APO-URSODEOXYCHOLIC ACID ursodeoxycholic acid 250 mg capsule blister pack

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

ursodeoxycholic acid, Quantity: 250 mg

Tilgængelig fra:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Ursodeoxycholic acid

Lægemiddelform:

Capsule

Sammensætning:

Excipient Ingredients: titanium dioxide; maize starch; silicon dioxide; Gelatin; magnesium stearate

Indgivelsesvej:

Oral

Enheder i pakken:

100

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

Ursodeoxycholic acid is indicated in the treatment of chronic cholestatic liver diseases.

Produkt oversigt:

Visual Identification: White hard gelatine capsules. The content - white or almost white powder; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorisation status:

Licence status A

Autorisation dato:

2017-04-20

Indlægsseddel

APO-URSODEOXYCHOLIC ACID
1
APO-
URSODEOXYCHOLIC
ACID
_Contains the active ingredient ursodeoxycholic acid _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about ursodeoxycholic
acid. It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.arrotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you or your child.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You or your child may want to read it
again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Ursodeoxycholic Acid Capsules. It
contains the active ingredient
ursodeoxycholic acid.
It is used to treat liver diseases such
as:
•
primary biliary cirrhosis (PBC)
•
primary sclerosing cholangitis
(PSC)
•
cystic fibrosis (CF)-related
cholestasis
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you or your
child. Your doctor may have
prescribed this medicine for another
reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS _
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.
There is no evidence that this
medicine is addictive.
_USE IN CHILDREN _
This medicine should not be used in

Produktets egenskaber

1
AUSTRALIAN PRODUCT INFORMATION – APO-URSODEOXYCHOLIC
ACID (URSODEOXYCHOLIC ACID) CAPSULES
1
NAME OF THE MEDICINE
Ursodeoxycholic Acid
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 250 mg of Ursodeoxycholic Acid, as the active
ingredient.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
White hard gelatine capsules. The content – white or almost white
powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ursodeoxycholic acid is indicated in the treatment of chronic
cholestatic liver diseases.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Ursodeoxycholic Acid capsules are intended for oral
administration. For PBC patients: In the first
3 months of treatment, APO-Ursodeoxycholic Acid capsules should be
taken in 2 to 3 doses over the
day. With improvement of the liver function parameters, the daily dose
may be taken as a single dose
in the evening.
For patients under 34 kg or patients who are unable to swallow
APO-Ursodeoxycholic Acid capsules,
UDCA oral suspension should be used (available from other brands).
For other cholestatic liver diseases, APO-Ursodeoxycholic Acid
capsules should be taken in 2 to 3 doses
over the day.
The capsules should be swallowed whole with some liquid.
Care should be taken to ensure that UDCA is taken regularly.
In patients with PBC, there may, in rare cases, be an initial
deterioration in symptoms, e.g. itching. If
this is the case, therapy can be continued with 1 capsule of UDCA
daily, and the daily dose gradually
increased weekly until the recommended daily dose has been reached.
For PSC patients, dominant stenoses of the bile ducts should be
dilated before and during treatment
with UDCA.
DOSAGE
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 UDCA is recommended.
For CF-related cholestasis, the recommended dose is 20 mg/kg/day of
UDCA.
2
For PSC, the dosage of 10-15 mg/kg body weight/day of UDCA is
recommended. A d