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Active substance(s): BUDESONIDE

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If you forget to use Budenofalk
Rectal Foam
Do not take a larger than normal
dose of Budenofalk Rectal Foam next
time, but continue treatment at the
prescribed dosage
If you stop using Budenofalk
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, Budenofalk Rectal
Foam can cause side effects, although
not everybody gets them.
The following effects have been
If you get any of the following
symptoms after taking this
medicine, you should contact
your doctor immediately:
The following side effects have been
Common side effects (that affect
less than 1 in 10 patients):
• Burning or pain in the rectum

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p. 9

Uncommon side effects (that affect
less than 1 in 100 patients):
• Anaemia or other changes
to the blood
• Headache, giddiness, disturbance
of smell
• Urinary tract infections
• High blood pressure
• Sleeplessness
• Nausea, abdominal pain, dyspepsia,
wind, tingling in the abdomen, anal
fissure, mouth rash, urgent need to
empty the bowels , haemorrhoids,
rectal bleeding
• Changes in liver function
• Changes in pancreatic function,
changes in adrenal hormones
• Acne, increased sweating
• Tiredness, increase in body weight.
• An increase in appetite
When Budenofalk Rectal Foam is
used, side effects may occur which
are typical of the more active cortisone
preparations (Cushing-like properties).
The side effects listed below depend
on the dose, the period of treatment,
whether there has been prior or
accompanying treatment with other
cortisone preparations and on the
individual sensitivity.
• Increased risk of infection
• Cushing Syndrome: Roundness of
the face, weight gain, increased risk
of high blood sugar, fluid retention,
reduced growth in children
Irregular periods in women,
male hair growth patterns in
women, impotence

p. 10

• Mood changes such as depression,
irritation or euphoria
• Blurred vision (e.g. glaucoma and
• Increased risk of blood clotting,
disease of the blood vessels
(associated with stopping steroid
use after long term therapy)
• Stomach complaints such as ulcers,
pancreatitis and constipation
• Muscle pain and bone weakness
(osteoporosis), loss of bone and
cartilage (aseptic bone necrosis)
• Rash from hypersensitivity reactions
(allergic exanthema), formation of
red stripes (striations) and bleeding
in the skin, delayed wound healing.
Local skin reactions such as
contact dermatitis may develop.
• Isolated cases: increased brain
pressure with possible additional
swelling of the optic disk in
Most of these unwanted effects were
noted after long-term use of oral
steroids and so these effects will be
less with Budenofalk Rectal Foam.
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 as follows:
Republic of Ireland:
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971

p. 11

Fax: +353 1 6762517
United Kingdom
Yellow Card Scheme
By reporting side effects you can help
provide more information on the safety
of this medicine.
5. H
 ow to store Budenofalk Rectal
Keep this medicine out of the sight
and reach of children.
Do not use Budenofalk Rectal Foam
after the expiry date which is stated
on the carton and on the pressurised
container. The expiry date refers to the
last day of that month.
The contents of the container must
be used within 4 weeks after first
Do not store above 25 °C.
Do not refrigerate or freeze
The container is pressurised and
contains flammable propellant. Do not
expose to temperature higher than
50°C, protect from direct sunlight. Do
not pierce or burn, even when empty.

your pharmacist how to throw away
medicines you no longer use. These
measures will help to protect the

What Budenofalk Rectal Foam
The active substance is budesonide.
Each dose of foam contains 2 mg
The other ingredients are cetyl alcohol,
emulsifying wax, purified water,
disodium edetate, macrogol stearyl
ether, propylene glycol, citric acid
monohydrate and n-butane, isobutane
and propane as propellants.
What Budenofalk Rectal Foam looks
like and contents of the pack
Budenofalk Rectal Foam is a white to
pale white, creamy, firm foam and is
presented in a pressurised container.
Budenofalk Rectal Foam is available
in packs containing 1 pressurised
container, 14 applicators and 14
plastic bags or in packs containing 2
pressurised containers, 28 applicators
and 28 plastic bags, for the hygienic
disposal of the applicators.
Each pressurised container contains at
least 14 doses of 1.2 g rectal foam.
Not all pack sizes may be marketed.


Budenofalk® 2mg/dose
Rectal Foam

6. C
 ontents of the pack and other

Do not throw away any medicines via
wastewater or household waste. Ask

p. 12

Marketing Authorisation Holder and

Read all of this leaflet carefully
before you start using this medicine
because it contains important
information for you.
This medicinal product is authorised
in the Member States of the EEA
und the following names:
Denmark, Finland, Great Britain,
Greece, Ireland, Luxembourg,
Romania and Sweden: Budenofalk®
Austria: Budo-San®
Italy: Rafton®
Spain: Intestifalk®
This leaflet was last revised in
PL 08637/0011

– 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
What is in this leaflet:
1. What Budenofalk Rectal Foam is
and what it is used for
2. What you need to know before you
use Budenofalk Rectal Foam
3. How to use Budenofalk Rectal
4. Possible side effects
5. How to store Budenofalk Rectal
6. Contents of the pack and other

