XADAGO safinamide (as mesilate) 100 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

safinamide mesilate, Quantity: 131.76 mg (Equivalent: safinamide, Qty 100 mg)

Available from:

Seqirus Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; crospovidone; Colour; hypromellose; macrogol 6000

Administration route:

Oral

Units in package:

10 x Tablets, 30 x Tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Xadago is indicated for the treatment of adult patients with fluctuating idiopathic Parkinson?s disease (PD) as add-on therapy to a regimen that includes levodopa (L-Dopa)

Product summary:

Visual Identification: Orange to copper, round, biconcave, immediate release, film-coated tablet (9mm in diameter) with metallic gloss and embossed with "100" on one side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2018-11-02

Patient Information leaflet

Xadago
®
Consumer Medicine Information (CMI)
Page 1 of 4
This medicine is subject to additional monitoring. This will allow
quick identification of new safety information. You
can help by reporting any side effects you may get. You can report
side effects to your doctor, or directly at
www.tga.gov.au/reporting-problems.
XADAGO
®
(_Za-da-go_)
_SAFINAMIDE_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Xadago
®
.
It does not contain all of the available
information. It does not take the place
of talking to your doctor or
pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you taking Xadago
®
against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
READ THIS LEAFLET CAREFULLY AND KEEP
IT WITH THE MEDICINE.
You may need to read it again.
WHAT XADAGO
® IS USED
FOR
Xadago
®
is used to treat Parkinson’s
disease. It is taken when levodopa on
its own (or with other medicines) does
not control the symptoms of
Parkinson’s Disease.
Xadago
®
belongs to a group of
medicines called monoamine oxidase
inhibitors (MAOIs). It contains an
active ingredient called safinamide.
Parkinson's disease is a condition of
the brain that mainly affects
movement. The three main symptoms
of Parkinson's disease are:

Shaking (tremor)

Muscle stiffn
ess

Sl
ow and unsteady moveme
nt.
The symptoms of Parkinson's disease
are caused by a lack of dopamine.
Dopamine is a natural substance that
is made in the brain and helps with
movement. Xadago
®
works by
increasing the level of dopamine in the
brain. This decreases the symptoms of
Parkinson's disease.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason. This medicine is
only available with a doctor’s
prescription. Xadago
®
is not addictive.
There is not enough information to
recommend the use of this medi

Summary of Product characteristics

XADAGO
® PRODUCT INFORMATION
AUST R 292144 AND 292145
Page
1
of
23
▼
This medicinal product is subject to additional monitoring in
Australia. This will allow
quick identification of new safety information. Healthcare
professionals are asked to report
any suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION – XADAGO
® (SAFINAMIDE)
1
NAME OF THE MEDICINE
Safinamide (as mesilate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Xadago
®
tablets contain 50 or 100 mg safinamide (as mesilate).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
_XADAGO_
_®_
_ 50 MG TABLETS_:
Orange to copper, round, biconcave, immediate release, film-coated
tablets (7 mm diameter) with metallic gloss and “50” embossed on
one side. Each tablet
contains 50 mg safinamide (as mesilate).
_XADAGO_
_®_
_ 100 MG TABLETS: _
Orange to copper, round, biconcave, immediate release, film-
coated tablets (9 mm diameter) with metallic gloss and “100”
embossed on one side. Each
tablet contains 100 mg safinamide (as mesilate).
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Xadago
®
is indicated for the treatment of adult patients with fluctuating
idiopathic
Parkinson’s disease (PD) as add-on therapy to a regimen that
includes levodopa (L-Dopa).
4.2
DOSE AND METHOD OF ADMINISTRATION
Xadago
®
treatment should be started at 50 mg/day. The dose may be increased to
100 mg/day
after two weeks on the basis of individual clinical need.
XADAGO
® PRODUCT INFORMATION
AUST R 292144 AND 292145
Page
2
of
23
Xadago
®
tablets are for oral use. Xadago
®
should be taken with water. Xadago
®
may be taken
with or without food. If a dose is missed, the next dose should be
taken at the usual time the
next day.
_Discontinuation: _
Xadago
®
50 mg can be discontinued without down titration.
Xadago
®
100 mg should be tapered by decreasing the dose to 50 mg for one week
prior to
discontinuation.
PAEDIATRIC PATIENTS
The safety and efficacy of safinamide in children and adolesce