BUDENOFALK 3MG GASTRO-RESISTANT CAPSULES

Active substance: 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/04.13 Farbigkeit: 2/2 (Schwarz + Pant. 644)
Variante 023
Laetuscode-Nr.: 118

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Budenofalk® 3mg
gastro-resistant capsules
Budesonide
Read all of this leaflet carefully before you start taking this
medicine.
–  eep this leaflet. You may need to read it again.
K
– f you have any further questions, please ask your doctor or your
I
pharmacist.
–  his medicine has been prescribed for you. Do not pass it on to others.
T
It may harm them, even if their symptoms are the same as yours.
– f any of the side effects gets serious, or if you notice any side
I
effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1.  hat Budenofalk® 3mg capsules are and what they are used for
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2.  efore you take Budenofalk® 3mg capsules
B
3.  ow to take Budenofalk® 3mg capsules
H
4.  ossible side effects
P
5.  ow to store Budenofalk® 3mg capsules
H
6.  urther information
F
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:
–  rohn’s disease: mild to moderate acute attacks of chronic inflamC
mation 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.
–  ymptomatic relief of chronic diarrhoea due to collagenous
S
colitis (a disease with chronic inflammation of the large bowel
which is characterized by chronic watery diarrhoea).
–  utoimmune hepatitis (a disease with chronic inflammation of
A
the liver).

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2.  EFORE YOU TAKE BUDENOFALK® 3mg CAPSULES
B
DO NOT take Budenofalk if you have:
–  n allergy (hypersensitivity) to budesonide or any of the other
a
ingredients in this medicine (see Section 6 and end of Section 2)
– a severe liver disease (liver cirrhosis)
®

Take special care with Budenofalk®
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.
−  you know that you need to be vaccinated please speak to your
If
doctor first.
−  you know that you are due to have an operation please tell your
If
doctor that you are using Budenofalk®.
−  you have been treated with a stronger cortisone preparation
If
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:
–  ardiac glycosides such as digoxin (medicines used to treat heart
C
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.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
It is important that you tell your doctor if you are, or think you may
be pregnant as 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
machinery.
Important information about some of the ingredients of
Budenofalk® 3mg capsules
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.  OW TO TAKE BUDENOFALK® 3mg CAPSULES
H
Always take Budenofalk® exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
Dosage
Crohn’s disease and symptomatic treatment of collagenous colitis
Adults (over 18 years)
Take one capsule 3 times a day (morning, midday and evening),
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.

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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.
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® 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 product, ask your
doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Budenofalk® can cause side effects, although not
everybody gets them.

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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).
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
5.  OW TO STORE BUDENOFALK® 3mg CAPSULES
H
Keep out of the reach and sight 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.  URTHER INFORMATION
F
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
Germany

E-mail: zentrale@drfalkpharma.de
www.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, Poland, Romania, Slovakia,
Slovenia, Sweden: Budenofalk®
Austria: Budo-San®
Portugal: Budo San®
Spain: Intestifalk®
France: Mikicort®
Italy: Intesticort®
This leaflet was last approved in 04/2013.
Mock-up GB-IE/04.13

11.04.13 15:30

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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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