Zantac syrup

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

RANITIDINE

Available from:

Glaxo Wellcome UK Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

ATC code:

A02BA02

INN (International Name):

RANITIDINE 150 mg

Pharmaceutical form:

SYRUP

Composition:

RANITIDINE 150 mg

Prescription type:

POM

Therapeutic area:

DRUGS FOR ACID RELATED DISORDERS

Authorization status:

Withdrawn

Authorization date:

2006-09-18

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZANTAC
®
SYRUP
RANITIDINE 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, pharmacist or
nurse.

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, pharmacist or nurse.
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:

heal and stop ulcers in the stomach, or the part of the gut it empties
into (the
duodenum)

help clear up infection in your stomach, when taken with antibiotic
medicines
(medicines taken to treat germs)

stop stomach ulcers when they are a side effect of some medicines

stop ulcers from bleeding

improve 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’

stop acid coming up from the stomach while under anaesthetic during an
operation.
For children (3 to 18 years) Zantac is used to:

heal ulcers in the stomach, of the part of the gut it empties into
(the duodenum)

heal and stop 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

Summary of Product characteristics

Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zantac Syrup
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml of syrup contains Ranitidine Hydrochloride 168.0 mg
(Equivalent
to Ranitidine 150.0 mg)
Each 10 ml of syrup also contains the following excipients:
-
800 mg ethanol
-
1.5 mg propyl hydroxybenzoate
-
0.75 mg butyl hydroxybenzoate
-
700 mg sorbitol
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Syrup
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults
Zantac syrup is indicated for the treatment of duodenal ulcer and
benign
gastric ulcer, including that associated with non-steroidal
anti-inflammatory
agents. In addition, Zantac syrup is indicated for the prevention of
NSAID
associated duodenal ulcers. Zantac syrup is also indicated for the
treatment of
post-operative ulcer, Zollinger-Ellison Syndrome and oesophageal
reflux
disease including long term management of healed oesophagitis. Other
patients with chronic episodic dyspepsia, characterised by pain
(epigastric or
retrosternal) which is related to meals or disturbs sleep but is not
associated
with the preceding conditions may benefit from ranitidine treatment.
Zantac
syrup is indicated for the following conditions where reduction of
gastric
secretion and acid output is desirable; the prophylaxis of
gastro-intestinal
haemorrhage from stress ulceration in seriously ill patients, the
prophylaxis of
recurrent haemorrhage in patients with bleeding peptic ulcers and
before
general anaesthesia in patients considered to be at risk of acid
aspiration
(Mendelson's Syndrome), particularly obstetric patients during labour.
For
appropriate cases Zantac injection is also available (see separate
SPC).
Page 2 of 11
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 ADMINISTRA