BUDENOFALK budesonide 3 mg enteric capsules

Страна: Австралія

мова: англійська

Джерело: Department of Health (Therapeutic Goods Administration)

Активний інгредієнт:

budesonide, Quantity: 3 mg

Доступна з:

Dr Falk Pharma Australia Pty Ltd

ІПН (Міжнародна Ім'я):

Budesonide

Фармацевтична форма:

Capsule, enteric

Склад:

Excipient Ingredients: sodium lauryl sulfate; purified talc; lactose monohydrate; ammonio methacrylate copolymer; methacrylic acid copolymer; titanium dioxide; erythrosine; iron oxide red; Gelatin; iron oxide black; povidone; triethyl citrate; maize starch; sucrose

Адміністрація маршрут:

Oral

Одиниць в упаковці:

10 pack, 50 pack, 9 pack, 90 pack

Тип рецепту:

(S4) Prescription Only Medicine

Терапевтичні свідчення:

BUDENOFALK enteric capsules are indicated for: Induction of remission in patients with mild to moderately active Crohn's disease affecting the ileum and/or the ascending colon (see CLINICAL TRIALS).

Огляд продуктів:

Visual Identification: Pink capsules, containing round white pellets; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Статус Авторизація:

Registered

Дата Авторизація:

2012-06-12

інформаційний буклет

BUDENOFALK ENTERIC CAPSULES - CMI
PAGE 1 OF 4
BUDENOFALK
® ENTERIC CAPSULES
_BUDESONIDE _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
BUDENOFALK enteric
capsules. 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
BUDENOFALK enteric capsules
against the benefits they expect
it will have for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
WHAT BUDENOFALK IS
USED FOR
BUDENOFALK enteric capsules
contain the active ingredient,
budesonide. Budesonide
belongs to a group of
medications called
corticosteroids. BUDENOFALK
enteric capsules are used to
treat Crohn’s disease affecting
the ileum and/or the ascending
colon (inflammation of the last
section of the small bowel
and/or the first section of the
large bowel) for 8 weeks.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have
prescribed it for another reason.
This medicine is not addictive.
This medicine is not expected to
affect your ability to drive a car
or operate machinery.
BUDENOFALK is only available
on a doctor’s prescription.
There is not enough information
to recommend the use of this
medicine for children or
adolescents.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE BUDENOFALK IF
YOU HAVE AN ALLERGY TO:
•
any medicine containing
budesonide
•
any of the ingredients listed
at the end of this leaflet.
Some symptoms of an allergic
reaction may include shortness
of breath, wheezing or difficulty
breathing; swelling of the face,
lips, tongue or other parts of the
body; rash, itching or hives on
the skin.
BUDENOFALK enteric capsules
contain lactose and sucrose.
This may cause a problem if you
have intolerance to some
sugars.
DO NOT TAKE BUDENOFALK IF
YOU SUFFER FROM A SEVERE LIVER
DISEASE (LIVER CIRRHOSIS).
DO NOT TAKE THIS MEDICI

Характеристики продукта

BUDENOFALK CAPSULES- Product Information
Page 1 of 13
_ _
_ _
AUSTRALIAN PRODUCT INFORMATION
BUDENOFALK
®
(BUDESONIDE)
ENTERIC CAPSULES
1.
NAME OF THE MEDICINE
Budesonide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
BUDENOFALK enteric capsules contain the active ingredient budesonide.
Excipients of known effect: Sugars (as lactose monohydrate and
sucrose).
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
BUDENOFALK 3 mg enteric capsules are presented as pink opaque, oblong
hard gelatin capsules.
Each enteric capsule contains 3 mg of budesonide.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BUDENOFALK enteric capsules are indicated for:
Induction of remission in patients with mild to moderately active
Crohn’s disease affecting the ileum
and/or the ascending colon (see Section 5.1 PHARMACODYNAMIC
PROPERTIES, CLINICAL
TRIALS).
4.2
DOSE AND METHOD OF ADMINISTRATION
_ADULTS AND THE ELDERLY: _
For acute Crohn’s disease (for 8 weeks):
-
9 mg budesonide once daily in the morning, or
-
3 mg budesonide 3 times daily (morning, midday and evening)
Safety and Efficacy of BUDENOFALK enteric capsules have been assessed
for up to 8 weeks in
adults. Continuous treatment beyond 8 weeks is not recommended.
Patients may receive episodic
treatment.
_AT DISCONTINUATION _
_At the end of treatment, the dosage should be tapered gradually, to
avoid the possibility of _
_insufficient function of the cortex of the suprarenal gland. _
_ _
In the first week, the dosage should be reduced to two capsules daily,
one in the morning, one in
the evening. In the second week, only one capsule should be taken in
the morning. After two weeks
of gradual dose reduction, treatment can be discontinued.
_ _
_Method of administration _
The enteric capsules may be taken whole, without chewing or crushing,
about 30 minutes before
meals with sufficient water. Patients with difficulty swallowing the
capsules may open the capsule
and administer the granules without chewing or crushing and with
plenty of liquid.