LEFLUNOMIDE 10 MG FILM-COATED TABLETS
Active substance: LEFLUNOMIDE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Leflunomide
Leflunomide 10 mg Film-coated Tablets Leflunomide 20 mg Film-coated Tablets
SZ00000LT000
What is in this leaflet: 1. What Leflunomide is and what it is used for 2. What you need to know before you take Leflunomide 3. How to take Leflunomide 4. Possible side effects 5. How to store Leflunomide 6. Contents of the pack and other information
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, pharmacist or nurse. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet .
Leflunomide which is contained in Leflunomide 10 mg and 20 mg film-coated tablets is also authorised to treat other conditions which are not mentioned in this leaflet. Ask your doctor or pharmacist if you have further questions.
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).
Leflunomide is used to treat adult patients with active rheumatoid arthritis.
Leflunomide belongs to a group of medicines called anti-rheumatic medicines.
1
What Leflunomide is and what it is used for
This is especially important if you are taking: other medicines for rheumatoid arthritis such as antimalarials (e.g. chloroquine and hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive drugs (e.g. methotrexate) as these combinations are not advisable,
Other medicines and Leflunomide Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Children and adolescents Leflunomide is not recommended for use in children and adolescents below 18 years of age.
Your doctor will carry out blood tests at regular intervals, before and during treatment with Leflunomide, to monitor your blood cells and liver. Your doctor will also check your blood pressure regularly as Leflunomide can cause an increase in blood pressure.
Leflunomide can occasionally cause some problems with your blood, liver, lungs or nerves in your arms or legs. It may also cause some serious allergic reactions, or increase the chance of a severe infection. For more information on these, please read section 4 (Possible Side Effects).
Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Leflunomide if you have ever suffered from tuberculosis or interstitial lung disease, if you are male and wish to father a child. As it can not be excluded that Leflunomide passes into semen, you should use reliable contraception during treatment with Leflunomide. If you wish to father a child you should contact your doctor who may advise you to stop taking Leflunomide and take certain medicines to remove Leflunomide rapidly and sufficiently from your body. You will then need a blood test to make sure that Leflunomide has been sufficiently removed from your body, and you should then wait for at least another 3 months before attempting to father a child.
Do not take Leflunomide 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. Steven-Johnson syndrome) peanut or soya or to any of the other ingredients of this medicine (listed in section 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 (e.g. AIDS), if 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, if you are suffering from a serious infection, if you are pregnant, think you may be pregnant, or are breast-feeding.
2
a medicine called colestyramine (used to reduce high cholesterol) or activated charcoal as these medicines can reduce the amount of Leflunomide which is absorbed by the body,
What you need to know before you take Leflunomide
If you are already taking a non-steroidal anti-inflammatory drug (NSAID) and/or corticosteroids, you may continue to take them after starting Leflunomide. Vaccinations If you have to be vaccinated, ask your doctor for advice. Certain vaccinations should not be given while taking Leflunomide, and for a certain amount of time after stopping treatment. Leflunomide with food, drink and alcohol Leflunomide may be taken with or without food. It is not recommended to drink alcohol during treatment with Leflunomide. Drinking alcohol while taking Leflunomide may increase the chance of liver damage.
phenytonin (used to treat epilepsy), Warfarin or phenprocoumon (used to thin the blood) or tolbutamide (used to treat type 2 diabetes) as these medicines may increase the risk of side effects.
For further information on the laboratory testing please contact your doctor.
Tell your doctor if you plan to become pregnant after stopping treatment with Leflunomide, as you need to ensure that all traces of Leflunomide have left your body 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 Leflunomide from your body. In either case it should be confirmed by a blood test that Leflunomide has been sufficiently removed from your body and you should then wait for at least another month before you become pregnant.
