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BUDENOFALK 9MG GASTRO-RESISTANT GRANULES

Active substance(s): BUDESONIDE / BUDESONIDE / BUDESONIDE

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Budenofalk® 9mg Granu-Stix Outsert für Großbritannien-Irland
Mat.-Nr.: Mock-up (Losan Pharma)
Format: 408 x 242 mm / 60 x 26 mm
Falk-Datumscode: GB-IE/04.17
Farbigkeit: 2/2 (Schwarz + Pant. 644)
Grammatur: 40g/m2
Laetuscode-Nr.: 969
Schriftgröße: 9pt / ZAB: 10,5pt

Package leaflet: information for the user

Budenofalk® 9mg
gastro-resistant granules
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 granules are and what they are used for
2. What you need to know before you take Budenofalk granules
3. How to take Budenofalk granules
4. Possible side effects
5. How to store Budenofalk granules
6. Contents of the pack and other information
1. What Budenofalk granules are and what they are used for
Budenofalk granules contain the active substance budesonide, a type
of locally acting steroid used to treat chronic inflammatory diseases of
the intestine.
Budenofalk granules 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).
2. What you need to know before you take Budenofalk granules
DO NOT take Budenofalk granules:
– 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 granules 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

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Budenofalk granules 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 granules at high
doses and for prolonged periods (see section 4. Possible side effects).
Further precautions during treatment with Budenofalk granules:
– 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 granules.
− If you have been treated with a stronger cortisone preparation
before starting treatment with Budenofalk granules, 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.
Other medicines and Budenofalk granules
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 granules 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 cholestyramine (for hypercholesterolaemia and also
used to treat diarrhoea) or antacids (for indigestion) in addition
to Budenofalk granules, take these medicines at least
2 hours apart.
Budenofalk granules could affect the results of tests performed by your
doctor or in hospital. Tell your doctor that you are taking Budenofalk
granules before any tests are carried out.
Budenofalk granules 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 granules 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 take Budenofalk granules if your doctor
tells you to.
Driving and using machines
Budenofalk granules are not expected to affect your ability to drive or
operate machinery.
Budenofalk granules contain sucrose, lactose and sorbitol
Each sachet contains 828 mg sucrose and 36 mg lactose monohydrate
and 900 mg sorbitol. 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 granules
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 and collagenous colitis
Adults (over 18 years)
Take one sachet in the morning unless your doctor instructs you
otherwise.
Use in children and adolescents
Budenofalk granules should NOT be used in children under
18 years of age.
Method of administration
Budenofalk granules are for oral use only.
You should take the Budenofalk granules about ½ hour before
breakfast. Place the granules directly on the tongue and then swallow
them with a glass of water. Do not chew the granules as they may not
work properly.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Budenofalk ® 9mg
gastro-resistant granules

Duration of treatment
Your treatment should last about 8 weeks.
Your doctor will decide how long you are to continue the medication,
depending on your condition.
If you take more Budenofalk granules 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 granules
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.

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If you stop taking Budenofalk granules
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, from one
sachet every day to one sachet every other day for at least 2 weeks.
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
The following side effects have also been reported:

Nicht
bedrucken!

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. 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 granules, your symptoms may reappear
when the medicine is changed.
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 listed below.
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. How to store Budenofalk granules
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
carton and sachet. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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 granules contain
The active substance is budesonide. Each sachet with gastro-resistant
granules contains 9 mg of budesonide.
The other ingredients are ammonio methacrylate copolymer (type A)
(Eudragit RL), ammonio methacrylate copolymer (type B) (Eudragit RS),
citric acid anhydrous, lactose monohydrate, lemon flavour,
magnesium stearate, methacrylic acid-methyl methacrylate copolymer (1:1)
(Eudragit L 100), methacrylic acid-methyl methacrylate copolymer (1:2)
(Eudragit S 100), povidone K25, sucralose, sugar spheres (consisting of
sucrose and maize starch), sorbitol (E420), talc, triethyl citrate, xanthan gum
(see section 2 for further information on lactose, sucrose and sorbitol).
What Budenofalk granules look like and contents of the pack
Budenofalk granules are white to off-white coloured gastro-resistant
granules with a smell of lemon flavour.
Budenofalk granules are available in pack sizes of 15, 20, 30, 50 and 60
sachets – not all may be marketed
Marketing Authorisation Holder and Manufacturer

For any information about this medicine, please contact the local
representative of the Marketing Authorisation Holder:
Dr Falk Pharma UK Ltd
Unit K, Bourne End Business Park
Cores End Road
Bourne End
SL8 5AS
Tel: 01628 536600
e-mail: office@drfalkpharma.co.uk
This medicinal product is authorised in the Member States
of the EEA under the following names:
Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, Germany,
Greece, Hungary, Ireland, Latvia, Lithuania, Luxembourg, The Netherlands,
Norway, Portugal, Romania, Slovakia, Slovenia, Sweden, United Kingdom:
Budenofalk®
Austria: Budo-San®
France: MIKICORT®
Italy: Intesticortmono®
Spain: Intestifalk®
This leaflet was last revised in 03/2017.
PA 573/2/3
PL 08637/0020

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GB-IE/04.17

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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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