APO-Leflunomide Tablets

APO-Leflunomide Tablets is a brand of medicine containing the active ingredients leflunomide (immune-system-modifying medicines).

Find out more about active ingredients.

Consumer medicine information (CMI) leaflet

Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.

APO-Leflunomide Tablets

Contains the active ingredient leflunomide


Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet

Read this leaflet carefully before taking your medicine. 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 or pharmacist.

The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available.

Ask your doctor or pharmacist:

  • if there is anything you do not understand in this leaflet,
  • if you are worried about taking your medicine, or
  • to obtain the most up-to-date information.

You can also download the most up to date leaflet from www.apotex.com.au.

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.

Pharmaceutical companies cannot give you medical advice or an individual diagnosis.

Keep this leaflet with your medicine. You may want to read it again.

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What this medicine is used for

The name of your medicine is APO- Leflunomide. It contains the active ingredient leflunomide.

It is used to treat:

  • rheumatoid arthritis

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.

This medicine is available only with a doctor's prescription.

How it works

Leflunomide belongs to a group of medicines called disease-modifying anti-rheumatic drugs (DMARDs), which act to decrease joint damage and disability due to rheumatoid arthritis.

In rheumatoid arthritis, leflunomide works by reducing the activity of the immune system, which helps to reduce inflammation, swelling and pain in affected joints. It also helps to reduce damage to those joints.

There is no evidence that this medicine is addictive.

Use in children

There is not enough information to recommend the use of this medicine in children under 18 years of age.

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Before you use this medicine

When you must not use it

Do not use this medicine if:

  • You are pregnant, planning to become pregnant or planning to father a child.
    Leflunomide may cause serious birth defects. If you wish to become pregnant or 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. Discuss this with your doctor.
  • You are not using reliable contraception.
    Women of childbearing potential and men who could potentially father a child, must use reliable contraception while taking leflunomide and for a certain period of time after stopping taking it.
  • You are breast-feeding or planning to breast-feed.
    Leflunomide passes into breast milk and there is a possibility that your baby may be affected.
  • You have or have had any of the following:
    - serious infection which is not being controlled by antibiotics
    - an illness which severely lowers your body's resistance to disease (e.g. HIV/AIDS)
    -significant disease of the blood or bone marrow
    -Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme (serious skin disorders with symptoms such as rashes, blisters, and/or peeling of large amounts of skin)
    -liver disease
    -a condition called hypoproteinaemia (when you do not have enough protein in your blood).
  • You are hypersensitive to, or have had an allergic reaction to, leflunomide or any of the ingredients listed at the end of this leaflet.
    Symptoms of an allergic reaction may include: cough, 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; fainting or hay fever-like symptoms.
    If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.
  • The expiry date (EXP) printed on the pack has passed.
  • The packaging is torn, shows signs of tampering or it does not look quite right.

Before you start to take it

Before you start taking this medicine, tell your doctor if:

  1. You have allergies to:
  • any other medicines
  • any other substances, such as foods, preservatives or dyes.
  1. You have or have had any medical conditions, especially the following:
  • decrease in the number of white blood cells
  • liver problems
  • kidney problems
  • chronic (ongoing) infections
  • an illness which lowers your body's resistance to disease (e.g. HIV/AIDS)
  • tuberculosis
  • diabetes
  • you are taking neurotoxic agents.
  1. You have, have had in the past, or have a family history of, lung problems such as interstitial lung disease, which is a serious and potentially fatal disease. This has the following symptoms: persistent dry cough and breathlessness during or after even mild physical exertion, with or without fever.
  2. You are currently pregnant or you plan to become pregnant.
  3. You are currently breast-feeding or you plan to breast-feed.
  4. You plan to father a child.
  5. You plan to stop using contraception.
  6. You have recently been vaccinated or plan to get a vaccination.
  7. You are planning to have surgery or an anaesthetic.
  8. You are currently receiving or are planning to receive dental treatment.
  9. You are taking or are planning to take any other medicines. This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.

