Ursodiol (Ursodeoxycholic acid)
Consumer Medicine Information
What is in this leaflet
This leaflet answers somecommon
questions aboutActigall .
Itdoes notcontain allthe available
information . It does not take the place
of talking toyour doctor or
Allmedicines have risks and
benefits. Your doctor has weighed
the risks of you taking thismedicine
againstthe benefitsitcan provide.
If you have any concerns about
this medicine, ask your doctor or
Keep this leaflet with the medicine.
You may need to read it again.
is used for
Actigall is usedinthe treatmentof
gallstone disease. Itistaken by
mouth todissolve the gallstones.
Actigall is usedinpatients with
gallstones who do notneed tohave
their gallbladders removed or in
those inwho surgeryshould be
avoided because of other medical
problems. However Actigall works
onlyinthose patients whose
gallstones are made of cholesterol
and works best when these stones are
small andofthe “floating” type.
The symptomsof these disorders
varyfromperson toperson. Your
doctor can provide you withmore
Ask your doctor ifyou have any
questions about whythis medicine
has been prescribed for you.
Your doctor mayhave prescribed it
This medicine is only available with
a doctor's prescription.
Before you take
When you must not take it
Do not take Actigallif you have an
ursodeoxycholicacid (the active
ingredient) or anyof the other
ingredients ofActigall listedat
the endofthis leaflet
or other productscontaining bile
Some ofthe symptoms ofanallergic
reaction mayinclude shortness of
breath, wheezing or difficulty
breathing; swelling of the face, lips,
tongue or other parts of the body;
rash, itching or hives on the skin.
Tellyour doctor ifyou are taking
any other medications before
starting Actigall treatment.
Do not take this medicine after the
expiry date printed on the pack or
ifthe packaging istorn or shows
signs of tampering.
Inthat case, returnit toyour
Before you start to take it
Tellyour doctor ifyou have any of
the following health
severe liver or kidneydisease
Your doctor maynotwantyou to
take this medicineor maywantto
take special precautions if you have
any of the above conditions.
properly at the start of treatment. A
laboratorytestneeds tobe done.
It is thought that body weight and
the kind of diet the patient follows
may affect how fast the stones
dissolve and whether new stones
will form. However check with
your doctor before going on any
Tell your doctor if you are
pregnant or intend to become
Thismedicine mayaffectyour baby
if you take itwhileyou are pregnant,
and isnotrecommended for use
Tell your doctor if you are breast-
feeding or plan to breast-feed.
Caution should be exercised when
Actigall is administeredwhile breast
feeding, as itisnotknown if Actigall
passes intothe breast milk.
Tellyour doctor ifyou are allergic
to any other medicines, foods, dyes
Your doctor will want to know if you
are prone toallergies.
Taking other medicines
Tell your doctor or pharmacist if
you are taking any other
medicines, including any that you
buy without a prescription from a
pharmacy, supermarket or health
Somemedicines and Actigallmay
interfere with each other. These
Oestrogens, oral contraceptives
You mayneed totake different
amounts of your medicines or you
mayneed totake differentmedicines.
Your doctor and pharmacisthave
If you have not toldyour doctor
about any of these things, tell
him/her before you start taking
How to take Actigall
Follow all directions given to you
by your doctor and pharmacist
If you do not understand the
instructions onthe label, ask your
doctor or pharmacist for help.
How much to take
The dose ofActigall will be different
for differentpatients. Follow your
doctor‘s orders or the directions on
the label. The followinginformation
includes only the average doses of
Actigall. If your dose isdifferent, do
notchange itunless your doctor tells
you todo so.
For gallstone disease:
The dose isbased on bodyweight
and mustbe determined byyour
doctor. The usualdose is10-
12mg/kg of bodyweightonce a
day. Each dose isusuallytaken
with a meal.
In patients taking bileacid binding
resins, Actigallshould be
administered either 2-3hours before
or 4 hours after the doses of resins.
When to take it
Take the capsules as advised by
your doctor or pharmacist.
How to take it
Swallow the capsules with a full
glass of water. If your stomach is
upset after taking the capsules,
take them with a meal or after a
How long to take it
Take this medicine until your
The lengthoftreatmentwill depend
on your condition and on how well
the medicine works.
If you forget to take it
If it is almost time for your next
dose (e.g. within 2 or 3 hours), skip
the dose you missed and take the
next one when you are meant to.
