PENTASA

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

MESALAZINE

متاح من:

PCO Manufacturing

ATC رمز:

A07EC02

INN (الاسم الدولي):

MESALAZINE

جرعة:

500 Milligram

الشكل الصيدلاني:

Tablet Prolonged Release

نوع الوصفة الطبية :

Product subject to prescription which may be renewed (B)

المجال العلاجي:

mesalazine

الوضع إذن:

Authorised

تاريخ الترخيص:

2009-08-21

نشرة المعلومات

_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
PENTASA
®
500MG PROLONGED
RELEASE TABLETS
Mesalazine
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 Pentasa Tablets are and what they are used for
2.
What you need to know before you take Pentasa
Tablets
3.
How to take Pentasa Tablets
4.
Possible side effects
5.
How to store Pentasa Tablets
6.
Contents of the pack and other information
1.
WHAT PENTASA TABLETS ARE AND WHAT
THEY ARE USED FOR
The name of this medicine is Pentasa 500mg Prolonged
Release Tablets. Each tablet contains mesalazine 500mg
as the active ingredient. Mesalazine belongs to a group of
medicines called salicylates.
Pentasa is used to treat mild to moderate inflammation of
the gut caused by conditions called ulcerative colitis or
Crohn’s disease. It can also be used to control these
conditions and prevent them from coming back.
The tablets release the active ingredient slowly which
then acts locally to reduce the inflammation and help
relieve or stop the pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
PENTASA TABLETS
DO NOT TAKE PENTASA TABLETS:

if you are ALLERGIC (HYPERSENSITIVE) to MESALAZINE or
any of the other ingredients of this medicine (listed
in Section 6)
if you are ALLERGIC to any other salicylates e.g. aspirin

if you have SEVERE LIVER AND/OR KIDNEY problems
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Pentasa
Tablets.
You should consult your doctor before taking these
tablets:

if you experience any unexplained bleeding,

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pentasa 500 mg Prolonged-release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains mesalazine 500mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
_Product imported from the UK, Italy and Portugal:_
White-grey to pale brown, speckled, round, prolonged-release tablets,
scored and marked ‘500mg’ on one side and
‘PENTASA’ on the reverse side.
4 CLINICAL PARTICULARS
As per PA1009/006/005
5 PHARMACOLOGICAL PROPERTIES
As per PA1009/006/005
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Povidone
Ethylcelluose
Magnesium stearate
Talc
Microcrystalline cellulose
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf-life expiry date of this product is 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
Do not store above 25
°
C.
Store in the original package as the product is sensitive to light.
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6.5 NATURE AND CONTENTS OF CONTAINER
Double aluminium foil blisters, containing 50 or 100 tablets,
presented in a cardboard carton or an overlabelled
cardboard carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM
SUCH M