Budenofalk 3mg gastro-resistant capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Budesonide

Available from:

Dr. Falk Pharma UK Ltd

ATC code:

A07EA06

INN (International Name):

Budesonide

Dosage:

3mg

Pharmaceutical form:

Gastro-resistant capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01050200; GTIN: 5060096430063

Patient Information leaflet

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 Budenof

Summary of Product characteristics

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 (adults aged _
≥
_ 18 years) _
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.
_Microscopic colitis (adults aged _
≥
_ 18_ _years) _
_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 _
In maintenance treatment, the lowest effective dose should be used. 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.
_Autoimmune hepatitis (adults aged _
≥
_ 18_ _years) _
_Induction of remission _
For the induction of remission (i.e. normalisation of elevated
laboratory
parameters) the recommended daily dose is one capsule (containing 3 mg
budesonide) three times daily (morning, midday and evening;
corresponding
to a total daily dose of 9 mg budesonid