Otherwise, take the dose as soon as
you remember, and then go back
to taking the tablets as you would
You can double dose to make up
for the one that you missed.
If you have trouble remembering
when to take your medicine, ask
your pharmacist for some hints.
If you take too much
Immediately telephone your doctor
or NationalPoisons Information
Centre (telephone 0800 POISON
or 0800 764 766) or go to Accident
and Emergency Department at
your nearest hospital, ifyou think
that you or anyone else may have
taken too much Actigall. Do this
even if there are no signs of
discomfort or poisoning.
Keep the telephone numbers for
these places handy.
If you take too much Actigall,you
maydevelop diarrhoea which should
While you are taking
Things you must do
If you become pregnant while
taking Actigall, tellyour doctor
Your doctor can discuss withyou the
risks of taking itwhileyou are
Be sure to keep all of your doctor's
appointments so that your
Your doctor maywanttotake some
blood tests and check your heartand
blood pressure fromtime totime.
Thishelps topreventunwanted side
It isimportant that your doctor
checks your progress at regular
Laboratory tests will have to be done
everyfew months whileyou are
taking thismedicine tomake sure
thatthe gallstones are dissolving and
your liver isworking properly.
Before having any surgery or
emergency treatment, even a
minor procedure, tell the doctor or
dentist incharge that you are
taking Actigall or have been taking
it within the last twoweeks orso.
If possible, thismedicine should be
stopped before surgerytoavoid
unnecessary side effects.
If you are about to be started on
any new medicine, remind your
doctor and pharmacist that you
are taking Actigall.
Tellany other doctor, dentist or
pharmacist who treats you that
you are taking Actigall.
Things you must not do
Do not stop taking Actigall or
change the dose without first
checking with your doctor. Do not
let yourself run out of medicine
over the weekend or on holidays.
If you stop taking thismedicine
suddenly, your condition may
worsen or you mayhave unwanted
Donot givethis medicine to
anyone else, even if their condition
seems similar to yours.
Do not use it to treat any other
complaints unless your doctor tells
Things to be careful of
Be careful driving, operating
machinery or doing jobs that
require you to be alert while you
are taking Actigall until you know
Tell your doctor or pharmacist as
soon as possible ifyou do not feel
well while youare takingActigall.
Allmedicines can have side effects.
Sometimes they are serious, most of
the time they are not. You may need
the side effects.
If you are over 65 years old, you
should be especially careful while
taking this medicine. Report any
side effects promptly to your
As people grow older, theyare more
likely toget side effects from
Do not be alarmed by these lists of
possible side effects. You may not
experience any of them. Ask your
doctor or pharmacist to answer
any questions you may have.
Tellyour doctor ifyou notice any
of these side effects and they worry
nausea (feeling sick), vomiting
Tell your doctor immediately or go
to Accident and Emergency at
your nearest hospitalifyou notice
any of the following:
signs of allergy such as rash,
itching or hives on the skin;
swelling of the face, lips, tongue
or other partof the body;
shortness of breath, wheezing or
Tellyour doctor ifyou notice
anything else that ismaking you
Somepeople mayhave other side
effects notyetknown or mentioned
After using Actigall
Keep your medicine inthe
original container until it is time
totake a dose.
Store it in a cool dry place at
Do notstore Actigallor any
other medicine inthe bathroom
or near a sink.
Do not leave it in the car or on
Keep the capsules where children
cannot reach them.
A locked cupboard atleastone-and-
a-halfmetres above the ground isa
good place to store medicines.
If your doctor tellsyou to stop
taking this medicine or the expiry
date has passed, ask your
pharmacist what to do with any
medicine you have left over.
What it looks like
Actigallissupplied in300mg hard
gelatine capsules with a pink cap and
whitebody, containing a
white/yellowish powder, branded in
black with“Actigall”on one partand
“300mg” on the other. Each pack of
Actigallcontains 100 capsules.
Actigallcapsules contain 300 mgof
ursodiolas the active ingredient.
They also contain:
Actigall is suppliedinNew Zealand
NOVARTIS New Zealand Limited
NovartisNew Zealand Limited
Private Bag 65904
BuildingG, 5Orbit Drive
Telephone:0800 652 422
®= Registered Trademark
This leaflet was prepared 23 June
2009 based on the currently
approved datasheetfor thisproduct