Pregnancy, breast-feeding and fertility Do not take Leflunomide if you are, or think you may be pregnant or are planning to have a baby. If you are pregnant or become pregnant while taking Leflunomide, the risk of having a baby with serious birth defects is increased. Women of childbearing potential must not take Leflunomide without using reliable contraceptive measures.
If you suspect that you are pregnant while taking Leflunomide or in the two years after you have stopped 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 certain medicines to remove Leflunomide rapidly and sufficiently from your body, as this may decrease the risk to your baby. Do not take Leflunomide when you are breast feeding, as leflunomide passes into the breast milk.
Driving and using machines Leflunomide can make you feel dizzy which may impair your ability to concentrate and react. If you are affected, do not drive, or use machines.
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Leflunomide contains lactose and soya lecithin If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine, If you are allergic to peanut or soya, do not use this medicine.
The recommended starting dosage of Leflunomide is one 100 mg tablet once daily for the first three days. After this, most patients need a dose of: 10 or 20 mg Leflunomide once daily, depending on the severity of the disease. It may take about 4 weeks or longer until you start to feel an improvement in your condition. Some patients may even still feel further improvements after 4 to 6 months of therapy. You will normally take Leflunomide over long periods of time. Swallow the tablet whole and with plenty of water.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
3
How to take Leflunomide
If you take more Leflunomide than you should If you take more Leflunomide than you should, contact your doctor or get other medical advice. If possible, take your tablets or the box with you to show the doctor.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
If you forget to take Leflunomide 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 forgotten dose.
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),
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, 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).
Tell your doctor immediately if you experience: 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 Leflunomide may increase the chance of a severe infection which may be life-threatening, a cough or breathing problems as these may indicate inflammation of the lung (interstitial lung disease), unusual tingling, weakness or pain in your hands or feet as these may indicate problems with your nerves (peripheral neuropathy).
Tell your doctor immediately and stop taking Leflunomide: if you experience weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic reaction, if you develop a skin rash or ulcers in your mouth, as these may indicate severe, sometimes life-threatening reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
Like all medicines, this medicine can cause side effects, although not everybody gets them. This includes any side effects not listed in this leaflet.
4
Possible side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
Other side effects such as kidney failure, a decrease in the levels of uric acid in your blood, and male infertility (which is reversible once treatment with Leflunomide is stopped) may also occur with a unknown frequency (frequency cannot be estimated from the available data).
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).
Rare side effects (may affect up to 1 in 1,000 people) an increase in the numbers of blood cells called eosinophiles (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).
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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Keep the bottle tightly closed in order to protect from moisture.
Do not use this medicine after the expiry date which is stated on the bottle and the outer carton. The expiry date refers to the last day of that month.
Keep this medicine out of the sight and reach of children.
5
How to store Leflunomide
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.
Not all pack size may be marketed.
The film-coated tablets are packed in bottles and are available in the following pack sizes 10, 15, 20, 28, 30, 42, 50, 56, 60, 90, 98 and 100.
Leflunomide 20 mg film-coated tablets are white to almost white and round with a diameter of about 8 mm and a break-mark on one side of the tablet. The tablet can be divided into equal halves.
What Leflunomide looks like and contents of the pack Leflunomide 10 mg film-coated tablets are white to almost white and round with a diameter of about 6 mm.
What Leflunomide contains The active substance is leflunomide. One film-coated tablet contains 10 mg of leflunomide. The active substance is leflunomide. One film-coated tablet contains 20 mg of leflunomide. The other ingredients are lactose monohydrate, low-substituted hydroproxypyl cellulose, tartaric acid, sodium laurilsulfate and magnesium stearate in the tablet core as well as lecithin (soybeans), poly (vinyl alcohol), talc, titanium dioxide (E171) and xanthan gum in the film-coating.
6
Contents of the pack and other information
Manufacturer: Haupt Pharma Mnster GmbH, Schleebrggenkamp 15, 48159 Mnster, Germany or Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany. This leaflet was last revised in 11/2012.
