Leflunomide Teva
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
18-03-2014
Karatteristiċi tal-prodott
(SPC)
18-03-2014
Rapport ta 'Valutazzjoni Pubblika
(PAR)
18-03-2014
Ingredjent attiv:
leflunomide
Disponibbli minn:
Teva Pharma B.V.
Kodiċi ATC:
L04AA13
INN (Isem Internazzjonali):
leflunomide
Grupp terapewtiku:
Immunosuppressants
Żona terapewtika:
Arthritis, Rheumatoid
Indikazzjonijiet terapewtiċi:
Leflunomide is indicated for the treatment of adult patients with active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD).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.
Sommarju tal-prodott:
Revision: 6
L-istatus ta 'awtorizzazzjoni:
Withdrawn
Data ta 'l-awtorizzazzjoni:
2011-03-10
Fuljett ta 'informazzjoni
53
B. PACKAGE LEAFLET
Medicinal product no longer authorised
54 PACKAGE LEAFLET: INFORMATION FOR THE USER
LEFLUNOMIDE TEVA 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.
WHAT IS IN THIS LEAFLET
1.
What Leflunomide Teva is and what it is used for
2.
What you need to know before you take Leflunomide Teva
3.
How to take Leflunomide Teva
4.
Possible side effects
5.
How to store Leflunomide Teva
6.
Contents of the pack and other information
1.
WHAT LEFLUNOAMIDE TEVA IS AND WHAT IT IS USED FOR
Leflunomide Teva belongs to a group of medicines called anti-rheumatic
medicines. It contains the
active substance leflunomide.
Leflunomide Teva is used to treat adult patients with active
rheumatoid arthritis.
Rheumatoid arthritis is a crippling form of arthritis. The symptoms
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 anemia (lack of red blood cells).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEFLUNOAMIDE TEVA
DO NOT TAKE LEFLUNOMIDE TEVA
-
If you are
ALLERGIC
to leflunomide (especially a serious skin reaction, often with fever,
joint pain,
red skin stains, or blisters e.g. Stevens-Johnson syndrome) or any of
the other ingredients of this
medicine (listed in section 6).
-
If you have
LIVER PROBLEMS
.
-
If you suffer from a severe condition that affects your
IMMUNE SYSTEM
e.g. AIDS.
-
If you have
BONE MARROW PROBLEMS
, or if you have low numbers of red or white blood cells or
a reduced
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
1
_ _
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Leflunomide Teva 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of leflunomide.
_Excipients with known effect: _
Each tablet contains 97.25 mg of lactose monohydrate and 3.125 mg
anhydrous lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, round film-coated tablets, engraved with “10” on one side
and “L” on the other.
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).
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.
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 _
Medicinal product no longer authorised
3
•
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 event
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