drug therapies such as antacids.
6.
Maintenance treatment to reduce the risk of relapse of reflux
oesophagitis.
7.
Treatment of scleroderma oesophagitis.
4.2 DOSE AND METHOD OF ADMINISTRATION
Ranitidine GH is an oral tablet.
DUODENAL OR GASTRIC ULCERATION
_ _
_ACUTE TREATMENT:_
300 mg taken as a single dose at bedtime, or 150 mg taken twice daily,
in the morning and at bedtime.
It is not necessary to time the dose in relation to meals. In most
cases healing will occur in four weeks
although a small number of patients may require an additional two to
four weeks of therapy.
Ranitidine GH v4.0
Page 2 of 10
(ranitidine hydrochloride) film-coated tablet
_MAINTENANCE TREATMENT_:
Duodenal ulcer: 150 mg taken at night.
As smoking is associated with a higher rate of ulcer relapse, patients
should be advised to stop smoking.
In patients unable to stop smoking, a dose of 300 mg at night provides
additional therapeutic benefit.
Gastric ulcer:
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