Zantac 300mg Film-coated Tablets

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Ranitidine

Inapatikana kutoka:

Imbat Limited

ATC kanuni:

A02BA; A02BA02

INN (Jina la Kimataifa):

Ranitidine

Kipimo:

300 milligram(s)

Dawa fomu:

Film-coated tablet

Dawa ya aina:

Product subject to prescription which may be renewed (B)

Eneo la matibabu:

H2-receptor antagonists; ranitidine

Idhini hali ya:

Authorised

Idhini ya tarehe:

2014-05-02

Taarifa za kipeperushi

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZANTAC
® 300MG FILM-COATED TABLETS
(ranitidine hydrochloride)
Your medicine is available using the above name but will be
referred to as Zantac throughout this 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
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
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
(oesoph

Tabia za bidhaa

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 hydrochloride.
_For a full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Film coated tablet (tablet).
_Product imported from the UK:_
White, capsule-shaped tablets, engraved ‘GXEC3’ on one face and
plain on the other side.
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 of this product shall be the date shown on
the blister strips and the outer carton of the product
as marketed in the country of origin.
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C.
6.5 NATURE AND CONTENTS OF CONTAINER
Over-labelled carton containing double foil blister packs
Pack size: 30 Tablets
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 AUT