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BUDENOFALK 3MG GASTRO-RESISTANT CAPSULES

Active substance(s): BUDESONIDE

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Budenofalk® 3mg gastro-resistant capsules
(Budesonide)
Your medicine is known by the above name, but will be referred to as
Budenofalk 3mg capsules throughout this:
Patient Information Leaflet
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.

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
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)
- 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.

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).

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.

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.

Driving and using machines
Budenofalk is not expected to affect your ability to drive or operate
machinery.

- Acute episodes of collagenous colitis (a disease with chronic
inflammation of the large bowel which is characterized by chronic watery
diarrhoea).

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.

- Autoimmune hepatitis (a disease with chronic inflammation of the
liver).

3) How to take Budenofalk 3mg capsules

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)
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
first.
- If you know that you are due to have an operation please tell your

Always take Budenofalk exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
Dosage
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 packet 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 the forgotten one.
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, 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, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
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 out of the reach and sight of children.
• Do not store 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 contains
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 acidmethyl
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 looks 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 blister pack sizes of 100
PL 10383/2014

Budenofalk 3mg gastro-resistant capsules POM

Who makes and repackages your medicine?
This product is manufactured by DR. Falk Pharma GmbH, Leinenweberstr.
5 79108 Freiburg, Germany. Procured from within the EU and repackaged
by the Product Licence Holder: Primecrown Ltd, 4/5 Northolt Trading
Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 08.08.2016
Budenofalk is a registered trademark holder of Dr. Falk Pharma GmbH,
Germany.

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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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