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LEFLUNOMIDE 10MG FILM-COATED TABLETS

Active substance(s): LEFLUNOMIDE / LEFLUNOMIDE / LEFLUNOMIDE

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Package leaflet: Information for the user

Leflunomide 10, 20mg
film-coated tablets

leflunomide

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. See section 4.
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

1. What Leflunomide is and
what it is used for
Leflunomide belongs to a group of medicines called
anti-rheumatic medicines. It contains the active
substance leflunomide.
Leflunomide 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).

2. What you need to know before you
take Leflunomide
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. Stevens-Johnson syndrome)
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 or breast-feeding.

Children and adolescents
Leflunomide is not recommended for use in
children and adolescents below 18 years of age.
Other medicines and Leflunomide
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,
D-penicillamine, 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 Leflunomide
which is absorbed by the body.
If you are already taking a non-steroidal antiinflammatory 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.

Pregnancy and breast-feeding
Do not take Leflunomide if you are, or think you may
be pregnant. 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.
Warnings and precautions
Tell your doctor if you plan to become pregnant after
Talk to your doctor, pharmacist or nurse before
stopping treatment with Leflunomide, as you need to
taking Leflunomide
ensure that all traces of Leflunomide have left your
 if you have ever suffered from interstitial lung
body before trying to become pregnant. This may
disease.
take up to 2 years. This may be reduced to a few
 if you have ever had tuberculosis or if you have
weeks by taking certain medicines which speed up
been in close contact with someone who has or has removal of Leflunomide from your body.
had tuberculosis. Your doctor may perform tests to
In either case it should be confirmed by a blood test
see if you have tuberculosis.
that Leflunomide has been sufficiently removed from
 if you are male and wish to father a child, as it
your body and you should then wait for at least
cannot be excluded that Leflunomide passes into
another month before you become pregnant.
semen, reliable contraception should be used
For further information on the laboratory testing
during treatment with Leflunomide. Men wishing
please contact your doctor.
to father a child should contact their doctor who
If you suspect that you are pregnant while taking
may advise them to stop taking Leflunomide and
Leflunomide or in the two years after you have
take certain medicines to remove Leflunomide
stopped treatment, you must contact your doctor
rapidly and sufficiently from their body. You will
immediately for a pregnancy test. If the test
then need a blood test to make sure that
confirms that you are pregnant, your doctor may
Leflunomide has been sufficiently removed from
suggest treatment with certain medicines to speed
your body, and you should then wait for at least
up the removal of Leflunomide from the body, as this
another 3 months before attempting to father
may decrease the risk to your baby.
a child.
 if you are due to have a specific blood test (calcium
Do not take Leflunomide when you are breastlevel). Falsely low levels of calcium can be detected. feeding, as leflunomide passes into the breast milk.
Driving and using machines
Leflunomide can occasionally cause some problems
with your blood, liver, lungs, or nerves in your arms or Leflunomide can make you feel dizzy which may
legs. It may also cause some serious allergic reactions impair your ability to concentrate and react. If you are
(including Drug Reaction with Eosinophilia and
affected, do not drive, or use machines.
Systematic Symptoms [DRESS]), or increase the
Leflunomide contains lactose
chance of a severe infection. For more information on
If you have been told by your doctor that you have an
these, please read section 4 (Possible side effects).
intolerance to some sugars, contact your doctor
DRESS appears initially as flu-like symptoms and a
before taking this medicinal product.
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 3. How to take Leflunomide
Always take this medicine exactly as your doctor or
cell (eosinophilia) and enlarged lymph nodes.
pharmacist has told you. Check with your doctor or
Your doctor will carry out blood tests at regular
pharmacist if you are not sure.
intervals, before and during treatment with
The usual starting dosage of Leflunomide is 100mg
Leflunomide, to monitor your blood cells and liver.
once daily for the first three days. After this, most
Your doctor will also check your blood pressure
patients need a dose of:
regularly as Leflunomide can cause an increase in
blood pressure.
 For rheumatoid arthritis: 10 or 20mg Leflunomide
once daily, depending on the severity of the disease.
Tell your doctor if you have unexplained chronic
 For psoriatic arthritis: 20mg Leflunomide
diarrhoea. Your doctor may perform additional tests
once daily.
for differential diagnosis.
Swallow the tablet whole and with plenty of water.