Some medicines and leflunomide may interfere with each other. These include:

  • warfarin, an anticoagulant medicine (i.e. a medicine used to stop blood from clotting)
  • tolbutamide, a medicine used for diabetes
  • phenytoin, a medicine used to treat epilepsy
  • rifampicin, a medicine used for tuberculosis (TB)
  • cholestyramine, a medicine used to reduce high levels of cholesterol in the blood. This medicine, along with activated charcoal, may also be used to decrease the amount of leflunomide in your body
  • medicines which may affect the liver, such as certain NSAIDs (non-steroidal anti-inflammatory drugs) and methotrexate.

These medicines may be affected by leflunomide or may affect how well it works. If you are taking any of these you may need a different dose or you may need to take different medicines.

Your doctor can tell you if you are taking any of these medicines. They may also have more information on medicines to be careful with or avoid while taking leflunomide.

Other interactions not listed above may also occur.

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How to take this medicine

Follow carefully all directions given to you by your doctor. Their instructions may be different to the information in this leaflet.

How much to take

Your doctor will advise how much of this medicine you should take, please ensure that you follow their directions carefully.

Do not stop taking your medicine or change your dosage without first checking with your doctor.

The usual dose is as follows:
100 mg (five tablets of 20 mg or ten tablets of 10 mg) once a day for the first 3 days, then 20 mg (one 20 mg tablet or two 10 mg tablets) once a day.

For some people, the daily dose may be reduced to 10 mg.

How to take it

Swallow the tablets whole, with a glass of water.

When to take it

Take this medicine at the same time each day. Taking it at the same time each day will have the best effect and will also help you remember when to take it.

It does not matter if you take it before, with or after food.

How long to take it

Continue taking your medicine for as long as your doctor tells you.

Whilst this medicine helps to control your condition it 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 missed dose and take your next dose at the usual time.

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 missed doses. This may increase the chance of you experiencing side effects.

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 hints.

If you take too much (overdose)

If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively go to the Accident and Emergency Department at your nearest hospital.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. If you take too much leflunomide, you may experience diarrhoea, stomach pain, changes in your blood, or liver damage.

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While you are taking this medicine

Things you must do

Your doctor will do a blood test before you start taking this medicine. Make sure you visit your doctor for blood and liver function tests regularly, as advised by your doctor.

Tell your doctor that you are taking this medicine if:

  • You are about to be started on any new medicine.
  • You are planning on stopping contraception.
    While you are taking this medicine you must use a reliable contraceptive such as condoms or the oral contraceptive pill.
    If you are planning on stopping contraception, you must discuss this with your doctor before doing so.
  • You are planning to father a child.
  • You are pregnant or are planning to become pregnant.
    This medicine may cause serious birth defects. Tell your doctor immediately if you become pregnant and do not take any more of your medicine.
  • You are planning to breast-feed.
  • You notice a fever or signs of an infection. You must inform your doctor immediately.
    Leflunomide may lower your immunity.
  • You develop symptoms such as pins and needles or tingling in the hands or feet or numbness or weakness of the arms and legs.
  • 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 fatal.
  • You develop liver problems. Symptoms of liver problems include yellowing of eyes, itchy and yellowing skin, bruising and bleeding easily.
    If you notice any of these symptoms, do not take any more of your medicine and notify your doctor immediately.
    Your doctor will check your liver function using blood tests on a regular basis while you are taking leflunomide.
  • You need to have a vaccination or immunisation while you are taking this medicine. This also applies for 6 months after you have stopped taking leflunomide.
    Live vaccines should be avoided while taking this medicine.
  • You are about to have any blood tests.
  • You are going to have surgery or an anaesthetic or are going into hospital.

Go to your doctor regularly for a check-up.

Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.

Things you must not do

Do not:

  • Give this medicine to anyone else, even if their symptoms seem similar to yours.
  • Take your medicine to treat any other condition unless your doctor tells you to.
  • Stop taking your medicine, or change the dosage, without first checking with your doctor.

Things to be careful of

It is recommended that your alcohol intake is kept to a minimum whilst you are taking leflunomide.

Leflunomide may worsen the effects of alcohol.

Be careful while driving or operating machinery until you know how leflunomide affects you.

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Possible side effects

Tell your doctor as soon as possible if you do not feel well while you are using this medicine or if you have any questions or concerns. Do not be alarmed by the following lists of side effects. You may not experience any of them. 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.

