Arava 20 mg. 30 tablets

Arava 20 mg. 30 tablets
€ 39.00
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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.

Arava 20 mg. 30 tablets 
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 should 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. Stevens-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 the blood (hypoproteinaemia)
- If you suffer from any problem which affects your immune system (such as AIDS)
- If you have a problem with the bone marrow or if you have low red or white blood cells in the blood or a reduced number of platelets in the blood
- If you have a serious infection,
- If you are pregnant, think you may be pregnant or breastfeeding.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before taking Arava.
- If you had tuberculosis or interstitial lung disease (lung disease)
- If you are male and wish to father. Since it can not be excluded that for the passage of Arava in the 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 some medication to remove Arava rapidly and sufficiently from your body. Will require you to do a blood test to confirm that Arava has been sufficiently removed from your body, then you need to wait at least another three months before trying to create children.
Arava can occasionally cause some problems with your blood, liver, lungs, or nerves of the arms or legs. 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 under 18 years. Other medicines and Arava
Tell your doctor or pharmacist if you are taking, have recently taken or might take other medicines.
This is especially important if you are taking:
- Other medicines for rheumatoid arthritis such as antimalarials (eg. Chloroquine and hydroxychloroquine), gold, intramuscularly or orally, D-penicillamine, azathioprine and other immunosuppressive drugs (eg. Methotrexate) as these combinations are not recommended
- A drug called cholestyramine (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 for the treatment of 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 taking nonsteroidal 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 used while taking Arava and for some time after stopping treatment.
Arava with food, beverages 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 they are using reliable measures to prevent pregnancy.
Tell your doctor if you intend to become pregnant after stopping treatment with Arava, as you need to make sure that no other traces of Arava in your body before trying to become pregnant. This can take up to two years. This may be reduced to a few weeks by taking certain medicines which speed up removal of Arava from your body.
In all cases, must be confirmed by a blood test that Arava has been sufficiently removed from your body and you have to wait 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 two years after its withdrawal, you should immediately contact your doctor for a pregnancy test. A positive pregnancy test, your doctor may suggest treatment with certain medicines to remove Arava rapidly and sufficiently from your body, as this can reduce the risk to your baby.
Do not take Arava during breast-feeding, as leflunomide passes into breast milk.
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 use machines.

Arava contains lactose
If your doctor has told you that you have an intolerance to some sugars, consult before taking this medicine.

3 How to take Arava?
Always take this medicine exactly as prescribed by your doctor or pharmacist. Am not sure about anything, ask your doctor or pharmacist.
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:
• 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 with plenty of water.
It may take at least 4 weeks of initiation of therapy to 'feel improvement in your condition. Some patients may even get a great improvement after 4 to 6 months of treatment.
You will normally take Arava over time.
If you take more than the amount of Arava
If you take more than the amount of Arava, ask your doctor or seek 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 for a 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 may indicate severe, sometimes life-threatening reactions (eg. Stevens-Johnson, toxic epidermal necrolysis, erythema multiforme).
Tell your doctor immediately if you experience:
- Pale skin, fatigue, or bruising, as these may indicate blood disorders caused by an imbalance in the different types of blood cells which make up blood
- Abdominal pain, and jaundice (yellowing of the eyes or skin) since they may indicate serious conditions such as liver failure, which may be fatal,
- Any signs 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 be a sign of problems with the nerves (peripheral NEUROPATHY).

Common side effects (may affect up to 1 in 10 people)
- A slight decrease in white blood cell count (leucopenia),
- Mild allergic reactions
- Loss of appetite, weight loss (usually minor)
- Fatigue (asthenia)
- Headache, dizziness,
- Abnormal skin sensations like tingling (paraesthesia)
- Mild increase in blood pressure,
- Diarrhea,
- Nausea, vomiting,
- Inflammation of the mouth or mouth ulcers
- Abdominal pain,
- An increase in some liver test results,
- Increased HAIR LOSS,
- Eczema, dry skin, rash, pruritus,
- 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)
- A reduction in the number of red blood cells (anemia), and reducing the number of platelets (thrombocytopenia),
- Reduce the level of potassium in the blood
- Anxiety,
- 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)
- Increase the number of blood cells called eosinophils (eosinophilia); a slight reduction in the number of white blood cells (leucopenia); 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 results which may lead to serious conditions such as hepatitis, jaundice,
- Severe infections called sepsis, which can be fatal,
- Increase of certain enzymes in the blood (lactate dehydrogenase).

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 in the levels of uric acid in the blood, male infertility (which is reversible once treatment is stopped, the drug), cutaneous lupus (characterized by rash / redness of the skin areas that are exposed to 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 container tightly closed.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6 Package Contents and more information
What does Arava?
- The active substance is leflunomide. Each 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, and talc (E553b), hypromellose (E464) , titanium dioxide (E 171) and macrogol 8000 in the film-coating.

Arava looks like and contents of the pack?
Arava 10 mg 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.
€ 39.00
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