Pentasa Sachet 4 g prolonged-release granules

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Mesalazine

থেকে পাওয়া:

PCO Manufacturing Ltd.

এটিসি কোড:

A07EC; A07EC02

INN (আন্তর্জাতিক নাম):

Mesalazine

ফার্মাসিউটিকাল ফর্ম:

Prolonged-release granules

থেরাপিউটিক এলাকা:

Aminosalicylic acid and similar agents; mesalazine

অনুমোদন তারিখ:

2023-05-05

তথ্য লিফলেট

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 can make you prone to

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
08 May 2023
CRN00DGKW
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pentasa Sachet 4 g prolonged-release granules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 4 g mesalazine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged release granules
_Product imported from Spain:_
White-grey to pale white-brown granules.
4 CLINICAL PARTICULARS
As per PA1009/006/008
5 PHARMACOLOGICAL PROPERTIES
As per PA1009/006/008
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 shall be 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 sachet
Pack sizes: 1 x 30 sachets
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
Any unused medicinal product or waste material should be disposed of
in accordance with local requirements.
Health Products Regulatory Authority
08 May 2023
CRN00DGKW
Page 2 of 2
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/450/004
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 5
th
May 2023
10 DATE OF REVISION OF THE TEXT