ASACOLON 400 Milligram Tablets Gastro-Resistant

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

MESALAZINE

Tilgængelig fra:

Tillotts Pharma Limited

INN (International Name):

MESALAZINE

Dosering:

400 Milligram

Lægemiddelform:

Tablets Gastro-Resistant

Recept type:

Product subject to prescription which may be renewed (B)

Autorisation status:

Authorised

Autorisation dato:

0000-00-00

Indlægsseddel

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ASACOLON 400 MG AND 800 MG GASTRO-RESISTANT TABLETS
Active substance: mesalazine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm 
them, even if their symptoms are the same as yours.
-
If  any of the side effects gets serious, or if you notice
any side effects not listed in this 
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Asacolon is and what it is used for
2. Before you take Asacolon 
3. How to take Asacolon 
4. Possible side-effects
5. How to store Asacolon 
6. Further 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 

Produktets egenskaber

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.
Excipients: also contains 76.4 mg of lactose monohydrate, _see section 4.4_. for further details.
For a 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
For the treatment of mild 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 in divided doses. If required the dose may be increased to 4.8 g (12 tablets) daily.
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.
Elderly population
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 in the elderly population.
Paediatric population
There is only limited documentation for an effect in children (age 6-18 years).
Children 6 years of age and older
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 14/01/2014_
_CRN 2140986_
_page number: 1_
•
_Active disease_: To be determined individually, starting with 30-50 mg/kg/day in divided doses. Maximum dose:
75 mg/kg/day in divided