ZANTAC 300 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

RANITIDINE HYDROCHLORIDE

Available from:

PCO Manufacturing

ATC code:

A02BA02

INN (International Name):

RANITIDINE HYDROCHLORIDE

Dosage:

300 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

H2-receptor antagonists

Authorization status:

Authorised

Authorization date:

1998-11-27

Patient Information leaflet

_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZANTAC
® 300MG 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)

treat 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

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zantac 300 mg Film-coated Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 300 mg ranitidine (as hydrochloride).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet.
White, capsule-shaped tablets with ‘GX EC3’ on one side and plain
on the other side.
4 CLINICAL PARTICULARS
As per 1077/013/004.
5 PHARMACOLOGICAL PROPERTIES
As per 1077/013/004.
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet Core
Microcrystalline cellulose (E460)
Croscarmellose sodium
Magnesium stearate
Film Coat
Hypromellose
Titanium dioxide (E171)
Triacetin
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf-life expiry date for this product shall be the date shown on
the container and outer package of the product on
the market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C. Store in the original package in order to
protect from moisture.
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6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs of 30 tablets contained in an overlabelled outer
cardboard carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.