Arava Leflunomide Tablets 10mg (Pack Of 30)

Arava

leflunomide
Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Arava.

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 Arava 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 need to read it again.

What Arava is used for

Arava is used for the treatment of rheumatoid arthritis or psoriatic arthritis. It is given 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.

Arava 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.

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

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

Arava is not recommended for use in children and adolescents, as there have been no studies of its effects in these age groups.

Before you take Arava

You must not take Arava:

  • 1.If you are pregnant or plan to become pregnant.

    • Arava must not be used in pregnant women or in women who are not using reliable birth control because Arava may increase the risk of birth defects.

    Women of childbearing potential must use reliable contraception while taking Arava.

    You must not become pregnant while taking Arava and for a certain period of time after stopping Arava. If you wish to become pregnant after you stop taking Arava, you must consult your doctor first. Your doctor will discuss a wash-out procedure with you. If you suspect that you are pregnant while taking Arava, consult your doctor immediately.

    If you wish to father a child:

    To prevent any risk to the developing baby, men taking Arava should consider stopping Arava and undergoing a wash-out procedure. Your doctor will discuss the wash-out procedure with you.

  • 2.If you are breast-feeding.

    • Arava passes into breast milk and therefore there is a possibility that the breast-fed baby may be affected.

  • 3.If you have an allergy to Arava or any of the ingredients listed at the end of this leaflet (Product Description).

    • Symptoms of an allergic reaction may include:

  • Rash, itching
  • Hives
  • Swelling of the face, lips, tongue or other parts of the body
  • Shortness of breath, wheezing or trouble breathing
  • A serious skin reaction
  • 4.If you suffer from a disease which reduces your body`s natural defences such as certain severe bacterial or viral infections.
  • 5.If you suffer from any diseases of the blood.
  • 6.If you suffer from serious skin disorders.
  • 7.If you have liver disease.
  • 8.If you do not have enough protein in your blood.
  • 9.If the packaging is torn or shows signs of tampering.
  • 10.If the expiry date on the pack has passed.

    • If you take this medicine after the expiry date has passed, it may not work as well, or it may be harmful.

    If you are not sure whether you should start taking Arava, contact your doctor or pharmacist.

    Before you start to take it

    Tell your doctor or pharmacist:

  • 1.If you have allergies to:
  • any other medicines
  • any other substances, such as foods, preservatives or dyes
  • 2.If you are pregnant or intend to become pregnant.
  • 3.If you are breast-feeding or plan to breast-feed.
  • 4.If you plan to father a child.
  • 5.If you have or have had any of the following medical conditions, especially:
  • a decrease in the number of white blood cells
  • liver problems
  • kidney problems
  • chronic infections
  • an illness which lowered your body`s resistance to disease
  • tuberculosis (TB)

    • If you have not told your doctor or pharmacist about any of the above, tell them before you start taking Arava.

    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 Arava may interfere with each other. These include:

  • Medicines used to prevent blood clots
  • Medicines used for diabetes
  • Medicines used to treat epilepsy
  • Medicines used for TB
  • Cholestyramine
  • Activated charcoal

    • These medicines may be affected by Arava, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor or pharmacist will advise you.

    In certain situations (if you experience a serious side effect, you change your medication or you want to fall pregnant), your doctor will ask you to take medication that will make your body get rid of Arava faster.

    It is recommended that you minimise your consumption of alcohol whilst you are taking Arava.

    Your doctor and pharmacist will have more information on medicines to be careful with or avoid while taking Arava.

    How to take Arava

    How much to take

    Your doctor or pharmacist will tell you how many tablets you will need to take each day. This depends on your condition and whether or not you are taking any other medicines.

    Follow all directions given to you by your doctor and pharmacist carefully.

    These directions may differ from the information contained in this leaflet.

    Arava tablets are taken once a day, by mouth. The usual dose for Arava is as follows: for the first 3 days, you will take a 100 mg tablet daily and after that you will take a 20 mg tablet daily. For some people, the daily dose may be 10 mg.

    If you do not understand the instructions on the box or bottle, ask your doctor or pharmacist for help.

    How to take it

    Swallow Arava tablets whole with a full glass of water.

    It does not matter if you take Arava before or after food.

    When to take it

    Take Arava at about the same time each day.

    Taking your tablets at the same time each day will have the best effect. It will also help you to remember when to take the tablets.

    If you forget to take it

    If it is almost time for 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.

