TIVEL 1MG TABLETS

Country: Ċipru

Lingwa: Grieg

Sors: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Ingredjent attiv:

RASAGILINE TARTRATE

Disponibbli minn:

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

Kodiċi ATC:

N04BD02

INN (Isem Internazzjonali):

RASAGILINE

Dożaġġ:

1MG

Għamla farmaċewtika:

TABLETS

Kompożizzjoni:

RASAGILINE TARTRATE (0136236527) 1,438MG

Rotta amministrattiva:

ORAL USE

Tip ta 'preskrizzjoni:

Εθνική Διαδικασία

Żona terapewtika:

RASAGILINE

Sommarju tal-prodott:

Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 10 TABS IN BLISTER(S) (ALU-ALU) () 10 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 30 TABS IN BLISTER(S) (ALU-ALU) () 30 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 10 TABS IN BLISTER(S) (PVC/PE/PVDC-ALU) () 10 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 30 TABS IN BLISTER(S) (PVC/PE/PVDC-ALU) () 30 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται

Fuljett ta 'informazzjoni

COMPARATIVE TABLE OF PIL-EN VS PIL-GR
PACKAGE LEAFLET: INFORMATION FOR THE USER
TIVEL 1 MG TABLETS
rasagiline
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 or pharmacist.

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 or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
1. What Tivel is and what it is used for
2. What you need to know before you take Tivel
3. How to take Tivel
4. Possible side effects
5. How to store Tivel
6. Contents of the pack and other information
1. WHAT TIVEL IS AND WHAT IT IS USED FOR
Tivel contains the active substance rasagiline and it is used for the
treatment of Parkinson’s disease in adults. It can be used together
with
ΦΎΛΛΟ ΟΔΗΓΙΏΝ ΧΡΉΣΗΣ: ΠΛΗΡΟΦΟΡΊΕΣ ΓΙΑ
ΤΟΝ ΧΡΉΣΤΗ
TIVEL 1 MG ΔΙΣΚΊΑ
ρασαγιλίνη
ΔΙΑΒΆΣΤΕ ΠΡΟΣΕΚΤΙΚΆ ΟΛΌΚΛΗΡΟ ΤΟ ΦΎΛΛΟ
ΟΔΗΓΙΏΝ ΧΡΉΣΗΣ 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
τον γιατρό ή τον
φαρμακοποιό σας.

Η συνταγή για αυτό το φάρμακο
χορηγήθηκε αποκλειστικά για
σας. Δεν πρέπει να δώσετε το φάρμακο σε
άλλους. Μπορεί να
τους προκαλέσει βλάβη, ακόμα και όταν
τα συμ

Karatteristiċi tal-prodott

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Tivel 1 mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg rasagiline (as tartrate).
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
White to off-white, round, flat, bevelled tablets.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tivel is indicated for the treatment of idiopathic Parkinson’s
disease (PD) as monotherapy (without
levodopa) or as adjunct therapy (with levodopa) in patients with end
of dose fluctuations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Poso
l
o
g
y
Rasagiline is administered orally, at a dose of 1 mg once daily with
or without levodopa.
It may be taken with or without food.
El derl y: No change in dose is required for elderly patients.
Paed
i
a
t
ri
c
pop
u
l
a
ti
o
n
: Tivel is not recommended for use in children and adolescents due to
lack of
data on safety and efficacy.
Pa
t
i
en
t
s with hepatic impairment
: Rasagiline use in patients with severe hepatic impairment is
contraindicated (see section 4.3). Rasagiline use in patients with
moderate hepatic impairment should
be avoided. Caution should be used when initiating treatment with
rasagiline in patients with mild
hepatic impairment. In case patients progress from mild to moderate
hepatic impairment rasagiline
should be stopped (see section 4.4).
Patients with renal impairment: No change in dose is required for
renal impairment.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
(see section 6.1).
1
Concomitant treatment with other monoamine oxidase (MAO) inhibitors
(including medicinal and
natural products without prescription e.g. St. John's Wort) or
pethidine (see section 4.5). At least 14
days must elapse between discontinuation of rasagiline and initiation
of treatment with MAO
inhibitors or pethidine.
Rasagiline is contraindicated in patients with severe hepatic
impairment.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The concomitant use of rasagiline and