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LEFLUNOMIDE 100 MG FILM-COATED TABLETS

Active substance(s): LEFLUNOMIDE / LEFLUNOMIDE / LEFLUNOMIDE

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Package leaflet: Information for the user

Ask your doctor or pharmacist for advice before
taking any medicine.

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

Leflunomide 100 mg Film-coated Tablets

Driving and using machines
Leflunomide Tablets may cause dizziness and
impairs the ability to concentrate and react. Do
not drive or use machines if you have such
symptoms.

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.

leflunomide

and liver. Your doctor will also check your blood
Read all of this leaflet carefully before you
pressure regularly as Leflunomide Tablets can
start taking this medicine because it
cause an increase in blood pressure.
contains important information for you.
Leflunomide Tablets contain lactose.
!
Keep this leaflet. You may need to read it
If you have been told by your doctor that you
Talk to your doctor if you have unexplained
again.
have intolerance to some sugars, contact your
chronic
diarrhoea.
Your
doctor
may
perform
!
If you have any further questions, ask your
doctor before taking this medicinal product.
additional tests for differential diagnosis.
doctor, pharmacist or nurse.
!
This medicine has been prescribed for you
3. How to take Leflunomide Tablets
Children and adolescents
only. Do not pass it on to others. It may
Leflunomide
Tablets
are
not
recommended
for
harm them, even if their signs of illness are
Always take this medicine exactly as your
use in children and adolescents below 18 years
the same as yours.
doctor or pharmacist has told you. Check with
of
age.
!
If you get any side effects, talk to your
your doctor or pharmacist if you are not sure.
doctor, pharmacist or nurse. This includes
The usual starting dosage is one 100 mg tablet
Other
medicines
and
Leflunomide
Tablets
Rare side effects (may affect up to 1 in 1,000
side effects not listed in this leaflet.
once daily for the first three days. After this,
Please tell your doctor or pharmacist if you are
people)
most
patients
need
a
dose
of:
taking, have recently taken or might take any
!
an increase in the numbers of blood cells
What is in this leaflet:
!
For rheumatoid arthritis: 10 or 20 mg once
other medicines. This includes medicines
called eosinophiles (eosinophilia); mild
1. What Leflunomide Tablets are and what
daily, depending on the severity of the
obtained without a prescription.
decrease in the number of white blood cells
they are used for
disease.
(leucopoenia); decrease in the number of all
2. What you need to know before you take
!
For psoriatic arthritis: 20 mg once daily.
This is especially important if you are taking:
blood cells (pancytopaenia),
Leflunomide Tablets
!
other medicines for rheumatoid arthritis
!
severe increase in blood pressure,
3. How to take Leflunomide Tablets
Swallow the tablet whole and with plenty of
such as antimalarials (e.g. chloroquine and
!
inflammation of the lung (interstitial lung
4. Possible side effects
water. It may take about 4 weeks or longer until
hydroxychloroquine), intramuscular or oral
disease),
5. How to store Leflunomide Tablets
you start to feel an improvement in your
gold, D-penicillamine, azathioprine and
!
an increase in some liver results which may
6. Contents of the pack and other information
condition. Some patients may even still feel
other immunosuppressive drugs (e.g.
develop into serious conditions such as
further improvements after 4 to 6 months of
methotrexate) as these combinations are
hepatitis and jaundice,
1. What Leflunomide Tablets are and what
therapy. You will normally take Leflunomide
not advisable,
!
severe infections called sepsis which may
they are used for
Tablets over long periods of time.
!
warfarin and other oral medicines used to
be fatal,
thin the blood, as monitoring is necessary to
!
an increase of certain enzymes in the blood
Leflunomide belongs to the group of drugs
If you take more Leflunomide Tablets than
reduce the risk of side effects of this
(lactate dehydrogenase).
known as anti-rheumatic medicines which are
you should
medicine
used in the treatment of adult patients with
If you take more of the medicine than you
!
teriflunomide for multiple sclerosis
Very rare side effects (may affect up to 1 in
active rheumatoid arthritis or with active
should, a physician or nearest hospital casualty
!
repaglinide,
pioglitazone,
nateglinide,
or
10,000 people)
psoriatic arthritis. It contains the active
department must be contacted immediately.
rosiglitazone for diabetes
!
a marked decrease of some white blood
substance leflunomide.
Take your medicine package to show a doctor.
!
daunorubicin, doxorubicin, paclitaxel, or
cells (agranulocytosis),
topotecan for cancer
!
severe and potentially severe allergic
Symptoms of Rheumatoid Arthritis include
If you forget to take Leflunomide Tablets
!
duloxetine for depression, urinary
reactions,
inflammation of joints, swelling, difficulty moving
incontinence or in kidney disease in
!
inflammation of the small vessels
and pain. Other symptoms that affect the entire
Take the missed dose as soon as you
diabetics
(vasculitis, including cutaneous necrotizing
body include loss of appetite, fever, loss of
remember, unless it is nearly time for your next
!
alosetron for the management of severe
vasculitis),
energy and anaemia (lack of red blood cells).
dose. Do not take two doses at the same time
diarrhoea
!
inflammation of the pancreas (pancreatitis),
to make up for forgotten individual doses. If you
!
theophylline for asthma
!
severe liver injury such as liver failure or
Symptoms of Active Psoriatic Arthritis include
have any further questions on the use of this
!
tizanidine, a muscle relaxant
necrosis which may be fatal,
inflammation of joints, swelling, difficulty
product, ask your doctor, pharmacist or nurse.
!
oral contraceptives (containing
!
severe sometimes life-threatening reactions
moving, pain and patches of red, scaly skin
ethinylestradiol and levonorgestrel)
(Stevens-Johnson syndrome, toxic
(skin lesions).
If you stop taking Leflunomide Tablets
!
cefaclor, benzylpenicillin (penicillin G),
epidermal necrolysis, erythaema
Do not stop taking the tablets unless your
ciprofloxacin for infections
multiforme).
2. What you need to know before you take
doctor tells you to. If you have any further
!
indomethacin, ketoprofen for pain or
Leflunomide Tablets
questions on how to take this product, ask your
inflammation
Other side effects such as kidney failure, a
doctor or pharmacist.
!
furosemide for heart disease (diuretic, water
decrease in the levels of uric acid in your blood,
Do not take Leflunomide Tablets if you
pill)
pulmonary hypertension, male infertility (which
!
are allergic to leflunomide or any of the
4. Possible side effects
!
zidovudine for HIV infection
is reversible once treatment with this medicine
other ingredients of this medicine (listed in
!
rosuvastatin, simvastatin, atorvastatin,
is stopped), cutaneous lupus (characterised by
section 6),
Like all medicines, this medicine can cause
pravastatin for hypercholesterolemia (high
rash/erythema on skin areas that are exposed
!
have decreased liver function,
side effects, although not everybody gets them.
cholesterol)
to light), psoriasis (new or worsening) and
!
have moderate to severe decreased kidney
Tell your doctor immediately and stop taking
!
sulfasalazine for inflammatory bowel
DRESS may also occur with an unknown
function,
Leflunomide Tablets:
disease or rheumatoid arthritis
frequency.
!
have severely low amounts of protein in
!
if you experience weakness, feel
!
a medicine called colestyramine (used to
your blood (hypoproteinaemia),
lightheaded or dizzy or have difficulty
reduce high cholesterol) or activated
Reporting of side effects
!
suffer from any problem which affects your
breathing, as these may be signs of a
charcoal
as
these
medicines
can
reduce
the
If you get any side effects, talk to your doctor or
immune system (e.g. AIDS),
serious allergic reaction,
amount of Leflunomide which is absorbed
pharmacist. This includes any possible side
!
have any problem with your bone marrow,
!
if you develop a skin rash or ulcers in
by the body.
effects not listed in this leaflet. You can also
or if you have low numbers of red or white
your mouth, as these may indicate severe,
report side effects directly via the Yellow Card
cells in your blood or a reduced number of
sometimes life-threatening reactions (e.g.
If you are already taking a non-steroidal antiScheme at: www.mhra.gov.uk/yellowcard. By
blood platelets,
Stevens-Johnson syndrome, toxic
inflammatory drug (NSAID) and/or
reporting side effects you can help provide
!
are suffering from a serious infection,
epidermal necrolysis, and erythaema
corticosteroids, you may continue to take
more information on the safety of this medicine.
!
are pregnant, think you may be pregnant
multiforme), Drug Reaction with
them after starting Leflunomide Tablets.
or are breast-feeding.
Eosinophilia and Systemic Symptoms
5. How to store Leflunomide Tablets
[DRESS]), see section 2.
Vaccinations
Warnings and Precautions
If you have to be vaccinated, ask your doctor
Keep this medicine out of the sight and reach of
Talk to your doctor, pharmacist or nurse before
Tell your doctor immediately if you experience:
for advice. Certain vaccinations should not be
children
taking Leflunomide Tablets
!
pale skin, tiredness, or bruising, as these
given while taking Leflunomide Tablets, and for
may indicate blood disorders caused by an
a certain amount of time after stopping
Do not use this medicine after the expiry date
!
if you have a history of interstitial lung
imbalance in the different types of blood
treatment.
which is stated on the package. The expiry date
disease.
cells which make up blood,
refers to the last day of that month.
!
if you have ever had tuberculosis or if you
!
tiredness, abdominal pain, or jaundice
Leflunomide Tablets with food, drink and
have been in close contact with someone
(yellow discolouration of the eyes or skin),
alcohol
Keep the container tightly closed.
who has or has had tuberculosis. Your
as these may indicate serious conditions
You
may
take
the
tablets
with
or
without
food.
doctor may perform tests to see if you have
such as liver failure, which may be fatal,
Alcohol should be avoided whilst taking this
Do not throw away any medicines via
tuberculosis.
!
any symptoms of an infection such as
medicine
as
it
may
increase
the
risk
of
side
wastewater or household waste. Ask your
!
if you are male and wish to father a child.
fever, sore throat or cough, as this
effects on the liver.
pharmacist how to throw away medicines you
As it cannot be excluded that Leflunomide
medicine may increase the chance of a
no longer use. These measures will help
Tablets passes into semen reliable
severe infection which may be lifePregnancy and breast-feeding
protect the environment.
contraception should be used during
threatening,
Pregnancy
treatment with Leflunomide Tablets. Men
!
a cough or breathing problems as these
Do not take Leflunomide Tablets if you are or
6. Contents of the pack and other
wishing to father a child should contact their
may indicate problems of the lung
think
you
might
be
pregnant.
If
you
are
information
doctor who may advise them to stop taking
(interstitial lung disease or pulmonary
pregnant or become pregnant whilst taking
Leflunomide Tablets and take certain
hypertension).
Leflunomide Tablets, the risk of having a baby
What Leflunomide Tablets contain
medicines to remove Leflunomide Tablets
!
unusual tingling, weakness or pain in your
with serious birth defects is increased. Women
The active substance is leflunomide. Each filmrapidly and sufficiently from their body. You
hands or feet as these may indicate
of childbearing potential must not take
coated tablet contains 100 mg of leflunomide.
will then need a blood test to make sure that
problems with your nerves (peripheral
Leflunomide Tablets without using reliable
The other ingredients are lactose monohydrate,
leflunomide has been sufficiently removed
neuropathy).
contraceptive measures. Leflunomide can last
lactose anhydrous, maize starch, low substituted
from your body, and you should then wait
for
a
long
time
in
the
body
after
treatment
is
hydroxypropyl cellulose, povidone, colloidal
for at least another 3 months before
Common side effects (may affect up to 1 in
stopped. You must not get pregnant while
anhydrous silica, magnesium stearate,
attempting to father a child.
10 people)
taking leflunomide and for at least two years
hypromellose, titanium dioxide (E171) and
!
if you are due to have a specific blood test
!
a slight decrease in the number of white
after
treatment
has
finished.
This
may
be
macrogol.
(calcium level). Falsely low levels of calcium
blood cells (leucopoenia),
reduced to a few weeks by taking certain
can be detected.
!
mild allergic reactions,
medicines which remove Leflunomide Tablets
What Leflunomide Tablets look like and
!
loss of appetite, weight loss (usually
rapidly
and
sufficiently
from
your
body.
In
either
contents of the pack
Leflunomide Tablets can occasionally cause
insignificant),
case it should be confirmed by a blood test that
Leflunomide 100 mg Tablets are white, circular,
some problems with your blood, liver, lungs, or
!
tiredness (asthenia),
Leflunomide
Tablets
has
been
sufficiently
biconvex film coated tablets plain on both sides.
nerves in your arms or legs. It may also cause
!
headache, dizziness,
removed from your body and you should then
Leflunomide 100mg Tablets are available in
some serious allergic reactions (including Drug
!
abnormal skin sensations like tingling
wait
for
at
least
another
month
before
you
blisters containing 7, 10, 14, 20, 28, 30, 56, 60,
Reaction with Eosinophilia and Systemic
(paraesthesia),
become pregnant. For further information on
84, 90, 100 and 112 film coated tablets.
Symptoms [DRESS]), or increase the chance of
!
mild increase in blood pressure,
the
laboratory
testing
please
contact
your
a severe infection. For more information on
!
colitis,
doctor. If you suspect that you are pregnant
Marketing Authorisation Holder
these, please read section 4 (Possible side
!
diarrhoea,
while
taking
Leflunomide
Tablets
or
in
the
two
Morningside Healthcare Ltd
effects).
!
nausea, vomiting,
years after you have stopped treatment, you
115 Narborough Road
!
inflammation of the mouth or mouth ulcers,
must contact your doctor immediately for a
Leicester
DRESS appears initially as flu-like symptoms
!
abdominal pain,
pregnancy test. If the test confirms that you are
LE3 0PA
and a rash on the face then an extended rash
!
an increase in some liver test results,
pregnant,
your
doctor
may
suggest
treatment
UK
with a high temperature, increased levels of
!
increased hair loss,
with certain medicines to speed up the removal
liver enzymes seen in blood tests and an
!
eczema, dry skin, rash, itching,
of Leflunomide Tablets from the body, as this
Manufacturer
increase in a type of white blood cell
!
tendonitis (pain caused by inflammation in
may decrease the risk to your baby.
Morningside Pharmaceuticals Ltd
(eosinophilia) and enlarged lymph nodes.
the membrane surrounding the tendons
5 Pavilion Way
usually in the feet or hands),
Breast-feeding
Loughborough
Your doctor will carry out blood tests at regular
!
an increase of certain enzymes in the blood
Do not take Leflunomide Tablets when you are
LE11 5GW
intervals, before and during treatment with
(creatine phosphokinase),
breast feeding, as leflunomide passes into the
UK
Leflunomide Tablets, to monitor your blood cells
breast milk.
This leaflet was last revised in July 2017

Expand Transcript

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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