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Active substance(s): BUDESONIDE

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Budenofalk 3mg Gebrauchsinformation (GI) für Großbritannien-Irland
Mat.-Nr.: Mock-up (Losan Pharma) Format: 290 x 195 mm
Falk-Datumscode: GB-IE/09.14 Farbigkeit: 2/2 (Schwarz + Pant. 644)
Grammatur: 50g/m²
Laetuscode-Nr.: 118


Budenofalk® 3mg
gastro-resistant capsules

Read all of this leaflet carefully before you start taking this
medicine. Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or your 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 is 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).
Note: Budenofalk is 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.
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
2. What you need to know before you take Budenofalk 3mg capsules

DO NOT take Budenofalk if you have:
– an allergy (hypersensitivity) to budesonide or any of the other
ingredients in this medicine (Listed in section 6 and end of section 2)
– a severe liver disease (liver cirrhosis)

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Warnings and precautions
Before you start taking this medicine, tell your doctor 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
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:
– 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
− 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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including those obtained without a
prescription. In particular:
Cardiac glycosides such as digoxin (medicines used to treat heart
– Diuretics (to remove excess fluid from the body)
– Ketoconazole or itraconazole (to treat fungal infections)
– Antibiotic drugs used to treat infections (such as clarithromycin)
– Ritonavir (for HIV infections)
– 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)
If you take cholestyramine (for hypercholestrolemia and also used to
treat diarrhoea) or antacids (for indigestion) in addition to Budenofalk, take
these medicines at least 2 hours apart.
Taking Budenofalk 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. Do not breast-feed during treatment with Budenofalk
as the drug may pass into breast milk.
Driving and using machines
Budenofalk is not expected to affect your ability to drive or operate
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 Budenofalk exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
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
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.

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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 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 packet and this
leaflet with you if possible.
If you forget to take Budenofalk
If you miss a dose, just continue your treatment at the prescribed dosage.
Do not take a double dose to make up for the forgotten one.
If you stop taking Budenofalk
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, Budenofalk 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 or psychiatric effects for example depression,
irritability and euphoria

The following side effects have also been reported:
Very rare (affecting less than 1 in 10,000 patients)
– Cushing’s syndrome - roundness of the face, weight gain, reduced
glucose tolerance, high blood sugar, fluid retention, increased excretion
of potassium (hypokaliemia), reduced growth in children, irregular
periods in women, unwanted body hair in women, impotence, abnormal
laboratory findings (reduced adrenal function), swelling of the legs
(because of fluid retention, oedema)
– increased pressure in the brain, possibly with increased pressure in the
eye (swelling of the optic disk) in adolescents
– constipation
– muscle and joint pain and weakness, muscle twitching
– brittle bones (osteoporosis)
– tiredness, general feeling of being ill.
The following side effects are typical of steroid medication and may
occur depending on your dose, period of treatment, whether you have
had or are having treatment with other cortisone preparations, and
your individual susceptibility. Most of the following side effects were
noted after use of stronger steroids and so should be less frequent with
Budenofalk 3mg capsules:
– Cushing’s Syndrome (for a description of typical symptoms, see above).
– increased risk of infection.
– mood changes such as depression, irritability or euphoria.
– blurred vision (caused by increased pressure in the eye (glaucoma) or
clouding of the lens (cataract)).
– high blood pressure, increased risk of blood clotting, inflammation of
the blood vessels (associated with stopping cortisone use after long
term therapy).
– stomach ache and complaints, nausea, vomiting (feeling sick), ulcers in the
stomach and/or small intestine, inflammation of the pancreas.
– rash from hypersensitivity reactions, red stripes on the skin, bleeding
in the skin, acne, delayed wound healing, local skin reactions such as
contact dermatitis.
– bone and cartilage loss (aseptic bone necrosis).
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:
Republic of Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
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.

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5. How to store Budenofalk 3mg capsules
Keep this medicine out of the sight and reach of children.
Do not store the medicine above 25°C.
Do not use Budenofalk after the expiry date which is stated on the carton and
blister pack. The expiry date refers to the last day of that month.
6. Contents of the pack and other information
What Budenofalk 3mg capsules contain
The active substance is budesonide. Each capsule with gastro-resistant
pellets contains 3 mg of budesonide.
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 acid-methyl 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


This medicinal product is authorised in the Member States
of the EEA under the following names:
Belgium, Bulgaria, Czech Republic, Denmark, Finland, Germany,
Great Britain, Greece, Hungary, Ireland, Latvia, Lithuania, Luxembourg,
The Netherlands, Poland, Romania, Slovakia,
Slovenia, Sweden: Budenofalk®
Austria: Budo-San®
Portugal: Budo San®
Spain: Intestifalk®
France: Mikicort®
Italy: Intesticort®
This leaflet was last approved in 09/2014.
Mock-up GB-IE/09.14

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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.