One film-coated tablet contains 10 mg or 20 mg of leflunomide.
Excipients/Inactive Ingredients: The other ingredients are: Lactose hydrate, Corn starch, Crospovidone, Povidone K30, Colloidal silicon dioxide, Magnesium stearate, Hypromellose, Polyethylene glycol 6000, Titanium oxide, Talc.
20 mg: Ferric oxide (yellow).
Aray belongs to a group of medicines called anti-rheumatic medicines. It contains the active substance leflunomide.
Aray 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).
Always take this medicine exactly as told by the the doctor or pharmacist. Check with the doctor or pharmacist if unsure.
The usual starting dose of leflunomide is one 100-mg tablet once daily for the first three days. After this, most patients need the following dose.
For rheumatoid arthritis: 10 or 20 mg Aray once daily, depending on the severity of the disease.
For psoriatic arthritis: 20 mg Aray once daily.
Consider other sources of preparation for dosage of one 100-mg tablet.
Swallow the tablet whole and with plenty of water.
It may take about 4 weeks or longer until an improvement in the condition will start to be felt. Some patients may even still feel further improvements after 4 to 6 months of therapy.
Aray will normally be taken over long periods of time.
If a dose has been forgotten to be taken, take it as soon as it is remembered, unless it is nearly time for the next dose. Do not take a double dose to make up for a forgotten dose.
If there are any further questions on the use of this medicine, ask the doctor, pharmacist or nurse.
If more Aray has been taken than what should have been, contact the doctor or get other medical advice. If possible, take the tablets or the box to show the doctor.
Do not take Aray: if with history of 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 this medicine (listed in Description), or if allergic to teriflunomide (used to treat multiple sclerosis); if with any liver problems; if with moderate to severe kidney problems; if with severely low numbers of proteins in the blood (hypoproteinaemia); if suffering from any problem which affects the immune system (e.g. AIDS); if with any problem with the bone marrow, or if with low numbers of red or white cells in the blood or a reduced number of blood platelets; if suffering from a serious infection; if pregnant, thinking may be pregnant, or breast-feeding.
Talk to the doctor, pharmacist or nurse before taking Aray: if with history of suffering from inflammation of the lung (interstitial lung disease); if with history of tuberculosis or being in close contact with someone who has or has had tuberculosis [tests may be performed by the doctor to see if positive for tuberculosis]; if male and wishing to father a child (see as follows); if due to have a specific blood test (calcium level) [falsely low levels of calcium can be detected].
As it cannot be excluded that Aray passes into semen, reliable contraception should be used during treatment with Aray. Men wishing to father a child should contact their doctor who may advise them to stop taking Aray and take certain medicines to remove Aray rapidly and sufficiently from their body. A blood test will then be needed to make sure that Aray has been sufficiently removed from the body, and then at least another 3 months should be waited before attempting to father a child.
Aray can occasionally cause some problems with the blood, liver, lungs, or nerves in the 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, see 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.
Rare cases of severe liver injury, including cases with fatal outcome, have been reported during treatment with leflunomide. Most of the cases occurred within the first 6 months of treatment. Cotreatment with other hepatotoxic medicinal products was frequently present. It is considered essential that monitoring recommendations are strictly adhered to.
The doctor will carry out blood tests at regular intervals, before and during treatment with Aray, to monitor the blood cells and liver. The doctor will also check the blood pressure regularly as Aray can cause an increase in blood pressure.
Tell the doctor if having unexplained chronic diarrhoea. The doctor may perform additional tests for differential diagnosis.
Aray contains lactose: If with an intolerance to some sugars as told by the doctor, contact the doctor before taking this medicine.
Driving and using machines: Aray can cause dizziness which may impair the ability to concentrate and react. If affected, do not drive or use machines.
Use in Children: Aray is not recommended for use in children and adolescents below 18 years of age.
Do not take Aray if pregnant or thinking may be pregnant. If pregnant or became pregnant while taking Aray, the risk of having a baby with serious birth defects is increased. Women of childbearing potential must not take Aray without using reliable contraceptive measures.
Tell the doctor if planning to become pregnant after stopping treatment with Aray, as ensuring that all traces of Aray have left the body is needed 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 Aray from the body.
In either case, it should be confirmed by a blood test that Aray has been sufficiently removed from the body, and then at least another month should be waited before becoming pregnant.
For further information on the laboratory testing, contact the doctor.