    How long to take it

    Arava helps control your condition, but does not cure it. Therefore you must take Arava every day. Continue taking the tablets for as long as your doctor or pharmacist tells you to.

    If you take too much (overdose)

    Immediately telephone your doctor or pharmacist or the Poisons Information Centre (in Australia, call 13 11 26. In New Zealand call 0800 POISON or 0800 764766), or go to the Accident and Emergency Centre at your nearest hospital, if you think that you or anyone else may have taken too much Arava. Do this even if there are no signs of discomfort or poisoning. You many need urgent medical attention.

    While you are using Arava

    Things you must do

  • If you become pregnant while taking Arava, tell your doctor immediately and stop taking it.
  • If you have an infection or notice a fever or signs of an infection while taking Arava, tell your doctor immediately.
  • If your skin becomes itchy or yellow, if the whites of your eyes become yellow, or if you start to bleed or bruise easily, you may be developing a liver problem. If this happens, you should tell your doctor immediately and stop taking Arava.
  • You must continue using appropriate reliable contraception (the `Pill` or condoms) while you are taking Arava. Tell your doctor before stopping contraception.
  • Tell your doctor if you need to have a vaccination during treatment with Arava or for 6 months after stopping treatment.
  • Tell any other doctors, dentists, and pharmacists who are treating you that you are taking Arava.

    • Things you must not do

    Do not give Arava to anyone else, even if they have the same condition as you.

    Do not take Arava to treat any other complaints unless your doctor or pharmacist tells you to.

    Do not stop taking Arava without checking with your doctor or pharmacist.

    Side effects

    Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Arava.

    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.

    Ask your doctor or pharmacist to answer any questions you may have about side effects.

    Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • Diarrhoea
  • Rashes, itching
  • Temporary increase in hair loss
  • Weight loss
  • Unusual tiredness or weakness

    • These are the more common side effects of Arava.

    If any of the following happen, stop taking Arava and either tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • Severe infection
  • Severe upper stomach pain, often with nausea and vomiting
  • Skin rash or sores in your mouth
  • If your skin becomes itchy or yellow, and if the whites of your eyes become yellow, or if you start to bleed or bruise easily. You may be developing a liver problem.
  • If your skin becomes pale, you start to feel tired, you become prone to infections or bruising. You may be developing a blood cell disorder.

    • These are very serious but very rare side effects. You may need urgent medical attention or hospitalisation.

    Other side effects not listed above may occur in some patients. Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

    Do not be alarmed by this list of possible side effects.

    You may not experience any of them.

    Your doctor may need to take blood samples to monitor the health of your liver and blood cells while you are taking Arava.

    After using Arava

    Storage

    Keep your tablets in the container until it is time to take them.

    Keep your tablets in a cool dry place where the temperature stays below 25 degrees C.

    Heat and dampness can destroy some medicines.

    Do not store Arava or any other medicine in the bathroom or near a sink.

    Do not leave it in the car on hot days or on window sills.

    Keep Arava where children cannot reach it.

    Disposal

    If your doctor or pharmacist tells you to stop taking Arava or the expiry date has passed, ask your pharmacist what to do with any tablets that are left over.

    Product description

    What Arava looks like

    Arava 10 mg tablets are white to almost white, round film-coated tablets with the embossing ZBN.

    Arava 20 mg tablets are yellowish to ochre, spherical triangular film-coated tablets with the embossing ZBO.

    Arava 100 mg tablets are white to almost white, round film-coated tablets with the embossing ZBP.

    Ingredients

    Each tablet contains 10mg, 20mg or 100mg of the active ingredient, leflunomide.

    There are also other inactive ingredients that are necessary for the manufacture of the tablets. These are: lactose, maize starch, povidone, colloidal anhydrous silica, magnesium stearate, crospovidone, hypromellose, macrogol 8000, talc and titanium dioxide. The 20 mg tablets also contain iron oxide yellow.

    Arava does not contain sucrose, gluten, tartrazine or any other azo dyes.

    Manufacturer

  • Arava is manufactured for:
  • Aventis Pharma Pty Limited
  • 27 Sirius Road
  • Lane Cove NSW 2066
  • Aventis Pharma Limited
  • Auckland
  • Australian Registration numbers:
  • Arava 10 mg: AUST R 69692
  • Arava 20 mg: AUST R 69694
  • Arava 100 mg: AUST R 69695
  • Date of preparation:
  • October 2005
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    1800 200 736