Asacolon 500 mg Suppositories

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:

500 milligram(s)

Pharmaceutical form:

Suppository

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Aminosalicylic acid and similar agents; mesalazine

Authorization status:

Marketed

Authorization date:

1995-06-26

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ASACOLON 500 MG SUPPOSITORIES
Mesalazine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, 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 any 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 use Asacolon
3.
How to use 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
Asacolon contains the active ingredient mesalazine, 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 Suppositories act locally on the lining (mucosa) of
the lower part of the
colon and rectum to reduce this inflammation. Asacolon Suppositories
are particularly useful
when the symptoms of ulcerative colitis affect the rectum.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ASACOLON
DO NOT USE ASACOLON
-
If you are allergic to mesalazine or any of the other ingredients of
this medication, listed
in section 6.
-
If you are allergic to salicylates (e.g. Aspirin).
-
If you have severe kidney impairment.
-
If you have severe liver impairment.
Asacolon 500 mg Suppositories contains soya oil. If you are allergic
to peanut or soya, do
not use this medicinal product
Do not use Asacolon in children under 2 years of age.
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Asacolon if you have any medical
conditions or illnesses,
particularly if

Summary of Product characteristics

Health Products Regulatory Authority
11 March 2024
CRN00F4D4
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Asacolon 500 mg Suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains: 500mg mesalazine.
Excipient(s) with known effect:
Each suppository contains 2.5g hard fat containing lecithin derived
from soya, see section 4.4.
For the 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
This medication is indicated in adults for:
For thetreatment 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
Posology
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.
Older people:
The normal adult dose can be used unless liver or renal function is
severely impaired, see section 4.3 and 4.4. No studies have
been carried out in older people.
Paediatric population
There is little experience and only limited documentation for an
effect in children.
Method of administration: rectal.
The suppositories are for rectal use and must not be swallowed. If one
or more doses have been missed, the next dose is to be
taken as usual.
4.3 CONTRAINDICATIONS
- Hypersensitivity to the active substance or any of the excipients
listed in section 6.1.
- Known hypersensitivity to salicylates.
- Known allergy to peanut or soya oil.
- Severe renal impairment (GFR less than 30 mL/min/1.73 m
2
).
- Severe liver impairment.
Health Products Regulatory