URSODOX GH ursodeoxycholic acid 250 mg capsules blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ursodeoxycholic acid, Quantity: 250 mg

Available from:

Generic Health Pty Ltd

INN (International Name):

Ursodeoxycholic acid

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: magnesium stearate; colloidal anhydrous silica; maize starch; titanium dioxide; iron oxide yellow; Gelatin

Administration route:

Oral

Units in package:

100 Capsules, 60 Capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

URSODOX GH (ursodeoxycholic acid) capsule is indicated in the treatment of chronic cholestatic liver diseases.

Product summary:

Visual Identification: Ursodeoxycholic acid 250 mg capsules. Hard gelatine capsules size 0 with yellow body and cap.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2016-02-15

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
URSODOX GH
(URSODEOXYCHOLIC ACID) CAPSULES
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Ursodox GH. 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
Ursodox GH against the benefits
they expect it will have for you or
your child.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING URSODOX GH, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET. You or your
child may want to read it again.
WHAT URSODOX GH IS
USED FOR
Ursodox GH 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.
Ursodox GH may be used to
treat liver diseases such as:
•
primary biliary cholangitis
(PBC);
•
primary sclerosing cholangitis
(PSC);
•
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.
Ursodox GH is not addictive.
Ursodox GH does not cause any
negative effect on driving ability
and operating machinery.
BEFORE YOU TAKE URSODOX
GH
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE URSODOX GH 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 look to be
deteriorating in any way;
•
the expiry date (EXP) printed
on the pack has passed, as it
may not work as well.
IF YOU ARE NOT SURE WHETHER
YOU OR YOUR CHILD SHOULD START
TAKING THIS MEDICINE, TALK TO
YOUR DOCTOR.
_BEFORE YOU START TO TAKE IT _
TELL YOUR DOCTOR IF YOU OR YOUR
CHILD:
•
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Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – URSODOX GH
(URSODEOXYCHOLIC ACID) CAPSULES
1
NAME OF THE MEDICINE
Ursodeoxycholic acid.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 250 mg of ursodeoxycholic acid.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Ursodox GH 250 mg capsules are hard gelatine capsules size 0 with
white body and cap.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ursodox GH capsules are 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 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.
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, Ursodox GH
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, Ursodox GH capsules should be
taken in 2 to 3 doses over the day.
Ursodox GH v4
Page 6 of 6
(ursodeoxycholic acid) capsules
For patients under 34 kg or patients who are unable to swallow Ursodox
GH capsules, a suspension
should be used (available in other brands).
The capsules should be swallowed whole with some liquid.
Care should be taken to ensure that Ursodox GH capsules are taken
regularly.
In patients with PBC, there may, in rare cases, be an initial
deterioration in symptoms, eg. itching. If this
is the case, therapy can be continued with 1 capsule of Ursodox GH
daily, and the da