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What Arava is and what it is used?
Arava belongs to a group of medicines called anti-rheumatic drugs. It contains the active substance leflunomide.
Arava is used to treat adult patients with active rheumatoid arthritis or 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 anemia (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 taking Arava?
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 eg. Johnson syndrome) or any of the other ingredients of this medicine (listed in paragraph 6)
- If you have any liver problems
- If you have moderate to severe kidney problems
- If you have severely low numbers of proteins in your blood (hypoproteinaemia)
- If you suffer from any problem which affects your immune system (eg AIDS)
- If you have a problem with the bone marrow, or if you have low numbers of red or white blood cells in the blood or a reduced number of platelets in the blood
- If you suffer from a serious infection,
- If you are pregnant, think you might be pregnant or breast-feeding.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before taking Arava.
- If you have ever suffered from tuberculosis or interstitial lung disease (lung disease)
- If you are male and wish to father a child. Since it can not be excluded that for the passage of Arava in semen must be used reliable contraception during treatment with Arava. Men wishing to father a child should contact their doctor who may advise them to stop taking Arava and take certain medicines to remove Arava rapidly and sufficiently from your body. You will need to make your blood test to confirm that Arava has been sufficiently removed from your body and then you need to wait at least another 3 months before attempting to create children.
Arava can occasionally cause some problems with your blood, liver, lungs, or nerves in your arms or legs. It can also cause serious allergic reactions, or increase the risk of severe infection. For more information on this, please read section 4 (Possible side effects).
Your doctor will do blood tests regularly 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.
Children and adolescents
Arava is not recommended for use in children and adolescents aged under 18 years. Other medicines and Arava
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines.
This is especially important if you are taking:
- Other medicines for rheumatoid arthritis such as antimalarials (eg. Chloroquine and hydroxychloroquine), gold, intramuscular or oral, D-penicillamine, azathioprine and other immunosuppressive drugs (eg. Methotrexate) as these combinations are not advisable,
- A medicine called colestyramine (used to reduce high cholesterol) or activated charcoal as these medicines can reduce the amount of Arava, which is absorbed by the body.
- Phenytoin (used to treat epilepsy), warfarin or phenprocoumon (used to thin the blood) or tolbutamide (used for the treatment of diabetes type 2), since these drugs can increase the risk of side effects.
If you are already taking non-steroidal anti-inflammatory drugs (NSAIDs) and / or corticosteroids, you may continue to take them after starting treatment with Arava.
If you need to be vaccinated, ask your doctor for advice. Certain vaccinations should not be given while taking Arava, and for some time after stopping treatment.
Arava with food, drink and alcohol
Arava may be taken with or without food.
It is not recommended to consume alcohol during treatment with Arava. Drinking alcohol while taking Arava may increase the risk of liver damage.
Pregnancy and lactation
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, unless using reliable measures to prevent pregnancy.
Tell your doctor if you plan to become pregnant
Driving and using machines
Arava can make you feel dizzy which may impair your ability to concentrate and react. If this happens, do not drive or operate machinery.
Arava contains lactose
If your doctor has told you that you have an intolerance to some sugars, consult him before taking this medicine.
3. How to take Arava?
Always take this medicine exactly as you have been told by your doctor or pharmacist. Am not sure about something, ask your doctor or pharmacist.
The usual starting dosage of Arava is one 100 mg tablet once daily for the first three days. After this, most patients need a dose of:
• For rheumatoid arthritis: 10 or 20 mg Arava once daily, depending on the severity of the disease.
• For psoriatic arthritis: 20 mg Arava once daily. Swallow the tablet whole and with plenty of water.
It may take at least four weeks of starting therapy, to feel 'improvement in your condition. Some patients may even receive greater improvement after 4 to 6 months of treatment.
You will normally take Arava over long periods of time.
If you take more Arava than
If you take more than the amount of Arava, ask your doctor or get other medical advice. If possible, take your tablets or the box with you to show.
