ZANTAC 150 MG Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

RANITIDINE HYDROCHLORIDE

Available from:

LTT Pharma Limited

ATC code:

A02BA02

INN (International Name):

RANITIDINE HYDROCHLORIDE

Dosage:

150 MG

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:

2011-05-06

Patient Information leaflet

ZANTAC 150MG FILM-COATED TABLETS
ranitidine (as hydrochloride)
PATIENT INFORMATION LEAFLET
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:
What Zantac is and what it is used for
What you need to know before you take Zantac
How to take Zantac Tablets
Possible side effects
How to store Zantac
Contents of the pack and other information
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 some 
times 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 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 ‘hear

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zantac 150mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150mg of ranitidine (as hydrochloride).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from the UK:_
White, round tablets engraved 'GX EC2' on one side and plain on the other side.
4 CLINICAL PARTICULARS
As per PA1077/013/003
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/013/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Microcrystalline cellulose
Magnesium stearate
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 blister and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30
o
C.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 22/08/2016_
_CRN 2180995_
_page number: 1_
6.5 NATURE AND CONTENTS OF CONTAINER
Over labelled blister strip. Packs of 60 tablets.
Not all pack sizes may be marketed.
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.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
LTT Pharma Limited
Unit 18 Oxleasow Road
East Moons Moat
Redditch
Worcestershire B98 0RE
United Kingdom
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1562/051/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 6
th
May 2011
10 DATE OF REVISION OF THE TEXT
August 2016
HEALTH PRODUCTS REGULATORY AUTHORITY
_______________________________