Ontilyv

Land: Den Europæiske Union

Sprog: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv bestanddel:

opicapone

Tilgængelig fra:

Bial Portela & Companhia S.A.

ATC-kode:

N04, N04BX04

INN (International Name):

opicapone

Terapeutisk gruppe:

Anti-Parkinson drugs

Terapeutisk område:

Parkinson Disease

Terapeutiske indikationer:

Ontilyv 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.

Produkt oversigt:

Revision: 1

Autorisation status:

Authorised

Autorisation dato:

2022-02-21

Indlægsseddel

28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ONTILYV 25 MG HARD CAPSULES
opicapone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ontilyv is and what it is used for
2.
What you need to know before you take Ontilyv
3.
How to take Ontilyv
4.
Possible side effects
5.
How to store Ontilyv
6.
Contents of the pack and other information
1.
WHAT ONTILYV IS AND WHAT IT IS USED FOR
Ontilyv contains the active substance opicapone. It is used to treat
Parkinson’s disease and associated
movement problems.
_ _
Parkinson's disease is a progressive disease of the nervous system
that causes
shaking and affects your movement.
Ontilyv is for use in adults who are already taking medicines
containing levodopa and DOPA
decarboxylase inhibitors. It increases the effects of levodopa and
helps to relieve the symptoms of
Parkinson’s disease and movement problems.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ONTILYV
DO NOT TAKE ONTILYV:
-
if you are allergic to opicapone or any of the other ingredients of
this medicine (listed in section
6);
-
if you have a tumour of the adrenal gland (known as
phaeochromocytoma), or of the nervous
system (known as paraganglioma), or any other tumour which increase
the risk of severe high
blood pressure;
-
if you have ever suffered from neuroleptic malignant syndrome which is
a rare reaction to
antipsychotic medicines;
-
if you have ever suffered from a rare muscle disorder called
rhabdomyolysis which was not
caused by injury;
-
if you are taking certain antidepr

Produktets egenskaber

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ontilyv
25 mg hard capsules
Ontilyv
50 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ontilyv
25 mg hard capsules
Each hard capsule contains 25 mg of opicapone.
Excipient(s) with known effect
Each hard capsule contains 171.9 mg
of lactose (as monohydrate).
Ontilyv
50 mg hard capsules
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 (capsule)
Ontilyv
25 mg hard capsules
Light blue capsules, size 1, approximately 19 mm, imprinted “OPC
25” on the cap and “Bial” on the
body.
Ontilyv
50 mg hard capsules
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
Ontilyv 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.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 50 mg of opicapone.
Ontilyv should be taken once-daily at bedtime at least one hour before
or after levodopa combinations.
_Dose adjustments of antiparkinsonian therapy _
Ontilyv 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 el