Actigall
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
18-09-2006
Summary of Product characteristics
(SPC)
18-09-2006
Active ingredient:
Ursodeoxycholic acid 150mg;
Available from:
Novartis New Zealand Ltd
INN (International Name):
Ursodeoxycholic acid 150 mg
Dosage:
150 mg
Pharmaceutical form:
Capsule
Composition:
Active: Ursodeoxycholic acid 150mg Excipient: Colloidal silicon dioxide Gelatin Magnesium stearate Starch
Units in package:
Bottle, plastic, HDPE,
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Dipharma Francis Srl
Product summary:
Package - Contents - Shelf Life: Bottle, plastic, HDPE - - 48 months from date of manufacture stored at or below 30°C
Authorization date:
1995-02-28
Patient Information leaflet
_____________________________________________________________________________________________________
Actigall
®
1
ACTIGALL
®
_300mg capsules _
_Ursodiol (Ursodeoxycholic acid)_
_____________________________________________________________________________________
CONSUMER MEDICINE INFORMATION
_____________________
WHAT IS IN THIS LEAFLET
__________________________________
This leaflet answers some common
questions about Actigall
.
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 this medicine
against the benefits it can provide.
IF YOU HAVE ANY CONCERNS ABOUT
THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
________________________
WHAT ACTIGALL
IS USED FOR
______________________
Actigall is used in the treatment of
gallstone disease. It is taken by
mouth to dissolve the gallstones.
Actigall is used in patients with
gallstones who do not need to have
their gallbladders removed or in
those in who surgery should be
avoided because of other medical
problems. However Actigall works
only in those patients whose
gallstones are made of cholesterol
and works best when these stones are
small and of the “floating” type.
The symptoms of these disorders
vary from person to person. Your
doctor can provide you with more
information.
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 purpose.
This medicine is only available with
Read the complete document
Summary of Product characteristics
NEW ZEALAND DATA SHEET
ACTIGALL
®
URSODIOL (URSODEOXYCHOLIC ACID)
QUALITATIVE AND QUANTITATIVE COMPOSITON
Actigall 300mg: Size 0 hard gelatin capsule with a pink cap and
white body containing a white/yellowish
powder branded in black "Actigall" on one part and "300mg" on the
other.
PHARMACEUTICAL FORM
Capsules for oral administration
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Chronic intrahepatic cholestatic diseases
including primary biliary cirrhosis and primary sclerosing
cholangitis.
In primary biliary cirrhosis Actigall improves liver enzymes and
IgM and prevents worsening of liver
histology in patients with less advanced forms of the disease, ie,
serum bilirubin less than 2 mg/dL and
histologic changes in liver confined to the portal
regions. Prevention of complications of chronic liver
disease has not been established.
DOSAGE AND METHOD OF ADMINISTRATION
For treatment of primary biliary cirrhosis(PBC) and
primary sclerosing cholangitis (PSC), the
recommended dose of Actigall is 10-12 mg/kg once-a-day. In
patients taking bile acid binding resins for
relief of pruritus, Actigall should be administered either 2-3
hours before or 4 hours after the doses of the
resin.
CHILDREN
The safety and effectiveness of Actigall in children have not been
established.
GERIATRIC USE
In worldwide clinical studies of Actigall, 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 in
safety and effectiveness were found. Other
reported clinical experience has not identified differences in
response in elderly and younger patients.
However, small differences in efficacy and greater sensitivity of
some
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