It may take about 4 weeks or longer until you start to Very rare side effects
feel an improvement in your condition. Some patients (may affect up to 1 in 10,000 people)
may even still feel further improvements after 4 to 6
 a marked decrease of some white blood cells
months of therapy.
(agranulocytosis),
You will normally take Leflunomide over long periods  severe and potentially severe allergic reactions,
of time.
 inflammation of the small vessels (vasculitis,
including cutaneous necrotizing vasculitis),
If you take more Leflunomide than you should
 inflammation of the pancreas (pancreatitis),
If you take more Leflunomide than you should,
 severe liver injury such as liver failure or necrosis
contact your doctor or get other medical advice. If
which may be fatal,
possible, take your tablets or the box with you to
 severe sometimes life-threatening reactions
show the doctor.
(Stevens-Johnson syndrome, toxic epidermal
necrolysis, erythema multiforme, DRESS).
If you forget to take Leflunomide
Other side effects such as kidney failure, a decrease
If you forget to take a dose, take it as soon as you
remember, unless it is nearly time for your next dose. in the levels of uric acid in your blood, pulmonary
hypertension, male infertility (which is reversible
Do not take a double dose to make up for a
once treatment with this medicine is stopped),
forgotten dose.
cutaneous lupus (characterised by rash/erythema on
If you have any further questions on the use of this
skin areas that are exposed to light) and psoriasis
product, ask your doctor, pharmacist or nurse.
(new or worsening) may also occur with a not
known frequency.

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:
 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, 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
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 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 (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,
 colitis,
 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 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).

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.
United Kingdom: You can also report side effects
directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
Ireland: You can also report side effects directly via:
HPRA Pharmacovigilance, Earlsfont Terrace, IRL Dublin 2. Tel: +352 1 6764971. Fax +353 1 6762517,
Website: www.hpra.ie, email: medsafety@hpra.ie.
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Leflunomide
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 packaging. The expiry date refers to
the last day of that month.
Bottle: 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 contains
 The active substance is leflunomide.
One film-coated tablet contains 10 or 20mg of
leflunomide.
 The other ingredients are: Cellulose
microcrystalline, pregelatinized starch
(maize starch 1500), povidone (E1201) (k30),
crospovidone (E1202) (Type A), silica colloidal
anhydrous, magnesium stearate (E470b), and
lactose monohydrate in the tablet core, as well as
Opadry II White OY-LS-28908 in the 10mg filmcoating [consisting of: Titanium dioxide (E171),
Lactose monohydrate, Hypromellose 15cP (E464),
Macrogol/PEG 4000, Hypromellose 3cP (E464),
Hypromellose 50cP (E464)] or
Opadry OY-SR-6497 in the 20mg film-coating
[consisting of: Hypromellose 15cP (E464),
Titanium dioxide (E171), Macrogol 6000, Talc,
Iron oxide yellow (E172)]
What Leflunomide looks like and
contents of the pack
 Leflunomide 10mg film-coated tablets are white,
round biconvex tablets.
 Leflunomide 20mg film-coated tablets are yellow,
round biconvex, with a scoreline on one side. The
score-line is for the purpose of identification only.
The tablets are packed in bottles and aluminium
(Alu/Alu) foil blisters of 30 tablets.
Marketing Authorisation Holder
Aspire Pharma Ltd
Unit 4, Rotherbrook Court
Bedford Road
Petersfield
Hampshire
GU32 3QG
United Kingdom
Manufacturer
Pharmathen SA
Dervenakion 6
Pallini 15351
Attiki
Greece
Alternative manufacturer
Pharmathen International S.A
Industrial Park Sapes
Rodopi Prefecture
Block No 5
Rodopi 69300
Greece
This leaflet was last revised
in 05/2017

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1010078-P12.1A

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Aspire Pharma Limited
Leflunomide
Black
Leaflet
420mm x 148mm
Yes
16 May 2012
Safety variation
12.1A
16.5.17
As swatch(es)
9pt Strada Pro Condensed
InDesign CS6
S786 (formerly S715)

Package leaflet: Information for the user

Leflunomide 10, 20mg
film-coated tablets

leflunomide

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. See section 4.
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

1. What Leflunomide is and what it is used for
Leflunomide belongs to a group of medicines called antirheumatic medicines. It contains the active substance
leflunomide.
Leflunomide 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).

2. What you need to know before you
take Leflunomide
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. StevensJohnson syndrome) 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 or breast-feeding.

