Skip to Content

LEFLUNOMIDE 10 MG FILM-COATED TABLETS

Active substance(s): LEFLUNOMIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ08201LT06A

Leflunomide 10 mg Film-coated Tablets
Leflunomide 20 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. 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

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.







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,

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).








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.

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.

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

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

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. 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.
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.
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
Tell your doctor, pharmacist or nurse if you
are taking, have recently taken or might
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

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.
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 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

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

Continued on next page >>

months of therapy.
You will normally take Leflunomide over
long periods of time.

reactions (Stevens-Johnson syndrome,
toxic epidermal necrolysis, erythema
multiforme, DRESS).

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.

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

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

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.
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.
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),
• 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.

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.

5

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.
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 infomation

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

hydroxypropyl 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.
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-vonGuericke-Allee 1, 39179 Barleben,
Germany
This leaflet was last revised in 04/2016.

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

SZ08201LT06A

51732049 CODE 1396

draft: 44032859, 44032870
laetus code: 1396
mat.no.: 51732049

Artwork Proof Box

Ref: V014: SPC & PIL update in line with PRAC + minor correction
Proof no.
008.1

Date prepared:
14/04/2016

Colours:
Black
Black 20%
Dimensions: 130 x 540 mm

Font size:
8pt
Fonts:
Helvetica

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