Pentasa Sachet 2 g prolonged-release granules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mesalazine

Available from:

IMED Healthcare Ltd.

ATC code:

A07EC02

INN (International Name):

Mesalazine

Pharmaceutical form:

Prolonged-release granules

Therapeutic area:

mesalazine

Authorization date:

2022-03-25

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
PENTASA SACHET 2 G PROLONGED-RELEASE GRANULES
PENTASA SACHET 4 G 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. 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. 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

Summary of Product characteristics

Health Products Regulatory Authority
09 October 2023
CRN00DV7L
Page 1 of 2
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 2 g mesalazine
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 of this product is the date shown on the
sachet 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 size: 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
09 October 2023
CRN00DV7L
Page 2 of 2
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/190/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 25
th
March 2022
10 DATE OF REVISION OF THE TEXT
October 2023