SALOFALK 1G/ACTUATION RECTAL FOAM

Active substance: MESALAZINE

View full screen / Print PDF » Download PDF ⇩

Transcript
Salofalk Rektalschaum GI für Großbritannien-Irland (GB-IE/09.13)
Open size: 371 x 140 mm
Printing Colour: Black (1/1)
Material number: EX13645 (ASM)
Folded size: 53 x 140 mm
Folding: zigzag-folding
Type font/line space: 8pt/9,5pt

If you stop using Salofalk rectal
foam
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.
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 immediately:
• 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
mesalazine:
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
A
and painful urgent need to empty
the bowels.
Rare side effects (that affect less
than 1 in 1,000 patients):
•  bdominal pain, diarrhoea, wind
A
(flatulence), nausea and vomiting
• Headache, dizziness.
•  hest pain, breathlessness or
C
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,
C
sometimes with swollen limbs
or flank pain
•  evere abdominal pain because
S
of acute inflammation of the
pancreas
•  hortness of breath, cough,
S
wheezing, lung shadow on
x-ray due to allergic and/or
inflammatory lung conditions

•  evere diarrhoea and abdominal
S

pain because of an allergic
reaction to this medicine within
the bowel
•  kin rash or inflammation
S
• Muscle and joint pain
•  ever, sore throat or malaise
F
because of blood count changes
•  aundice or abdominal pain
J
because of liver and bile flow
disorders
•  air loss and the development of
H
baldness.
•  umbness and tingling in the
N
hands and feet (peripheral
neuropathy)
•  eversible decrease in semen
R
production
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:
Ireland
Pharmacovigilance Section
Irish Medicines Board
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie

United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/
yellowcard
By reporting side effects, you can
help provide more information on
the safety of this medicine.
5.  ow to store Salofalk rectal
H
foam
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
opening.
Do not store above 30°C.
Do not refrigerate or freeze.
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
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.

Marketing Authorisation Holder
and Manufacturer

DR. FALK PHARMA GmbH
6.  ontents of the pack and
C
other information
What Salofalk rectal foam
contains
The active substance of Salofalk
rectal foam is mesalazine and each
spray actuation contains 1 g of
mesalazine.
The other ingredients are sodium
metabisulphite (E 223), disodium
edetate, cetostearyl alcohol,
polysorbate 60, propylene glycol
and propane, n-butane, isobutane
as propellants.
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.

Leinenweberstr. 5
79108 Freiburg
Germany
Tel. +49 (0) 761/1514-0
Fax +49 (0) 761/1514-321
e-mail: zentrale@drfalkpharma.de

Salofalk rectal foam is authorised
in the Member States of the EEA
under the following name:
Austria, Denmark, Finland, Germany,
Great Britain, Greece, Ireland,
Luxembourg, The Netherlands,
Norway, Portugal, Spain and
Sweden: Salofalk.
This leaflet was last revised in
11/2013
Marketing authorisation numbers:
PL 08637/0003
PA573/4/5

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.
Each spray can of Salofalk rectal
foam contains 80 grams of foam,
which is sufficient for 14 spray
actuations (equivalent to 7 doses).
Not all pack sizes may be marketed.

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.

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

• f you have any further questions,
I
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
I
your doctor or pharma­ ist. This
c
includes any possible side effects
not listed in this leaflet. See
section 4.
What is in this leaflet:
1.  hat Salofalk rectal foam is
W
and what it is used for
2.  hat you need to know before
W
you use Salofalk rectal foam
3.  ow to use Salofalk rectal foam
H
4.  ossible side effects
P
5.  ow to store Salofalk rectal foam
H
6.  ontents of the pack and other
C
information

EX13645 GB-IE/09.13

EX13645_SAF_GI_GB-IE.indd 1

p. 9

28.11.13 12:51

p. 10

p. 11

p. 12

p. 13

p. 14 = last page

p. 1

1.  hat Salofalk rectal foam is
W
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:
• nflammation of the large
I
intestine (colon) and rectum
(back passage) known by
doctors as ulcerative colitis.
2.  hat you need to know before
W
you use Salofalk rectal foam
Do not use Salofalk rectal foam
• f you are or have been told you
I
are allergic (hypersensitive) 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
I
kidney disease.
Warnings and precautions
Before you start using this medicine you should tell your doctor:
• f you have a history of problems
I
with your lungs, particularly if you
suffer from bronchial asthma.
• f you have a history of allergy
I
to sulphasalazine, a substance
related to mesalazine.

• f you suffer with problems of your
I
liver.
• f you suffer with problems of your
I
kidney.
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 tests.
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):
•  ertain agents that inhibit
C
blood clotting (medicines for
thrombosis or to thin your blood,
e.g., warfarin)
•  zathioprine, 6-mercaptopurine
A
or thioguanine (medicines used
to treat immune disorders).
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
or are planning to have a baby, ask
your doctor or pharmacist for advice
before taking this medicine.

3.  ow to use Salofalk rectal foam
H

Preparing to use the foam:

Always use Salofalk rectal foam
exactly as your doctor has told you.
Check with your doctor or
pharmacist if you are not sure.

Store and use Salofalk rectal foam
at room temperature (between 20
and not more than 30°C; see also
section 5).

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

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.

Push the applicator
firmly onto the spout
of the spray can.
Shake the spray can
for about 20 seconds
to mix the contents.

Dosage:

Before first use,
remove the safety
lock (plastic flap) from
under the pump dome.

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.
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 that may
be experienced in the form of
breathing problems.
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).

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).
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
children.

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

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 house-hold
waste in the plastic
bag provided. Use a
new applicator for
another admini­stration.

•  lease wash your hands and try
P

not to empty your bowels until the
next morning.
• f you go to hospital or see
I
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.

EX13645_SAF_GI_GB-IE.indd 2

p. 2

28.11.13 12:51

p. 3

p. 4

p. 5

p. 6

p. 7

p. 8

Expand view ⇕

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.

Hide
(web5)