Asacolon 800 mg Gastro-resistant Tablets

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Mesalazine

Commercializzato da:

Lexon (UK) Ltd

Codice ATC:

A07EC; A07EC02

INN (Nome Internazionale):

Mesalazine

Dosaggio:

800 milligram(s)

Forma farmaceutica:

Gastro-resistant tablet

Tipo di ricetta:

Product subject to prescription which may be renewed (B)

Area terapeutica:

Aminosalicylic acid and similar agents; mesalazine

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2017-05-19

Foglio illustrativo

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, please 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 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:
What Asacolon is and what it is used for
What you need to know before you take Asacolon
How to take Asacolon
Possible side effects
How to store Asacolon
Contents of the pack and other information
WHAT ASACOLON IS AND WHAT IT IS USED FOR
The name of your medicine is Asacolon 800 mg Gastro-resistant Tablets.
The tablets are called gastro-resistant tablets because they are
covered with
a coating which allows the tablets to pass through the stomach without
dissolving. The tablet coating will break down in the bowel where the
active
mesalazine is released.
Asacolon Gastro-resistant Tablets contain the active substance
mesalazine.
This is an anti-inflammatory medicine used to treat ulcerative colitis
and to
prevent further episodes of Crohn’s disease.
*
Ulcerative colitis is a disease in which the lining of the large bowel
(colon)
or back passage (rectum) becomes inflamed (red and swollen). Asacolon
acts locally at the inflamed sites to reduce the inflammation. It can
also be
used to prevent further attacks of ulcerative colitis.
*
Crohn’s disease is a disease in which the lining of the small and
large
bowel is affected and becomes inflamed. If you have been treated by
surgery for Crohn’s disease and it is under control, Asacolon act to
prevent
further episodes of Crohn’s disease.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ASACOLON
DO NOT TAKE ASACOLON
*
If you are allergic to mesalazine or any of the other ingredients of
this
medicine (listed in section

Scheda tecnica

Health Products Regulatory Authority
11 March 2020
CRN009MZW
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Asacolon 800 mg Gastro-resistant Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains: Mesalazine 800 mg.
Excipient with known effect: lactose, _see section 4.4_.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant Tablet.
_Product imported from the United Kingdom_
The tablets are reddish to brownish and oblong-shaped.
4 CLINICAL PARTICULARS
As per PA2018/001/002
5 PHARMACOLOGICAL PROPERTIES
As per PA2018/001/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate
Sodium starch glycolate (Type A)
Triethyl citrate
Talc E553b
Methacrylic acide - methylmethacrylate copolymer (1:2)
Povidone E1201
Magnesium stearate (vegetable origin)
Iron oxides E172
Macrogol 6000
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for 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 25ºC. Store in the original package in order to
protect from moisture.
Health Products Regulatory Authority
11 March 2020
CRN009MZW
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Blister strips contained within an outer cardboard carton, containing
90 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements for disposal. Any unused medicinal product or
waste material should be disposed of in accordance
with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Lexon (UK) Ltd
Unit 18, Oxleasow Road
East Moons Moat
Redditch
Worcestershire
B98 0RE
United Kingdom
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1097/008/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 19
th
May 2017
10 DATE OF REVISION OF THE TEXT
March 2020