Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about leflunomide. It does not contain
all the available information. It does not take the place of talking to your doctor
All medicines have risks and benefits. Your doctor has weighed the risks of you using
this medicine against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may want to read it again.
What this medicine is used for
Leflunomide is used to treat rheumatoid arthritis and psoriatic arthritis.
It belongs to a group of medicines called disease-modifying anti-rheumatic drugs (DMARDs).
How it works
Leflunomide works by selectively interfering with the ability of white blood cells
called lymphocytes to produce the disease response that ultimately leads to pain,
inflammation and joint damage.
Leflunomide helps to slow down the process of joint damage and to relieve the symptoms
of the disease, such as joint tenderness and swelling, pain and morning stiffness.
Ask your doctor if you have any questions about why this medicine has been prescribed
Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor's prescription.
This medicine is not addictive.
There is not enough information to recommend the use of this medicine in children
under 18 years of age.
Before you take this medicine
When you must not take it
Do not take this medicine if you have an allergy to:
any of the 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, throat or other parts of the body
rash, itching or hives on the skin
Do not take this medicine if you have or have had any of the following medical conditions:
any illnesses which reduce your body's natural defences, such as bacterial or viral
an illness which severely lowers your body's resistance to disease, such as AIDS
significant disease of the blood or bone marrow, such as anaemia
serious allergic skin conditions, such as Stevens-Johnson syndrome, toxic epidermal
necrolysis or erythema multiforme
hypoproteinaemia (when you do not have enough protein in your blood).
Do not take this medicine if you are pregnant, suspect you are pregnant, or you are
planning to become pregnant.
Leflunomide may affect your developing baby if you take it during pregnancy or conception.
It may increase the risk of birth defects.
If you want to become pregnant, you will need to stop taking leflunomide and may need
to take another medicine to remove any leflunomide left in your body.
If there is any delay in the onset of menses or you suspect you are pregnant, notify
your doctor immediately to test for pregnancy.
Do not take this medicine if you are not using reliable contraception.
Women of childbearing potential and men must use reliable contraception while taking
leflunomide and for a certain period of time after stopping taking it.
Do not breastfeed if you are taking leflunomide.
Leflunomide may pass into human breast milk and there is a possibility that your baby
may be affected.
Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives
Tell your doctor if you have or have had any of the following medical conditions:
decrease in the number of white blood cells
liver or kidney problems
chronic (ongoing) infections
an illness which lowers your body's resistance to disease
you are taking neurotoxic agents
a history or have a family history of lung problems such as interstitial lung disease
(an inflammation of lung tissue), a serious and potentially fatal disease.
Tell your doctor if you plan to father a child.
Leflunomide may increase the risk of birth defects. If you wish to father a child,
you will need to stop taking leflunomide and may need to take another medicine to
get rid of any leflunomide left in your body.
Tell your doctor if you have recently been vaccinated or if you need to have a vaccination
during treatment with this medicine or for 6 months after stopping leflunomide.
Live vaccines should be avoided while taking this medicine.
If you have not told your doctor about any of the above, tell them before you start
taking this medicine.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any
that you get without a prescription from your pharmacy, supermarket or health food
Some medicines and leflunomide may interfere with each other. These include:
warfarin, a medicine used to prevent blood clots
medicines used for diabetes (e.g. tolbutamide)
medicines used to treat epilepsy (e.g. phenytoin)
rifampicin, a medicine used to treat tuberculosis
cholestyramine, a medicine used to reduce high levels of cholesterol in the blood.
This medicine, along with activated charcoal, may also be used to remove leflunomide
quickly from your body in certain situations, such as if you experience a serious
side effect, you change your medication or you want to fall pregnant
medicines which may affect the liver (e.g. NSAIDs (non-steroidal anti-inflammatory
drugs) or methotrexate)
medicines which have side effects on the blood
These medicines may be affected by this medicine or may affect how well it works.
You may need different amounts of your medicines, or you may need to take different
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking leflunomide.
Other medicines not listed above may also interact with leflunomide.
How to take this medicine
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 bottle, ask your doctor or pharmacist
How much to take
Your doctor will tell you how much of this medicine you should take. This will depend
on your condition and whether you are taking any other medicines.
The usual dose for adults is 100 mg (five tablets of 20 mg or ten tablets of 10 mg)
once a day for the first 3 days, then after that one 10 mg or 20 mg tablet daily.
How to take it
Swallow the tablets whole with a full glass of water.
When to take it
Take your medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
It does not matter if you take this medicine before or after food.
How long to take it
Continue taking your medicine for as long as your doctor tells you.
This medicine helps to control your condition, but does not cure it. It is important
to keep taking your medicine even if you feel well.
Make sure you have enough to last over weekends and holidays.
