Equfina Film coated Tablets 50 mg

Țară: Malaezia

Limbă: engleză

Sursă: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredient activ:

Safinamide mesylate

Disponibil de la:

EISAI (MALAYSIA) SDN BHD (18039-D)

INN (nume internaţional):

Safinamide mesylate

Unități în pachet:

28 Tablets

Produs de:

Meiji Seika Pharma Co., Ltd., Odawara Plant,

Prospect

EQUFINA
® FILM COATED TABLET 50MG
Safinamide 50mg
1
_CONSUMER MEDICATION INFORMATION LEAFLET _
_(RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Equfina is used for
2.
How Equfina
works
3.
Before you use Equfina
4.
How to use Equfina
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Equfina
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT EQUFINA
IS USED FOR
Improvement
of
wearing-off
phenomenon
(effects
of
levodopa
diminish before it is time for the next
dose)
in
Parkinson's
disease
currently
treated
with
levodopa-containing
medicines.
HOW EQUFINA
WORKS
Equfina 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.
BEFORE YOU USE EQUFINA
-
_When you must not use it _

If you are allergic to safinamide or
any
of
the
ingredients
of
this
medicine.

If you are taking any of the following
medicines:
-
Monoamine
oxidase
(MAO)
inhibitors
such
as
selegiline,
rasagiline
(e.g.
for
treatment
of
Parkinson’s disease or depression,
or used for any other condition).
-
Tricyclic
antidepressants
such
as
amitriptylline,
dosulepin,
imipramine
-
Tetracyclic antidepressants such as
mianserin, maprotiline
-
Selective
serotonin
reuptake
inhibitors (SSRIs) typically used to
treat
anxiety
disorders,
and
some
personality
disorders
(e.g.
fluvoxamine or escitalopram)
-
Serotonin–norepinephrine
reuptake
inhibitors
(SNRIs),
used
in
the
treatment of major depression and
other
mood
disorders,
such
as
venlafaxine
-
Selective
noradrenaline
reuptake
inhibitors such as atomoxetine
-
Noradrenergic
and
serotonergic
antidepressant such as mirtazapine
-
Central nervous system stimulants
such as methylphenidate
-
Pethidine,
tramadol,
tapentadol
(strong painkiller).
You must wait at least 14 days after
stopping
Equfina
treatment
before
starting treatment with most of the
group of medicines mentioned.

If you have been

Caracteristicilor produsului

1
Equfina
®
FILM COATED TABLETS 50 mg
1.
COMPOSITION AND PRODUCT DESCRIPTION
1.1
Composition
Brand name
Equfina® Film coated Tablets 50 mg
Active ingredient
Safinamide mesilate 65.88 mg (safinamide 50 mg) per tablet
Inactive
ingredients
Lactose hydrate, corn starch, Sodium starch glycolate (Type A),
hydroxypropylcellulose, light anhydrous silicic acid, magnesium
stearate,
hypromellose, D-mannitol, Macrogol 6000, talc, and carnauba wax
1.2
Product Description
Description
White film-coated tablets
Appearance
Surface
Reverse
Side
Diameter (mm)
Approximately 7.1
Thickness (mm)
Approximately 3.5
Weight (mg)
Approximately 130.0
2.
INDICATION
Improvement of wearing-off phenomenon in Parkinson's disease currently
treated with
levodopa-containing products.
PRECAUTIONS CONCERNING INDICATIONS
This drug should be used in patients with wearing-off phenomenon
despite adjustment of
the dose or frequency of levodopa-containing products.
3.
DOSAGE AND ADMINISTRATION
This drug is used in combination with levodopa-containing products.
The usual adult
dosage for oral use is 50 mg of safinamide once daily. The dosage for
oral use may be
administered at 100 mg once daily according to the patient’s
condition.
2
4.
PRECAUTIONS CONCERNING DOSAGE AND ADMINISTRATION
4.1
Coadministration with levodopa-containing products may cause adverse
reactions of
levodopa origin (dyskinesia, etc.). Therefore, patients should be
closely monitored when
the dosing of this drug is started or the dose of this drug is
increased, and if such adverse
reactions occur, the dose of this drug or levodopa-containing products
should be adjusted.
4.2
The dose of Equfina should not exceed 50 mg daily for patients with
moderate hepatic
impairment (Child-Pugh B) [See 6.2.2 in PRECAUTIONS CONCERNING
PATIENTS
WITH SPECIFIC BACKGROUNDS and 11.6.2 in PHARMACOKINETICS: PATIENTS
WITH SPECIFIC BACKGROUNDS].
5.
IMPORTANT PRECAUTIONS
5.1
This drug may induce daytime somnolence or sudden onset of sleep with
no signs.
Therefore, patients should be cautioned against engaging in