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BUDENOFALK 9MG GASTRO-RESISTANT GRANULES

Active substance(s): BUDESONIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Budenofalk® Uno 9mg gastro-resistant granules
(budesonide)
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 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® Uno granules are and what they are used for
2. What you need to know before you take Budenofalk® Uno granules
3. How to take Budenofalk® Uno granules
4. Possible side effects
5. How to store Budenofalk® Uno granules
6. Contents of the pack and other information

1.

What Budenofalk® Uno granules are and what they are used for

Budenofalk® Uno granules contain the active substance budesonide, a type of
locally acting steroid used to treat chronic inflammatory diseases of the intestine.
Budenofalk® Uno 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).


2.

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

What you need to know before you take Budenofalk® Uno
granules

DO NOT take Budenofalk® Uno granules 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
Budenofalk Uno granules is not suitable for patients with Crohn's disease affecting
the upper gastrointestinal tract.
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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® Uno granules at high doses and for
prolonged periods (see section 4. Possible side effects).
Further precautions during treatment with Budenofalk® Uno granules:
− 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® Uno granules.
− If you have been treated with a stronger cortisone preparation before starting
treatment with Budenofalk® Uno granules, your symptoms may reappear when
the medicine is changed. If this happens, contact your doctor.
[Blue Box] Use of the medicinal product, Budenofalk® Uno granules, can lead to
positive results in doping tests.
Other medicines and Budenofalk® Uno
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)
− 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 hypercholesterolaemia and also used to treat
diarrhoea) or antacids (for indigestion) in addition to Budenofalk® Uno granules,
take these medicines at least 2 hours apart.
Taking Budenofalk® Uno 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® Uno granules during pregnancy if your doctor
tells you to.
Budesonide passes in small amounts into the breast milk. If you are breastfeeding
you should only take Budenofalk® Uno granules if your doctor tells you to.
Driving and using machines
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Budenofalk® Uno granules are not expected to affect your ability to drive or operate
machinery.
Budenofalk® Uno granules contains 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® Uno granules

Always take Budenofalk® Uno granules exactly as your doctor has told you. Check
with your doctor or pharmacist if you are not sure.
Dosage
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® Uno granules should NOT be used in children under 18 years of
age.
Method of administration
Budenofalk® Uno granules are for oral use only.
You should take the Budenofalk® Uno 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.
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® Uno 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® Uno granules
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® Uno 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 1 week.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

4.

Possible side effects

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Like all medicines, Budenofalk® Uno granules 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:
Common side effects (affecting less than 1 in 10 persons treated but more than 1
in 100):
− 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), muscle and joint pain,
muscle weakness, muscle twitching
− increased risk of infection
− mood changes, such as depression, irritability or euphoria
− rash from hypersensitivity reactions, red stripes on the skin, bleeding in the
skin, acne, delayed wound healing, local skin reactions, such as contact
dermatitis
− brittle bones (osteoporosis)
− headache.
Very rare side effects (affecting less than 1 in 10,000 persons):
− growth impairment in children
− blurred vision (caused by increased pressure in the eye (glaucoma) or
clouding of the lens (cataract))
− bone and cartilage shrinkage (aseptic bone necrosis)
− stomach ache and complaints, nausea (feeling sick), vomiting (being sick),
ulcers in the stomach and/or small intestine, constipation, inflammation of the
pancreas
− tiredness, general feeling of being ill
− various psychiatric effects or such as affect behaviour
− increased risk of blood clotting, inflammation of the blood vessels (associated
with stopping cortisone use after long-term therapy)
− increased pressure in the brain, possibly with increased pressure in the eye
(swelling of the optic disk) in adolescents.


These 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.

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 in Appendix V*. By reporting side
effects you can help provide more information on the safety of this medicine.
[*For the printed material, please refer to the guidance of the annotated QRD
template.]
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5.

HOW TO STORE BUDENOFALK® UNO GRANULES

Keep out of the sight and reach of children.
Do not use Budenofalk® Uno granules 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.
[Bue Box:]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® Uno 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® Uno granules look like and contents of the pack
Budenofalk® Uno granules are white to off-white coloured gastro-resistant
granules.
Budenofalk® Uno granules are available in pack sizes of 15, 20, 30, 50 and 60
sachets – not all may be marketed
Marketing Authorisation Holder and Manufacturer
Dr. Falk Pharma GmbH
Leinenweberstr. 5
79108 Freiburg
Germany
Tel.: +49 (0) 761/1514-0
Fax: +49 (0) 761/1514-321
E-mail: zentrale@drfalkpharma.de
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,
Norway, Portugal, Romania, Slovakia, Slovenia, Sweden: Budenofalk®
Austria: Budo-San®
Spain: Intestifalk®
This leaflet was last revised in 08/2013.

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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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