Leflunomide Zentiva (previously Leflunomide Winthrop)

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

leflunomide

Saatavilla:

Zentiva k.s.

ATC-koodi:

L04AA13

INN (Kansainvälinen yleisnimi):

leflunomide

Terapeuttinen ryhmä:

Immunosuppressants

Terapeuttinen alue:

Arthritis, Rheumatoid; Arthritis, Psoriatic

Käyttöaiheet:

Leflunomide is indicated for the treatment of adult patients with:active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD);active psoriatic arthritis.Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects.Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.

Tuoteyhteenveto:

Revision: 18

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2010-01-08

Pakkausseloste

75
B.
PACKAGE LEAFLET
76
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEFLUNOMIDE ZENTIVA 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.
What Leflunomide Zentiva is and what it is used for
2.
What you need to know before you take Leflunomide Zentiva
3.
How to take Leflunomide Zentiva
4.
Possible side effects
5.
How to store Leflunomide Zentiva
6.
Contents of the pack and other information
1.
WHAT LEFLUNOMIDE ZENTIVA IS AND WHAT IT IS USED FOR
Leflunomide Zentiva belongs to a group of medicines called
anti-rheumatic medicines. It contains the
active substance leflunomide.
Leflunomide Zentiva 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 ZENTIVA
DO NOT TAKE LEFLUNOMIDE ZENTIVA
-
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.
Stevens-Johnson syndrome) or
to any of the other ingredients of this medicine (listed in section
6), or if you are allergic

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Leflunomide Zentiva 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of leflunomide.
Excipients with known effect
Each tablet contains 78 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to almost white, round film-coated tablet, imprinted with ZBN on
one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Leflunomide is indicated for the treatment of adult patients with:
•
active rheumatoid arthritis as a "disease-modifying antirheumatic
drug" (DMARD),
•
active psoriatic arthritis.
Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs
(e.g. methotrexate) may
result in an increased risk of serious adverse reactions; therefore,
the initiation of leflunomide
treatment has to be carefully considered regarding these benefit/risk
aspects.
Moreover, switching from leflunomide to another DMARD without
following the washout procedure
(see section 4.4) may also increase the risk of serious adverse
reactions even for a long time after the
switching.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The treatment should be initiated and supervised by specialists
experienced in the treatment of
rheumatoid arthritis and psoriatic arthritis.
Alanine aminotransferase (ALT) or serum glutamopyruvate transferase
(SGPT) and a complete blood
cell count, including a differential white blood cell count and a
platelet count, must be checked
simultaneously and with the same frequency:
•
before initiation of leflunomide,
•
every two weeks during the first six months of treatment, and
•
every 8 weeks thereafter (see section 4.4).
Posology
_ _
•
In rheumatoid arthritis: leflunomide therapy is usually started with a
loading dose of 100 mg
once daily for 3 days. Omission of the loading dose may decrease the
risk of adverse events (see
section 5.1).
3
The recommended maintenance dose is leflunomide 10 mg to 20 mg o