URSOSAN ursodeoxycholic acid 250 mg capsule blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
10-11-2017
Active ingredient:
ursodeoxycholic acid, Quantity: 250 mg
Available from:
Boucher & Muir Pty Ltd
INN (International Name):
Ursodeoxycholic acid
Pharmaceutical form:
Capsule, hard
Composition:
Excipient Ingredients: maize starch; colloidal anhydrous silica; pregelatinised maize starch; magnesium stearate; titanium dioxide; Gelatin; sodium lauryl sulfate; sorbitan monolaurate
Administration route:
Oral
Units in package:
100 capsules
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Ursosan is indicated in the treatment of chronic cholestatic liver diseases.
Product summary:
Visual Identification: Hard gelatin capsule, white body, white cap, containing white or almost white powder; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Licence status A
Authorization date:
2014-11-07
Patient Information leaflet
1
URSOSAN
®
05022019
Consumer Medicine Information
URSOSAN
®
_URSODEOXYCHOLIC ACID _
Capsules 250 mg
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start taking Ursosan.
This leaflet answers some common questions about Ursosan. It does not
contain all the
available information. The most up-to-date Consumer Medicine
Information can be
downloaded
from
www.ebs.tga.gov.au
(Australia)
or
www.medsafe.govt.nz
(New
Zealand).
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
Ursosan against the benefits this medicine is expected to 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 want to read it again.
WHAT URSOSAN IS USED FOR
Ursosan 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.
Ursosan may be used to treat liver diseases such as primary biliary
cirrhosis (PBC),
primary sclerosing cholangitis (PSC), and cystic fibrosis (CF)-related
cholestasis.
Your doctor may have prescribed this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR
YOU.
Ursosan is only available with a doctor's prescription.
Ursosan is not addictive.
2
URSOSAN
®
05022019
BEFORE YOU TAKE URSOSAN
_ _
Ursosan is not suitable for everyone.
_WHEN YOU MUST NOT TAKE IT _
_ _
DO NOT TAKE URSOSAN IF:
you are allergic to any medicine containing ursodeoxycholic acid, bile
acids or any of
the ingredients listed at the end of this leaflet
you have a bile duct or gall bladder that is swollen, painful or
blocked
you have certain types of cholesterol stones or bile pigment stones
your doctor advises you that you will have your gall bladder removed.
DO NOT TAKE IT AFTER THE EXPIRY DATE PRINTED ON THE PACK.
If you take it after t
Read the complete document
Summary of Product characteristics
URSOSAN
®
1
AUSTRALIAN PRODUCT INFORMATION
URSOSAN
®
URSODEOXYCHOLIC ACID
CAPSULE, HARD
1
NAME OF THE MEDICINE
Ursodeoxycholic acid
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One capsule contains ursodeoxycholic acid (UDCA) 250 mg.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Ursosan capsules are white, hard gelatin capsules.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ursosan is indicated in the treatment of chronic cholestatic liver
diseases.
4.2 DOSE AND METHOD OF ADMINISTRATION
For patients under 34 kg or patients who are unable to swallow Ursosan
capsules an oral
suspension 250 mg/5 mL is available in another brand.
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.
For PSC, the dosage of 10 – 15 mg/kg body weight/day of UDCA 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.
URSOSAN
®
2
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 treatment, Ursosan 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 other cholestatic liver diseases, Ursosan 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 Ursosan 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 Ursosan daily, and
the daily dose gradually increased weekly until the recommended daily
dose has been
reached.
For
Read the complete document
