EQUFINA FILM-COATED TABLET 50MG

Страна: Сінгапур

мова: англійська

Джерело: HSA (Health Sciences Authority)

Активний інгредієнт:

Safinamide mesylate eqv safinamide

Доступна з:

EISAI (SINGAPORE) PTE. LTD.

Код атс:

N04BD03

Фармацевтична форма:

TABLET, FILM COATED

Склад:

Safinamide mesylate eqv safinamide 50mg

Адміністрація маршрут:

ORAL

Тип рецепту:

Prescription Only

Виробник:

Meiji Seika Pharmatech Co., Ltd.

Статус Авторизація:

ACTIVE

Дата Авторизація:

2022-09-28

інформаційний буклет

Drug for Parkinson's Disease
FILM-COATED TABLETS 50 MG

CONTRAINDICATIONS
(This drug is contraindicated in the following patients)
1. Patients using other MAO inhibitors (eg, selegiline hydrochloride,
rasagiline mesilate)
[see “INTERACTIONS” section]
2. Patients using pethidine hydrochloride-containing products,
tramadol hydrochloride-containing
products, or tapentadol hydrochloride [see “INTERACTIONS” section]
3. Patients using tricyclic antidepressants (eg, amitriptyline
hydrochloride, amoxapine, imipramine
hydrochloride, clomipramine hydrochloride, dosulepin hydrochloride,
trimipramine maleate, nortriptyline
hydrochloride, lofepramine hydrochloride), tetracyclic antidepressants
(eg, maprotiline hydrochloride,
mianserin hydrochloride, setiptiline maleate), selective serotonin
reuptake inhibitors (eg, fluvoxamine
maleate, paroxetine hydrochloride hydrate, sertraline hydrochloride,
escitalopram oxalate), serotonin–
noradrenaline reuptake inhibitors (eg, milnacipran hydrochloride,
duloxetine hydrochloride, venlafaxine
hydrochloride), selective noradrenaline reuptake inhibitor
(atomoxetine hydrochloride), noradrenergic
and serotonergic antidepressant (mirtazapine), or central nervous
system stimulants (eg,
methylphenidate hydrochloride, lisdexamfetamine mesilate) [see
“INTERACTIONS” section]
4. Patients with severe hepatic impairment (Child-Pugh C)
[see “PRECAUTIONS CONCERNING PATIENTS WITH SPECIFIC BACKGROUNDS”
section]
5. Patients with a history of hypersensitivity to any of the
ingredients of this drug
6. Pregnant women or women suspected of being pregnant
[see “PRECAUTIONS CONCERNING PATIENTS WITH SPECIFIC BACKGROUNDS”
COMPOSITION AND PRODUCT DESCRIPTION
1. Composition
Brand name
Equfina Film-Coated Tablets 50 mg
Active ingredient
65.88mg safinamide mesilate (equivalent to 50mg safinamide) per tablet
Inactive ingredients
Lactose hydrate, corn starch, sodium carboxymethyl starch,
hydroxypropylcellulose, light anhydrous silicic acid, magnesium
stearate,
hypromellose, D-mannitol,

Характеристики продукта

1
Drug for Parkinson's Disease
EQUFINA
® FILM-COATED TABLETS 50 MG

CONTRAINDICATIONS
(This drug is contraindicated in the following patients)
1. Patients using other MAO inhibitors (eg, selegiline hydrochloride,
rasagiline mesilate)
[see “INTERACTIONS” section]
2. Patients using pethidine hydrochloride-containing products,
tramadol hydrochloride-containing
products, or tapentadol hydrochloride [see “INTERACTIONS” section]
3. Patients using tricyclic antidepressants (eg, amitriptyline
hydrochloride, amoxapine, imipramine
hydrochloride, clomipramine hydrochloride, dosulepin hydrochloride,
trimipramine maleate,
nortriptyline hydrochloride, lofepramine hydrochloride), tetracyclic
antidepressants (eg, maprotiline
hydrochloride, mianserin hydrochloride, setiptiline maleate),
selective serotonin reuptake inhibitors
(eg, fluvoxamine maleate, paroxetine hydrochloride hydrate, sertraline
hydrochloride, escitalopram
oxalate), serotonin–noradrenaline reuptake inhibitors (eg,
milnacipran hydrochloride, duloxetine
hydrochloride, venlafaxine hydrochloride), selective noradrenaline
reuptake inhibitor (atomoxetine
hydrochloride), noradrenergic and serotonergic antidepressant
(mirtazapine), or central nervous
system stimulants (eg, methylphenidate hydrochloride, lisdexamfetamine
mesilate) [see
“INTERACTIONS” section]
4. Patients with severe hepatic impairment (Child-Pugh C)
[see “PRECAUTIONS CONCERNING PATIENTS WITH SPECIFIC BACKGROUNDS”
section]
5. Patients with a history of hypersensitivity to any of the
ingredients of this drug
6. Pregnant women or women suspected of being pregnant
[see “PRECAUTIONS CONCERNING PATIENTS WITH SPECIFIC BACKGROUNDS”
section]
COMPOSITION AND PRODUCT DESCRIPTION
1.
Composition
Brand name
Equfina Film-Coated Tablets 50 mg
Active ingredient
65.88mg safinamide mesilate (equivalent to 50mg safinamide) per tablet
Inactive ingredients
Lactose hydrate, corn starch, sodium carboxymethyl starch,
hydroxypropylcellulose, light anhydrous silicic acid, magnesium
stearate,
hypro