Children and adolescents
Leflunomide is not recommended for use in children and
adolescents below 18 years of age.
Other medicines and Leflunomide
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, D-penicillamine, 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 Leflunomide 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.


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.

Pregnancy and breast-feeding
Do not take Leflunomide if you are, or think you may be
pregnant. 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
Warnings and precautions
must not take Leflunomide without using reliable
contraceptive measures.
Talk to your doctor, pharmacist or nurse before
taking Leflunomide
Tell your doctor if you plan to become pregnant after stopping
treatment with Leflunomide, as you need to ensure that all
 if you have ever suffered from interstitial lung disease.
traces of Leflunomide have left your body before trying to
 if you have ever had tuberculosis or if you have been in
become pregnant. This may take up to 2 years. This may be
close contact with someone who has or has had
reduced to a few weeks by taking certain medicines which
tuberculosis. Your doctor may perform tests to see if you
speed up removal of Leflunomide from your body.
have tuberculosis.
In either case it should be confirmed by a blood test that
 if you are male and wish to father a child, as it cannot be
Leflunomide has been sufficiently removed from your body and
excluded that Leflunomide passes into semen, reliable
you should then wait for at least another month before you
contraception should be used during treatment with
become pregnant.
Leflunomide. Men wishing to father a child should contact
For further information on the laboratory testing please
their doctor who may advise them to stop taking
contact your doctor.
Leflunomide and take certain medicines to remove
Leflunomide rapidly and sufficiently from their body. You will If you suspect that you are pregnant while taking Leflunomide
then need a blood test to make sure that Leflunomide has
or in the two years after you have stopped treatment, you must
been sufficiently removed from your body, and you should
contact your doctor immediately for a pregnancy test. If the
then wait for at least another 3 months before attempting to test confirms that you are pregnant, your doctor may suggest
father a child.
treatment with certain medicines to speed up the removal of
Leflunomide from the body, as this may decrease the risk to
 if you are due to have a specific blood test (calcium level).
Falsely low levels of calcium can be detected.
your baby.
Leflunomide can occasionally cause some problems with your Do not take Leflunomide when you are breast-feeding, as
leflunomide passes into the breast milk.
blood, liver, lungs, or nerves in your arms or legs. It may also
cause some serious allergic reactions (including Drug Reaction Driving and using machines
with Eosinophilia and Systematic Symptoms [DRESS]), or
Leflunomide can make you feel dizzy which may impair your
increase the chance of a severe infection. For more information ability to concentrate and react. If you are affected, do not
on these, please read section 4 (Possible side effects).
drive, or use machines.
DRESS appears initially as flu-like symptoms and a rash on
Leflunomide contains lactose
the face then an extended rash with a high temperature,
If you have been told by your doctor that you have an
increased levels of liver enzymes seen in blood tests and an
intolerance to some sugars, contact your doctor before taking
increase in a type of white blood cell (eosinophilia) and
this medicinal product.
enlarged lymph nodes.
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.
Tell your doctor if you have unexplained chronic diarrhoea.
Your doctor may perform additional tests for differential
diagnosis.

3. How to take Leflunomide
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 of Leflunomide is 100mg once daily
for the first three days. After this, most patients need a dose of:
 For rheumatoid arthritis: 10 or 20mg Leflunomide once
daily, depending on the severity of the disease.
 For psoriatic arthritis: 20mg Leflunomide once daily.
Swallow the tablet whole and with plenty of water.

