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BUDENOFALK 2MG/DOSE RECTAL FOAM

Active substance(s): BUDESONIDE / BUDESONIDE / BUDESONIDE

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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.

Typical effects of cortisone
preparations may occur which may
affect all parts of the body, particularly
when you use Budenofalk Rectal
Foam at high doses and for prolonged
periods (see section 4. Possible side
effects).

Warnings and precautions
Talk to your doctor before using
Budenofalk Rectal Foam if you have:
– tuberculosis
– high blood pressure
– diabetes, or if diabetes has been
diagnosed in your family
– brittle bones (osteoporosis)
– ulcers in the stomach or first part of
the small intestine (peptic ulcer)
– increased pressure in your eye
(glaucoma) or eye problems such as
clouding of the lens (cataracts) or
if glaucoma has been diagnosed in
your family
– severe liver problems

Further precautions during
treatment with Budenofalk
Rectal Foam
– Tell your doctor if you have an
infection. The symptoms of some
infections can be atypical or less
pronounced.
– Keep away from people who
have chickenpox or herpes zoster
(shingles), if you have never had
them. They could affect you
severely. If you do come into contact
with chickenpox or shingles, see
your doctor straight away.
– Tell your doctor if you have not yet
had 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.
– Contact your doctor if you
experience blurred vision or other
visual disturbances.

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2. What you need to know before
you use Budenofalk Rectal Foam
Do not use Budenofalk Rectal Foam
– if you are allergic to budesonide or
any of the other ingredients of this
medicine (listed in section 6)
– if you have a severe liver disease
(liver cirrhosis).

Other medicines and Budenofalk
Rectal Foam
Tell your doctor or pharmacist if you
are taking, have recently taken or might
take any other medicines. In particular:
– cardiac glycosides such as digoxin
(medicines used to treat heart
conditions)
– diuretics (to remove excess fluid
from the body)
– ketoconazole or itraconazole
(to treat fungal infections)
– antibiotic drugs used to treat
infections (such as clarithromycin)
– carbamazepine (used in the
treatment of epilepsy)
– rifampicin (for treating tuberculosis)
– oestrogens or oral contraceptives
Some medicines may increase the
effects of Budenofalk Rectal Foam
and your doctor may wish to monitor
you carefully if you are taking these
medicines (including some medicines
for HIV: ritonavir, cobicistat).
Budenofalk Rectal Foam could affect
the results of tests performed by your
doctor or in hospital. Tell your doctor
that you are using Budenofalk Rectal
Foam before any tests are carried out.
Budenofalk Rectal Foam with food
and drink
You should not drink grapefruit juice
whilst you are using this medicine as
this can alter its effects.
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

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doctor for advice before using this
medicine.
You should only use Budenofalk
Rectal Foam during pregnancy if your
doctor tells you to.
Budesonide passes in small amounts
into the breast milk. If you are
breast-feeding you should only use
Budenofalk Rectal Foam if your doctor
tells you to.
Driving and using machines
Budenofalk Rectal Foam is not
expected to affect your ability to drive
or operate machinery.
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 dermatitis).
3. H
 ow to use Budenofalk Rectal
Foam
Always use this medicine exactly as
your doctor has told you. Check with
your doctor or pharmacist if you are
not sure.
The recommended dose is
Dose for adults over 18 years of age
The usual dose is 1 spray actuation
per day, either in the morning or to be
used at bedtime.
Emptying your bowels before using
Budenofalk Rectal Foam produces
the best results.

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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.
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.
Picture of the spray can
pump dome
spout
applicator
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

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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 as vertically as
possible.
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
administration.

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In order to prevent the inadvertent loss
of foam from the spray can between
applications turn the pump dome around
so that the semi-circular gap faces the
opposite direction to the nozzle.
– Please wash your hands and try not
to empty your bowels until the next
morning.
– 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
If you have used too much medicine
on one occasion, use your next dose
as prescribed. Do not use a smaller
amount. Contact a doctor if you are in
doubt, so he or she can decide what
to do; take the carton and this leaflet
with you if possible.
If you forget to use Budenofalk
Rectal Foam
If you miss a dose, just continue your
treatment at the prescribed dosage.
Do not use a double dose to make up
for a forgotten dose.

