Asacolon 400mg Gastro-Resistant Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mesalazine

Available from:

Tillotts Pharma GmbH

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:

Marketed

Authorization date:

1990-12-11

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ASACOLON 400 MG AND 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 400 mg Gastro-resistant Tablets
/ 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.

Summary of Product characteristics

Health Products Regulatory Authority
02 March 2023
CRN00DD7R
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Asacolon 400mg Gastro-Resistant Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains: Mesalazine 400mg.
Excipient with known effect: 76.4 mg lactose, _see section 4.4_.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant Tablet.
The tablets are reddish to brownish and oblong-shaped.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Asacolon is indicated in adults, children above 6 years and
adolescents:
For the treatment of mild to moderate acute ulcerative colitis. For
the maintenance of remission of ulcerative colitis.
For the maintenance of surgically-induced remission of Crohn’s
Disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults:
_Ulcerative colitis:_
Induction of remission:
2.4 g (6 tablets) per day once daily or in divided doses. If required
the dose may be increased to 4.8 g (12 tablets) per day in
divided doses. Above 2.4 g daily in divided doses only.
The dosage can be adjusted in accordance with the response to the
treatment.
Maintenance of remission:
1.2 to 2.4 g (3 to 6 tablets) per day once daily or in divided doses.
_ _
_Crohn's disease:_
Maintenance of remission:
2.4 g (6 tablets) per day once daily or in divided doses.
Older people
As for adults above unless liver or renal function is severely
impaired (see section 4.3 and 4.4). No studies have been carried
out older people.
Paediatric population
There is only limited documentation for an effect in children (age
6-18 years).
Children 6 years of age and older

_Active disease_: To be determined individually, starting with 30-50
mg/kg/day in divided doses. Maximum dose: 75
mg/kg/day in divided doses. The total dose should not exceed 4.0
g/day.
Health Products Regulatory Authority
02 March 2023
CRN00DD7R
Page 2 of 9

_Maintenance treatment_: To be determined individually, starting with
15-30 mg/kg/day in divided dose