Repso
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
21-04-2016
Valmisteyhteenveto
(SPC)
21-04-2016
Julkisesta arviointikertomuksesta
(PAR)
28-03-2011
Aktiivinen ainesosa:
leflunomide
Saatavilla:
Teva B.V.
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: 11
Valtuutuksen tilan:
Withdrawn
Valtuutus päivämäärä:
2011-03-14
Pakkausseloste
38
B. PACKAGE LEAFLET
Medicinal product no longer authorised
39
PACKAGE LEAFLET: INFORMATION FOR THE USER
REPSO 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 Repso is and what it is used for
2.
What you need to know before you take Repso
3.
How to take Repso
4.
Possible side effects
5.
How to store Repso
6.
Contents of the pack and other information
1.
WHAT REPSO IS AND WHAT IT IS USED FOR
Repso belongs to a group of medicines called anti-rheumatic medicines.
It contains the active
substance leflunomide.
Repso is used to treat adult patients with active rheumatoid arthritis
or with active psoriatic 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).
Psoriatic arthritis is the combination of psoriasis and arthritis. The
symptoms 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 REPSO
DO NOT TAKE REPSO
-
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), or if you are allergic to
teriflunomide (used to treat multiple
sclerosis).
-
If you ha
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Repso 10 mg film-coated tablets
Repso 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Repso 10 mg film-coated tablets
Each film-coated tablet contains 10 mg of leflunomide.
_Excipients with known effect _
Each film-coated tablet contains 97.25 mg of lactose monohydrate and
3.125 mg anhydrous lactose.
Repso 20 mg film-coated tablets
Each film-coated tablet contains 20 mg of leflunomide.
_Excipients with known effect _
Each film-coated tablet contains 194.5 mg of lactose monohydrate and
6.25 mg anhydrous lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Repso 10 mg film-coated tablets
White, round film-coated tablets, engraved with “10” on one side
and “L” on the other.
Repso 20 mg film-coated tablets
Dark beige, triangle shaped, film-coated tablets, engraved with
”20” 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),
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.
Medicinal product no longer authorised
3
Alanine aminotransferase (ALT) or serum glutamopyruvate transferase
(SGPT)
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