Asacolon 1000 mg Suppository

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mesalazine

Available from:

Tillotts Pharma GmbH

ATC code:

A07EC02

INN (International Name):

Mesalazine

Dosage:

1000 milligram(s)

Pharmaceutical form:

Suppository

Therapeutic area:

mesalazine

Authorization status:

Marketed

Authorization date:

2021-01-29

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ASACOLON 1000 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 1000 mg Suppositories are and what they are used for
2.
What you need to know before you use Asacolon 1000 mg Suppositories
3.
How to use Asacolon 1000 mg Suppositories
4.
Possible side effects
5.
How to store Asacolon 1000 mg Suppositories
6.
Contents of the pack and other information
1.
WHAT ASACOLON 1000 MG SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR
Asacolon 1000 mg Suppositories contain the active substance
mesalazine, an anti-inflammatory agent
used to treat inflammatory bowel disease.
Asacolon 1000 mg Suppositories are used for the treatment of acute
mild to moderate ulcerative colitis
limited to the rectum (ulcerative proctitis).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ASACOLON 1000 MG SUPPOSITORIES
DO NOT USE ASACOLON 1000 MG SUPPOSITORIES
-
if you are allergic to salicylic acid, to salicylates such as
acetylsalicylic acid (aspirin) or the
other ingredients of this medicine (listed in section 6).
-
If you have a serious liver or kidney disease.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR BEFORE USING ASACOLON 1000 MG SUPPOSITORIES
-
If you have a history of problems with your lungs, particularly if you
suffer from
BRONCHIAL
ASTHMA.
-
If you have a history of allergy to sulphasalazine, a substance
related to mesalazine.
-
If you suffer with problems of your LIVER.
-
If you suffer with problems of your
KIDNEY.
-
If you have ev

Summary of Product characteristics

Health Products Regulatory Authority
20 December 2023
CRN00DVZ4
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Asacolon 1000 mg Suppository
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 1000 mg mesalazine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suppository
Light beige coloured, torpedo-shaped suppositories dimension of 33 x
11 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of acute mild to moderate ulcerative colitis limited to the
rectum (ulcerative proctitis).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and older people_
One Mesalazine 1000 mg Suppository once daily (equivalent to 1000 mg
mesalazine daily) inserted into the rectum.
_ _
_Paediatric population_
There is little experience and only limited documentation for an
effect in children.
_ _
Method of administration
For rectal administration only.
Asacolon 1000 mg Suppositories should be administered preferably at
bedtime.
Treatment with Asacolon 1000 mg Suppositories must be administered
regularly and consistently, because only in this way can
healing be successfully achieved.
_Duration of treatment_
The duration of use is determined by the physician.
4.3 CONTRAINDICATIONS
Asacolon 1000 mg Suppositories are contraindicated in patients with:
- known hypersensitivity to salicylates or to the excipient listed in
section 6.1
- severe impairment of hepatic or renal function
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Blood tests (differential blood count; liver function parameters such
as ALT or AST; serum creatinine) and urinary status
(dip-sticks) should be determined prior to and during treatment, at
the discretion of the treating physician. As a guideline,
follow-up tests are recommended 14 days after commencement of
treatment, then a further two to three tests at intervals of 4
weeks.
If the findings are normal, follow-up tests should be carried out
every 3 months. If additional symptoms occur, these tests
should be performed immediate