Active ingredient
- leflunomide
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: EU/1/99/118/003.
Arava 10mg Tablets
Package leaflet: Information for the user
Arava 10 mg film-coated tablets
leflunomide
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Arava is and what it is used for
2. What you need to know before you take Arava
3. How to take Arava
4. Possible side effects
5. How to store Arava
6. Contents of the pack and other information
1. What Arava is and what it is used for
Arava belongs to a group of medicines called anti-rheumatic medicines. It contains the active substance leflunomide.
Arava is used to treat adult patients with active rheumatoid arthritis or with active psoriatic arthritis. Symptoms of rheumatoid arthritis include inflammation of joints, swelling, difficulty moving and pain. Other symptoms that affect the entire body include loss of appetite, fever, loss of energy and anaemia (lack of red blood cells).
Symptoms of active psoriatic arthritis include inflammation of joints, swelling, difficulty moving, pain and patches of red, scaly skin (skin lesions).
2. What you need to know before you take Arava
Do not take Arava
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Arava
Arava can occasionally cause some problems with your blood, liver, lungs, or nerves in your arms or legs. It may also cause some serious allergic reactions (including Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]), or increase the chance of a severe infection. For more information on these, please read section 4 (Possible side effects).
DRESS appears initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.
Your doctor will carry out blood tests at regular intervals, before and during treatment with Arava, to monitor your blood cells and liver. Your doctor will also check your blood pressure regularly as Arava can cause an increase in blood pressure.
Tell your doctor if you have unexplained chronic diarrhoea. Your doctor may perform additional tests for differential diagnosis.
Children and adolescents
Arava is not recommended for use in children and adolescents below 18 years of age.
Other medicines and Arava
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription.
This is especially important if you are taking:
If you are already taking a nonsteroidal anti-inflammatory drug (NSAID) and/or corticosteroids, you may continue to take them after starting Arava.
Vaccinations
If you have to be vaccinated, ask your doctor for advice. Certain vaccinations should not be given while taking Arava, and for a certain amount of time after stopping treatment.
Arava with food, drink and alcohol
Arava may be taken with or without food.
It is not recommended to drink alcohol during treatment with Arava. Drinking alcohol while taking Arava may increase the chance of liver damage.
Pregnancy and breast-feeding
Do not take Arava if you are, or think you may be pregnant. If you are pregnant or become pregnant while taking Arava, the risk of having a baby with serious birth defects is increased. Women of childbearing potential must not take Arava without using reliable contraceptive measures.
Tell your doctor if you plan to become pregnant after stopping treatment with Arava, as you need to ensure that all traces of Arava have left your body before trying to become pregnant. This may take up to 2 years. This may be reduced to a few weeks by taking certain medicines which speed up removal of Arava from your body.
In either case it should be confirmed by a blood test that Arava has been sufficiently removed from your body and you should then wait for at least another month before you become pregnant.
For further information on the laboratory testing please contact your doctor.
If you suspect that you are pregnant while taking Arava or in the two years after you have stopped treatment, you must contact your doctor immediately for a pregnancy test. If the test confirms that you are pregnant, your doctor may suggest treatment with certain medicines to remove Arava rapidly and sufficiently from your body, as this may decrease the risk to your baby.
Do not take Arava when you are breast-feeding, as leflunomide passes into the breast milk.
Driving and using machines
Arava can make you feel dizzy which may impair your ability to concentrate and react. If you are affected, do not drive, or use machines.
Arava contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Arava
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The usual starting dose of Arava is one 100 mg tablet once daily for the first three days. After this, most patients need a dose of:
Swallow the tablet whole and with plenty of water.
It may take about 4 weeks or longer until you start to feel an improvement in your condition. Some patients may even still feel further improvements after 4 to 6 months of therapy.
You will normally take Arava over long periods of time.
If you take more Arava than you should
If you take more Arava than you should, contact your doctor or get other medical advice. If possible, take your tablets or the box with you to show the doctor.
If you forget to take Arava
If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately and stop taking Arava:
Tell your doctor immediately if you experience:
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1,000 people)
Very rare side effects (may affect up to 1 in 10,000 people)
Other side effects such as kidney failure, a decrease in the levels of uric acid in your blood, pulmonary hypertension, male infertility (which is reversible once treatment with this medicine is stopped), cutaneous lupus (characterized by rash/erythema on skin areas that are exposed to light), psoriasis (new or worsening) and DRESS may also occur with an unknown frequency.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
United Kingdom
You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Ireland
You can also report side effects directly via
Malta
You can also report side effects directly via
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Arava
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Blister: Store in the original package.
Bottle: Keep the bottle tightly closed.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Arava contains
What Arava looks like and contents of the pack
Arava 10 mg film-coated tablets are white to almost white and round. Imprint on one side: ZBN.
The tablets are packed in blisters or bottles. Packs of 30 and 100 tablets are available.
Not all pack size may be marketed.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
This leaflet was last revised in October 2020
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website:http://www.ema.europa.eu/.
Art 61.3 – Local rep update to IT-MT-SK-NL
Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
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