Leflunomide medac - Patient Information Sheet
Dear Patient,
If you are receiving this leaflet your physician intends to prescribe you Leflunomide
medac. The purpose of this leaflet is to inform you about all important issues
potentially coming along with this treatment. Please read this information carefully
and ask your physician in case of any incomprehensibility.
1) Reproduction and Pregnancy
Like most other DMARDs (Disease Modifying Anti Rheumatic Drugs), Leflunomide
medac may harm an unborn baby. That is why the following precautions are crucial:

Pregnancy must be excluded before the start of the treatment with
leflunomide medac

While taking Leflunomide medac both men and women must use reliable
contraception

The usage of Leflunomide medac is not licensed in pregnant woman or
in women with childbearing potential who are not using a reliable
contraception
Drug elimination procedure after Leflunomide medac treatment
Women and men are advised to wait 2 years between stopping Leflunomide medac
therapy and trying to become pregnant. This 2-year period can be reduced to 3
months if you receive a special washout procedure. This will help to eliminate
Leflunomide medac completely from your body.

To ensure the effectiveness of the washout treatment, two blood serum
tests at intervals of two weeks are required. This will give you certainty
that no drug is left in your body
The blood test is commercially available. For further information please send
an email with your concern to Leflunomide@medac.eu or call the local
representative. The marketing authorisation holder provides an ad hoc
information service and will come back to you with further information
immediately.
If you become pregnant while taking Leflunomide medac, you should discuss
this with your physician immediately! Moreover in case of planning to become
pregnant after stopping Leflunomide medac, it is also important to consult the
physician to discuss remaining risks for your unborn child.
2) Liver damage
Patients with preexisting kidney or liver disease
The use of Leflunomide medac in patients with kidney or liver disease has not been
studied adequately. Because metabolites (breakdown products) of leflunomide are
excreted by the kidney, however, the drug should be used with caution in patients
with kidney disease
Treatment with Leflunomide medac should be avoided in people with liver disease
because the drug is metabolized and excreted by the liver and because it can cause
liver damage

A major concern during treatment with Leflunomide medac is the development
of hepatotoxicity, or liver damage. This complication is extremely rare

The damage may manifest as cirrhosis or necrosis (death of liver cells).
Patients can develop jaundice, hepatitis, or liver failure

In very rare cases the toxicity can result in death. Hepatotoxicity is detected by
blood tests, which are done before and during treatment. The treatment is
stopped if the test results are abnormal
3) Risk of Infection
Immunosuppressed patients
Leflunomide medac is contraindicated (should be avoided) in patients with moderate
to severe disorders of the immune system or bone marrow, and those with serious
infections.
Taking Leflunomide medac can make you more likely to develop infections.
If you notice signs of infections, like
 your throat becomes sore,

fever,

unexplained bruising,

bleeding or rash,

unproductive cough,

if you become breathless,
or if you develop any other unexpected new symptoms after starting the treatment
with Leflunomide medac, you should tell your physician immediately.
4) Combination with other drugs
Like most other drugs administered to treat your condition, Leflunomide
medac may affect the liver. If you develop symptoms such as

unusual tiredness,

abdominal pain,

if your eyes or skin turn yellow,
you should consult your physician straight away.
Special precaution is recommended in the case of combination with other drugs
(especially other DMARDs), which might impair the liver function as well. Therefore
your physician will monitor your liver function by regular blood tests.
AND: Please remember to always tell any other doctor treating you that you are
taking Leflunomide medac!