ASACOLON 500 Milligram Suppositories

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MESALAZINE

Available from:

Tillotts Pharma Limited

INN (International Name):

MESALAZINE

Dosage:

500 Milligram

Pharmaceutical form:

Suppositories

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ASACOLON 500 MG SUPPOSITORIES
Active substance: mesalazine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 use Asacolon 
3. How to use 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 500 mg Suppositories. Your suppositories contain the active 
ingredient  mesalazine.
This  is  an  anti-inflammatory  medicine  used  to  treat 
proctitis,  procto-
sigmoiditis and ulcerative colitis. These are diseases of the large bowel (colon) and the back passage 
(rectum),  in  which  the  bowel  lining  becomes  inflamed  (red  and  swollen).  ‘Asacolon’  500  mg 
Suppositories  act  locally  in  the  colon  and  rectum  to  reduce  this  inflammation.  ‘Asacolon’  500  mg 
Suppositories are particularly useful when the symptoms of ulcerative
colitis affect the rectum.
2. BEFORE YOU USE ASACOLON
DO NOT USE ASACOLON
-
If you are allergic (hypersensitive) to mesalazine or any of the other
ingredients of Asacolon 
suppositories
-
If you have a history of allergy to salicylates
-
If you have kidney problems
-
If you have severe liver problems
-
If you have ulcers of the stomach and the part of the gut following
the stomach.
TAKE SPECIAL CARE WITH ASACOLON
Please tell your doctor if you have any medical conditions or
i

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Asacolon 500 mg Suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains: Mesalazine 500 mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suppository.
Torpedo-shaped suppositories with a light grey-brown colour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of mild to moderate proctitis and proctosigmoiditis.
As an adjunct to oral therapy in severe generalised ulcerative colitis affecting the rectum or rectosigmoid colon.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Rectal administration.
Adults:
One suppository to be inserted up to three times daily, after defaecation. The dosage is dependent upon the severity of
the disease and it may be possible to reduce the dosage as the condition improves. In severe generalised ulcerative
colitis affecting the rectum or rectosigmoid, and in cases slow to respond to oral therapy, one suppository may be used
morning and evening, as an adjunct to oral therapy.
Renal impairment/hepatic impairment:
No data from controlled clinical studies are available warranting a specific dose adjustment in patients with mild to
moderate renal or hepatic impairment. The maximum daily adult dose of 1.5 g mesalazine for rectal administration
appears to carry little additional risk in these patients considering 4.0 g mesalazine being approved as maximum daily
dose for oral administration (Asacolon tablets) to treat mild acute ulcerative colitis, see section 4.4. For severe renal or
hepatic impairment, see section 4.3.
The elderly:
As for adults above unless renal function is severely impaired (see section 4.3 and 4.4). No studies have been carried
out in the elderly.
Paediatric population:
There is little experience and only l