PENTASA SACHET

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

MESALAZINE

Disponible desde:

PCO Manufacturing

Código ATC:

A07EC02

Designación común internacional (DCI):

MESALAZINE

Dosis:

2 Grams

formulario farmacéutico:

Granules Prolonged Release

Vía de administración:

Oral use

Unidades en paquete:

1 x 60 sachets

tipo de receta:

Product subject to prescription which may be renewed (B)

Fabricado por:

Ferring GmbH

Grupo terapéutico:

Intestinal anti-inflammatory agents, aminosalicylic acid and similar agents

Área terapéutica:

mesalazine

indicaciones terapéuticas:

It is indicated for mild to moderate ulcerative colitis

Estado de Autorización:

Authorised

Fecha de autorización:

2015-04-17

Información para el usuario

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
PENTASA
®
SACHET 2G PROLONGED RELEASE GRANULES
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. 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.
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. acetylsalicylic 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

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pentasa Sachet 2 g prolonged release granules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains mesalazine 2 g
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged release granules
_Product imported from Greece:_
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 of this product is the date shown on the
container 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 single dose container.
Pack sizes: 1 x 60 sachets
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6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
Any unused product or waste material should be disposed of in
accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing
Unit 10 Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMB