Xadago

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

safinamide methanesulfonate

Διαθέσιμο από:

Zambon SpA

Φαρμακολογική κατηγορία (ATC):

N04B

INN (Διεθνής Όνομα):

safinamide

Θεραπευτική ομάδα:

Anti-Parkinson drugs

Θεραπευτική περιοχή:

Parkinson Disease

Θεραπευτικές ενδείξεις:

Xadago is indicated for the treatment of adult patients with idiopathic Parkinson’s disease (PD) as add-on therapy to a stable dose of Levodopa (L-dopa) alone or in combination with other PD medicinal products in mid-to late-stage fluctuating patients.

Περίληψη προϊόντος:

Revision: 13

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2015-02-23

Φύλλο οδηγιών χρήσης

27
B. PACKAGE LEAFLET
28
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
XADAGO 50 MG FILM-COATED TABLETS
XADAGO 100 MG FILM-COATED TABLETS
safinamide
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.
-
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. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Xadago is and what it is used for
2.
What you need to know before you take Xadago
3.
How to take Xadago
4.
Possible side effects
5.
How to store Xadago
6.
Contents of the pack and other information
1.
WHAT XADAGO IS AND WHAT IT IS USED FOR
Xadago is a medicine that contains the active substance safinamide. It
acts to increase the level of a
substance called dopamine in the brain, which is involved in the
control of movement and is present in
reduced amounts in the brain of patients with Parkinson’s disease.
Xadago is used for the treatment of
Parkinson’s disease in adults.
In mid- to late-stage patients experiencing sudden switches between
being “ON” and able to move and
being “OFF” and having difficulties moving about, Xadago is added
to a stable dose of the medicine
called levodopa alone or in combination with other medicines for
Parkinson’s disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE XADAGO
DO NOT TAKE XADAGO
-
If you are allergic to safinamide or any of the other ingredients of
this medicine (listed in
section 6).
-
If you are taking any of the following medicines:
-
Monoamine oxidase (MAO) inhibitors such as selegiline, rasagiline,
moclobemide,
phenelzine, isocarboxazid, tranylcypromine (e.g. for treatment of
Parkinson’s disease or
depression, or used for any other condition).
-
Pethidine (a strong pain

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Xadago 50 mg film-coated tablets
Xadago 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Xadago 50 mg film-coated tablets
Each film-coated tablet contains safinamide methansulfonate equivalent
to 50 mg safinamide.
Xadago 100 mg film-coated tablets
Each film-coated tablet contains safinamide methansulfonate equivalent
to 100 mg safinamide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Xadago 50 mg film-coated tablets
Orange to copper, round, biconcave, film-coated tablet of 7 mm
diameter with metallic gloss,
embossed with the strength “50” on one side of the tablet.
Xadago 100 mg film-coated tablets
Orange to copper, round, biconcave, film-coated tablet of 9 mm
diameter with metallic gloss,
embossed with the strength “100” on one side of the tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Xadago is indicated for the treatment of adult patients with
idiopathic Parkinson’s disease (PD) as
add-on therapy to a stable dose of levodopa (L-dopa) alone or in
combination with other PD medicinal
products in mid-to late-stage fluctuating patients.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treatment with safinamide should be started at 50 mg per day. This
daily dose may be increased to
100 mg/day on the basis of individual clinical need.
If a dose is missed the next dose should be taken at the usual time
the next day.
Elderly
No change in dose is required for elderly patients.
Experience of use of safinamide in patients over 75 years of age is
limited.
3
Hepatic impairment
Safinamide use in patients with severe hepatic impairment is
contraindicated (see section 4.3). No
dose adjustment is required in patients with mild hepatic impairment.
The lower dose of 50 mg/day is
recommended for patients with moderate hepatic impairment. If patients
progress from moderate to
severe hepatic impairment safinamide should be stopped (see section
4.4).
Rena