ZANTAC 300 MG Film Coated Tablet

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

RANITIDINE HYDROCHLORIDE

から入手可能:

LTT Pharma Limited

ATCコード:

A02BA02

INN（国際名）:

RANITIDINE HYDROCHLORIDE

投薬量:

300 MG

医薬品形態:

Film Coated Tablet

処方タイプ:

Product subject to prescription which may be renewed (B)

治療領域:

H2-receptor antagonists

認証ステータス:

Authorised

承認日:

2011-06-03

情報リーフレット

ZANTAC 300MG 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 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 ‘indigestion’, dyspepsia’

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zantac 300mg 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
_Product imported from the UK:_
White, round tablets engraved ‘GXEC3’ on one side and plain on the other.
4 CLINICAL PARTICULARS
As per PA1077/013/004
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/013/004
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet core
Microcrystalline cellulose
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 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°C.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 22/08/2016_
_CRN 2180995_
_page number: 1_
6.5 NATURE AND CONTENTS OF CONTAINER
Foil blister strips of 5 tablets in and overlabelled outer carton. 30 tablet pack.
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 Ltd.
Unit 18, Oxleasow Road
East Moons Moat
Redditch
Worcestershite
B98 0RE
United Kingdom
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1562/051/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 3rd June 2011
10 DATE OF REVISION OF THE TEXT
August 2016
HEALTH PRODUCTS REGULATORY AUTHOR