10 mg film-coated tablets
1. What Arava is and what it is used for
Arava belongs to a group of medicines called anti-rheumatic medicines. Arava 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 the joints, swelling, difficulty moving, and pain. Other symptoms that can affect the whole body include decreased appetite, fever, decreased energy, and anemia (lack of red blood cells ).
Symptoms of active psoriatic arthritis include inflammation of the joints, swelling, difficulty moving and pain, and red and scaly patches on the skin (skin damage).
2. What you need to know before using Arava
Do not use Arava
- if you have ever had an allergic reaction to leflunomide (especially a severe skin reaction, often accompanied by fever, joint pain, red spots on the skin, or blisters, such as Stevens-Johnson syndrome) or any of the other ingredients of this medicine (listed in section 6 ), or if you are allergic to teriflunomide (used to treat multiple sclerosis ).
- if you have liver problems,
- if you have moderate to severe renal impairment,
- if you have a sharp drop in your blood protein (egg white) concentration(hypoproteinemia),
- if you suffer from any disease that weakens your immune system (ex AIDS),
- if you have impaired bone marrow function or if the number of red or white blood cells or the number of platelets is low,
- if you suffer from a serious infection,
- if you are pregnant, think you may be pregnant or breastfeeding.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Arava
- if you have ever had inflammation of the lungs (interstitial lung disease).
- if you have ever had tuberculosis or if you have been in close contact with someone who has or has had tuberculosis. Your doctor may take samples to see if you have tuberculosis.
- if you are a man and want to have children. As it cannot be ruled out that Arava passes into the semen, a reliable contraceptive should be used during treatment with Arava.
Men who wish to have children should contact their doctor who may advise them to discontinue treatment with Arava and take certain medications to quickly remove Arava from the body. A blood test will confirm that Arava has been secreted enough. After that, you should wait at least another 3 months before trying to have children.
- if you are going to take a specific blood test (calcium level). Measurements can show falsely low calcium levels.
Arava can affect your blood, your liver, your lungs, or the nerves in your arms or legs. Arava can also cause severe allergic reactions (including drug reactions with eosinophilia and systemic symptoms [DRESS]), or increase the risk of developing serious infections. For further information, see section 4 (Possible side effects ).
DRESS initially appears with flu-like symptoms and rashes on the face, followed by widespread rashes and high fever, increased liver enzyme levels seen in blood tests, and an increase in a type of white blood cell ( eosinophilia ) and enlarged lymph nodes.
Your doctor will regularly take blood samples, before and during treatment with Arava, to check your blood and your liver. Your doctor will also regularly check your blood pressure as Arava may cause high blood pressure.
Tell your doctor if you have diarrhea that lasts for a long time for no particular reason. Your doctor may need to perform additional tests to find out what this is causing.
Children and young people
Arava is not recommended for children and adolescents under 18 years of age.
Other medicines and Arava
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines.
This is especially important if you are using:
- other drugs for rheumatoid arthritis such as antimalarial drugs (eg chloroquine and hydroxychloroquine); intramuscular or oral gold, D-penicillamine, azathioprine, and other immunosuppressive drugs (eg methotrexate) as these combinations are not recommended.
- warfarin and other oral blood thinners, as monitoring is necessary to reduce the risk of side effects of this medicine
- teriflunomide in multiple sclerosis
- repaglinide, pioglitazone, nateglinide, or rosiglitazone in diabetes
- daunorubicin, doxorubicin, paclitaxel, or topotecan in cancer
- duloxetine for depression, urinary incontinence, or kidney disease in diabetics
- alosetron in the treatment of severe diarrhea
- theophylline in asthma
- tizanidine, a muscle relaxant
- birth control pills (containing Ethinyl estradiol and levonorgestrel)
- cefaclor, benzylpenicillin ( penicillin G), ciprofloxacin in case of infection are
- indomethacin, ketoprofen for pain or inflammation
- furosemide for heart disease (diuretic, diuretic)
- zidovudine, HIV – infection
- rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia(high cholesterol )
- sulfasalazine in inflammatory bowel disease or rheumatoid arthritis
- a drug called cholestyramine (used to treat increased blood fat levels) and activated charcoal as these drugs can reduce the body’s uptake of Arava.
If you are already taking non-steroidal anti-inflammatory drugs ( NSAIDs ) and/or corticosteroids, you can continue to take them after starting treatment with Arava.
If you need to be vaccinated, ask your doctor for advice. Some vaccines should not be given during treatment with Arava, and for a period after stopping treatment.
Arava with food, drink, and alcohol
Arava can be taken independently of food intake.
Alcohol intake should be avoided during treatment with Arava. Consumption of alcohol during treatment may increase the risk of liver damage.
Pregnancy and breastfeeding
Do not use 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 child with severe birth defects increases. Women of childbearing potential should not use Arava without the use of reliable contraception.
Tell your doctor if you are planning to become pregnant after stopping treatment with Arava as you need to make sure that Arava is completely excreted from your body before attempting to conceive.
This can take up to 2 years, but this period can be shortened to a few weeks if you take special medicines that accelerate the excretion of Arava from your body.
In both cases, a blood test should confirm that Arava has been sufficiently excreted from your body. After that, you have to wait at least another month before you get pregnant.
For further information on laboratory tests, please contact your doctor.
If you suspect that you are pregnant during treatment with Arava or for the next two years after stopping 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 specific drugs to quickly remove Arava from your body as this may reduce the risk to your baby.
