Leflunomide ratiopharm

Země: Evropská unie

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktivní složka:

leflunomide

Dostupné s:

Ratiopharm GmbH

ATC kód:

L04AA13

INN (Mezinárodní Name):

leflunomide

Terapeutické skupiny:

Immunosuppressants

Terapeutické oblasti:

Arthritis, Rheumatoid

Terapeutické indikace:

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.

Přehled produktů:

Revision: 16

Stav Autorizace:

Authorised

Datum autorizace:

2010-11-28

Informace pro uživatele

32
B. PACKAGE LEAFLET
33
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEFLUNOMIDE RATIOPHARM 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 ratiopharm is and what it is used for
2.
What you need to know before you take Leflunomide ratiopharm
3.
How to take Leflunomide ratiopharm
4.
Possible side effects
5.
How to store Leflunomide ratiopharm
6.
Contents of the pack and other information
1.
WHAT LEFLUNOMIDE RATIOPHARM IS AND WHAT IT IS USED FOR
Leflunomide ratiopharm contains the active substance leflunomide which
belongs to a group of
medicines called anti-rheumatic medicines.
Leflunomide ratiopharm 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 RATIOPHARM
DO NOT TAKE LEFLUNOMIDE RATIOPHARM
-
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), to peanut or soya or to any of the other ingredients of
this medicine

Charakteristika produktu

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Leflunomide ratiopharm 10 mg film-coated tablets
Leflunomide ratiopharm 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Leflunomide ratiopharm 10 mg film-coated tablets
Each film-coated tablet contains 10 mg of leflunomide.
Leflunomide ratiopharm 20 mg film-coated tablets
Each film-coated tablet contains 20 mg of leflunomide.
Excipients with known effect
_Leflunomide ratiopharm 10 mg film-coated tablets _
Each film-coated tablet contains 76 mg of lactose and 0.06 mg of soya
lecithin.
_Leflunomide ratiopharm 20 mg film-coated tablets _
Each film-coated tablet contains 152 mg of lactose and 0.12 mg of soya
lecithin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Leflunomide ratiopharm 10 mg film-coated tablets
White to almost white, round film-coated tablet with a diameter of
about 6 mm.
Leflunomide ratiopharm 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 doses.
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 pso