If suspecting pregnancy while taking Aray or in the two years after stopping treatment, contact the doctor immediately for a pregnancy test. If the test confirms pregnancy, the doctor may suggest treatment with certain medicines to remove Aray rapidly and sufficiently from the body, as this may decrease the risk to the baby.
Do not take Aray when breast-feeding, as leflunomide passes into the breast milk.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell the doctor immediately and stop taking Aray: if experiencing weakness, feeling light-headed or dizzy or having difficulty breathing, as these may be signs of a serious allergic reaction; if a skin rash or ulcers develop in the mouth, as these may indicate severe, sometimes life-threatening reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]) (see Precautions).
Tell the doctor immediately if experiencing: pale skin, tiredness, or bruising, as these may indicate blood disorders caused by an imbalance in the different types of blood cells which make up blood; tiredness, abdominal pain, or jaundice (yellow discolouration of the eyes or skin), as these may indicate serious conditions such as liver failure, which may be fatal; any symptoms of an infection such as fever, sore throat or cough, as this medicine may increase the chance of a severe infection which may be life-threatening; cough or breathing problems, as these may indicate problems of the lung (interstitial lung disease or pulmonary hypertension); unusual tingling, weakness or pain in the hands or feet, as these may indicate problems with the 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); tiredness (asthenia); headache, dizziness; abnormal skin sensations like tingling (paraesthesia); mild increase in blood pressure; colitis; diarrhoea; 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, itching; tendonitis (pain caused by inflammation in the membrane surrounding the tendons usually in the feet or hands); an increase of certain enzymes in the blood (creatine phosphokinase); problems in the nerves of the arms or legs (peripheral neuropathy).
Uncommon side effects (may affect up to 1 in 100 people): a decrease in the number of red blood cells (anaemia) and a decrease in the number of blood platelets (thrombocytopenia); a decrease in the levels of potassium in the blood; anxiety; taste disturbances; urticaria (nettle rash); tendon rupture; an increase in the levels of fat in the blood (cholesterol and triglycerides); a decrease in the levels of phosphate in the blood.
Rare side effects (may affect up to 1 in 1,000 people): an increase in the number of blood cells called eosinophils (eosinophilia), mild decrease in the number of white blood cells (leucopenia), decrease in the number of all blood cells (pancytopenia); severe increase in blood pressure; inflammation of the lung (interstitial lung disease); an increase in some liver results which may develop into serious conditions such as hepatitis and jaundice; severe infections called sepsis which may be fatal; an 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 the small 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 syndrome, toxic epidermal necrolysis, erythema multiforme).
Other side effects such as kidney failure, a decrease in the levels of uric acid in the 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 any side effects occur, talk to the doctor or pharmacist. This includes any possible side effects not previously listed. By reporting side effects, more information on the safety of this medicine can be provided.
Other medicines and Aray: Tell the doctor or pharmacist if taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription.
This is especially important if taking: other medicines for rheumatoid arthritis such as antimalarials (e.g. chloroquine and hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive medicines (e.g. methotrexate), as these combinations are not advisable; warfarin and other oral medicines used to thin the blood, as monitoring is necessary to reduce the risk of side effects of this medicine; teriflunomide for multiple sclerosis; repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes; daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer; duloxetine for depression, urinary incontinence or in kidney disease in diabetics; alosetron for the management of severe diarrhoea; theophylline for asthma; tizanidine, a muscle relaxant; oral contraceptives (containing ethinylestradiol and levonorgestrel); cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections; indomethacin, ketoprofen for pain or inflammation; furosemide for heart disease (diuretic, water pill); zidovudine for HIV infection; rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol); sulfasalazine for inflammatory bowel disease or rheumatoid arthritis; a medicine called colestyramine (used to reduce high cholesterol) or activated charcoal, as these medicines can reduce the amount of Aray which is absorbed by the body.
If already taking a nonsteroidal anti-inflammatory drug (NSAID) and/or corticosteroids, taking them may be continued after starting Aray.
Vaccinations: If to be vaccinated, ask the doctor for advice. Certain vaccinations should not be given while taking Aray, and for a certain amount of time after stopping treatment.
Aray with food, drink and alcohol: Aray may be taken with or without food.
It is not recommended to drink alcohol during treatment with Aray. Drinking alcohol while taking Aray may increase the chance of liver damage.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.
Keep the bottle tightly closed.
L04AK01 - leflunomide ; Belongs to the class of dihydroorotate dehydrogenase (DHODH) inhibitors. Used as immunosuppressants.
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