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LEFLUNOMIDE 10MG FILM-COATED TABLETS

Active substance(s): 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.

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.
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
Warnings and precautions
body before trying to become pregnant. This may
Talk to your doctor, pharmacist or nurse before
take up to 2 years. This may be reduced to a few
taking Leflunomide
weeks by taking certain medicines which speed up
removal of Leflunomide from your body.
 if you have ever suffered from interstitial lung
disease.
In either case it should be confirmed by a blood test
that Leflunomide has been sufficiently removed from
 if you have ever had tuberculosis or if you have
been in close contact with someone who has or has your body and you should then wait for at least
had tuberculosis. Your doctor may perform tests to another month before you become pregnant.
see if you have tuberculosis.
For further information on the laboratory testing
please contact your doctor.
 if you are male and wish to father a child, as it
cannot be excluded that Leflunomide passes into
If you suspect that you are pregnant while taking
semen, reliable contraception should be used
Leflunomide or in the two years after you have
during treatment with Leflunomide. Men wishing
stopped treatment, you must contact your doctor
to father a child should contact their doctor who
immediately for a pregnancy test. If the test
may advise them to stop taking Leflunomide and
confirms that you are pregnant, your doctor may
take certain medicines to remove Leflunomide
suggest treatment with certain medicines to speed
rapidly and sufficiently from their body. You will
up the removal of Leflunomide from the body, as this
then need a blood test to make sure that
may decrease the risk to your baby.
Leflunomide has been sufficiently removed from
Do not take Leflunomide when you are breastyour body, and you should then wait for at least
feeding, as leflunomide passes into the breast milk.
another 3 months before attempting to father
Driving and using machines
a child.
Leflunomide can make you feel dizzy which may
Leflunomide can occasionally cause some problems
with your blood, liver, lungs, or nerves in your arms or impair your ability to concentrate and react. If you are
legs. It may also cause some serious allergic reactions affected, do not drive, or use machines.
(including Drug Reaction with Eosinophilia and
Leflunomide contains lactose.
Systematic Symptoms [DRESS]), or increase the
chance of a severe infection. For more information on If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor
these, please read section 4 (Possible side effects).
before taking this medicinal product.
DRESS appears initially as flu-like symptoms and a
rash on the face then an extended rash with a high
3. How to take Leflunomide
temperature, increased levels of liver enzymes seen
in blood tests and an increase in a type of white blood Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
cell (eosinophilia) and enlarged lymph nodes.
pharmacist if you are not sure.
Your doctor will carry out blood tests at regular
The usual starting dosage of Leflunomide is 100mg
intervals, before and during treatment with
once daily for the first three days. After this, most
Leflunomide, to monitor your blood cells and liver.
patients need a dose of:
Your doctor will also check your blood pressure
 For rheumatoid arthritis: 10 or 20mg Leflunomide
regularly as Leflunomide can cause an increase in
once daily, depending on the severity of the disease.
blood pressure.
 For psoriatic arthritis: 20mg Leflunomide
Tell your doctor if you have unexplained chronic
once daily.
diarrhoea. Your doctor may perform additional tests
for differential diagnosis.
Swallow the tablet whole and with plenty of water.
It may take about 4 weeks or longer until you start to
Children and adolescents
feel an improvement in your condition. Some patients
Leflunomide is not recommended for use in
may even still feel further improvements after 4 to 6
children and adolescents below 18 years of age.
months of therapy.

You will normally take Leflunomide over long periods
of time.
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 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.
If you have any further questions on the use of this
product, ask your doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
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).

severe sometimes life-threatening reactions
(Stevens-Johnson syndrome, toxic epidermal
necrolysis, erythema multiforme, DRESS).
Other side effects such as kidney failure, a decrease
in the levels of uric acid in your blood, pulmonary
hypertension, 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) and psoriasis
(new or worsening) may also occur with a not
known frequency.


Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet.
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 of 30 tablets.
Marketing Authorisation Holder
Aspire Pharma Ltd
Bellamy House
Winton Road
Petersfield,
Hampshire
GU32 3HA
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 11/2015

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,
1010078-P9.2

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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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