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If you stop using Budenofalk
Rectal Foam
Speak to your doctor if you want to
interrupt or end your treatment early.
It is important that you do not stop
using your medicine suddenly as it
could make you ill. Keep using your
medicine until your doctor tells you to
stop, even if you start to feel better.
If you have any further questions
on the use of this medicine, ask
your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine
can cause side effects, although not
everybody gets them.
If you get any of the following
symptoms after using this
medicine, you should contact
your doctor immediately:
– infection
– headache
– changes in behaviour such as
depression, irritability, euphoria,
restlessness, anxiety or aggression
The following side effects have also
been reported:
Common: may affect up to 1 in
10 people
– burning or pain in the rectum
– Cushing’s syndrome – e.g. with
roundness of the face, weight gain,
reduced glucose tolerance, high
blood sugar, high blood pressure,
fluid retention in the tissues (e.g.

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swollen legs), increased excretion of
potassium (hypokalaemia), irregular
periods in women, unwanted body
hair in women, impotence, abnormal
laboratory findings (reduced adrenal
function), red stripes on the skin
(stretch marks), acne.
– indigestion, irritable stomach
(dyspepsia)
– increased risk of infection
– muscle and joint pain, muscle
weakness, muscle twitching
– brittle bones (osteoporosis)
– headache
– mood changes, such as depression,
irritability or euphoria
– rash from hypersensitivity reactions,
red spots from bleeding in the skin,
delayed wound healing, local skin
reactions such as contact dermatitis
Uncommon: may affect up to 1 in
100 people
– an increase in appetite
– changes to the blood (increase in
erythrocyte sedimentation rate,
increase in the number of white
blood cells)
– nausea, abdominal pain, wind,
tingling or numbness in the
abdomen, anal fissure, mouth
ulcers, frequent need to empty the
bowels, rectal bleeding
– ulcers in the stomach or small
intestine
– changes in liver function parameters
– changes in pancreatic function,
changes in adrenal hormones
– urinary tract infections
– giddiness, disturbance of smell

– sleeplessness, restlessness with
increased physical activity, anxiety
– increased sweating, weakness
Rare: may affect up to 1 in
1,000 people
– blurred vision
– inflammation of the pancreas
– bone loss due to poor circulation of
blood (osteonecrosis)
– aggression
– bruising
Very rare: may affect up to 1 in
10,000 people
– slowed growth in children
– constipation
– increased pressure in the brain,
possibly with increased pressure in
the eye (swelling of the optic disk) in
adolescents
– increased risk of blood clotting,
inflammation of the blood vessels
(associated with stopping cortisone
use after long-term therapy)
– tiredness, general feeling of being ill
These side effects are typical of
steroid medication and most of them
can also be expected for treatments
with other steroids. They may occur
depending on your dose, duration
of treatment, whether you have had
or are having treatment with other
cortisone preparations, and your
individual susceptibility.
Some of these unwanted effects were
only reported after long-term use of
oral budesonide.

In general, the risk of side effects with
Budenofalk Rectal Foam is lower than
with systemically acting (affecting the
whole body) cortisone preparations
due to its local action.

Do not use this medicine 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.

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.

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.

The contents of the container must
be used within 4 weeks after first
opening.

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.
Not all pack sizes may be marketed.

Do not store above 25 °C.
Do not refrigerate or freeze!

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
Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: medsafety@hpra.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. H
 ow to store Budenofalk Rectal
Foam
Keep this medicine out of the sight
and reach of children.

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.

Marketing Authorisation Holder and
Manufacturer

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 to protect the
environment.
6. C
 ontents of the pack and other
information
What Budenofalk Rectal Foam
contains
The active substance is budesonide.
Each dose of foam contains 2 mg
budesonide.
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.

E-mail: zentrale@drfalkpharma.de
www.drfalkpharma.de

This medicinal product is authorised
in the Member States of the EEA
under the following names:
Denmark, Finland, Greece, Ireland,
Romania, Sweden, United Kingdom:
Budenofalk
Austria: Budo-San®
Italy: Intesticort®
Spain: Intestifalk®
This leaflet was last revised in
05/2017
Mock-up

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GB-IE/05.17

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Package leaflet:
Information for the user

Budenofalk®
2mg/dose
Rectal Foam
budesonide

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 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 Foam
4. Possible side effects
5. How to store Budenofalk Rectal
Foam
6. Contents of the pack and other
information

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Expand Transcript

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.

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