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,
If you take more Leflunomide than you should
 inflammation of the small vessels (vasculitis, including
If you take more Leflunomide than you should, contact your
cutaneous necrotizing vasculitis),
doctor or get other medical advice. If possible, take your tablets  inflammation of the pancreas (pancreatitis),
or the box with you to show the doctor.
 severe liver injury such as liver failure or necrosis which may
be fatal,
If you forget to take Leflunomide
 severe sometimes life-threatening reactions (StevensIf you forget to take a dose, take it as soon as you remember,
Johnson syndrome, toxic epidermal necrolysis, erythema
unless it is nearly time for your next dose. Do not take a double
multiforme, DRESS).
dose to make up for a forgotten dose.
Other side effects such as kidney failure, a decrease in the
If you have any further questions on the use of this product, ask levels of uric acid in your blood, pulmonary hypertension, male
your doctor, pharmacist or nurse.
infertility (which is reversible once treatment with this
medicine is stopped), cutaneous lupus (characterised by rash/
4. Possible side effects
erythema on skin areas that are exposed to light) and psoriasis
(new or worsening) may also occur with a not known frequency.
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Reporting of side effects
Tell your doctor immediately and stop taking Leflunomide:
If you get any side effects, talk to your doctor, pharmacist or
 if you experience weakness, feel light-headed or dizzy or
nurse. This includes any possible side effects not listed in
have difficulty breathing, as these may be signs of a
this leaflet.
serious allergic reaction,
United Kingdom: You can also report side effects directly via
 if you develop a skin rash or ulcers in your mouth, as these
the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
may indicate severe, sometimes life-threatening reactions
(e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, Ireland: You can also report side effects directly via: HPRA
erythema multiforme, DRESS), see section 2.
Pharmacovigilance, Earlsfont Terrace, IRL - Dublin 2.
Tel: +352 1 6764971. Fax +353 1 6762517,
Tell your doctor immediately if you experience:
Website: www.hpra.ie, email: medsafety@hpra.ie.
 pale skin, tiredness, or bruising, as these may indicate
blood disorders caused by an imbalance in the different
By reporting side effects you can help provide more
types of blood cells which make up blood,
information on the safety of this medicine.
 tiredness, abdominal pain, or jaundice (yellow
discolouration of the eyes or skin), as these may indicate
5. How to store Leflunomide
serious conditions such as liver failure, which may be fatal,
Keep this medicine out of the sight and reach of children.
 any symptoms of an infection such as fever, sore throat or
Do not use this medicine after the expiry date which is stated
cough, as this medicine may increase the chance of a severe
on the packaging. The expiry date refers to the last day of
infection which may be life-threatening,
that month.
 cough or breathing problems as these may indicate
Bottle: Keep the container tightly closed.
problems of the lung (interstitial lung disease or
Do not throw away any medicines via wastewater or
pulmonary hypertension),
household waste. Ask your pharmacist how to throw away
 unusual tingling, weakness or pain in your hands or feet as
medicines you no longer use. These measures will help protect
these may indicate problems with your nerves (peripheral
the environment.
neuropathy).
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.

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,
 colitis,
 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 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).

6. Contents of the pack and
other information
What Leflunomide contains
 The active substance is leflunomide.
One film-coated tablet contains 10 or 20mg of leflunomide.
 The other ingredients are: Cellulose microcrystalline,
pregelatinized starch (maize starch 1500), povidone
(E1201) (k30), crospovidone (E1202) (Type A), silica colloidal
anhydrous, magnesium stearate (E470b), and lactose
monohydrate in the tablet core, as well as Opadry II White
OY-LS-28908 in the 10mg film- coating [consisting of:
Titanium dioxide (E171), Lactose monohydrate,
Hypromellose 15cP (E464), Macrogol/PEG 4000,
Hypromellose 3cP (E464), Hypromellose 50cP (E464)] or
Opadry OY-SR-6497 in the 20mg film-coating [consisting of:
Hypromellose 15cP (E464), Titanium dioxide (E171),
Macrogol 6000, Talc, Iron oxide yellow (E172)]
What Leflunomide looks like and
contents of the pack
 Leflunomide 10mg film-coated tablets are white, round
biconvex tablets.
 Leflunomide 20mg film-coated tablets are yellow, round
biconvex, with a scoreline on one side. The score-line is for
the purpose of identification only.
The tablets are packed in bottles and aluminium (Alu/Alu) foil
blisters of 30 tablets.
Marketing Authorisation Holder
Aspire Pharma Ltd
Unit 4, Rotherbrook Court
Bedford Road
Petersfield
Hampshire
GU32 3QG
United Kingdom
Manufacturer
Pharmathen SA
Dervenakion 6
Pallini 15351
Attiki
Greece
Alternative manufacturer
Pharmathen International S.A
Industrial Park Sapes
Rodopi Prefecture
Block No 5
Rodopi 69300
Greece
This leaflet was last revised
in 05/2017

1010078-P2.1

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Aspire Pharma Limited
Leflunomide
Black
Leaflet
420mm x 148mm
Yes
16 May 2012
Safety variation - foil artwork
2.1
16.5.17
As swatch(es)
9pt Strada Pro Condensed
InDesign CS6
S786 (formerly S715)

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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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