Active substance: MESALAZINE

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Salofalk Rektalschaum Gebrauchsinformation (GI) für Europa allgemein (CXP/09.13)
Open size: 371 x 140 mm
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Material number: Mock-up (ASM)
Folded size: 53 x 140 mm
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Salofalk 1g/Actuation Rectal Foam, Dr. Falk Pharma GmbH
All medicines can cause allergic
reactions although serious allergic reactions are very rare. If you
get any of the following symptoms after using this medicine,
you should contact your doctor
• Allergic skin rash
• Fever
• Breathing difficulties.
If you experience a marked reduction of your general health, especially, if accompanied by fever, and/
or a sore throat and mouth, stop
using this foam and contact your
doctor immediately.
These symptoms can, very rarely,
be due to a fall in the number of
white cells in your blood (a condition
called agranulocytosis), which may
make you more prone to developing
a serious infection. A blood test can
confirm, whether your symptoms
are due to an effect of this medicine
on your blood.
The following side effects have also
been reported by patients using
Common side effects (that affect
less than 1 in 10 patients):
• Abdominal discomfort.
Uncommon side effects (that
affect less than 1 in 100 patients):
•  nal discomfort, anal irritation
and painful urgent need to empty
the bowels.

Rare side effects (that affect less
than 1 in 1,000 patients):
•  bdominal pain, diarrhoea, wind
(flatulence), nausea and vomiting
• Headache, dizziness
•  hest pain, breathlessness or
swollen limbs because of an effect on your heart
Very rare side effects (that affect
less than 1 in 10,000 patients):
•  hanges in kidney function,
sometimes with swollen limbs or
flank pain
•  evere abdominal pain, because
of acute inflammation of the
•  ever, sore throat or malaise,
because of blood count changes
•  hortness of breath, cough,
wheezing, lung shadow on x-ray
due to allergic and/or inflammatory lung conditions
•  evere diarrhoea and abdominal
pain, because of an allergic reaction to this medicine within the
•  kin rash or inflammation
•  uscle and joint pain
•  aundice or abdominal pain
because of liver and bile flow
•  air loss and the development
of baldness
•  umbness and tingling in the
hands and feet (peripheral
•  eversible decrease in semen

Mock-up - package leaflet
Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist . This includes
any possible side effects not listed
in this leaflet. You can also report
side effects directly via the national
reporting system listed in Appendix
V*. By reporting side effects you can
help provide more information on the
safety of this medicine.
[*For the printed material, please refer
to the guidance of the annotated
QRD template.]

use. Do not spray near a flame or
incandescent material.
Do not throw away any medicines
via wastewater or household waste.
Ask your pharmacist how to throw
away medicines you no longer use.
These measures will help protect
the environment.

Package leaflet:
Information for the user

Each spray can of Salofalk rectal
foam contains 80 grams of foam,
which is sufficient for 14 spray actuations (equivalent to 7 doses).

Salofalk® 1g Rectal Foam

Not all pack sizes may be marketed.
Marketing Authorisation Holder
and Manufacturer

Read all of this leaflet carefully
before you start using this
medicine because it contains
important information for you.

6.  ontents of the pack and
other information
What Salofalk rectal foam
The active substance of Salofalk®
rectal foam is mesalazine and each
spray actuation contains 1 g of

•  eep this leaflet. You may need to
read it again.


5.  ow to store Salofalk® rectal
Keep this medicine out of the sight
and reach of children.
Do not use Salofalk® rectal foam
after the expiry date which is stated
on the carton and the spray can.
The expiry date refers to the last day
of that month.
The contents of the container must
be used within 12 weeks after first

The other ingredients are sodium
metabisulphite (E223), disodium
edetate, cetostearyl alcohol, polysorbate 60, propylene glycol and
propane, n-butane, isobutane as

Do not refrigerate or freeze.

What Salofalk® rectal foam looks
like and contents of the pack
Salofalk® rectal foam is a whitegreyish to slightly reddish-violet
and creamy firm foam.

The container is pressurised and
contains 3.75% by weight of flammable propellant. Protect from
sunlight and temperatures over
50°C. Do not force open, pierce or
burn empty containers, even after

Salofalk® rectal foam is available
in packs containing 1 spray can
and 14 applicators and as a bundle
pack. A bundle pack consists of
4 packs containing 1 spray can
and 14 applicators each.

Do not store above 30 °C.

• f you have any further questions,
ask your doctor or pharmacist.

•  his medicine has been preT


scribed 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.
• f 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.

Salofalk rectal foam is authorised in the Member States of the
EEA under the following names:
Austria, Denmark, Finland, Germany, Great Britain, Greece, Ireland,
Luxembourg, The Netherlands, Norway, Portugal, Spain and Sweden:

What is in this leaflet
1. What Salofalk® rectal foam is and
what it is used for
2.  hat you need to know before
you use Salofalk® rectal foam
3. How to use Salofalk® rectal foam
4. Possible side effects
5.  ow to store Salofalk® rectal
6.  ontents of the pack and other

This leaflet was last approved in
[To be completed nationally]
Marketing authorisation number:

Mock-up CXP/09.13

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Salofalk 1g/Actuation Rectal Foam, Dr. Falk Pharma GmbH

Mock-up - package leaflet

1. What Salofalk rectal foam
is and what it is used for

• f you suffer with problems of your

You should only use Salofalk rectal
foam during pregnancy if your doctor tells you to.

Salofalk® rectal foam contains the
active substance mesalazine, an
anti-inflammatory agent used to
treat inflammatory bowel disease.