00000000 00000000 CODE 000 SZ00000LT000
Leflunomide
Leflunomide 10 mg Film-coated Tablets Leflunomide 20 mg Film-coated Tablets
SZ00000LT000
What is in this leaflet: 1. What Leflunomide is and what it is used for 2. What you need to know before you take Leflunomide 3. How to take Leflunomide 4. Possible side effects 5. How to store Leflunomide 6. Contents of the pack and other information
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, pharmacist or nurse. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet .
Leflunomide which is contained in Leflunomide 10 mg and 20 mg film-coated tablets is also authorised to treat other conditions which are not mentioned in this leaflet. Ask your doctor or pharmacist if you have further questions.
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).
Leflunomide is used to treat adult patients with active rheumatoid arthritis.
Leflunomide belongs to a group of medicines called anti-rheumatic medicines.
1
What Leflunomide is and what it is used for
This is especially important if you are taking: other medicines for rheumatoid arthritis such as antimalarials (e.g. chloroquine and hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive drugs (e.g. methotrexate) as these combinations are not advisable,
Other medicines and Leflunomide Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Children and adolescents Leflunomide is not recommended for use in children and adolescents below 18 years of age.
Your doctor will carry out blood tests at regular intervals, before and during treatment with Leflunomide, to monitor your blood cells and liver. Your doctor will also check your blood pressure regularly as Leflunomide can cause an increase in blood pressure.
Leflunomide can occasionally cause some problems with your blood, liver, lungs or nerves in your arms or legs. It may also cause some serious allergic reactions, or increase the chance of a severe infection. For more information on these, please read section 4 (Possible Side Effects).
Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Leflunomide if you have ever suffered from tuberculosis or interstitial lung disease, if you are male and wish to father a child. As it can not be excluded that Leflunomide passes into semen, you should use reliable contraception during treatment with Leflunomide. If you wish to father a child you should contact your doctor who may advise you to stop taking Leflunomide and take certain medicines to remove Leflunomide rapidly and sufficiently from your body. You will then need a blood test to make sure that Leflunomide has been sufficiently removed from your body, and you should then wait for at least another 3 months before attempting to father a child.
Do not take Leflunomide 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. Steven-Johnson syndrome) peanut or soya or to any of the other ingredients of this medicine (listed in section 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 (e.g. AIDS), if 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, if you are suffering from a serious infection, if you are pregnant, think you may be pregnant, or are breast-feeding.
2
a medicine called colestyramine (used to reduce high cholesterol) or activated charcoal as these medicines can reduce the amount of Leflunomide which is absorbed by the body,
What you need to know before you take Leflunomide
If you are already taking a non-steroidal anti-inflammatory drug (NSAID) and/or corticosteroids, you may continue to take them after starting Leflunomide. Vaccinations If you have to be vaccinated, ask your doctor for advice. Certain vaccinations should not be given while taking Leflunomide, and for a certain amount of time after stopping treatment. Leflunomide with food, drink and alcohol Leflunomide may be taken with or without food. It is not recommended to drink alcohol during treatment with Leflunomide. Drinking alcohol while taking Leflunomide may increase the chance of liver damage.
phenytonin (used to treat epilepsy), Warfarin or phenprocoumon (used to thin the blood) or tolbutamide (used to treat type 2 diabetes) as these medicines may increase the risk of side effects.
For further information on the laboratory testing please contact your doctor.
Tell your doctor if you plan to become pregnant after stopping treatment with Leflunomide, as you need to ensure that all traces of Leflunomide have left your body 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 Leflunomide from your body. In either case it should be confirmed by a blood test that Leflunomide has been sufficiently removed from your body and you should then wait for at least another month before you become pregnant.
Pregnancy, breast-feeding and fertility Do not take Leflunomide if you are, or think you may be pregnant or are planning to have a baby. If you are pregnant or become pregnant while taking Leflunomide, the risk of having a baby with serious birth defects is increased. Women of childbearing potential must not take Leflunomide without using reliable contraceptive measures.
