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BUDENOFALK 3MG GASTRO-RESISTANT CAPSULES

Active substance(s): BUDESONIDE / BUDESONIDE / BUDESONIDE

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Package leaflet:
information for the user

Budenofalk® 3mg
gastro-resistant capsules
Budesonide
Read all of this leaflet carefully before you start taking 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 3mg capsules are and what they are used for
2. What you need to know before you take Budenofalk 3mg capsules
3. How to take Budenofalk 3mg capsules
4. Possible side effects
5. How to store Budenofalk 3mg capsules
6. Contents of the pack and other information
1. What Budenofalk 3mg capsules are and
what they are used for
Budenofalk 3mg capsules contain the active substance budesonide,
a type of locally acting steroid used to treat chronic inflammatory
diseases of the intestine and the liver.
Budenofalk capsules are used in the treatment of:
– Crohn’s disease mild to moderate acute attacks of chronic
inflammation of the intestine affecting the lower part of the small
bowel (ileum) and/or upper part of the large bowel (the ascending
colon).
– Acute episodes of collagenous colitis (a disease with chronic
inflammation of the large bowel which is characterized by chronic
watery diarrhoea).
– Autoimmune hepatitis (a disease with chronic inflammation of
the liver).

2. What you need to know before you take
Budenofalk 3mg capsules
DO NOT take Budenofalk capsules:
– if you are allergic to budesonide or any of the other ingredients in
this medicine (listed in section 6)
– if you have a severe liver disease (liver cirrhosis)
Warnings and precautions
Talk to your doctor before taking Budenofalk capsules 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
Budenofalk capsules are not suitable for patients with Crohn's
disease affecting the upper gastrointestinal tract.
Sometimes this disease may cause symptoms outside the intestine
(e.g. affecting the skin, eyes and joints) which are unlikely to respond
to this medicine.
Typical effects of cortisone preparations may occur which may
affect all parts of the body, particularly when you take Budenofalk at
high doses and for prolonged periods (see section 4. Possible side
effects).
Further precautions during treatment with Budenofalk 3mg
capsules:
– Tell your doctor if you have an infection. The symptoms of some
infections can be unusual 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.
− If you have been treated with a stronger cortisone preparation
before starting treatment with Budenofalk, your symptoms may
reappear when the medicine is changed. If this happens, contact
your doctor.

− If you have autoimmune hepatitis, your doctor will carry out liver
function tests regularly and will adjust the dosage of this medicine
periodically.
– Contact your doctor if you experience blurred vision or other visual
disturbances.
Other medicines and Budenofalk 3mg capsules
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
– cimetidine (used to inhibit the production of acid in the stomach)
Some medicines may increase the effects of Budenofalk 3mg
capsules and your doctor may wish to monitor you carefully if you
are taking these medicines (including some medicines for HIV:
ritonavir, cobicistat).
If you take colestyramine (for hypercholestrolemia and also
used to treat diarrhoea) or antacids (for indigestion) in addition to
Budenofalk, take these medicines at least 2 hours apart.
Budenofalk 3mg capsules could affect the results of tests performed
by your doctor or in hospital. Tell your doctor that you are taking
Budenofalk before any tests are carried out.
Budenofalk 3mg capsules with food and drink
You should not drink grapefruit juice whilst you are taking 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 doctor for advice before taking
this medicine. You should only take Budenofalk during pregnancy
if your doctor tells you to. Budesonide passes, in small amounts,
into breast milk. If you are breast-feeding you should only take
Budenofalk if your doctor tells you to.
Driving and using machines
Budenofalk capsules are not expected to affect your ability to drive
or operate machinery.