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p. 14 = last page

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25.09.14 13:39

1. What Budenofalk Rectal Foam is
and what it is used for
Budenofalk Rectal Foam contains the
active substance budesonide, a type
of locally acting steroid used to treat
inflammatory bowel disease.
Budenofalk Rectal Foam is used for
the treatment of:
• Inflammation of the rectum (back
passage) and the lower part of the
colon (sigmoid colon), known by
doctors as ulcerative colitis.
2. What you need to know before
you use Budenofalk Rectal Foam
Do not use Budenofalk Rectal Foam
• If you are or have been told you
are allergic (hypersensitive) to
budesonide or any of the other
ingredients of Budenofalk Rectal
Foam (listed in section 6)
• If you have a serious liver disease
(e.g. liver cirrhosis).
Warnings and precautions
Before you start using this medicine
you should tell your doctor:
• If you know or have been told
that you have tuberculosis, high
blood pressure, fragile bones
• If you or any of your family suffers
with diabetes (diabetes mellitus), or
glaucoma (increase in the pressure
within the eye)

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p. 2

• If you suffer with ulcers in the
stomach or duodenum (peptic ulcer)
• If you suffer with eye problems such
as cataracts.
• If you suffer with problems of your
Further precautions:
Tell your doctor if you have not yet
had chickenpox or measles, or if
you have come into contact with
anybody who has chickenpox,
shingles or measles.
If you know that you need to be
vaccinated please speak to your
doctor first.
If you know that you are due to have
an operation please tell your doctor
that you are using Budenofalk
Rectal Foam.
If you have been treated with a
stronger cortisone preparation
before starting treatment with
Budenofalk Rectal Foam, your
symptoms may reappear when
the medicine is changed. If this
happens, contact your doctor!
Other medicines and Budenofalk
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):
Medicines used to treat heart
conditions (cardiac glycosides
such as digoxin)
• Diuretics (medicines used to
treat excess fluid in your body)

p. 3

Ketoconazole and itraconazole
(substances used to treat fungal
Antibiotic drugs used to treat
infections (such as clarithromycin)
Ritonavir (a substance used for
treating HIV infections)
Carbamazepine (substance used
for treating epilepsy)
Rifampicin (substance used against
Contraceptive pill
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 Budenofalk Rectal
Foam and your doctor will be able to
decide what is suitable for you.
Budenofalk Rectal Foam with
food and drink
You should not drink grapefruit juice
during your treatment with Budenofalk
Rectal Foam, as this can change the
effects of Budenofalk Rectal Foam.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your
doctor or pharmacist for advice before
taking this medicine.
It is important that you tell your
doctor if you are, or think you may
be pregnant, as you should only
use Budenofalk Rectal Foam during
pregnancy if your doctor tells you to.

p. 4

You should only use Budenofalk Rectal
Foam during breast-feeding if your
doctor tells you to, as it is not known if
budesonide passes into breast milk.
Driving and using machines
There are no effects on the ability to
drive and use machines.
Budenofalk Rectal Foam contains
cetyl alcohol and propylene glycol
This medicine contains cetyl alcohol
and propylene glycol which can cause
local skin reactions (e.g. contact
3. How to use Budenofalk Rectal
Always use Budenofalk 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.
Dose for adults over 18 years of
The usual dose is 1 spray actuation
per day, either in the morning or to be
taken at bedtime.

p. 5

Emptying your bowels before using
Budenofalk Rectal Foam produces
the best results.

spray can is now ready
for use.
Using the foam:

Use in children and adolescents:
Budenofalk Rectal Foam should not
be used in children under 18 years
of age, because there is very limited
experience with Budenofalk Rectal
Foam in this age group.
Picture of the spray can:
pump dome
spray can

The applicators are in a special rail.
Please hold the rail firmly and pull the
applicator out sharply.
Preparing to use the foam:
Push applicator firmly
onto the spout of the
spray can.
Shake the spray can
for about 15 seconds
to mix the contents.
Before the first use,
remove the safety lock
(plastic flap) from under
the pump dome.
Twist the dome on the
top of the spray can
until the semi-circular
gap underneath is in
line with the nozzle. The

p. 6

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 as vertically as
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 Budenofalk
Rectal Foam, push
down fully the pump
dome once and
release it very 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

p. 7

In order to prevent the
inadvertent loss of foam
from the spray can
between applications
turn the pump dome
around so that the semicircular gap faces the
opposite direction to the
• Please wash your hands and try not
to empty your bowels until the next
• If you go to hospital or see another
doctor or dentist tell them you are
using this medicine.
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.
Acute episodes of inflammatory bowel
disease (ulcerative colitis) generally
subside after 6 - 8 weeks.
If you think that the effect of
Budenofalk Rectal Foam is too strong
or too weak, talk to your doctor.
If you use more Budenofalk 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 Budenofalk Rectal
Foam on one occasion, just take your
next dose as prescribed. Do not use a
smaller amount.

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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.