Pentasa Sachet 2g prolonged-release granules

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Mesalazine

Disponible desde:

Originalis B.V.

Código ATC:

A07EC02

Designación común internacional (DCI):

Mesalazine

formulario farmacéutico:

Prolonged-release granules

Área terapéutica:

mesalazine

Fecha de autorización:

2022-09-23

Información para el usuario

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. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.
-
If you get any side effect, 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 Sachet is and what it is used for
2.
What you need to know before you take Pentasa Sachet
3.
How to take Pentasa Sachet
4.
Possible side effects
5.
How to store Pentasa Sachet
6.
Contents of the pack and other information
1. WHAT PENTASA SACHET IS AND WHAT IT IS USED FOR
Pentasa Sachet is used for the treatment of mild to moderate
attacks of ulcerative colitis and to help maintain freedom
from further attacks.
Ulcerative colitis is an inflammatory bowel disease in which the
lining of the intestine becomes inflamed and develops many tiny
breaks in its surface (ulcers) which may bleed.
Pentasa Sachet contains granules that slowly release the active
ingredient (mesalazine). This helps reduce the inflammation and
the painful symptoms.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
PENTASA SACHET
Do not take Pentasa Sachet
-
if you are allergic (hypersensitive) to mesalazine or any of
the other ingredients of this medicine (see Section 6)
-
if you are allergic to other salicylates e.g. acetylsalisylic
acid
-
if you have severe liver and/or kidney problems
Warnings and precautions
Talk to your doctor or pharmacist before taking Pentasa
Sachet:
-
if you are allergic to sulphasalazine (risk of allergy to
salicylates)
-
if you currently have or have previously had liver or kidney
disease
-
if you have a medical condition that can make you prone to
bleeding
-
if you have an active peptic ulcer (stomach ulcer or
duodenal ulcer)
-
if you are on medication that may affect

Ficha técnica

Health Products Regulatory Authority
28 September 2022
CRN00D010
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pentasa Sachet 2g prolonged-release granules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains mesalazine 2 g
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged release granules
_Product imported from Greece and Spain _
White-grey to pale white-brown granules.
4 CLINICAL PARTICULARS
As per PA1009/006/006
5 PHARMACOLOGICAL PROPERTIES
As per PA1009/006/006
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Ethylcellulose
Povidone
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the sachets and outer package of the product on the
market in the country of origin.
The granules should be used immediately after first opening of the
sachet.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
Aluminium foil sachets'.
Pack sizes: 1 x 60 sachets
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
Any unused product or waste material should be disposed of in
accordance with local requirements.
Health Products Regulatory Authority
28 September 2022
CRN00D010
Page 2 of 2
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Originalis B.V.,
Joop Geesinkweg 901,
1114 AB Amsterdam-Duivendrecht,
The Netherlands
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA2306/010/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 23
rd
September 2022
10 DATE OF REVISION OF THE TEXT