Further precautions:
During treatment your doctor may
want to keep you under close medical supervision, and you may need
to have regular blood and urine

You should also only use Salofalk®
rectal foam during breast-feeding,
if your doctor tells you to, as this
medicine may pass into breast milk.


Salofalk rectal foam is used for the
treatment of:
• nflammation of the large intesI
tine (colon) and rectum (back
passage) known by doctors as
ulcerative colitis.

2.  hat you need to know before
you use Salofalk® rectal foam
Do not use Salofalk rectal foam
• f you are or have been told you
are hypersensitive (allergic) to
salicylic acid, to salicylates such
as Aspirin® or to any of the other
ingredients of Salofalk® rectal
foam (listed in section 6).
• f you have a serious liver or
kidney disease.

Warnings and precautions
Before you start using this medicine you should tell your doctor
• f you have a history of problems
with your lungs, particularly if you
suffer from bronchial asthma.
• f you have a history of allergy
to sulphasalazine, a substance
related to mesalazine.
• f you suffer with problems of your


Other medicines and Salofalk®
rectal foam
Please tell your doctor if you take or
use any of the medicines mentioned
below as the effects of these medicines may change (interactions):

•  zathioprine, 6-mercaptopurine

or thioguanine (medicines used
to treat immune disorders).
•  ertain agents that inhibit
blood clotting (medicines for
thrombosis or to thin your blood,
e.g. warfarin)

Tell your doctor or pharmacist if you
are taking or have recently taken
or might take any other medicines,
including medicines obtained without a prescription. It may still be all
right for you to use Salofalk® rectal
foam and your doctor will be able to
decide what is suitable for you.
Pregnancy and breast-feeding
If you are pregnant or breastfeeding, think you may be pregnant
of are planning to have a baby, ask
your doctor or pharmacist for advice
before taking this medicine.


Driving and using machines
There are no effects on the ability to
drive and use machines.
Salofalk® rectal foam contains
sulphite, propylene glycol and
cetostearyl alcohol
This medicine contains sulphite
which may very rarely cause allergic
reactions, which may be experienced in the form of breathing
This medicine contains propylene
glycol, which can cause certain
blood changes, and may cause
slight to mild skin irritation.
This medicine contains cetostearyl
alcohol which may cause local skin
reactions (e.g. contact dermatitis).
3.  ow to use Salofalk® rectal
Always use Salofalk rectal foam
exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.

Method of administration
This medicine may only be used rectally, so it has to be inserted through
the anus. It is not intended to be
taken by mouth. Do not swallow.

for about 20 seconds
to mix the contents.
Before first use,
remove the safety
lock (plastic flap) from
under the pump dome.

Dose for adults
The usual dose is 2 spray actuations
once a day at bedtime. If you have
difficulty retaining this amount of
foam, it may also be administered in
two separate doses: one at bedtime
and the other during the night or
early in the morning (after excreting
the first dose).

Twist the dome on the
top of the spray can
until the semi-circular
gap under­ eath is in
line with the nozzle.
The spray can is now
ready for use.
Using the foam

Emptying your bowels before using
Salofalk® rectal foam produces the
best results.
Use in Children
Salofalk® rectal foam should not
be used in children, because there
is little experience and only limited
documentation for an effect in
Preparing to use the foam
Store and use Salofalk® rectal foam at
room temperature
(between 20 and not
more than 30 °C; see
also section 5).
Push the applicator
firmly onto the spout
of the spray can.
Shake the spray can

Place your index finger
on the top of pump
dome and turn the can
upside down. Please
note that the spray can
will only work properly
when held with the
pump dome pointing
Insert the applicator
into your rectum as
far as possible. The
best way to do this
is to place one foot
on a chair or stool. To
administer a dose of
Salofalk® rectal foam,
push down fully the
pump dome once
and slowly release it.
For the second spray,

push the dome again
and release slowly.
Wait 10-15 seconds
before withdrawing the
applicator as the foam
still expands a little
and would otherwise
drop out of the applicator.
After administering the
foam, remove the applicator and dispose of
it as household waste
in the plastic bag
provided. Use a new
applicator for another

•  lease wash your hands and try

not to empty your bowels until the
next morning.
• f you go to hospital or see
another doctor, tell them you are
using this medicine.

You should use Salofalk® rectal
foam regularly and consistently to
achieve the desired effect.
Duration of treatment
How long you will use the medicine
depends upon your condition. Your
doctor will decide how long you are
to continue the medication.
Mild acute episodes of inflammatory
bowel disease (ulcerative colitis)
generally subside after 4-6 weeks.
If long-term treatment is required,
your doctor will prescribe you an

oral form of mesalazine, e.g. Salofalk® granules.
If you think that the effect of Salofalk® rectal foam is too strong or too
weak, talk to your doctor.
If you use more Salofalk® rectal
foam than you should
Contact a doctor if you are in doubt,
so he or she can decide what to do.
If you use too much Salofalk® rectal
foam on one occasion, just take
your next dose as prescribed. Do
not use a smaller amount.
If you forget to use Salofalk®
rectal foam
Do not take a larger than normal
dose of Salofalk® rectal foam next
time, but continue treatment at the
prescribed dosage.
If you stop using Salofalk® rectal
Do not stop using this product until
you have talked to your doctor.
If you have any further questions
on the use of this medicine, ask
your doctor or pharmacist.
4. Possible side effects
Like all medicines, Salofalk® rectal
foam can cause side effects, although not everybody gets them.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.