Salofalk 1g/Actuation Rectal Foam

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Mesalazine

Beschikbaar vanaf:

Dr. Falk Pharma GmbH

ATC-code:

A07EC; A07EC02

INN (Algemene Internationale Benaming):

Mesalazine

Dosering:

1 gram(s)

farmaceutische vorm:

Rectal foam

Prescription-type:

Product subject to prescription which may be renewed (B)

Therapeutisch gebied:

Aminosalicylic acid and similar agents; mesalazine

Autorisatie-status:

Marketed

Autorisatie datum:

2009-01-09

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SALOFALK
® 1G/ACTUATION RECTAL FOAM
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 rectal foam is and what it is used for
2.
What you need to know before you use Salofalk rectal foam
3.
How to use Salofalk rectal foam
4.
Possible side effects
5.
How to store Salofalk rectal foam
6.
Contents of the pack and other information
1.
WHAT SALOFALK RECTAL FOAM IS AND WHAT IT IS USED FOR
Salofalk rectal foam contains the active substance mesalazine, an
anti-inflammatory agent used to
treat inflammatory bowel disease.
Salofalk rectal foam is used for the treatment of:
-
Inflammation of the large intestine (colon) and rectum (back passage)
known by doctors as
ulcerative colitis.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SALOFALK RECTAL FOAM
DO NOT USE SALOFALK RECTAL FOAM
-
If you are allergic to mesalazine, to salicylic acid, to salicylates
such as acetylsalicylic acid
(e.g., Aspirin
®
) or to any of the other ingredients of this medicine (listed in
section 6).
-
If you have a serious liver or kidney disease.
WARNINGS AND PRECAUTIONS
BEFORE YOU START USING THIS MEDICINE YOU SHOULD TELL YOUR DOCTOR
-
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 ever developed a severe skin rash or skin peeling,
blis

Productkenmerken

Health Products Regulatory Authority
14 February 2024
CRN00DLPP
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Salofalk 1g/Actuation Rectal Foam
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 actuation contains: Mesalazine 1.0g
Excipients with known effect:
Each actuation of Salofalk rectal foam contains 3.44 g propylene
glycol, 50 mg sodium metabisulphite and 9.1 mg cetostearyl
alcohol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Rectal foam.
White-greyish to slightly reddish-violet, creamy firm foam.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of active, mild ulcerative colitis of the sigmoid colon and
rectum.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and elderly:_
Two administrations once a day at bedtime. Salofalk rectal foam should
be used at room temperature (between 20°C and not
more than 30°C; see also section 6.4. The canister is first fitted
with an applicator and then shaken for about 20 seconds before
the applicator is inserted into the rectum as far as comfortable. To
administer a dose of Salofalk, the pump dome is fully
pushed down and released. Note that the spray will only work properly
when held with the pump dome pointing down.
Following the first or second activation depending upon need (see
below) the applicator should be held in position for 10-15
seconds before being withdrawn from the rectum. If the patient has
difficulty in holding this amount of foam, the foam can
also be administered in divided doses: one at bedtime and the other
during the night (after evacuation of the first single dose)
or in the early morning. The best results are obtained when the
intestine is evacuated prior to administration of Salofalk rectal
foam.
In general, an acute episode of a mild ulcerative colitis subsides
after 4-6 weeks. It is recommended to continue the
maintenance therapy with an oral mesalazine preparation e.g., Salofalk
prolonged release granules at a dosage recommended
for this preparation.
_Paediatric pop