Zantac 150 mg/10 ml Syrup

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/ 10 millilitre

Pharmaceutical form:

Syrup

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

H2-receptor antagonists; ranitidine

Authorization status:

Not marketed

Authorization date:

1989-04-26

Patient Information leaflet

Reason for update: Updated in line with PSUSA and schedule check
update.
Market: IE
Agency Approval Date:
Text Date: 23/05/2019
Text Issue and Draft No.: Issue 4 Draft 1
LOGO GSK
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZANTAC
150 MG/ 10 ML
SYRUP
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 Syrup
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)
•
treat pro

Summary of Product characteristics

Health Products Regulatory Authority
03 December 2019
CRN0097YJ
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zantac 150 mg/10 ml Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml of Syrup contains ranitidine hydrochloride equivalent to
150 mg of ranitidine.
Excipients: Each 10 ml of Ranitidine syrup contains:
Approximately 7.5% (800 mg) Ethanol equivalent to 750 mg of pure
ethanol
1.5 mg Propyl parahydroxybenzoate (E216)
0.75 mg Butyl parahydroxybenzoate
1 g of Sorbitol
For a full list of excipients, see Section 6.1
3 PHARMACEUTICAL FORM
Syrup.
A clear, colourless to pale yellow liquid with an odour of mint.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zantac syrup is used 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
syrup is 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.
See section 4.4 Special warnings and precautions for use.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS(INCLUDING THE ELDERLY)/ADOLESCENTS (12 YEARS AND OVER)
The usual initial dosage is 150 mg bd or 300 mg nocte. This may be
increased to ranitidine 300 mg twice daily without an
increased incidence of unwanted effects.
Subsequently a maintenance dose of 150 mg nocte 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 nocte
provides additional therapeutic benefi