XADAGO 50 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SAFINAMIDE AS METHANESULFONATE

Available from:

MEDISON PHARMA LTD

ATC code:

N04BD03

Pharmaceutical form:

FILM COATED TABLETS

Composition:

SAFINAMIDE AS METHANESULFONATE 50 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ZAMBON S.P.A., ITALY

Therapeutic area:

SAFINAMIDE

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.

Authorization date:

2020-05-10

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
XADAGO 50 MG
XADAGO 100 MG
FILM-COATED TABLETS
ACTIVE INGREDIENT: Each tablet contains 50 mg or 100 mg safinamide as
safinamide
methanesulfonate.
Inactive ingredients and allergens: see section 6 ‘Additional
Information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains concise
information about this medicine.
If you have any further questions, consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm them,
even if it seems to you that their illness is similar to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Xadago is used to treat idiopathic (that has developed for an unknown
reason) Parkinson’s disease in
adult patients. It is added to a stable dose of levodopa alone or to a
stable dose of levodopa in
combination with other medicines for Parkinson’s disease. It is used
in patients that are in the mid- to
late-stage of the disease.
THERAPEUTIC GROUP
Parkinson medication, monoamine oxidase-B inhibitors.
Xadago is a medicine that contains the active ingredient 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.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:

You are sensitive to the active ingredient (safinamide) or to any of
the other ingredients in
this medicine (see the list in section 6).

You are taking any of the following medicines:
o
monoamine oxidase inhibitors (MAO) such as selegiline, rasagiline,
moclobemide,
phenelzine, isocarboxazid, tranylcypromine (for example to treat
Parkinson’s disease or
depression, or any other condition).
o
pethidine (a strong pain killer). You must wait at least 7 days after
stopping Xadago
before starting treatment with

Summary of Product characteristics

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PHYSICIAN’S PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Xadago 50 mg
Xadago 100 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Xadago 50 mg
:
Each film-coated tablet contains safinamide methanesulfonate
equivalent to 50 mg safinamide.
Xadago 100 mg
:
Each film-coated tablet contains safinamide methanesulfonate
equivalent to 100 mg safinamide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Xadago 50 mg film-coated tablets
Orange to copper with metallic gloss, round, biconcave, 7 mm
film-coated tablets, embossed with
“50” on one side.
Xadago 100 mg film-coated tablets
Orange to copper with metallic gloss, round, biconcave, 9 mm
film-coated tablets, embossed with
“100” on one side.
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 Xadago 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.
_Hepatic impairment _
Xadago 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
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recommended for patients with moderate hepatic impairment. If patients
progress from moderate
to severe hepatic impairment Xadago should be stopped (see section
4.4).
_Renal impairment _
No change in dose is required for patients with renal impairment.
_Paediatric population _
Xadag