Asacolon 400 mg Gastro-resistant Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mesalazine

Available from:

Imbat Limited

ATC code:

A07EC; A07EC02

INN (International Name):

Mesalazine

Dosage:

400 milligram(s)

Pharmaceutical form:

Gastro-resistant tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Aminosalicylic acid and similar agents; mesalazine

Authorization status:

Authorised

Authorization date:

2009-06-19

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ASACOLON
® 400MG GASTRO-RESISTANT TABLETS
(mesalazine)
Your medicine is imported from the UK under the name of
‘Octasa’ but is marketed as ‘Asacolon’ in Ireland.
Your medicine is available using the above name but will be
referred to as Asacolon throughout this leaflet.
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 400mg
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 a

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Asacolon 400 mg Gastro-resistant Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains Melsalazine 400mg.
Excipient with known effect: lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant Tablet
_Product imported from the UK:_
The tablets are reddish to brownish and oblong-shaped and plain on all
sides.
4 CLINICAL PARTICULARS
As per PA2018/001/001
5 PHARMACOLOGICAL PROPERTIES
As per PA2018/001/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate
Sodium starch glycolate
Magnesium stearate
Talc
Povidone
Methacrylic acid-methyl methacrylate copolymer (1:2)
Triethyl citrate
Macrogol 6000
Iron oxides (E172)
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.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25
°
C.
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Store in the original package in order to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Cardboard outer containing blister strip of 10 tablets.
Pack size: 100 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIV