CORTIMENT budesonide 9 mg prolonged release tablet blister pack

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

budesonide, Quantity: 9 mg

Dostopno od:

Ferring Pharmaceuticals Pty Ltd

INN (mednarodno ime):

Budesonide

Farmacevtska oblika:

Tablet, modified release

Sestava:

Excipient Ingredients: stearic acid; lecithin; microcrystalline cellulose; hyprolose; lactose monohydrate; silicon dioxide; magnesium stearate; methacrylic acid copolymer; purified talc; titanium dioxide; triethyl citrate

Pot uporabe:

Oral

Enote v paketu:

20 modified release tablets, 80 modified release tablets, 10 modified release tablets, 50 modified release tablets, 30 modified release tablets, 60 modified release tablets

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

CORTIMENT prolonged-release tablets are indicated in adults for induction of remission in patients with mild to moderate active ulcerative colitis (UC) where 5-ASA treatment is not sufficient or not tolerated.

Povzetek izdelek:

Visual Identification: Each tablet is a white to off-white, round, biconvex, film-coated tablet, approximately 9.5 mm diameter and 4.7 mm thickness, debossed on one side with "MX9"; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Status dovoljenje:

Licence status A

Datum dovoljenje:

2015-08-31

Navodilo za uporabo

CORTIMENT
®
_PROLONGED-RELEASE TABLETS_
_budesonide_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CORTIMENT. 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 CORTIMENT
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 the medicine.
You may need to read it again.
WHAT CORTIMENT IS
USED FOR
CORTIMENT tablets are indicated in
adults for induction of remission in
patients with mild to moderate active
ulcerative colitis (UC) where 5-ASA
treatment is not sufficient or not
tolerated.
CORTIMENT contains the active
ingredient, budesonide. Budesonide
belongs to a group of medicines
called corticosteroids, which are used
to help reduce inflammation.
CORTIMENT is used to treat
inflammation of the large intestine
(colon), which is an area commonly
affected in UC. The tablets are
designed to release the active
ingredient, budesonide in a
controlled manner along the colon.
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.
CORTIMENT is available only with
a doctor's prescription.
There is not enough information to
recommend the use of this medicine
for patients under the age of 18 years.
BEFORE YOU TAKE
CORTIMENT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE CORTIMENT IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
budesonide
•
any of the ingredients listed at the
end of this leaflet
•
peanut oil.
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 TAKE CORTIMENT IF YOU
ARE ALLERGIC TO PEANUT OIL OR SOY.
CORTIMENT contains l

Lastnosti izdelka

Page 1 of 11
#36864-v7A
AUSTRALIAN PI - CORTIMENT
® (BUDESONIDE) 9 MG PROLONGED
RELEASE TABLETS
1. NAME OF THE MEDICINE
Budesonide
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each CORTIMENT prolonged-release tablet contains 9 mg of budesonide.
Each tablet is a
white to off-white, round, biconvex, film-coated, tablet,
approximately 9.5 mm in diameter,
approximately 4.7 mm in thickness, debossed on one side with
“MX9”.
CORTIMENT prolonged-release tablets also contain the following
excipients:
Tablet core: stearic acid (E570), lecithin (E322), microcrystalline
cellulose (E460), hyprolose
(E463), lactose monohydrate, silicon dioxide (E551), magnesium
stearate (E470b).
Tablet film-coating: methacrylic acid copolymer, talc - purified
(E553b), titanium dioxide
(E171), triethyl citrate.
CORTIMENT prolonged-release tablets contain lactose and lecithin (of
Soya origin).
3. PHARMACEUTICAL FORM
The active ingredient in CORTIMENT is budesonide. Budesonide is a
white or almost white,
crystalline powder. Practically insoluble in water, freely soluble in
methylene chloride,
sparingly soluble in ethanol.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CORTIMENT prolonged-release tablets are indicated in adults for
induction of remission in
patients with mild to moderate active ulcerative colitis (UC) where
5-ASA treatment is not
sufficient or not tolerated.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Adults
The recommended daily dose for induction of remission is one 9 mg
tablet in the morning, for
up to 8 weeks.
Paediatric population
The safety and efficacy of CORTIMENT prolonged-release tablets in
children aged 0-18 years
has not yet been established. No data are available, therefore the use
in paediatric population
is not recommended until further data become available.
Elderly
No
special
dose
adjustment
is
recommended.
However,
experience
of
the
use
of
CORTIMENT prolonged-release tablets in the elderly is limited.
Page 2 of 11
#36864-v7A
Hepatic and renal impairment population
CORTIMENT was not studied in patients w