ONGENTYS 50 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

OPICAPONE

متاح من:

TRUEMED LTD, ISRAEL

ATC رمز:

N04BX04

الشكل الصيدلاني:

HARD CAPSULE

تركيب:

OPICAPONE 50 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

BIAL - PORTELA & Cª, S.A, PORTUGAL

المجال العلاجي:

OPICAPONE

الخصائص العلاجية:

ONGENTYS is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.

تاريخ الترخيص:

2022-07-18

نشرة المعلومات

Page 2 of 6
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor's prescription only
ONGENTYS 50 MG
HARD CAPSULES
ACTIVE INGREDIENT:
EACH HARD CAPSULE OF ONGENTYS 50 MG CONTAINS OPICAPONE 50 MG.
For Inactive ingredients and allergens in this medicine see section 2
‘Important information about some
of this medicine’s ingredients’, and 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 for you. Do not pass it on to
others. It may harm them, even if it
seems to you that their medical condition is similar to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Ongentys 50 mg is used as adjunctive therapy in adults with
Parkinson’s disease who are taking
medicines containing levodopa/DOPA decarboxylase inhibitors and who
are not sufficiently controlled.
THERAPEUTIC GROUP: Anti-Parkinson drugs, other dopaminergic agents.
Treatment with Ongentys 50 mg increases the effectiveness of levodopa
and helps relieve the
symptoms of Parkinson’s disease and movement problems.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient opicapone or to
any of the other
ingredients this medicine contains (see section 6 'Additional
information');
•
you have a tumour of the adrenal gland (known as phaeochromocytoma),
or of the nervous
system (known as paraganglioma), or any other tumour which increases
the risk of severe
high blood pressure;
•
you have ever suffered from neuroleptic malignant syndrome which is a
rare reaction to
antipsychotic medicines;
•
you have ever suffered from a rare muscle disorder called
rhabdomyolysis which was not
caused by injury;
•
you are taking certain antidepressants called monoamine-oxidase
inhibitors (MAOI) (e.g.
phenelzine, tranylcypromine

خصائص المنتج

1
1.
NAME OF THE MEDICINAL PRODUCT
Ongentys®
50 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 50 mg of opicapone.
Excipient(s) with known effect
Each hard capsule contains 148.2 mg
of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
Dark blue capsules, size 1, approximately 19 mm, imprinted “OPC
50” on the cap and “Bial” on the
body.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ongentys 50 mg is indicated as adjunctive therapy to preparations of
levodopa/ DOPA decarboxylase
inhibitors (DDCI) in adult patients with Parkinson’s disease and
end-of-dose motor fluctuations who
cannot be stabilised on those combinations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 50 mg of opicapone.
Ongentys 50 mg should be taken once-daily at bedtime at least one hour
before or after levodopa
combinations.
_Dose adjustments of antiparkinsonian therapy _
Ongentys 50 mg is to be administered as an adjunct to levodopa
treatment and enhances the effects of
levodopa. Hence, it is often necessary to adjust levodopa dose by
extending the dosing intervals and/or
reducing the amount of levodopa per dose within the first days to
first weeks after initiating the
treatment with opicapone according to the clinical condition of the
patient (see section 4.4).
_Missed dose _
If one dose is missed, the next dose should be taken as scheduled. The
patient should not take an extra
dose to make up for the missed dose.
Special populations
_Elderly _
No dose adjustment is needed for elderly patients (see section 5.2).
Caution must be exercised in patients ≥ 85 years of age as there is
limited experience in this age group.
2
_Renal impairment _
No dose adjustment is necessary in patients with renal impairment, as
opicapone is not excreted by the
kidney (see section 5.2).
_ _
_Hepatic impairment _
No dose adjustment is necessary in patients with mild hepatic
impairment (Child-Pugh Class A).
There is limited clinical ex