Zantac 150mg Film-coated Tablets.

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Ranitidine

Commercializzato da:

IMED Healthcare Ltd.

Codice ATC:

A02BA; A02BA02

INN (Nome Internazionale):

Ranitidine

Dosaggio:

150 milligram(s)

Forma farmaceutica:

Film-coated tablet

Tipo di ricetta:

Product subject to prescription which may be renewed (B)

Area terapeutica:

H2-receptor antagonists; ranitidine

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2008-07-04

Foglio illustrativo

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 H2-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 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”, “dy

Scheda tecnica

Health Products Regulatory Authority
05 June 2019
CRN008XYL
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zantac 150mg Film-coated Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 150mg of the active ingredient ranitidine (as
hydrochloride).
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from the UK:_
White, round tablet 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
Tablet Core
Microcrystalline cellulose (E460)
Magnesium stearate
Film Coat
Hydroxypropylmethylcellulose (E464),
Triacetin
Titanium Dioxide (E171)
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
blister strips and outer carton of the product as marketed in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C. Keep container tightly closed in order to
protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Aluminium foil blisters in a printed carton containing 60 tablets.
Health Products Regulatory Authority
05 June 2019
CRN008XYL
Page 2 of 2
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
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/003/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of First Authorisation: July 4th 2008.
10 DATE OF REVISION OF THE TEXT
June 2019