Do not use Arava if you are breast-feeding as Arava may be excreted in human milk.
Driving and using machines
Arava can cause dizziness, which can impair your ability to concentrate and react. If you feel affected, do not drive or operate machinery.
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.
How to use Arava
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The usual starting dose is 100 mg Arava once a day for the first three days. Then, most people need:
- In rheumatoid arthritis: 10 or 20 mg Arava once a day, depending on the severity of the disease.
- In psoriatic arthritis: 20 mg Arava once a day.
Swallow the tablet whole with plenty of water.
It may take about 4 weeks or longer before you feel an improvement in your condition. Some patients may even feel further improvement after 4 to 6 months of treatment.
Treatment with Arava usually takes place over extended periods of time.
If you take more Arava than you should
If you take more Arava than you should, contact your doctor, or seek other medical advice. If possible, take your tablets or pack to 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 time for the 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 product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately and stop using Arava:
- if you feel weak, dizzy, or have difficulty breathing, as this may be a symptom of a severe allergic reaction.
- if you get a skin rash or mucous membrane damage in the mouth, as these may be symptoms of severe, sometimes life-threatening, reactions (eg Stevens-Johnson syndrome, toxic epidermal necrolysis , erythema multiforme), drug reaction with eosinophilia and systemic symptoms [DRESS]), see section 2.
Contact your doctor immediately if you experience:
- pallor, fatigue, or increased propensity for bruising, as this may indicate blood disease caused by an imbalance between different types of blood cells in the blood.
- fatigue, abdominal pain, or jaundice (yellowing of the eyes and skin), as this may indicate serious conditions such as liver problems which can be life-threatening.
- symptoms of infection such as fever, sore throat, or cough, as this medicine may increase the risk of serious infection you can be life-threatening.
- cough or difficulty breathing as this may indicate lung problems (interstitial lung disease or pulmonary hypertension ).
- unusual tingling, weakness, or pain in your hands or feet as these may indicate problems with your nerves ( peripheral neuropathy ).
Common side effects (may affect up to 1 in 10 people)
- a marginal decrease in the number of white blood cells ( leukopenia ),
- mild allergic reactions,
- loss of appetite, weight loss (usually insignificant),
- fatigue ( asthenia )
- headache, dizziness,
- abnormal skin sensations such as tingling ( paresthesia ),
- slightly increased blood pressure,
- colitis (intestinal inflammation),
- nausea, vomiting,
- inflammation of the mouth or affected oral mucosa,
- abdominal pain,
- increase in certain liver values,
- hair loss,
- eczema, dry skin, rash, and itching,
- tendonitis (pain caused by inflammation of the membrane surrounding the tendon, usually in the feet or hands),
- an increase in certain blood enzymes (creatine kinase).
Uncommon side effects (may affect up to 1 in 100 people)
- a decrease in the number of red blood cells ( anemia ) and a decrease in the number of platelets ( thrombocytopenia ),
- a decrease in potassium levels in the blood,
- taste changes,
- tendon rupture,
- an increase in blood fat levels ( cholesterol and triglycerides ),
- a decrease in the level of phosphate in the blood.
Rare side effects (may affect up to 1 in 1000 people)
- increase in the number of eosinophilic blood cells ( eosinophilia ); a slight decrease in the number of white blood cells ( leukopenia ); and a decrease in the number of blood cells (pancytopenia).
- sharply increased blood pressure,
- inflammation of the lungs (interstitial lung disease),
- an increase in certain liver values that can develop into serious conditions such as hepatitis and jaundice,
- severe infection, so-called sepsis, which can be life-threatening,
- an increase in certain enzymes in the blood ( lactate dehydrogenase ).
Very rare side effects (may affect up to 1 in 10,000 people)
- a marked decrease in certain white blood cells ( agranulocytosis ),
- severe and possibly severe allergic reactions,
- inflammation of the small blood vessels ( vasculitis, including cutaneous necrotizing vasculitis ),
- peripheral nerve effects in the arms and legs ( peripheral neuropathy ),
- inflammation of the pancreas ( pancreatitis ),
- severe liver damage such as liver failure or necrosis, which can be fatal.
- severe, sometimes life-threatening, reactions ( Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
Other side effects such as kidney failure, a decrease in uric acid in the blood, pulmonary hypertension , male infertility (this side effect returns when treatment with this drug is stopped), cutaneous lupus (characterized by rash/redness on exposed skin areas), psoriasis (new or aggravated) and DRESS may also occur with unknown frequency.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
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 carton.
The expiration date is the last day of the specified month.
|Blister:||Store in the original package.|
|Can:||Close the jar tightly.|
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
- The active substance is leflunomide. One film-coated tablet contains 10 mg leflunomide.
- The other ingredients are maize starch, povidone (E1201), crospovidone (E1202), colloidal anhydrous silica, magnesium stearate (E470b), and lactose monohydrate in the tablet core as well as talc (E553b), hypromellose (E464171) titanium dioxide, and titanium dioxide.
What the medicine looks like and the contents of the pack
Arava 10 mg film-coated tablets are white to off-white and round.
Engraving on one side: BZN.
The tablets are packaged in pressure packs or cans. Packs of 30 or 100 tablets are available.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sanofi-Aventis Deutschland GmbH
Sanofi Winthrop Industrie
56, Route de Choisy au Bac
F 60205 Compiegne Cedex, France
Contact the representative of the marketing authorization holder to find out more about this medicine:
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