Arava 10 mg/20 mg Film-Coated Tablets

ARAVA contains the active substance leflunomide, which belongs to a group of antirheumatic medicines called “disease-modifying antirheumatic medicines”. ARAVA is used to treat active rheumatoid arthritis in adults.

It works by slowing down the process of joint damage and relieves the symptoms of the disease, such as inflammation of joints, swelling, difficulty moving and pain.

Do not take ARAVA if

• You have ever had an allergic reaction to leflunomide (especially a serious skin reaction, often accompanied by fever, joint pain, red skin stains, or blisters, e.g. Stevens-Johnson syndrome) or to any of the other ingredients of ARAVA listed in section 6, or if you are allergic to teriflunomide (used to treat multiple sclerosis). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue (see section 4. Possible side effects).
• You have any liver problems.
• You suffer from any problem which affects your immune system (e.g. AIDS).
• You have any problem with your bone marrow, or if you have low numbers of red or white cells in your blood or a reduced number of blood platelets.
• You are suffering from a serious infection.
• You have moderate to severe kidney problems.
• You have severely low numbers of proteins in your blood (hypoproteinaemia).
• You are pregnant, think you may be pregnant, or you are a woman of childbearing potential and are not using reliable contraception (Pregnancy must be excluded with a pregnancy test before the start of treatment).
• You are breastfeeding.
• You are male: reliable contraception must also be guaranteed as there is a possibility of male mediated harm to the unborn baby by men using ARAVA.
• You are younger than 18 years of age.

Do not take ARAVA if any of the above applies to you. If you are not sure, talk to your doctor before taking ARAVA.

Do not share medicines prescribed for you with any other person. Always take ARAVA exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

Your doctor will tell you how many ARAVA tablets to take, at what time and for how long. The usual starting dose is ARAVA 100 mg daily (5 x 20 mg tablets daily) for the first three days. After this, most patients need a dose of ARAVA 10 mg or 20 mg once daily, depending on the severity of the disease.

ARAVA may be taken during meals or at any time between meals. Swallow the tablet whole with sufficient liquid. It may take about 4 to 6 weeks or longer until you start to feel an improvement in your condition. You will normally take ARAVA over long periods of time.

If you take more ARAVA than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take ARAVA

If you forget to take your tablets, take them as soon as you remember on the same day. If it is nearly time for the next dose, take the next dose as usual. Do not take a double dose to make up for the forgotten tablets.

If you stop taking ARAVA

After stopping ARAVA, traces of ARAVA will remain in your body for up to 2 years. If ARAVA was stopped due to serious side effects or pregnancy, or planned pregnancy (both male and female patients), your doctor may reduce the levels of ARAVA in your body within a few weeks by giving you certain medicines which speed up the removal of ARAVA from your body. Speak to your doctor if this is applicable to you.

ARAVA can have side effects. Not all side effects reported for ARAVA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ARAVA, please consult your health care professional for advice.

If any of the following happens, stop taking ARAVA and tell your doctor immediately or go to the casualty department at your nearest hospital:

Less frequent:

• Serious allergic reactions. Signs may include: a rash, swelling of your lips, face, throat or tongue which may cause difficulty breathing, weakness, light-headedness or dizziness and collapse.
• If you develop a skin rash or ulcers in your mouth, as these may indicate severe, sometimes life-threatening reactions such as:
• Stevens-Johnson syndrome (blistering of the skin, mouth, eyes and genital area, red/purple rash, fever, headache, cough and joint pain) or erythema multiforme (blotchy red skin rash)
• toxic epidermal necrolysis (severe extensive skin damage, e.g. separation of the epidermis (surface layer of the skin) and superficial mucous membranes).

Frequency unknown:

• Drug reaction with eosinophilia and systemic symptoms (DRESS), a medicine hypersensitivity reaction which affects your internal organs and increases the white cells (eosinophilia) in your blood. See: Warnings and precautions above.

These are all very serious side effects. If you have them, you may have had a serious allergic or other reaction to ARAVA. You may need urgent medical attention or hospitalisation.

Store your tablets at or below 25 °C in the original container. Keep the bottle tightly closed.

Do not use your tablets after the expiry date shown on the container.

Store all medicines out of reach of children.

Return all left-over medicine to your pharmacist or clinic. Do not dispose of unused medicine in the drains or sewerage systems (e.g. toilets).