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 the missed 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:
- If you experience weakness, feel dizzy and you feel faint or have difficulty breathing, as these may be signs of a serious allergic reaction
- If you get a skin rash or ulcers in the mouth, as they can indicate severe, sometimes life-threatening reactions (eg. Syndrome Stevens-Johnson, toxic epidermal necrolysis, erythema multiforme).
Tell your doctor immediately if you experience:
- Pale skin, tiredness, or bruising, as these may indicate blood disorders caused by an imbalance of the different types of blood cells that make up blood
- Fatigue, abdominal pain or jaundice (yellowing of the eyes or skin), as these may indicate serious conditions such as liver failure, which can be fatal,
- Any symptoms of infection such as fever, sore throat or cough, as this medicine may increase the risk of severe infection that can be life-threatening,
- Coughing or breathing difficulties, since it can indicate inflammation of the lung (interstitial lung disease),
- Unusual tingling, weakness or pain in hands or feet, as this may indicate problems with your nerves (peripheral neuropathy).
Common side effects (may affect up to 1 in 10 people)
- A slight decrease in the number of white blood cells (leucopenia),
- Mild allergic reactions
- Loss of appetite, weight loss (usually insignificant)
- Fatigue (asthenia)
- Headache, dizziness,
- Abnormal skin sensations like tingling (paraesthesia)
- Mild increase in blood pressure,
- Nausea, vomiting,
- Inflammation of the mouth or mouth ulcers
- stomach ache,
- An increase in some liver test results,
- Increased hair loss,
- Eczema, dry skin, rash, itching,
- Tendonitis (pain caused by inflammation of the membrane surrounding the tendons usually in the feet or hands)
- Increase of certain enzymes in the blood (creatine phosphokinase)
- Problems with the nerves of the arms or legs (peripheral neuropathy).
Uncommon side effects (may affect up to 1 in 100 people)
- Reducing the number of red blood cells (anemia) and a decrease in the number of platelets (thrombocytopenia),
- Reduce the level of potassium in the blood
- Taste disturbances,
- Urticaria (hives)
- Tendon rupture,
- Raising the level of blood lipids (cholesterol and triglycerides)
- Lowering the level of phosphate in the blood.
Rare side effects (may affect up to 1 in 1000 people)
- An increase in the number of blood cells called eosinophils (eosinophilia); a slight decrease in the number of white blood cells (leukopenia); reducing the number of all blood cells (pancytopenia),
- A significant increase in blood pressure,
- Inflammation of the lung (interstitial lung disease),
- An increase in some liver test results
Very rare side effects (may affect up to 1 in 10,000 people)
- A marked decrease of some white blood cells (agranulocytosis)
- Severe and potentially severe allergic reactions
- Inflammation of small blood vessels (vasculitis, including cutaneous necrotizing vasculitis)
- Inflammation of the pancreas (pancreatitis)
- Severe liver injury such as liver failure or necrosis which may be fatal
- Severe, sometimes life-threatening reactions (Stevens-Johnson, toxic epidermal necrolysis, erythema multiforme).
Other side effects such as renal failure, decrease the level of uric acid in the blood, male infertility (which is reversible once treatment is stopped with this drug), cutaneous lupus (characterized by rash / redness of the skin areas that are exposed light) and psoriasis (new or worsening) can also occur with unknown frequency.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Arava?
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Blister: Store in original container.
Bottle: Keep the bottle tightly closed.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
- The active substance is leflunomide. One tablet contains 10 mg of leflunomide.
- The other ingredients are: corn starch, povidone (E 1201), crospovidone (E 1202), colloidal anhydrous silica, magnesium stearate (E470b), and lactose monohydrate in the tablet core as well as talc (E553Y), hypromellose (E464) , titanium dioxide (E 171) and macrogol 8000 in the film coating.
Looks like Arava, and contents of the pack?
Arava 10 mg film-coated tablets are white to off-white and round. Imprint on one side: ZBN.
The tablets are packaged in blister packs or bottles. Packs of 30 and 100 tablets.
Not all pack sizes may be marketed.
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