ENTOCORT Budesonide 3mg modified release capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

budesonide, Quantity: 3 mg

Available from:

Chiesi Australia Pty Ltd

Pharmaceutical form:

Capsule, modified release

Composition:

Excipient Ingredients: sodium lauryl sulfate; iron oxide yellow; tributyl acetylcitrate; colloidal anhydrous silica; titanium dioxide; liquid paraffin; dimeticone 1000; purified talc; iron oxide black; ethylcellulose; Gelatin; triethyl citrate; methacrylic acid copolymer; iron oxide red; polysorbate 80; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; potassium hydroxide; maize starch; sucrose

Administration route:

Oral

Units in package:

90 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

The induction of remission in adult patients with mild to moderate Crohn's disease affecting the ileum and/or the ascending colon.

Product summary:

Visual Identification: A two-piece hard gelatin capsule, size 1 with opaque light grey body and opaque pink cap. The cap has black print CIR 3mg.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1998-01-16

Patient Information leaflet

ENTOCORT
®
CMI v 3.1 December 2021
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
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 available only with a
doctor's prescription.
BEFORE YOU START TO TAKE IT
TELL YOUR DOCTOR IF YOU HAVE
ALLERGIES TO ANY OTHER MEDICINES,
FOODS, PRESERVATIVES OR DYES.
TELL YOUR DOCTOR IF YOU HAVE OR
HAVE HAD ANY MEDICAL CONDITIONS,
ESPECIALLY THE FOLLOWING:

any recent infection (including
chicken pox and measles)
the risks of you taking Entocort

tuberculosis
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING ENTOCORT, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
ENTOCORT.
You may need to read it again.
WHAT ENTOCORT IS
FOR
Entocort is used in the treatment of
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 released
capsules are designed to release
their contents in the small bowel
and the first part of the large bowel.
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
difficul

Summary of Product characteristics

Entocort Product Information v3.3
1(9)
AUSTRALIAN PRODUCT INFORMATION - ENTOCORT
®
(BUDESONIDE) MODIFIED
RELEASE CAPSULES
1.
NAME OF THE MEDICINE
budesonide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Entocort contains 3 mg of budesonide and is a hard gelatin capsule
filled with gastric acid-
resistant, prolonged release granules for oral use. The granules are
practically insoluble in
gastric juice and have prolonged release properties adjusted to
release budesonide in the
ileum and the ascending colon
Excipients with known effect: sugars.
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS
3.
PHARMACEUTICAL FORM
Entocort 3 mg modified released 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 modified released capsules are indicated for the induction of
remission in adult
patients with mild to moderate Crohn's disease affecting the ileum
and/or the ascending
colon.
4.2 DOSE AND METHOD OF ADMINISTRATION
The modified released capsules should be swallowed whole with water.
The modified
release capsules must not be chewed.
Adults
The recommended daily dose for induction of remission is 9 mg,
administered once daily in
the morning. The dose should be taken before meals.
When treatment with Entocort modified release capsules is to be
discontinued, the dose
should be tapered over the last 2 to 4 weeks of therapy and not
stopped abruptly. The total
duration of therapy should be no more than 12 weeks in any single
course.
Children
There is presently no experience with Entocort modified released
capsules in children.
Elderly
No special dose adjustment is recommended. However, experience with
Entocort modified
release capsules in the elderly is limited.
4.3 CONTRAINDICATIONS
Systemic or local bacterial, fungal or viral infections.
Hypersensitivity to any of the ingredients listed in section 6.1 LIST
OF EXCIPIENTS.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE