Skip to Content

LEFLUNOMIDE 10 MG TABLETS

Active substance(s): LEFLUNOMIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user
Leflunomide 10 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, 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.
2.
3.
4.
5.
6.

What Leflunomide Tablets are and what they are used for
What you need to know before you take Leflunomide Tablets
How to take Leflunomide Tablets
Possible side effects
How to store Leflunomide Tablets
Contents of the pack and other information

1.

What Leflunomide Tablets are and what they are used for

The name of your medicine is Leflunomide 10 mg Film-coated Tablets but in the rest of this leaflet it
will be called Leflunomide Tablets.
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 Tablets

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) or
to any of the other ingredients of this medicine (listed in section 6).
have any liver problems,
have moderate to severe kidney problems,
have severely low numbers of proteins 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,
1

-

are suffering from a serious infection,
are pregnant, think you may be pregnant or breast-feeding.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Leflunomide Tablets if you
have ever suffered from tuberculosis (a lung disease) 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.
have ever suffered from interstitial lung disease (lung disease),
are male and wish to father a child, as Leflunomide can cause birth defects in new born
infants. To minimise any possible risk, men wishing to father a child should contact their doctor
who may advise you to stop taking Leflunomide tablets and take certain medicines to speed up
the removal of Leflunomide 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.
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).
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, 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.
Children and adolescents
Leflunomide is 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, 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

2

-

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 Tablets 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 tablets may increase the
chance of liver damage.
Pregnancy and breast-feeding
Do not take Leflunomide if you are, or think you may be pregnant. 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 speed up the
removal of Leflunomide from the 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 Tablets

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:
for rheumatoid arthritis: 10 or 20 mg Leflunomide once daily, depending on the severity of the
disease.
for psoriatic arthritis: 20 mg Leflunomide once daily.
Swallow the tablet whole and with plenty of water.
3

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 Tablets 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 Tablets
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 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, erythema
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 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,
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),
4

-

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).
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).
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),
psoriasis (new or worsening) and DRESS may also occur with an unknown frequency.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell 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 the national reporting system
Yellow Card Scheme; Website: 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 packaging. The expiry date refers
to the last day of that month.
Keep the container of the bottle tightly closed.
5

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 contains
The active substance is leflunomide.
Each tablet contains 10 mg of leflunomide.
The other ingredients are: lactose monohydrate, lactose anhydrous, maize starch,
hydroxypropyl cellulose, povidone, colloidal anhydrous silica, magnesium stearate.
The film coating for 10 mg tablets contains hypromellose (E464), titanium dioxide (E171),
polyethylene glycol and purified water.
What Leflunomide Tablets looks like and contents of the pack
Leflunomide 10 mg tablets are white, circular, biconvex film coated tablets plain on both sides.
Leflunomide 10 mg tablets are packed in bottles containing 30 tablets.
Leflunomide Tablets are available in packs of 30 tablets.

Marketing Authorisation Holder
APTIL Pharma Limited,
Unite 4, Charlwood Court
County Oak Way,
Crawley,
RH11 7XA,
United Kingdom
Manufacturer
Torrent Pharma (UK) Limited,
Unite 4, Charlwood Court,
County Oak Way,
Crawley,
RH11 7XA,
United Kingdom

This leaflet was last revised in 02/2016

6

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.

Hide