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LEFLUNOMIDE 100 MG FILM-COATED TABLETS

Active substance(s): LEFLUNOMIDE

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Package leaflet: Information for the user

Leflunomide 100 mg Film-coated Tablets

Leflunomide Tablets contain lactose.
If you have been told by your doctor that you have
intolerance to some sugars, contact your doctor before
taking this medicinal product.

leflunomide
3. How to take Leflunomide Tablets
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 side effects not
listed in this leaflet.
What is in this leaflet:
1. What Leflunomide Tablets are and what they are used
for
2. What you need to know before you take Leflunomide
Tablets
3. How to take Leflunomide Tablets
4. Possible side effects
5. How to store Leflunomide Tablets
6. Contents of the pack and other information
1. What Leflunomide Tablets are and what they are
used for
Leflunomide belongs to the group of drugs known as antirheumatic medicines which are used in the treatment of
adult patients with active rheumatoid arthritis or with active
psoriatic arthritis. It contains the active substance
leflunomide.
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).
2. What you need to know before you take
Leflunomide Tablets
Do not take Leflunomide Tablets if you
! are allergic to leflunomide or any of the other
ingredients of this medicine (listed in section 6),
! have decreased liver function,
! have moderate to severe decreased kidney function,
! have severely low amounts of protein in your blood
(hypoproteinaemia),
! suffer from any problem which affects your immune
system (e.g. AIDS),
! 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,
! are suffering from a serious infection,
! are pregnant, think you may be pregnant or are
breast-feeding.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before taking
Leflunomide Tablets
!
!

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if you have a history of 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 perform tests to see if
you have tuberculosis.
if you are male and wish to father a child. As it cannot be
excluded that Leflunomide Tablets passes into semen
reliable contraception should be used during treatment
with Leflunomide Tablets. Men wishing to father a child
should contact their doctor who may advise them to
stop taking Leflunomide Tablets and take certain
medicines to remove Leflunomide Tablets rapidly and
sufficiently from their 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.

Leflunomide Tablets 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
(including Drug Reaction with Eosinophilia and Systemic
Symptoms [DRESS]), or increase the chance of a severe
infection. For more information on these, please read
section 4 (Possible 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.
Your doctor will carry out blood tests at regular intervals,
before and during treatment with Leflunomide Tablets, to
monitor your blood cells and liver. Your doctor will also check
your blood pressure regularly as Leflunomide Tablets can
cause an increase in blood pressure.

Children and adolescents
Leflunomide Tablets are not recommended for use in
children and adolescents below 18 years of age.
Other medicines and Leflunomide Tablets
Please tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. This
includes medicines obtained without a prescription.
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, Dpenicillamine, azathioprine and other
immunosuppressive drugs (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 Lefunomide which is
absorbed by the body.
If you are already taking a non-steroidal anti-inflammatory
drug (NSAID) and/or corticosteroids, you may continue to
take them after starting Leflunomide Tablets.
Vaccinations
If you have to be vaccinated, ask your doctor for advice.
Certain vaccinations should not be given while taking
Leflunomide Tablets, and for a certain amount of time after
stopping treatment.
Leflunomide Tablets with food, drink and alcohol
You may take the tablets with or without food. Alcohol should
be avoided whilst taking this medicine as it may increase the
risk of side effects on the liver.
Pregnancy and breast-feeding
Pregnancy
Do not take Leflunomide Tablets if you are or think you
might be pregnant. If you are pregnant or become
pregnant whilst taking Leflunomide Tablets, the risk of
having a baby with serious birth defects is increased.
Women of childbearing potential must not take Leflunomide
Tablets without using reliable contraceptive measures.
Leflunomide can last for a long time in the body after
treatment is stopped. You must not get pregnant while taking
leflunomide and for at least two years after treatment has
finished. This may be reduced to a few weeks by taking
certain medicines which remove Leflunomide Tablets
rapidly and sufficiently from your body. In either case it
should be confirmed by a blood test that Leflunomide
Tablets has been sufficiently removed from your body and
you should then wait for 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 Leflunomide Tablets 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 speed up the removal of
Leflunomide Tablets from the body, as this may decrease
the risk to your baby.
Breast-feeding
Do not take Leflunomide Tablets when you are breast
feeding, as leflunomide passes into the breast milk.
Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
Leflunomide Tablets may cause dizziness and impairs the
ability to concentrate and react. Do not drive or use
machines if you have such symptoms.

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure. The usual starting dosage 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 once daily,
depending on the severity of the disease.
! For psoriatic arthritis: 20 mg once daily.
Swallow the tablet whole and with plenty of water. 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 Tablets over long periods of
time.
If you take more Leflunomide Tablets than you should
If you take more of the medicine than you should, a
physician or nearest hospital casualty department must be
contacted immediately. Take your medicine package to
show a doctor.
If you forget to take Leflunomide Tablets
Take the missed dose as soon as you remember, unless it is
nearly time for your next dose. Do not take two doses at the
same time to make up for forgotten individual doses. If you
have any further questions on the use of this product, ask
your doctor, pharmacist or nurse.
If you stop taking Leflunomide Tablets
Do not stop taking the tablets unless your doctor tells you to.
If you have any further questions on how to take this product,
ask your doctor or pharmacist.
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 Leflunomide Tablets:
! if you experience weakness, feel lightheaded 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, and erythaema multiforme), Drug
Reaction with Eosinophilia and Systemic Symptoms
[DRESS]), see section 2.
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 this medicine may increase the
chance of a severe infection which may be lifethreatening,
! 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).
Common side effects (may affect up to 1 in 10 people)
! a slight decrease in the number of white blood cells
(leucopoenia),
! 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),
! 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),

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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 numbers of blood cells called
eosinophiles (eosinophilia); mild decrease in the
number of white blood cells (leucopoenia); decrease in
the number of all blood cells (pancytopaenia),
! 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 (StevensJohnson syndrome, toxic epidermal necrolysis,
erythaema multiforme).
Other side effects such as kidney failure, a decrease in the
levels of uric acid in your blood, male infertility (which is
reversible once treatment with this medicine is stopped),
cutaneous lupus (characterised by rash/erythema on skin
areas that are exposed to light), psoriasis (new or
worsening) and DRESS may also occur with a not known
frequency.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Leflunomide Tablets
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 package. The expiry date refers to the last day of that
month.
Keep the container tightly closed.
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.
6. Contents of the pack and other information
What Leflunomide Tablets contain
The active substance is leflunomide. Each film-coated tablet
contains 100 mg of leflunomide.
The other ingredients are lactose monohydrate, lactose
anhydrous, maize starch, low substituted hydroxypropyl
cellulose, povidone, colloidal anhydrous silica, magnesium
stearate, hypromellose, titanium dioxide (E171) and
macrogol.
What Leflunomide Tablets look like and contents of the
pack
Leflunomide 100 mg Tablets are white, circular, biconvex
film coated tablets plain on both sides.
Leflunomide 100mg Tablets are available in blisters
containing 7, 10, 14, 20, 28, 30, 56, 60, 84, 90, 100 and 112
film coated tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder
Morningside Healthcare Ltd
115 Narborough Road, Leicester, LE3 0PA, UK
Manufacturer
Morningside Pharmaceuticals Ltd
5 Pavilion Way, Loughborough, LE11 5GW, UK
This leaflet was last revised in December 2014

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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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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