deferasirox
Consumer Medicine Information
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about . It does not contain all the information that is known about . It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.
What Exjade is used for
Exjade is used to treat a condition called iron overload, which happens when the body has too much iron. This can occur after repeated blood transfusions.
The body has no natural way to remove excess iron which comes with blood transfusions. Over time, this excess iron can damage important organs such as the liver and heart.
This medicine contains an active substance called deferasirox. It attaches itself to the iron molecules to remove the excess iron from the body. This will help prevent iron-induced organ damage.
Exjade is to be taken every day.
This type of medicine must be taken every day to help remove the excess iron from your body.
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 reason.
This medicine is not addictive.
This medicine is available only with a doctor's prescription.
Before you take Exjade
When you must not take it
Do not take Exjade if you have an allergy to deferasirox, the active ingredient, or to any of the other ingredients listed at the end of this leaflet.
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.
If you develop a severe rash, or experience difficulty breathing and dizziness or swelling mainly of the face and throat (signs of severe allergic reaction) tell your doctor straight away.
Do not take this medicine if you have severe kidney problems.
Do not take this medicine if you have an advanced stage of myelodysplastic syndrome (MDS) or advanced cancer.
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.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have a low level of platelets in your blood test.
Tell your doctor if you have or have had any problems with your kidneys or liver.
Your doctor may want to take special precautions in this case.
Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.
Your doctor can discuss with you the risks and benefits involved.
Tell your doctor if you have an intolerance to lactose.
This medicine contains lactose.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Exjade may interfere with each other. These include:
cyclosporin, used in transplantation to prevent organ rejection or to treat rheumatoid arthritis or atopic dermatitis
simvastatin (medicines used to lower cholesterol)
hormonal contraceptive agents (birth control medicines)
certain painkillers or anti-inflammatory medicines (e.g. aspirin, ibuprofen, corticosteroids)
oral bisphosphonates (medicines used to treat osteoporosis)
anticoagulant medicines (medicines used to prevent or treat blood clotting)
antacid preparations containing aluminium, which should not be taken at the same time of day as Exjade
a medicine for type 2 diabetes called repaglinide
certain medicines for epilepsy or sedation (phenytoin, phenobarbitone)
a medicine for HIV called ritonavir
a medicine for tuberculosis called rifampicin
a medicine for cancer called paclitaxel
a medicine for asthma called theophylline
You may need 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.
How to take Exjade
Follow all directions given to you by your doctor or 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.
How much to take
The usual starting dose is 20 mg per kilogram body weight each day. A higher or lower starting dose may be recommended by your doctor based on your individual treatment needs.
Depending on your response, your doctor may increase the dose to a maximum 30 mg per kilogram body weight each day.
How to take it
Disperse the required number of tablets completely by stirring in a 100 - 200 mL glass of water or orange juice or apple juice until a suspension forms.
When dispersing in juice, it helps to first disperse the tablets in about two tablespoons of water, before diluting with juice.
Drink the entire contents of the glass, then add a little water or juice to what is left in the empty glass and drink that too.
Do not disperse the tablets in fizzy drinks or milk.
Do not chew, split or crush the tablets. Do not swallow them whole.
When to take it
Take Exjade once a day, every day, at about the same time each day. Take it on an empty stomach at least 30 minutes before eating any food.
Taking it at the same time each day, 30 minutes before eating food will have the best effect. It will also help you remember when to take it.
How long to take it
Do not stop taking Exjade unless your doctor tells you to - even if you feel well.
This medicine helps to control your condition, but does not cure it. Therefore, you must take it every day. Continue taking the medicine as long as your doctor tells you to.
If you forget to take it
If it is almost time for your next dose, skip the dose you missed and take the next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking it as you would normally.
Do not take a double dose to make up for the dose that you missed.
This may increase the chance of you getting an unwanted side effect.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Exjade. Do this even if there are no signs of discomfort or poisoning. Keep the telephone numbers for these places handy.
You may experience nausea, vomiting, headache or diarrhoea if you have taken too much Exjade.
While you are taking Exjade
Things you must do
If you notice substantially reduced urine output tell your doctor straight away.
This could be a sign of a problem with your kidneys.
Elderly patients should be monitored closely by their doctor.
Elderly patients may experience more side effects than younger patients and their doctor may adjust their dose.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor will do some blood and urine tests to make sure the medicine is working and to prevent unwanted side effects.
If you become pregnant while taking this medicine, tell your doctor immediately.
It may affect your developing baby. Your doctor will discuss the risks and benefits of continuing treatment in this case.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
It may affect other medicines used during surgery.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking this medicine.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
Things you must not do
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.
Things to be careful of
Be careful driving, operating machinery or doing jobs that require you to be alert until you know how Exjade affects you.
This medicine may cause dizziness in some people. If you experience dizziness, do not drive, operate machinery or do anything else that could be dangerous. Children should be careful when riding bicycles or climbing trees.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Exjade even if you do not think it is connected with the medicine.
All medicines can have side effects. Sometimes they are serious, but most of the time they are not. You may need medical treatment if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them. Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor as soon as possible if you notice any of the following:
severe rash or experience difficulty breathing and dizziness or swelling mainly of the face and throat (signs of severe allergic reaction)
rash, skin reddening, blistering of lips, eyes or mouth, skin peeling, sore throat (signs of severe skin reaction)
a substantially reduced urine output (sign of kidney problem)
drowsiness, upper right abdominal pain, yellowing of your skin or eyes and dark urine (sign of liver problems)
vomiting with blood and/or black stools
frequent heartburn or abdominal pain (ulcers), particularly after eating or taking the drug
blurred, cloudy or partial loss of vision
hearing disturbances
The above list includes serious side effects which may require medical attention. These side effects do not occur frequently.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
nausea or diarrhoea
pain in the abdomen, bloating, constipation or indigestion
rash or itchy skin
headache
fever or symptoms of a cold or flu
cough or sore throat
dizziness
swelling of arms or legs
change in the colour of the skin
anxiety
trouble sleeping
tiredness
sore muscles or joints
hair loss
The above list includes the more common side effects of your medicine. They are usually mild and short-lived.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Some people may have other side effects not yet known or mentioned in this leaflet. Some of these side effects, for example, changes in kidney and liver function, can only be found when your doctor does tests from time to time to check your progress.
After using Exjade
Storage
Keep your medicine in the original container until it is time to take it.
Store it in a cool, dry place, below 30 degrees Celsius
Do not store this medicine or any other medicine in the bathroom or near a sink
Do not leave it in the car or on window sills.
Keep the medicine where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
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.
Product description
What it looks like
Exjade tablets are off-white, round, flat tablets with beveled edge. Exjade 125 mg tablets are imprinted with "J125" on one side and "NVR" on the other. Exjade 250 mg tablets are imprinted with "J250" on one side and "NVR" on the other. Exjade 500 mg tablets are imprinted with "J500" on one side and "NVR" on the other.
Exjade comes in packs of 28 dispersible tablets.
Ingredients
Contains either 125, 250 or 500 mg of (deferasirox) as the active ingredient. It also contains:
lactose
crospovidone
povidone
sodium lauryl sulphate
microcrystalline cellulose
silica- colloidal anhydrous
magnesium stearate
Sponsor
EXJADE® is supplied in Australia by:
NOVARTIS Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
North Ryde NSW 2113
Telephone 1 800 671 203
Web site: www.novartis.com.au
®= Registered Trademark
This leaflet was prepared in
March 2011
Australian Registration Number.
Exjade 125 mg AUST R 119230
Exjade 250 mg AUST R 119231
Exjade 500 mg AUST R 119232
