Ursosan

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ursodeoxycholic acid 250mg;  ;  

Available from:

Boucher & Muir (New Zealand) Limited t/a BNM Group

INN (International Name):

Ursodeoxycholic acid 250 mg

Dosage:

250 mg

Pharmaceutical form:

Capsule

Composition:

Active: Ursodeoxycholic acid 250mg     Excipient: Capsugel white OP Colloidal silicon dioxide Magnesium stearate Maize starch Pregelatinised maize starch

Units in package:

Blister pack, PVC/PVdC/Al foil, 100 capsules

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

ICE SpA

Therapeutic indications:

Ursosan is indicated in the treatment of chronic cholestatic liver diseases, including primary biliary cirrhosis (PBC) and primary sclerosing cholangitis (PSC). In primary biliary cirrhosis ursodeoxycholic acid improves liver enzymes and IgM and prevents worsening of liver histology in patients with less advanced forms of the disease, i.e. serum bilirubin less that 2 mg/dL and histologic changes in liver confined to the portal regions. Prevention of complications of chronic liver disease has not been established.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC/Al foil - 100 capsules - 48 months from date of manufacture stored at or below 25°C

Authorization date:

2011-03-23

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

Summary of Product characteristics

1
URSOSAN
®
URSODEOXYCHOLIC ACID CAPSULES 250 MG
NEW ZEALAND DATA SHEET
1
URSOSAN
URSOSAN
250 mg capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One Ursosan capsule contains ursodeoxycholic acid (UDCA) 250 mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Ursosan capsules are white hard gelatin capsules, containing a white
or almost white
powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ursosan is indicated in the treatment of chronic cholestatic liver
diseases, including
primary biliary cirrhosis (PBC) and primary sclerosing cholangitis
(PSC).
In primary biliary cirrhosis ursodeoxycholic acid improves liver
enzymes and IgM and
prevents worsening of liver histology in patients with less advanced
forms of the disease,
i.e. serum bilirubin less that 2 mg/dL and histologic changes in liver
confined to the portal
regions. Prevention of complications of chronic liver disease has not
been established.
4.2
DOSE AND METHOD OF ADMINISTRATION
This product may not be interchangeable with similar products on the
New Zealand
market.
2
URSOSAN
®
URSODEOXYCHOLIC ACID CAPSULES 250 MG
DOSE
_ADULTS _
The degree of biliary enrichment of UDCA does not depend on the
formulation or the
number of doses administered per day, but rather the total daily dose.
10 – 15 mg UDCA per kg per day in either a single dose or two to
four divided doses are
recommended for PBC (primary biliary cirrhosis) and chronic
cholestatic liver diseases
other than CF (cystic fibrosis). This dose can be approximated as
follows:
For CF, the general recommended dose is up to 20 mg/kg/day. This dose
has been shown
to improve histology in PSC patients.
_ELDERLY _
In worldwide clinical studies of UDCA, approximately 14% of subjects
were over
65 years of age (approximately 3% were over 75 years old). In a
subgroup analysis of
existing clinical trials, patients greater than 56 years of age did
not exhibit statistically
significantly different complete dissolution rates from the younger
population. No
age-related differences i