Entocort

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Budesonide 3mg

Available from:

Chiesi New Zealand Limited t/a Emerge Health

INN (International Name):

Budesonide 3 mg

Dosage:

3 mg

Pharmaceutical form:

Modified release capsule

Composition:

Active: Budesonide 3mg Excipient: Acetyl tributyl citrate Ethylcellulose Gelatin Methacrylic acid - ethyl acrylate copolymer Polysorbate 80 Purified talc Simeticone Sugar spheres Triethyl citrate

Units in package:

Bottle, plastic, HDPE 90, 90 capsules

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Minakem Dunkerque Production

Therapeutic indications:

ENTOCORT capsules are indicated for the induction of remission in patients with mild to moderate Crohn's disease affecting the ileum and/or the ascending colon.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, HDPE - 90 capsules - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE - 100 capsules - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1994-12-19

Patient Information leaflet

ENTOCORT
®
CMI v4.0
1
ENTOCORT
®
_Budesonide _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Entocort.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Entocort
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT ENTOCORT IS
USED FOR
Entocort is used to treat Crohn’s
disease. It can be used to treat acute
attacks.
Crohn’s disease is an inflammatory
disease of the bowel. It mainly
affects the small bowel and the first
part of the large bowel and causes
symptoms such as stomach pain,
diarrhoea and fever.
Entocort contains budesonide. This
belongs to the group of medicines
called corticosteroids, which are used
to help reduce inflammation in many
parts of the body.
Entocort modified release capsules
are designed to release their contents
gradually in the small bowel and the
first part of the large bowel.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ENTOCORT HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
Entocort is not addictive.
Entocort is only available with a
doctor’s prescription.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
BEFORE YOU TAKE
ENTOCORT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ENTOCORT IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
budesonide
•
any ingredients listed at the end
of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
rash, itching or hives on the skin
•
shortness of breath, wheezing or
difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body.
DO NOT GIVE ENTOCORT TO CHILDREN.
There is only limited information
available about the use of Entocort in
children

Summary of Product characteristics

ENTOCORT Data Sheet v4.2
1
NEW ZEALAND DATA SHEET
1
PRODUCT NAME (STRENGTH PHARMACEUTICAL FORM)
ENTOCORT 3 mg modified release capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 3 mg budesonide.
Excipients with known effect: sugars (sucrose).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
ENTOCORT 3 mg modified release capsules are two-piece hard gelatin
capsule, size 1 with an
opaque light grey body and an opaque pink cap. The cap has black print
CIR 3mg.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ENTOCORT capsules are indicated for the induction of remission in
patients with mild to
moderate Crohn’s disease affecting the ileum and/or the ascending
colon.
4.2
DOSAGE AND METHOD OF ADMINISTRATION
DOSE
_ADULTS _
The recommended daily dose for induction of remission is 9 mg,
administered once daily for up
to eight weeks. The dose should be taken in the morning before
breakfast. Full effect is usually
achieved within 2-4 weeks. When treatment with ENTOCORT capsules is to
be discontinued,
the dose should be tapered for 2 to 4 weeks and not stopped abruptly.
_CHILDREN _
There are limited data on the use of ENTOCORT capsules in children.
The available data are
insufficient to support safety and efficacy in the paediatric
population, therefore such use cannot
be recommended until further data become available.
_Influence on Growth_
It is recommended that the height of children receiving prolonged
treatment
with corticosteroids is regularly monitored. If growth is slowed,
therapy should be re-evaluated.
The benefits of corticosteroid therapy and the possible risk of growth
suppression must be
carefully weighed. Long- term studies have not been performed in
children treated with
ENTOCORT capsules.
_ELDERLY _
No special dose adjustment is recommended. However, experience with
ENTOCORT capsules
in the elderly is limited.
ENTOCORT Data Sheet v4.2
2
METHOD OF ADMINISTRATION
The capsules should be swallowed whole with water. For patients with
difficulty swallowing,
the c