Budenofalk 3 mg gastro-resistant capsules

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Budesonide

Fáanlegur frá:

Dr. Falk Pharma GmbH

ATC númer:

A07EA; A07EA06

INN (Alþjóðlegt nafn):

Budesonide

Skammtar:

3 milligram(s)

Lyfjaform:

Gastro-resistant capsule, hard

Gerð lyfseðils:

Product subject to prescription which may be renewed (B)

Lækningarsvæði:

Corticosteroids acting locally; budesonide

Leyfisstaða:

Marketed

Leyfisdagur:

2001-04-06

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
BUDENOFALK 3MG GASTRO-RESISTANT CAPSULES
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 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 3mg capsules 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).
-
MICROSCOPIC COLITIS: a disease with the subtypes collagenous and
lymphocytic
colitis, characterised by chronic inflammation of the large bowel
typically
accompanied by chronic watery diarrhoea.
-
AUTOIMMUNE HEPATITIS: a disease with chronic inflammation of the
liver.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BUDENOFALK 3MG CAPSULES
DO NOT TAKE BUDENOFALK 3MG CAPSULES:
-
if you are ALLERGIC to budesonide or any of the other ingredients of
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

Vara einkenni

Health Products Regulatory Authority
07 January 2020
CRN008VJ8
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Budenofalk 3 mg gastro-resistant capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 3 mg budesonide
Excipients with known effect: Each capsule contains 240 mg sucrose and
12 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsules, hard (gastro-resistant capsules)
Capsule, hard, pink containing white gastro-resistant granules
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

Crohn's disease
Induction of remission in patients with mild to moderate active
Crohn's disease affecting the ileum and/or the ascending colon

Microscopic colitis

Autoimmune hepatitis
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Crohn's disease _
_Induction of remission _
The recommended daily dose is three capsules once daily in the morning
or one capsule (containing 3 mg budesonide) three
times daily (morning, midday and evening; corresponding to a total
daily dose of 9 mg budesonide) if this is more convenient
to the patient.
_Duration of treatment_
The duration of treatment in active Crohn's Disease should be limited
to 8 weeks.
_ _
_Microscopic colitis _
_ _
_Induction of remission _
The recommended dose is three capsules once daily in the morning
(corresponding to a daily dose of 9 mg budesonide).
_Maintenance of remission _
Maintenance therapy should only be initiated in patients with
frequently recurring symptoms of microscopic colitis after
successful induction treatment. A dosage regimen of two capsules once
daily in the morning (6 mg budesonide) or of two
capsules once daily in the morning alternating with one capsule daily
in the morning (corresponding to an average daily dose
of 4.5 mg budesonide) can be applied, according to the individual
requirements of the patient. The lowest effective dose
should be used.
_Duration of treatment_
The duration of treatment in active microscopic co