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LEFLUNOMIDE JENSON 10 MG FILM-COATED TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

LEFLUNOMIDE
10
& 20 mg
FIL
LETS
R
refully before you start taking this
medicine because it contains important information for you.

t. 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 an
ects, talk to your doctor or pharmacist.
This includes an
ects not list
t.
See section 4.
:
Wha
1. What L
at it is used for
2. What you need to know before you take L
3. How to take L
4. P
ects
5. How to store L
6. Contents of the pack and other information
1. WHAT LEFLUNOMIDE IS AND WHAT IT IS USED FOR
L unomide belongs to a group of medicines called 'anti-rheumatic
medicines'. It contains the active substance l unomide.
L
to treat adult patients with active
rheumatoid arthritis.
ation of the
Symptoms of rheumatoid arthr
joints, swelling
ty moving and pain. Other symptoms that
ect the entire body include loss of appetite, fever, loss of energy
and anaemia (lack of red blood cells)
Film-coated Tablets may also be authorised to treat other
conditions which are not men
t. Ask your
doctor or pharmacist if you have further questions.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEFLUNOMIDE
Do not take L
• if you have ever had an allergic reaction t
omide (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)
• 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)
er from any pr
ects your immune
• if y
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 ar
ering from a serious infection
• if you are pregnant, think you may be pregnant or are
breast-feeding.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking L unomide:
• if you have ev
ered from tuberculosis or interstitial lung
disease (lung disease),
• if you are male and wish to father a child. As it cannot be
nto semen, reliable
excluded that L
contraception should be used during treatment with
L
e. Men wishing to father a child should contact
their doctor who may advise them to stop taking L
and take certain medicines to remove L
rapidly and
ntly from their body. You will then need a blood test
to make sure that L
ntly removed
from your body, and you should then wait for at least another
•L
ccasionally cause some problems with your
blood, liver or 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 severe infection. For more information on these,
ects).
please read section 4, (P

toms 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 L
e, to monitor your blood
cells and liver. Your doctor will also check your blood pressure
regularly as L
rease in blood pressure.
Children and adolescents
recommended for use in children and
L
Other medicines and L
Tell your doctor or pharmacist if you are taking, have recently
taken or may take 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 and, other
immunosuppressive drugs (eg. methotrexate), as these
combinations are not advisable.
• a medicine called cholestyramine (used to reduce high
cholesterol) or activated charcoal as these medicines can reduce
the amount of L unomide 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
If you are already taking a non-steroidal an
atory drug
(NSAID) and/or corticosteroids, you may continue to take them
after starting L
Vaccinations
If you have to be vaccinated, ask your doctor for advice. Certain
e, and
vaccinations should not be given while taking L
for a certain amount of time after stopping treatment.
L
food, drink and alcohol:
•L
ay be taken with or without food.
• It is not recommended to drink alcohol during treatment with
e. Drinking alcohol while taking L
ay
L
increase the chance of liver damage.
Pregnancy and breast-feeding:
you are, or think you may be
• Do not take L
pregnant. If you are pregnant or become pregnant while taking
L
e, the risk of having a baby with serious birth defects
is increased. Women of childbearing potential must not take
contraceptive measures.
L
Tell your doctor if you plan to become pregnant after stopping
e, as you need to ensure that all traces
treatment with L
of L
ave left your body before trying to become
few weeks by taking certain medicines, which speed up removal
of L
rom your body.
rmed by a blood test that
In either case it should be c
L
ntly 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 L
or in the two years after you have stopped treatment, you must
contact your doctor immediately for a pregnancy test. If the
test c
rms that you are pregnant, your doctor may suggest
rapidly
treatment with certain medicines to remove L
ntly from your body, as this may decrease the risk to
your baby.
Do not take L

you are breast-feeding, as
nto the breast milk.

Driving and using machines
you feel dizzy which may impair your
L
ability to concentrate and react. If you ar
ected, do not drive,
or use machines.
contains lactose.
L
If your doctor has told you that you have intolerance to some
sugars, such as lactose, contact your doctor before taking this
medicinal product.
3. HOW TO TAKE LEFLUNOMIDE
Always take this medicine exactly as your doctor or pharmacist
has told you. You should check with your doctor or pharmacist if
you are not sure.

Adults
After this, most patients need a dose of:

depending on the severity of the disease.
Swallow the tablet whole and with plenty of water.
improvement in your condition. Some patients may even still feel
You will normally take L

over long periods of time.

you should
If you take more L
If you take more L
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 L
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. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine
not everybody gets them.

ects, although

Tell your doctor immediately and stop taking L
• if you experience weakness, feel light-headed or dizzy or
have
ty 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 imbalanc
erent 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
ation 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).
The follo


















ects have also been reported:

a slight decrease in the number of white blood cells (leucopenia),
mild allergic reactions,
nt),
loss of appetite, weight loss (usually insig
tiredness (asthenia),
headache, dizziness,
abnormal skin sensations like tingling (paraesthesia),
problems in the nerves of the arms or legs
(peripheral neuropathy),
mild increase in blood pressure,
diarrhoea,
nausea, vomiting,
ation of the mouth or mouth ulcers,
abdominal pain,
an increase in some liver test results,
increased hair loss,
eczema, dry skin, rash, itching,
ation in the membrane
tendonitis (pain caused b
surrounding the tendons usually in the feet or hands),
an increase of certain enzymes in the blood
(creatine phosphokinase).

• 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.

• 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,

ation 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).
• a marked decrease of some white blood cells (agranulocytosis),
• severe and potentially severe allergic reactions,

ation of the small vessels (vasculitis, including cutaneous
necrotizing vasculitis),
ation of the pancreas (pancreatitis),

• sever 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 sid
ects include 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 (characterised by rash/
erythema on skin areas that are exposed to light) and psoriasis (new or
worsening) may also occur with an unknown frequency.
If an
ects gets serious, or if you notice any side
ects not list
you are taking this medicine,
please tell your doctor or pharmacist.
Repor
ects
ects, talk to your doctor, pharmacist or
If you get an
nurse. This includes an
ects not listed in this
t. You can also repor
ects directly via
ects you can
www.mhra.gov.uk/yellowcard. By repor
help provide more information on the safety of this medicine.
5. HOW TO STORE LEFLUNOMIDE
Keep out of the sight and reach of children.
Do not use the tablets after the expiry date ('EXP') which is
stated on the label of the container, the blisters and on the outer
package. The expiry date refers to the last day of that month.
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 to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What L
Active substanc

contains:

The other ingredients are: Pregelatinised maize starch, povidone,
Crospovidone, cellulose microcrystalline, silica colloidal
anhydrous, magnesium stearate and lactose monohydrate.
Film coat: titanium dioxide (E171), polydextrose (E1200),
only) and Iron oxide black (E172) (20mg only)
What L

ke and contents of the pack

Your medicine is in the for

-coated tablet.

10mg tablet: white in colour, engraved with 'M' on one side of the
tablet and 'L31' on the other side.
20mg tablet: beige in colour, engraved with 'M' over 'L32'on one
side of the tablet.
L

-coated tablets are available in blisters packs

coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Jenson Pharmaceutical Services Limited
Carradine House
London
United Kingdom
Manufacturer:
McDermott Laboratories Limited (t/a Gerard Laboratories)
Grange Road,
Dublin 13
Ireland
T
was last revised in
January 2014.

370350
00000000

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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