LEFLUNOMIDE 10 MG FILM-COATED TABLETS

Active substance: LEFLUNOMIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Leflunomide 10 mg Film-coated Tablets
Leflunomide 20 mg Film-coated Tablets

SZ00000LT000

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

Children and adolescents
Leflunomide is not recommended for use in children
and adolescents below 18 years of age.
Other medicines and Leflunomide
Tell your doctor, pharmacist or nurse if you are taking,
have recently taken or might take any other medicines.

What Leflunomide is and what it is
used for

Leflunomide belongs to a group of medicines called
anti-rheumatic medicines.

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,

Leflunomide is used to treat adult patients with active
rheumatoid 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).



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.

2



What you need to know before you
take Leflunomide

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.

If you are already taking a non-steroidal anti-inflammatory
drug (NSAID) and/or corticosteroids, you may continue
to take them after starting 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. 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.

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, 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.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking
Leflunomide
• if you have ever suffered from tuberculosis or
interstitial lung disease (lung disease),
• if you are male and wish to father a child. As it
cannot 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.

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.

For further information on the laboratory testing please
contact your doctor.

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 (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).

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.

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.

Do not take Leflunomide when you are breast feeding,
as leflunomide passes into the breast milk.

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.

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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,

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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Date prepared:
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Colours:
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Dimensions: 130 x 300 mm

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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.

3








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).

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 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.
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 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
medicine, ask your doctor, pharmacist or nurse.

4

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, DRESS).

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 (characterized by rash/erythema on
skin areas that are exposed to light) and psoriasis (new
or worsening) may also occur with an unknown frequency.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist
or nurse. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via Yellow Card Scheme:
www.mhra.gov.uk/yellowcard. By reporting side effects
you can help provide more information on the safety of
this medicine.

Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them. This includes any
side effects not listed in this leaflet.

5

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, Drug Reaction with Eosinophilia and
Systemic Symptoms [DRESS]), see section 2.

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 bottle and the outer carton. The expiry
date refers to the last day of that month.
Keep the bottle tightly closed in order to protect from
moisture.

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,
• 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).

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 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.

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),
• problems in the nerves of the arms or legs
(peripheral neuropathy).

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.

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.

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.
Not all pack size may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz Ltd, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Manufacturer:
Haupt Pharma Münster GmbH, Schleebrüggenkamp 15,
48159 Münster, Germany or
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1,
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39179 Barleben, Germany

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,

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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.

This leaflet was last revised in 10/2014.

Artwork Proof Box
Ref: V013 - SPC & PIL update - PRAC recomm + Nat Phase
Proof no.
006.1

Date prepared:
20/10/2014

Colours:
Black
Black 20%
Dimensions: 130 x 300 mm

Font size:
6pt
Fonts:
Helvetica

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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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