BUDENOFALK 2MG/DOSE RECTAL FOAM

Active substance: BUDESONIDE

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Budenofalk Rektalschaum GI für Europa allgemein (CXP/03.14)
Open size: 371 x 140 mm
Printing Colour: Black (1/1)
Producer: Mock-up (ASM)
Folded size: 53 x 140 mm
Folding: zigzag-folding
Type font/line space: 8pt/9,5pt

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 taking this product until
you have talked to your doctor.
If you have any further questions
on the use of this product, 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
reported:
If you get any of the following
symptoms after taking this
medicine, you should contact
your doctor immediately:
• 
Infection
•  eadache
H
The following side effects have been
reported:
Common side effects (that affect
less than 1 in 10 patients):
• 
Burning or pain in the rectum



Mockup_BUF_GI_CXP.indd 1

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.
•  increase in appetite
An
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
• 
Burred vision (e.g. glaucoma and
cataract)
• 
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
adolescents
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.
If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell
your doctor or pharmacist.

5.  OW TO STORE BUDENOFALK®
H
RECTAL FOAM
Keep out of the reach and sight of
children.
Do not use Budenofalk® Rectal Foam
after the expiry date which is stated
on the carton and on the pressurised
container.
The contents of the container must
be used within 4 weeks after first
opening.
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.
Medicines should not be disposed of
via wastewater or household waste.
Ask your pharmacist how to dispose
of medicines no longer required. These
measures will help to protect the
environment.

6. FURTHER 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.
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.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Denmark, Finland, Great Britain,
Greece, Ireland, Luxembourg,
Romania and Sweden: Budenofalk®
Austria: Budo-San®
Italy: Rafton®
Spain: Intestifalk®

Budenofalk® 2mg/dose
Rectal Foam

This leaflet was last approved in
MM/YYYY
[To be completed nationally]
MA no. XXXXXX

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.

p. 12

p. 13

Budesonide

Read all of this leaflet carefully before you start using this medicine.
•  eep this leaflet. You may need to
K
read it again.
• f you have any further questions,
I
ask your doctor or pharmacist.
•  his medicine has been prescribed
T
for you. Do not pass it on to others.
It may harm them, even if their
symptoms are the same as yours.
• f any of the side effects gets serious,
I
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1. What Budenofalk® Rectal Foam
is and what it is used for
2.  efore you use Budenofalk®
B
Rectal Foam
3.  ow to use Budenofalk®
H
Rectal Foam
4.  ossible side effects
P
5.  ow to store Budenofalk®
H
Rectal Foam
6. Further information

Marketing Authorisation Holder and
Manufacturer

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

p. 11

This medicinal product is authorised
in the Member States of the EEA
under the following names:

Mock-up CXP/03.14

p. 14 = last page

p. 1

20.03.14 11:20

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.  EFORE YOU USE
B
BUDENOFALK® RECTAL FOAM
Do not use Budenofalk® Rectal
Foam
•  you are or have been told you are
If
allergic (hypersensitive) to budesonide or any of the other ingredients of
Budenofalk® Rectal Foam (these are
listed in section 6, Further information)
•  you have a serious liver disease
If
(e.g. liver cirrhosis).
Take special care with Budenofalk®
Rectal Foam.
Before you start using this medicine
you should tell your doctor:
•  you know or have been told
If
that you have tuberculosis, high
blood pressure, fragile bones
(osteoporosis)



Mockup_BUF_GI_CXP.indd 2

p. 2

•  you or any of your family suffers
If
with diabetes (diabetes mellitus), or
glaucoma (increase in the pressure
within the eye)
•  you suffer with ulcers in the stomIf
ach or duodenum (peptic ulcer)
•  you suffer with eye problems
If
such as cataracts.
• If you suffer with problems
of your liver
Further precautions:
•  your doctor if you have not yet
Tell
had chickenpox or measles, or if
you have come into contact with
anybody who has chickenpox,
shingles or measles.
•  you know that you need to be
If
vaccinated please speak to your
doctor first.
•  you know that you are due
If
to have an operation please tell
your doctor that you are using
Budenofalk® Rectal Foam.
•  you have been treated with
If
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!
Using other medicines
Please tell your doctor if you take or
use any of the medicines mentioned
below as the effects of these medicines may change (interactions):
•  edicines used to treat heart
M
conditions (cardiac glycosides
such as digoxin)

p. 3

• Diuretics (medicines used to
treat excess fluid in your body)
•  etoconazole and itraconazole
K
(substances used to treat fungal
infections)
•  ntibiotic drugs used to treat
A
infections (such as clarithromycin)
•  itonavir (a substance used for
R
treating HIV infections)
•  arbamazepine (substance used
C
for treating epilepsy)
•  ifampicin (substance used against
R
tuberculosis)
•  ontraceptive pill
C
Please tell your doctor or pharmacist
if you are taking or have recently taken
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.
Using 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
Ask your doctor or pharmacist for
advice before taking any 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.
Important information about some
of the ingredients of Budenofalk®
Rectal Foam
This medicine contains cetyl alcohol
and propylene glycol which can cause
local skin reactions (e.g. contact
dermatitis).
3.  OW TO USE BUDENOFALK®
H
RECTAL FOAM
Always use Budenofalk® Rectal Foam
exactly as your doctor has told you.
You should 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.
Dosage:
Dose for adults over 18 years of age:
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:

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
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

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
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.

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 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.
•  you go to hospital or see another
If
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.

p. 8

20.03.14 11:20

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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.

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