Salofalk 1g Suppositories

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Mesalazine

Tilgjengelig fra:

Dr. Falk Pharma GmbH

ATC-kode:

A07EC; A07EC02

INN (International Name):

Mesalazine

Dosering :

1 gram(s)

Legemiddelform:

Suppository

Resept typen:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Aminosalicylic acid and similar agents; mesalazine

Autorisasjon status:

Marketed

Autorisasjon dato:

2010-06-18

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
SALOFALK 1G 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 Salofalk 1g Suppositories are and what they are used for
2.
What you need to know before you use Salofalk 1g Suppositories
3.
How to use Salofalk 1g Suppositories
4.
Possible side effects
5.
How to store Salofalk 1g Suppositories
6.
Contents of the pack and other information
1.
WHAT SALOFALK 1G SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR
Salofalk 1g Suppositories contain the active substance mesalazine, an
anti-inflammatory agent used
to treat inflammatory bowel disease.
Salofalk 1g Suppositories are used for
−
the treatment of mild to moderate acute episodes of an inflammatory
disease limited to the rectum
(back passage) known by doctors as ulcerative colitis or ulcerative
proctitis.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SALOFALK 1G SUPPOSITORIES
DO NOT USE SALOFALK 1G SUPPOSITORIES
−
If you are allergic to salicylic acid, to salicylates such as
acetylsalicylic acid (e.g., Aspirin
®
) or
the other ingredient 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 SALOFALK 1G 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

Preparatomtale

Health Products Regulatory Authority
15 August 2023
CRN00DGJ5
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Salofalk 1g Suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 1 g mesalazine.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Suppositories
Appearance: light beige coloured, torpedo-shaped suppositories
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of acute mild to moderate ulcerative colitis that is limited
to the rectum (ulcerative proctitis).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults and older people_
One Salofalk 1g Suppository once daily (equivalent to 1 g mesalazine
daily) inserted into the rectum.
_Paediatric population_
There is little experience and only limited documentation for an
effect in children.
_Duration of treatment_
The treatment of acute episodes of ulcerative colitis usually lasts 8
weeks. The duration of use is determined by the physician.
Method of administration
For rectal administration only.
Salofalk 1g Suppositories should be administered preferably at
bedtime.
Treatment with Salofalk 1g Suppositories must be administered
regularly and consistently, because only in this way can healing
be successfully achieved.
4.3 CONTRAINDICATIONS
Salofalk 1g Suppositoriesare contraindicated in patients with:
- known hypersensitivity to salicylates or to the excipient listed in
section 6.1
- severe impairment of hepatic or renal function
Health Products Regulatory Authority
15 August 2023
CRN00DGJ5
Page 2 of 7
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 sh