If you suspect that you are pregnant while taking Leflunomide or in the two years after you have stopped 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 certain medicines to remove Leflunomide rapidly and sufficiently from your body, as this may decrease the risk to your baby. Do not take Leflunomide when you are breast feeding, as leflunomide passes into the breast milk.
Driving and using machines Leflunomide can make you feel dizzy which may impair your ability to concentrate and react. If you are affected, do not drive, or use machines.
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Continued on the next page >>
Leflunomide contains lactose and soya lecithin If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine, If you are allergic to peanut or soya, do not use this medicine.
The recommended starting dosage of Leflunomide is one 100 mg tablet once daily for the first three days. After this, most patients need a dose of: 10 or 20 mg Leflunomide once daily, depending on the severity of the disease. It may take about 4 weeks or longer until you start to feel an improvement in your condition. Some patients may even still feel further improvements after 4 to 6 months of therapy. You will normally take Leflunomide over long periods of time. Swallow the tablet whole and with plenty of water.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
3
How to take Leflunomide
If you take more Leflunomide than you should If you take more Leflunomide than you should, contact your doctor or get other medical advice. If possible, take your tablets or the box with you to show the doctor.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
If you forget to take Leflunomide 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 forgotten dose.
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),
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, 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).
Tell your doctor immediately if you experience: 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 Leflunomide may increase the chance of a severe infection which may be life-threatening, a cough or breathing problems as these may indicate inflammation of the lung (interstitial lung disease), unusual tingling, weakness or pain in your hands or feet as these may indicate problems with your nerves (peripheral neuropathy).
Tell your doctor immediately and stop taking Leflunomide: if you experience weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic reaction, if you develop a skin rash or ulcers in your mouth, as these may indicate severe, sometimes life-threatening reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
Like all medicines, this medicine can cause side effects, although not everybody gets them. This includes any side effects not listed in this leaflet.
4
Possible side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
Other side effects such as kidney failure, a decrease in the levels of uric acid in your blood, and male infertility (which is reversible once treatment with Leflunomide is stopped) may also occur with a unknown frequency (frequency cannot be estimated from the available data).
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).
Rare side effects (may affect up to 1 in 1,000 people) an increase in the numbers of blood cells called eosinophiles (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).
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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Keep the bottle tightly closed in order to protect from moisture.
Do not use this medicine after the expiry date which is stated on the bottle and the outer carton. The expiry date refers to the last day of that month.
Keep this medicine out of the sight and reach of children.
5
How to store Leflunomide
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.
Not all pack size may be marketed.
The film-coated tablets are packed in bottles and are available in the following pack sizes 10, 15, 20, 28, 30, 42, 50, 56, 60, 90, 98 and 100.
Leflunomide 20 mg film-coated tablets are white to almost white and round with a diameter of about 8 mm and a break-mark on one side of the tablet. The tablet can be divided into equal halves.
What Leflunomide looks like and contents of the pack Leflunomide 10 mg film-coated tablets are white to almost white and round with a diameter of about 6 mm.
What Leflunomide contains The active substance is leflunomide. One film-coated tablet contains 10 mg of leflunomide. The active substance is leflunomide. One film-coated tablet contains 20 mg of leflunomide. The other ingredients are lactose monohydrate, low-substituted hydroproxypyl cellulose, tartaric acid, sodium laurilsulfate and magnesium stearate in the tablet core as well as lecithin (soybeans), poly (vinyl alcohol), talc, titanium dioxide (E171) and xanthan gum in the film-coating.
6
Contents of the pack and other information
Manufacturer: Haupt Pharma Mnster GmbH, Schleebrggenkamp 15, 48159 Mnster, Germany or Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany. This leaflet was last revised in 11/2012.
00000000 00000000 CODE 000 SZ00000LT000
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
