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

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

ranitidine hydrochloride

Commercializzato da:

Sandoz Pty Ltd

Stato dell'autorizzazione:

Registered

Foglio illustrativo

RANITIDINE SANDOZ
®
1
RANITIDINE SANDOZ
®
_ranitidine hydrochloride film-coated tablets _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Ranitidine Sandoz.
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
SANDOZ IS USED FOR
This medicine is used to treat:
•
Treat stomach and duodenal ulcer
disease (also known as 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 Sandoz is
also used to help stop these ulcers
from coming back.
•
Stop these ulcers from coming
back
•
Treat 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.
•
Treat Zollinger-Ellison syndrome,
a rare condition where the
stomach produces very large
amounts of acid, much more than
in ulcers and reflux disease.
•
Treat 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 H2 antagonists or
H2 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 re

Scheda tecnica

181220-Ranitidine Sandoz-pi
Page 1 of 9
AUSTRALIAN PRODUCT INFORMATION
RANITIDINE SANDOZ (RANITIDINE HYDROCHLORIDE) TABLETS
1.
NAME OF THE MEDICINE
Ranitidine hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Ranitidine Sandoz 150 mg tablets contains 150 mg ranitidine
hydrochloride.
Each Ranitidine Sandoz 300 mg tablets contains 300 mg ranitidine
hydrochloride.
List of excipients with known effect: lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Ranitidine Sandoz 150 mg Tablets: yellow, round, film-coated tablets,
scored on one side.
Ranitidine Sandoz 300 mg Tablets: yellow, oblong, film-coated tablets,
scored on one side.
4.
CLINICAL PARTICULARS
T
HERAPEUTIC INDICATIONS
•
Short-term treatment of proven duodenal ulcer and gastric ulcer.
•
Maintenance treatment to reduce the risk of relapse in duodenal ulcer.
•
Maintenance treatment for periods up to one year to reduce the risk of
relapse in patients
with documented healing of benign gastric ulcer.
•
Treatment of gastrinoma (Zollinger-Ellison syndrome)
•
Short-term symptomatic treatment of reflux oesophagitis unresponsive
to conservative
anti-reflux measures and simple drug therapies such as antacids.
•
Maintenance treatment to reduce the risk of relapse of reflux
oesophagitis.
•
Treatment of scleroderma oesophagitis.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_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.
_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.