URSOFALK ursodeoxycholic acid 500 mg tablet blister pack

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

ursodeoxycholic acid, Quantity: 500 mg

Fáanlegur frá:

Dr Falk Pharma Australia Pty Ltd

INN (Alþjóðlegt nafn):

Ursodeoxycholic acid

Lyfjaform:

Tablet, film coated

Samsetning:

Excipient Ingredients: povidone; purified talc; polysorbate 80; hypromellose; magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica; crospovidone; macrogol 6000

Stjórnsýsluleið:

Oral

Einingar í pakka:

100 tablets, 50 tablets, 25

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

Treatment of chronic cholestatic liver diseases

Vörulýsing:

Visual Identification: White, oblong tablets equipped with a double-sided breaking notch.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Leyfisstaða:

Licence status A

Leyfisdagur:

2016-10-06

Upplýsingar fylgiseðill

_Consumer Medicine Information _
_URSOFALK_
_®_
_ _
URSOFALK
®
URSODEOXYCHOLIC ACID
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about URSOFALK. It does not
contain all of
the available information. Reading this leaflet 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
URSOFALK against the benefits they expect it will have for you or your
child.
IF YOU HAVE ANY CONCERNS ABOUT TAKING URSOFALK, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET.
You or your child may want to read it again.
WHAT URSOFALK IS USED FOR
URSOFALK contains ursodeoxycholic acid. Ursodeoxycholic acid is a bile
acid, which may
have a protective effect on the liver by reducing the absorption of
other potentially toxic bile
salts.
URSOFALK may be used to treat liver diseases such as primary biliary
cholangitis (PBC),
primary sclerosing cholangitis (PSC), and cystic fibrosis (CF)-related
cholestasis.
However, your doctor may prescribe this medicine for another use.
IF YOU OR YOUR CHILD WANTS MORE INFORMATION, ASK YOUR DOCTOR.
ASK YOUR DOCTOR IF YOU OR YOUR CHILD HAS ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS
BEEN PRESCRIBED FOR YOU OR YOUR CHILD.
URSOFALK is not addictive.
URSOFALK does not cause any negative effect on driving ability and
operating machinery.
BEFORE YOU OR YOUR CHILD TAKES URSOFALK
URSOFALK is not suitable for everyone.
_WHEN YOU OR YOUR CHILD MUST NOT TAKE _
_URSOFALK _
DO NOT TAKE URSOFALK IF:
•
you or your child is allergic to ursodeoxycholic acid or any other
ingredients listed at the end
of this leaflet
•
you or your child has a bile duct or gall bladder that is swollen,
painful or blocked
•
the packaging is torn or shows signs of tampering
•
the capsules, tablets or suspension, look to be deteriorating in any
way
•
the expiry date (EXP) printed on the pack has passed, as it may not
work as well
•
do not use URSOFALK suspension after 4 months of opening the bot

Vara einkenni

_Product Information _
_URSOFALK_
_®_
1
AUSTRALIAN PRODUCT INFORMATION -URSOFALK
®
(URSODEOXYCHOLIC ACID)
1.
NAME OF THE MEDICINE
Ursodeoxycholic Acid
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
URSOFALK Capsule contains ursodeoxycholic acid 250 mg.
URSOFALK Suspension contains ursodeoxycholic acid 50 mg/mL.
URSOFALK Tablet contains ursodeoxycholic acid 500 mg.
For the full list of excipients, see Section 6.1 List of excipients.
Excipient with known effect:
The Ursofalk suspension contains a maximum of 7.68 g of xylitol (based
on a body weight of
60 kg and a maximum dose of 20mg/kg (xylitol content/mL = 320mg/mL)
which may have a
laxative effect or cause diarrhoea.
3.
PHARMACEUTICAL FORM
URSOFALK Capsules contain 250 mg ursodeoxycholic acid and
_ _
are presented as white,
opaque, hard gelatin capsules.
URSOFALK Suspension contains 50 mg/mL ursodeoxycholic acid and is
presented as a
white homogenous suspension containing small air bubbles and with
lemon flavour PHL-
134488
URSOFALK Tablets contain 500 mg ursodeoxycholic acid and are presented
as white,
oblong tablets equipped with a double-sided breaking notch.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
URSOFALK is indicated in the treatment of chronic cholestatic liver
diseases.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE FOR ADULTS AND THE ELDERLY:
For PBC and chronic cholestatic liver diseases other than CF and PSC,
the dosage of 12 – 16
mg/kg body weight/day of ursodeoxycholic acid is recommended.
For CF-related cholestasis, the recommended dose is 20 mg/kg/day of
ursodeoxycholic acid.
_Product Information _
_URSOFALK_
_®_
2
For PSC, the dosage of 10-15 mg/kg body weight/day of ursodeoxycholic
acid is
recommended. A dosage of 20 mg/kg body weight /day has also been shown
to improve
histology and liver function tests in PSC patients.
DOSAGE FOR CHILDREN:
Data on use in children are very limited. In the few available
studies, dosages used have
generally been up to 15 - 20 mg/kg/day.
ADMINISTRATION:
For PBC patients: In the first 3 months of treatm