Asacolon 800 mg Gastro-resistant Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mesalazine

Available from:

PCO Manufacturing Ltd.

ATC code:

A07EC; A07EC02

INN (International Name):

Mesalazine

Dosage:

800 milligram(s)

Pharmaceutical form:

Gastro-resistant tablet

Therapeutic area:

Aminosalicylic acid and similar agents; mesalazine

Authorization date:

2021-04-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ASACOLON
® 800 MG GASTRO-RESISTANT
TABLETS
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, 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:
1.
What Asacolon is and what it is used for
2.
What you need to know before you take Asacolon
3.
How to take Asacolon
4.
Possible side effects
5.
How to store Asacolon
6.
Contents of the pack and other information
1.
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ASACOLON
DO N

Summary of Product characteristics

Health Products Regulatory Authority
05 July 2023
CRN00DP6N
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: 800 mg mesalazine
Excipient with known effect: lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
_Product imported from Portugal:_
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 carboxymethyl starch (type A)
Magnesium stearate (E572)
Talc (E553b)
Povidone
Film Coating
Methacrylic acid-methyl methacrylate copolymer (1:2)
Talc
Triethyl citrate
Yellow pigment (ferric oxide) (E172)
Macrogol 6000
Red pigment (ferric oxide) (E172)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the blister and outer package of the product on the market
in the country of origin.
Health Products Regulatory Authority
05 July 2023
CRN00DP6N
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25 °C. Store in the original package in order to
protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister strips of aluminium foil and PVC, and outer cardboard carton
containing 90 tablets per pack.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements. Any unused medicinal product or waste
material should be disposed of in accordance with local
requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/465/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 1
st
April 2021
10 DATE OF REVISION OF THE TEXT
July 2023