The name of your medicine is APO- Leflunomide. It contains the active ingredient leflunomide.
It is used to treat:
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.
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.
There is not enough information to recommend the use of this medicine in children under 18 years of age.
Do not use this medicine if:
Before you start taking this medicine, tell your doctor if:
1. You have allergies to:
2. You have or have had any medical conditions, especially the following:
3. 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.
4. You are currently pregnant or you plan to become pregnant.
5. You are currently breast-feeding or you plan to breast-feed.
6. You plan to father a child.
7. You plan to stop using contraception.
8. You have recently been vaccinated or plan to get a vaccination.
9. You are planning to have surgery or an anaesthetic.
10. You are currently receiving or are planning to receive dental treatment.
11. 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:
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.
Follow carefully all directions given to you by your doctor.
Their instructions may be different to the information in this leaflet.
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.
Swallow the tablets whole, with a glass of water.
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.
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 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 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.
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:
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.
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.
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:
These are the more common side effects of leflunomide.
Tell your doctor as soon as possible if you notice any of the following:
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:
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.
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:
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.
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.
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.
Each tablet contains 10 mg or 20 mg of the active ingredient leflunomide.
It also contains the following inactive ingredients:
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
APO-Leflunomide 10 mg blister pack: AUST R 129482.
APO-Leflunomide 20 mg blister pack: AUST R 129538.