AROTAN 10MG FILM COATED TABLETS

País: Chipre

Língua: grego

Origem: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Ingredientes ativos:

LEFLUNOMIDE

Disponível em:

DELORBIS PHARMACEUTICALS LTD (0000009620) 17 ATHINON STREET, ERGATES INDUSTRIAL AREA, LEFKOSIA, 2081, 28629

Código ATC:

L04AA13

DCI (Denominação Comum Internacional):

LEFLUNOMIDE

Dosagem:

10MG

Forma farmacêutica:

FILM COATED TABLETS

Composição:

LEFLUNOMIDE (0075706126) 10MG

Via de administração:

ORAL USE

Tipo de prescrição:

Εθνική Διαδικασία

Área terapêutica:

LEFLUNOMIDE

Resumo do produto:

Νομικό καθεστώς: Με Ιατρική Συνταγή; BOTTLE WITH 30 TABS (300000101) 30 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή

Folheto informativo - Bula

COMPARATIVE TABLE PIL-EN VS PIL-GR
PACKAGE LEAFLET: INFORMATION FOR THE USER
AROTAN 10 MG FILM-COATED TABLETS
AROTAN 20 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 Arotan is and what it is used for
2. What you need to know before you take Arotan
3. How to take Arotan
4. Possible side effects
5. How to store Arotan
6. Contents of the pack and other information
1. WHAT AROTAN IS AND WHAT IT IS USED FOR
ΦΎΛΛΟ ΟΔΗΓΙΏΝ ΧΡΉΣΗΣ: ΠΛΗΡΟΦΟΡΊΕΣ ΓΙΑ
ΤΟΝ ΧΡΉΣΤΗ
AROTAN 10 MG ΕΠΙΚΑΛΥΜΜΈΝΑ ΜΕ ΛΕΠΤΌ ΥΜΈΝΙΟ
ΔΙΣΚΊΑ
AROTAN 20 MG ΕΠΙΚΑΛΥΜΜΈΝΑ ΜΕ ΛΕΠΤΌ ΥΜΈΝΙΟ
ΔΙΣΚΊΑ
Λεφλουνομίδη
ΔΙΑΒΆΣΤΕ ΠΡΟΣΕΚΤΙΚΆ ΟΛΌΚΛΗΡΟ ΤΟ ΦΎΛΛΟ
ΟΔΗΓΙΏΝ ΠΡΙΝ ΑΡΧΊΣΕΤΕ ΝΑ
ΠΑΊΡΝΕΤΕ ΑΥΤΌ ΤΟ ΦΆΡΜΑΚΟ, ΔΙΌΤΙ
ΠΕΡΙΛΑΜΒΆΝΕΙ ΣΗΜΑΝΤΙΚΈΣ ΠΛΗΡΟΦΟΡΊΕΣ
ΓΙΑ ΣΑΣ.
-
Φυλάξτε αυτό το φύλλο οδηγιών χρήσης.
Ίσως χρειαστεί να το
διαβάσετε ξανά.
-
Εάν έχετε περαιτέρω απορίες, ρωτήστε
το γιατρό, το φαρμακοποιό ή το
νοσοκόμο σας.
-
Η συνταγή για αυτό το φάρμακο
χορηγήθηκε αποκλειστικά για σας. Δεν
πρέπει να δώσετε το φάρμακο σε άλλους.
Μπορεί να τους προκαλέσε�

Características técnicas

1.
NAME OF THE MEDICINAL PRODUCT
Arotan 10 mg Film-coated tablets
Arotan 20 mg Film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
For 10 mg strength:
Each tablet contains 10 mg of leflunomide.
Excipient(s) with known effect:
Each tablet contains 80 mg of lactose monohydrate.
For 20 mg strength:
Each tablet contains 20 mg of leflunomide.
Excipient(s) with known effect:
Each tablet contains 160 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
For 10 mg strength:
White to off-white, round, biconvex film coated tablets.
For 20 mg strength:
White to off-white, round, biconvex film coated tablets with one sided
break-mark.
_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:
1
SUMMARY OF PRODUCT CHARACTERISTICS

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 (s