Leflunomide works by decreasing your body's immune response. Because of this, you may develop side effects such as infections and inflammation.

Tell your doctor if you notice any of the following side effects:

  • diarrhoea, constipation, sore throat, wind
  • mouth, tongue, gum or tooth problems
  • dry skin, mild skin rashes, acne, skin discolouration, itching skin, eczema, changes in your nails
  • hair loss or discolouration
  • loss of weight
  • anorexia
  • feeling unusually weak or tired
  • migraine
  • nosebleed, stuffy nose
  • eye problems
  • strange taste sensations
  • varicose veins, bruised skin
  • numbness, tingling, pins and needles
  • muscle, joint or bone pain, muscle cramps, ruptured tendons
  • dry mouth, problems sleeping, sweating, feeling giddy.

These are the more common side effects of leflunomide.

Tell your doctor as soon as possible if you notice any of the following:

  • stomach pain, nausea and/or vomiting, black tarry faeces
  • pain on urinating, frequent urinating, bladder infection, bloody or cloudy urine
  • prostate problems
  • menstrual problems
  • swelling of ankles due to fluid
  • rash with inflamed blood vessels, ulcers on your skin
  • you feel anxious or depressed
  • increased blood pressure; it is hard to know if you have high blood pressure, but tell your doctor if you have ongoing symptoms of headache, dizziness, blurred vision or nausea
  • overactive thyroid - indicated by symptoms of palpitations, tremor, anxiety, diarrhoea and/or weight loss.

The above side effects are mostly rare or uncommon. However, they may be serious and you may require medical attention.

Tell your doctor immediately or go to the Accident and Emergency Department at your nearest hospital if you notice any of the following:

  • angina, thumping heartbeat (palpitations), irregular or fast heartbeat
  • symptoms of diabetes or hyperglycaemia (high blood sugar): feeling hungry, thirsty and/or frequent or excessive urination
  • severe pain in the upper stomach, with or without vomiting
  • severe infection or an infection getting worse (including abscesses, cysts, skin ulcers, chickenpox, cold sores, thrush, bronchitis, pneumonia), or fever
  • asthma or problems breathing
  • the sudden appearance or a worsening of, a persistent dry cough and/or getting out of breath during routine activities - getting dressed, talking on the phone, even eating. You may or may not have a fever at the same time. This may indicate that you have a very serious inflammation of the lung called interstitial lung disease, which can be fatal.
  • serious skin disorders, such as rashes, blisters, and/or peeling of large amounts of skin, sometimes combined with ulcers in your mouth
  • your skin becomes pale, you start to feel tired, you become prone to infections or bruising
  • yellowing of the skin and eyes (jaundice) and/or pale stools, together with tiredness and abdominal pain. This could indicate a serious problem with your liver.

The above side effects are very rare. However, they are very serious side effects which may become fatal and you should seek immediate medical attention.

Other side effects not listed above may occur in some patients.

Allergic reactions

If you think you are having an allergic reaction to leflunomide, do not take any more of this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.

Symptoms of an allergic reaction may include some or all of the following:

  • cough, 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
  • fainting
  • hay fever-like symptoms.

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Storage and disposal

Storage

Keep your tablets in a cool dry place where the temperature will stay below 25°C.

Do not store your 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 this 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 it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.

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Product description

What APO-Leflunomide looks like

  • APO-Leflunomide 10 mg is a white, round, tablet. Engraved "LE" over "10" on one side and "APO" on the other side.
  • APO-Leflunomide 20 mg is a white, arc-triangular shaped tablet. Engraved "LE" over "20" on one side and "APO" on the other side.

Ingredients

Each tablet contains 10 mg or 20 mg of the active ingredient leflunomide.

It also contains the following inactive ingredients:

  • lactose
  • crospovidone
  • magnesium stearate
  • silica colloidal anhydrous.

This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo dyes.

APO-Leflunomide tablets are available in:
Blister packs of 30 tablets

Not all strengths, pack types and/or pack sizes may be available

Australian Registration Numbers

  • APO-Leflunomide 10 mg blister pack: AUST R 129482.
  • APO-Leflunomide 20 mg blister pack: AUST R 129538.

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CMI provided by MIMS Australia, March 2014  

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