Pentasa 1 g prolonged-release tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Mesalazine

Tilgjengelig fra:

IMED Healthcare Ltd.

ATC-kode:

A07EC; A07EC02

INN (International Name):

Mesalazine

Legemiddelform:

Prolonged-release tablet

Terapeutisk område:

Aminosalicylic acid and similar agents; mesalazine

Autorisasjon dato:

2022-12-16

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
PENTASA
®
1 G PROLONGED-RELEASE TABLETS
mesalazine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR
YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have 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 1 g prolonged-release
tablets. Each tablet contains mesalazine 1 g 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 other salicyclates 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, bruising, skin
rashes, fever or

Preparatomtale

Health Products Regulatory Authority
19 December 2022
CRN00D89X
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pentasa 1 g prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains mesalazine 1 g.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
_Product imported from Italy_
White-grey to pale brown, speckled, oval tablet. Embossing on both
sides: PENTASA
4 CLINICAL PARTICULARS
As per PA1009/006/007
5 PHARMACOLOGICAL PROPERTIES
As per PA1009/006/007
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Povidone
Ethylcellulose
Magnesium stearate
Talc
Microcrystalline cellulose
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
Do not store above 25ºC.
Store in the original package in order to protect from light.
6.5 NATURE AND CONTENTS OF CONTAINER
Pack of 60 tablets.
Health Products Regulatory Authority
19 December 2022
CRN00D89X
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
PPA1463/110/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 16
th
December 2022
10 DATE OF REVISION OF THE TEXT