INFORMATION FOR CONSUMERS
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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.
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 a doctor's prescription.
Do not take Actigall if you have an allergy to:
Some of the symptoms of an allergic reaction may include 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.
Tell your doctor if you are taking any other medications before starting Actigall treatment.
Do not take this medicine after the expiry date printed on the pack or if
the packaging is torn or shows signs of tampering.
In that case, return it to your pharmacist.
Tell your doctor if you have any of the following health problems/medical conditions:
Your doctor may not want you to take this medicine or may want to take special precautions if you have any of the above conditions.
It is important that your doctor checks that you liver is working properly at the start of treatment. A laboratory test needs to be 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 diet.
Tell your doctor if you are pregnant or intend to become pregnant.
This medicine may affect your baby if you take it while you are pregnant,
and is not recommended for use during pregnancy.
Tell your doctor if you are breast-feeding or plan to breast-feed.
Caution should be exercised when Actigall is administered while breast
feeding, as it is not known if Actigall passes into the breast milk.
Tell your doctor if you are allergic to any other medicines, foods, dyes
or preservatives.
Your doctor will want to know if you are prone to allergies.
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 food shop.
Some medicines and Actigall may interfere with each other. These include:
You may need to take different amounts of your medicines or you may need to take different medicines. Your doctor and pharmacist have more information.
If you have not told your doctor about any of these things, tell him/her before you start taking this medicine.
Follow all directions given to you by your doctor and pharmacist
carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the label, ask your doctor or pharmacist for help.
The dose of Actigall will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of Actigall. If your dose is different, do not change it unless your doctor tells you to do so.
In patients taking bile acid binding resins, Actigall should be administered either 2-3hours before or 4 hours after the doses of resins.
Take the capsules as advised by your doctor or pharmacist.
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 snack.
Take this medicine until your doctor tells you to stop treatment.
The length of treatment will depend on your condition and on how well the
medicine works.
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 normally.
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.
Immediately telephone your doctor or National Poisons Information Centre (telephone 0800 POISON or 0800 764 766) or go to Accident and Emergency Department at your nearest hospital, if you 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 may develop diarrhoea which should
be treated symptomatically.
If you become pregnant while taking Actigall, tell your doctor
immediately.
Your doctor can discuss with you the risks of taking it while you are
pregnant.
Be sure to keep all of your doctor's appointments so that your progress can be checked.
Your doctor may want to take some blood tests and check your heart and blood pressure from time to time. This helps to prevent unwanted side effects.
It is important that your doctor checks your progress at regular visits.
Laboratory tests will have to be done every few months while you are taking this
medicine to make sure that the gallstones are dissolving and your liver is
working properly.
Before having any surgery or emergency treatment, even a minor procedure,
tell the doctor or dentist in charge that you are taking Actigall or have been
taking it within the last two weeks or so.
If possible, this medicine should be stopped before surgery to avoid
unnecessary side effects.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Actigall.
Tell any other doctor, dentist or pharmacist who treats you that you are taking Actigall.
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 this medicine suddenly, your condition may worsen or you may
have unwanted side effects.
Do not give this 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 you to.
Be careful driving, operating machinery or doing jobs that require you to be alert while you are taking Actigall until you know how it affects you.
Tell your doctor or pharmacist as soon as possible if you do not feel well
while you are taking Actigall.
All medicines can have side effects. Sometimes they are serious, most of the
time they are not. You may need medical treatment if you get some of 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 doctor.
As people grow older, they are more likely to get side effects from medicines.
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.
Tell your doctor if you notice any of these side effects and they worry you:
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:
Tell your doctor if you notice anything else that is making you feel
unwell.
Some people may have other side effects not yet known or mentioned in this
leaflet.
Keep the capsules where children cannot reach them.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine you have left over.
Actigall is supplied in 300mg hard gelatine capsules with a pink cap and white body, containing a white/yellowish powder, branded in black with "Actigall" on one part and "300mg" on the other. Each pack of Actigall contains 100 capsules.
Actigall capsules contain 300 mg of ursodiol as the active ingredient. They also contain:
Actigall is supplied in New Zealand by:
Novartis New Zealand Limited
Private Bag 65904
Mairangi Bay
Auckland
Building G, 5 Orbit Drive
Rosedale
Auckland 0632
Telephone 0800 652 422
® = Registered Trademark
This leaflet was prepared on the 23 June 2009 based on the currently approved data sheet for this product.