Zantac 150 milligram(s) Film-coated tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

RANITIDINE HYDROCHLORIDE

Available from:

GlaxoSmithKline (Ireland) Limited

ATC code:

A02BA; A02BA02

INN (International Name):

RANITIDINE HYDROCHLORIDE

Dosage:

150 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

H2-receptor antagonists; ranitidine

Authorization status:

Not marketed

Authorization date:

1982-12-01

Patient Information leaflet

Reason for update: Updated in line with PSUSA and schedule check
update
Market: IE
Agency Approval Date:
Text Date: 30/05/2019
Text Issue and Draft No.: Issue 5 Draft 2
LOGO GSK
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZANTAC 150 MG FILM COATED TABLETS
RANITIDINE (AS HYDROCHLORIDE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It
may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1
What Zantac is and what it is used for
2
What you need to know before you take Zantac
3
How to take Zantac Tablets
4
Possible side effects
5
How to store Zantac
6
Contents of the pack and other information
1
WHAT ZANTAC IS AND WHAT IT IS USED FOR
Zantac contains a medicine called ranitidine. This belongs to a group
of medicines
called H
2
-receptor antagonists. It lowers the amount of acid in your stomach.
FOR ADULTS (INCLUDING THE ELDERLY) Zantac is used to:

treat ulcers in the stomach, or the part of the gut it empties into
(the duodenum)

prevent stomach ulcers when they are a side effect of some medicines

treat problems caused by acid in the food pipe (oesophagus) or too
much acid in
the stomach. Both of these can cause pain or discomfort sometimes
known as
‘indigestion’, ‘dyspepsia’ or ‘heartburn’

treat other conditions where reduction of acid in the stomach is
likely to be
beneficial

treat Zollinger-Ellison syndrome – a condition in which there is
increased
production of the hormone gastrin
FOR CHILDREN (3 TO 18 YEARS) Zantac is used to:

treat ulcers in the stomach, or the part of the gut it empties into
(the duodenum)

tr

Summary of Product characteristics

Health Products Regulatory Authority
28 February 2020
CRN0097YN
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zantac 150 milligram(s) Film-coated tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg of ranitidine as ranitidine
(as hydrochloride).
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
White round tablets engraved 'GXEC2' on one side and plain on the
other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of duodenal ulcer and benign gastric ulcer including
that associated with non-steroidal anti-inflammatory
agents. Prevention of non-steroidal anti-inflammatory drug (including
aspirin) associated duodenal ulcers, especially in patients
with a history of peptic ulcer disease. Zantac Tablets are also
indicated for treatment of post-operative ulcer, reflux
oesophagitis, Zollinger-Ellison syndrome and other conditions where
reduction of gastric acid secretion is likely to be
beneficial.
CHILDREN (3 TO 18 YEARS)

Short term treatment of peptic ulcer

Treatment of gastro-oesophageal reflux, including reflux oesophagitis
and symptomatic relief of
gastro-oesophageal reflux disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS (INCLUDING THE ELDERLY) / ADOLESCENTS (12 YEARS AND OVER)
The usual initial dosage in duodenal and benign gastric ulcer is 150
mg twice daily or 300 mg at night. This may be increased
to ranitidine 300 mg twice daily without an increased incidence of
unwanted effects. Subsequently a maintenance dose of
150mg at night may be used. Smoking is associated with a higher rate
of ulcer relapse, and such patients should be advised to
stop smoking. In those who fail to comply with such advice, a dose of
300 mg at night provides additional therapeutic benefit
over the standard dose.
The standard dosage regimen for post-operative ulcer is 150 mg twice
daily.
In most cases of duodenal ulcer, benign gastric ulcer and post
operative ulcer, healing occurs with