If you forget to take it
If it is almost time to take your next dose, skip the dose you missed and take your
next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking your medicine
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 are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some
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 of this medicine. Do this even
if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Symptoms on an overdose may include diarrhoea, stomach pain, changes in your blood,
or liver damage.
While you are taking this medicine
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking leflunomide.
Tell any other doctors, dentists and pharmacists who treat you that you are taking
Tell your doctor if you are planning on stopping contraception, or if you are planning
to father a child.
You must use a reliable contraceptive method (e.g. condoms or the oral contraceptive
pill) whilst taking leflunomide. If you plan to stop your contraception, you must
first discuss this with your doctor.
If you become pregnant whilst taking this medicine, stop taking your medicine and
tell your doctor immediately.
This medicine may cause serious birth defects.
Tell your doctor immediately if you notice a fever or signs of an infection.
Leflunomide may lower your immunity.
Tell your doctor if you develop symptoms such as pins and needles or tingling in the
hands or feet or numbness or weakness of the arms and legs.
Tell your doctor if you develop worsening or new symptoms such as breathing issues
or a cough.
These may be symptoms of an inflammation of your lung tissue, which is potentially
Tell your doctor immediately and stop taking your medicine if you develop any symptoms
of liver problems, including yellowing of eyes, itchy and yellowing skin, bruising
and bleeding easily.
Your doctor will check the health of your liver using blood tests on a regular basis
while you are taking leflunomide.
Tell your doctors if you are going to have surgery or an anaesthetic or are going
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor will do blood tests and monitor your blood pressure before starting and
during treatment. This is to make sure the medicine is working and to prevent unwanted
Things you must not do
Do not take this medicine to treat any other complaints unless your doctor tells you
Do not give your medicine to anyone else, even if they have the same condition as
Do not stop taking your medicine or lower the dosage without checking with your doctor.
Things to be careful of
Be careful while driving or operating machinery until you know how leflunomide affects
This medicine may cause tiredness in some people. If you have any of these symptoms,
do not drive, operate machinery or do anything else that could be dangerous.
Be careful when drinking alcohol while you are taking this medicine.
Leflunomide may worsen the effects of alcohol. It is recommended that you minimise
your alcohol intake while taking leflunomide.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking leflunomide.
Leflunomide helps most people with rheumatoid and psoriatic arthritis, but it may
have unwanted side effects in a few people. All medicines can have side effects. Sometimes
they are serious, most of the time they are not. You may need medical attention if
you get some of the side effects. You may experience some side effects due to a weakened
immune system caused by leflunomide.
Do not be alarmed by the following lists of side effects. You may not experience any
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
nausea, vomiting, abdominal pain
rashes, itchy skin
loss of weight
feeling unusually weak or tired
The above list includes the more common side effects of leflunomide.
If any of the following happen, tell your doctor immediately or go to Accident and
Emergency at your nearest hospital:
symptoms of an allergic reaction, such as swelling of the face, lips, mouth or throat;
shortness of breath, wheezing or difficulty breathing; rash, itching, hives on the
signs and symptoms of severe infection, such as fever
severe upper stomach pain, often with nausea and vomiting
severe skin rash or sores in your mouth
pale skin, tiredness, increased infections or bruising
new or worsening symptoms such as cough or trouble breathing, with or without a fever
yellowing of the skin and eyes (jaundice)
blisters and bleeding in the lips, eyes, mouth, nose and genitals
thickened patches of red skin
The above list includes very serious side effects. You may need urgent medical attention
or hospitalisation. These side effects are very rare.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.
Storage and Presentation
Keep your tablets in the pack until it is time to take them.
If you take the tablets out of the pack they may not keep well.
Keep your medicine in a cool dry place where the temperature stays below 30°C.
Do not store this medicine or any other medicine in the bathroom or near a sink. Do
not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep it 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.
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 left over.
What it looks like
Leflunomide APOTEX 10 mg tablets (bottle pack of 30 tablets):
Film coated, white, round, biconvex tablet. AUST R 251992.
Leflunomide APOTEX 20 mg tablets (bottle pack of 30 tablets):
Film coated, yellow, round biconvex tablets with a scoreline on one side. AUST R 251993
* Not all strengths, pack types and/or pack sizes may be available.
Each tablet contains 10 mg or 20 mg of leflunomide as the active ingredient.
Each tablet also contains the following:
colloidal anhydrous silica
Opadry II complete film coating system OY-LS-28908 White (PI 4527) (10 mg only)
Opadry Aqueous Film Coating OY-SR-6497 Yellow (PI 3965) (20 mg only).
This medicine is free from gluten, sucrose, tartrazine and other azo dyes.
This medicine is sponsored in Australia by:
Apotex Pty Ltd
16 Giffnock Ave
Macquarie Park, NSW 2113
APO and APOTEX are registered trade marks of Apotex Inc.
This leaflet was prepared in August 2018.