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LEFLUNOMIDE MYLAN 10 MG FILM-COATED TABLETS

Active substance(s): LEFLUNOMIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Leflunomide 10 mg
film-coated tablets
Leflunomide 20 mg
film-coated tablets
Leflunomide 100 mg
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
or pharmacist.
• 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 or pharmacist.
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. 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 (reduction of red blood cells).
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 levels 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 due to causes other than
rheumatoid arthritis,
• if you are suffering from a serious infection,
• if you are pregnant, think you may be pregnant or are
breast-feeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking leflunomide:
• if you have ever suffered from 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 passes into semen, reliable
contraception should be used during treatment
with leflunomide.
Men wishing to father a child should contact their 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.
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
and 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’.
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.
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.

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 any other 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,
Tumour Necrosis Factor alpha-Inhibitors and other
immunosuppressive drugs (e.g. methotrexate) as these
combinations are not advisable,
• 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,
• phenytoin (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.
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.
Taking 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 contraceptives 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 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.
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.
Leflunomide contains lactose.
If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE LEFLUNOMIDE
Always take Leflunomide exactly as your doctor or pharmacist
has told you. You should check with your doctor or pharmacist
if you are not sure.
The usual starting dosage of Leflunomide is 100 mg once daily
for the first three days. After this, most patients need a dose of:
• For rheumatoid arthritis: 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.
You may have any of these symptoms: stomach pain, diarrhea,
itching and rash.

Date: 17 Sep 2014
Description Leflunomide 10/20/100mg 28/30/50/60/100/500 No. of colours
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 446393

SAP No. N/A

Superceded Affiliate Item Code 368447
TrackWise PR No. 446393
MA No. N/A

Vendor Job No. 232075
Proof No. 2
Client Market UK

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code TBC

Barcode Info N/A

Sign-offs

Colours

1

Time: 15:44
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 200 x 400mm

Body Text Size 9.5 pt

If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

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
www.mhra.gov.uk/yellowcard. By reporting side effects you
can help provide more information on the safety of
this medicine.

4. POSSIBLE SIDE EFFECTS

5. HOW TO STORE LEFLUNOMIDE

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

Keep this medicine out of the sight and reach of children.

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.

Tell your doctor immediately and stop taking Leflunomide:
• if you experience weakness, feel light-headed or dizzy
or have difficulty breathing, (with or without skin rash
including red itchy skin, swelling of the hands, feet ankles,
face, lips, mouth or throat with difficultly in swallowing), 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 4.
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, ulcers in your
mouth (signs of agranulocytosis-marked decrease of some
white blood cells-very rare), sore throat or cough, as this
medicine may increase the chance of a severe infection,
including sepsis(rare), 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)
• inflammation of the pancreas (pancreatitis).
Other side effects:
Common (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).
Uncommon (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.

Do not use this medicine after the expiry date which is stated
on the blister / bottle and outer packaging. The expiry date
refers to the last day of that month.
This medicinal product does not require any special
storage conditions.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
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, 20 or 100 mg of leflunomide.
The tablet core: contains microcrystalline cellulose,
pregelatinized maize starch, povidine K 30 (E1201),
crospovidone (E1202), silica colloidal anhydrous, magnesium
stearate (E470b) and lactose monohydrate.
The film coating additionally contains titanium dioxide (E171),
hypromellose (E464) and macrogol. The 20 mg tablet also
contains talcum and yellow iron oxide (E172).
What Leflunomide looks like and contents of the pack
• Leflunomide 10mg film-coated tablets are white, round
biconvex tablets with a diameter of about 6.1mm. The
product is packaged in a cardboard box containing PA/ALU/
PVC – Aluminum (Alu/Alu) foil blisters or a white opaque
HDPE bottle with an integrated desiccant (white silica gel) or
desiccant sachet.
Pack sizes: 30, 100 film-coated tablets
• Leflunomide 20mg film-coated tablets are yellow, round
biconvex, with a score line on one side with a diameter of
about 8.1mm. The product is packaged in a cardboard box
containing PA/ALU/PVC – Aluminum (Alu/Alu) foil blisters or
a white opaque HDPE bottle with an integrated desiccant
(white silica gel) or desiccant sachet.
Pack sizes of 28, 30, 50, 60, 100 and 500 tablets are available.
Pack sizes: 30, 100, 500 (only in HDPE bottle) film-coated tablets
• Leflunomide 100mg film-coated tablets are white, oblong
biconvex, with a score line on one side with dimensions
about 19.4mm×7.8mm. The product is packed in a cardboard
box containing PA/ALU/PVC – Aluminum (Alu/Alu) foil
blisters. Pack sizes: 3 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire En6 1TL United Kingdom
Manufacturer
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange
Road, Dublin 13 Ireland
Pharmathen S.A., Dervenakion 6, 15351 Pallini Attiki, Greece
Pharmathen International S.A. Industrial Park Sapes, Rodopi
Prefecture, Block No 5, Rodopi 69300, Greece

Rare (may affect up to 1 in 1000 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,
• an increase in some liver results which may develop into
serious conditions such as hepatitis and jaundice,
• an increase of certain enzymes in the blood
(lactate dehydrogenase).
Very rare (may affect up to 1 in 10,000 people)
• inflammation of the small vessels (vasculitis, including
cutaneous necrotizing vasculitis),
Not known (frequency cannot be estimated from the
available data)
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 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.
This leaflet was last revised in 09/2014

Date: 17 Sep 2014
Description Leflunomide 10/20/100mg 28/30/50/60/100/500 No. of colours
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 446393

SAP No. N/A

Superceded Affiliate Item Code 368447
TrackWise PR No. 446393
MA No. N/A

Vendor Job No. 232075
Proof No. 2
Client Market UK

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code TBC

Barcode Info N/A

Sign-offs

Colours

1

446393

Time: 15:44
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 200 x 400mm

Body Text Size 9.5 pt

Expand view ⇕

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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