Pentasa 1 g prolonged-release tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Mesalazine

Tilgjengelig fra:

PCO Manufacturing Ltd.

ATC-kode:

A07EC; A07EC02

INN (International Name):

Mesalazine

Legemiddelform:

Prolonged-release tablet

Terapeutisk område:

Aminosalicylic acid and similar agents; mesalazine

Autorisasjon dato:

2023-03-31

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 s and what it is used for
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, bru

Preparatomtale

Health Products Regulatory Authority
31 March 2023
CRN00DFPP
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 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 25 °C.
Store in the original package as the product is sensitive to light.
6.5 NATURE AND CONTENTS OF CONTAINER
Aluminium foil blisters, containing 60 tablets, presented in cardboard
cartons.
Health Products Regulatory Authority
31 March 2023
CRN00DFPP
Page 2 of 2
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/450/003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of authorisation: 31
st
March 2023
10 DATE OF REVISION OF THE TEXT