Leflunomide medac

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

leflunomide

Διαθέσιμο από:

medac Gesellschaft für klinische Spezialpräparate mbH

Φαρμακολογική κατηγορία (ATC):

L04AA13

INN (Διεθνής Όνομα):

leflunomide

Θεραπευτική ομάδα:

Selective immunosuppressants

Θεραπευτική περιοχή:

Arthritis, Rheumatoid

Θεραπευτικές ενδείξεις:

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.

Περίληψη προϊόντος:

Revision: 19

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2010-07-27

Φύλλο οδηγιών χρήσης

30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEFLUNOMIDE MEDAC 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 medac is and what it is used for
2.
What you need to know before you take Leflunomide medac
3.
How to take Leflunomide medac
4.
Possible side effects
5.
How to store Leflunomide medac
6.
Contents of the pack and other information
1.
WHAT LEFLUNOMIDE MEDAC IS AND WHAT IT IS USED FOR
Leflunomide medac belongs to a group of medicines called
anti-rheumatic medicines. It contains the
active substance leflunomide.
Leflunomide medac 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 in moving,
pain, and patches of red, scaly skin (skin lesions).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEFLUNOMIDE MEDAC
DO NOT TAKE LEFLUNOMIDE MEDAC
•
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), peanut or soya or to any of the other ingredients of this
medicine (listed in
section 6), or if you are all

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Leflunomide medac 10 mg film-coated tablets
Leflunomide medac 15 mg film-coated tablets
Leflunomide medac 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Leflunomide medac 10 mg
film-coated tablets
Each film-coated tablet contains 10 mg of leflunomide.
Leflunomide medac 15 mg
film-coated tablets
Each film-coated tablet contains 15 mg of leflunomide.
Leflunomide medac 20 mg
film-coated tablets
Each film-coated tablet contains 20 mg of leflunomide.
_Excipients with known effect _
Leflunomide medac 10 mg
film-coated tablets
Each film-coated tablet contains 76 mg of lactose (as monohydrate) and
0.06 mg of soya lecithin.
Leflunomide medac 15 mg
film-coated tablets
Each film-coated tablet contains 114 mg of lactose (as monohydrate)
and 0.09 mg of soya lecithin.
Leflunomide medac 20 mg
film-coated tablets
Each film-coated tablet contains 152 mg of lactose (as monohydrate)
and 0.12 mg of soya lecithin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Leflunomide medac 10 mg
film-coated tablets
White to almost white, round film-coated tablet with a diameter of
about 6 mm.
Leflunomide medac 15 mg
film-coated tablets
White to almost white, round film-coated tablet, debossed with
“15” on one side with a diameter of
about 7 mm.
Leflunomide medac 20 mg
film-coated tablets
White to almost white, round film-coated tablet with a diameter of 8
mm and a break-mark on one side
of the tablet. The tablet can be divided into equal halves.
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.
3
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 carefu