Zantac 75mg Film-Coated Tablets

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

RANITIDINE HYDROCHLORIDE

Доступно од:

Imbat Limited

АТЦ код:

A02BA; A02BA02

INN (Међународно име):

RANITIDINE HYDROCHLORIDE

Дозирање:

75 milligram(s)

Фармацеутски облик:

Film-coated tablet

Тип рецептора:

Product not subject to medical prescription

Терапеутска област:

H2-receptor antagonists; ranitidine

Статус ауторизације:

Authorised

Датум одобрења:

2008-03-28

Информативни летак

Page 1 of 2
PATIENT INFORMATION LEAFLET
ZANTAC
® 75MG FILM-COATED TABLETS
ranitidine (as hydrochloride)
Your medicine is available using the above name but will be
referred to as Zantac 75 Tablets throughout this leaflet.
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TO TAKE THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to take Zantac 75 Tablets carefully to get the best results
from them.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

You must contact a doctor if your symptoms worsen or do
not improve after 14 days.

If any of the side effects get serious or if you notice any side
effect not listed in this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1.
What Zantac 75 Tablets are and what are they used for
2.
Before you take Zantac 75 Tablets
3.
How to take Zantac 75 Tablets
4.
Possible side effects
5.
How to store Zantac 75 Tablets
6.
Contents of the pack and other information
1.
WHAT ZANTAC 75 TABLETS ARE AND WHAT ARE
THEY USED FOR
Each tablet contains 75mg of ranitidine (as hydrochloride).
Ranitidine belongs to a group of medicines known as histamine H2
antagonists.
The stomach contains hydrochloric acid which helps to digest your
food. Sometimes your stomach produces too much acid. This
excess acid can lead to the conditions known as heartburn and
dyspepsia (acid indigestion).
Zantac 75 Tablets are for the short-term relief of the symptoms of
heartburn, excess acid and dyspepsia (acid indigestion).
2.
BEFORE YOU TAKE ZANTAC 75 TABLETS
DO NOT TAKE ZANTAC 75 TABLETS:

if you are allergic to ranitidine or any of the other
ingredients listed in Section 6.

if you suffer from a rare condition called porphyria.
TAKE SPECIAL CARE AND CONSULT YOUR DOCTOR BEFORE
YOU TAKE ZANTAC 75 TABLETS:

if you are middle aged or older and have acid indigestion
symptoms for the first time or symptoms that have recently
ch

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zantac 75mg Film-Coated Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75mg ranitidine (as hydrochloride).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-Coated Tablets
Product imported from the UK
Five-sided biconvex, pink tablet with ‘Z’ engraved on one side and
‘75’ on the reverse.
4 CLINICAL PARTICULARS
As per PA1186/013/001.
5 PHARMACOLOGICAL PROPERTIES
As per PA1186/013/001.
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Microcrystalline cellulose
Magnesium stearate
Hypromellose
Titanium dioxide (E171)
Triacetin
Iron oxide (E172)
6.2 INCOMPATIBILITIES
Not Applicable
6.3 SHELF LIFE
The shelf life expiry date of 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
Store below 30°C
6.5 NATURE AND CONTENTS OF CONTAINER
Blister strips reboxed into cartons. Pack size: 12 or 24 tablets.
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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
Imbat Limited
Unit L2
North Ring Business Park
Santry
Dub