Budenofalk 3mg capsules contain sucrose and lactose.
Each capsule contains 240 mg sucrose and 12 mg lactose
monohydrate – if you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this
medicinal product.
3. How to take Budenofalk 3mg capsules
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Crohn’s disease
Adults (over 18 years)
Take three capsules once daily in the morning or one capsule 3 times
a day (morning, midday and evening), unless your doctor instructs
you otherwise.
Collagenous colitis
Adults (over 18 years)
Take three capsules once daily in the morning, unless your doctor
instructs you otherwise.
Autoimmune hepatitis
Adults (over 18 years)
Treatment of acute inflammation:
Take one capsule 3 times a day (morning, midday and evening),
unless your doctor instructs you otherwise. Depending on the
results of laboratory examinations, your doctor will decide how long
you should take 3 capsules per day.
Maintenance treatment:
Take one capsule 2 times a day (morning and evening), unless
your doctor instructs you otherwise. Depending on the results of
laboratory examinations, your doctor will decide how long you should
take 2 capsules per day.
Please note that in most cases your doctor will prescribe Budenofalk
together with azathioprine, a medicine that works by reducing the
body’s immune response.
Use in children (all indications)
Budenofalk 3mg capsules should NOT be used in children under
12 years of age.
There is only limited experience with the use of this medicine in
children older than 12 years of age.

Method of administration
Budenofalk 3mg capsules are for oral use only.
The capsules are to be swallowed whole, with a glass of water about
½ hour before meals. Do not chew the capsules.
Duration of treatment
Your doctor will decide how long you are to continue the medication,
depending on your condition.
Crohn’s disease and collagenous colitis
Your treatment should last about 8 weeks.
Autoimmune hepatitis
Depending on the results of examinations of your blood and liver
tissue, your doctor will decide how long you should take this
medicine and how many capsules per day you should take.
If you take more Budenofalk 3mg capsules than you should
If you have taken too much medicine on one occasion, take your
next dose as prescribed. Do not take 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 take Budenofalk 3mg capsules
If you miss a dose, just continue your treatment at the prescribed
dosage. Do not take a double dose to make up for a forgotten dose.
If you stop taking Budenofalk 3mg capsules
Speak to your doctor if you want to interrupt or end your treatment
early. It is important that you do not stop taking your medicine
suddenly as it could make you ill. Keep taking your medicine until
your doctor tells you to stop, even if you start to feel better.
Your doctor will probably want to reduce your dose gradually, first
from three to two capsules for 1 week (one in the morning and one
in the evening) and then only one capsule a day in the last week of
treatment (taken in the morning).
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 taking this
medicine, you should contact your doctor immediately:
– infection
– headache
– changes in behaviour such as depression, irritability, euphoria,
restlessness, anxiety or aggression

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.
If you have been treated with a stronger cortisone preparation
before starting treatment with Budenofalk 3mg capsules, your
symptoms may reappear when the medicine is changed.

The following side effects have also been reported:

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:

Common: may affect up to 1 in 10 people
– 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. 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
– ulcers in the stomach or small intestine
– restlessness with increased physical activity, anxiety
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.

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

The other ingredients are ammonio methacrylate copolymer (type
A) (Eudragit RL), ammonio methacrylate copolymer (type B) (Eudragit
RS), lactose monohydrate, maize starch, methacrylic acid-methyl
methacrylate copolymer (1:1) (Eudragit L 100), methacrylic acidmethyl methacrylate copolymer (1:2) (Eudragit S 100), povidone
K25, purified water, sucrose, talc, triethyl citrate, gelatin, erythrosine
(E127), titanium dioxide (E171), red and black iron oxide (E172),
sodium laurilsulphate (see also end of Section 2 for further, important
information on lactose and sucrose).
What Budenofalk 3mg capsules look like and contents of the pack
Budenofalk 3mg capsules are pink coloured gastro-resistant hard
capsules contained in blister strips.
Budenofalk 3mg capsules are available in pack sizes of 10, 50, 90,
100 or 120 – not all may be marketed.
Marketing Authorisation Holder and Manufacturer

Leinenweberstr. 5
79108 Freiburg
Germany

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. How to store Budenofalk 3mg capsules
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the
carton and blister pack. The expiry date refers to the last day of that
month.

E-mail: zentrale@drfalkpharma.de
This medicinal product is authorised in the Member States of
the EEA under the following names:
Denmark, Finland, Ireland, Sweden, United Kingdom: Budenofalk®
Spain: Intestifalk®
France: MIKICORT®
Italy: Intesticort®
This leaflet was last approved in 03/2017.

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.
6. Contents of the pack and other information
What Budenofalk 3mg capsules contain
The active substance is budesonide. Each capsule with gastroresistant pellets contains 3mg of budesonide.
Mock-up

GB-IE/03.17

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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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