Okedi

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

Risperidone

MAH:

Laboratorios Farmacéuticos Rovi, S.A.

ATC_code:

N05AX08

INN:

risperidone

therapeutic_group:

Psycholeptics

therapeutic_area:

Schizophrenia

therapeutic_indication:

Treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone.

leaflet_short:

Revision: 2

authorization_status:

Authorised

authorization_date:

2022-02-14

PIL

41
B.
PACKAGE
LEAFLET
42
PACKAGE LEAFLET: INFORMATION FOR THE USER
OKEDI 75
MG POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION
risperidone
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 OKEDI is and what it is used for
2.
What you need to know before you use OKEDI
3.
How to use OKEDI
4.
Possible side effects
5.
How to store OKEDI
6.
Contents of the pack and other information
1.
WHAT OKEDI IS AND WHAT IT IS USED FOR
OKEDI contains the active substance risperidone which belongs to the
group of medicines
called ‘antipsychotics’.
OKEDI is used in adult patients to treat schizophrenia, where you may
see, hear or feel things
that are not there, believe things that are not true or feel unusually
suspicious, or confused.
OKEDI is intended for patients who show tolerability and effectiveness
to oral (e.g. tablets)
risperidone.
OKEDI can help alleviate the symptoms of your disease and stop your
symptoms from coming
back.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE OKEDI
DO NOT USE OKEDI:
•
If you are allergic (hypersensitive) to risperidone or any of the
other ingredients of this
medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking OKEDI if:
•
You have a heart problem. Examples include an irregular heart rhythm
or if you are prone
to low blood pressure or if you are using medicines for your blood
pressure. OKEDI may
cause low blood pressure. Your dose may need to be adjusted
•
You know of any factors which would favour yo

SPC

1
ANNEX I
SUMMARY
OF
PRODUCT
CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
OKEDI 75 mg powder and solvent for prolonged-release suspension for
injection
OKEDI 100 mg powder and solvent for prolonged-release suspension for
injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
OKEDI 75 mg powder and solvent for prolonged-release suspension for
injection
1 pre-filled syringe contains 75 mg of risperidone.
OKEDI 100 mg powder and solvent for prolonged-release suspension for
injection
1 pre-filled syringe contains 100 mg risperidone.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for prolonged-release suspension for injection.
_Pre-filled syringe of powder _
White to white-yellowish non-aggregated powder.
_Pre-filled syringe of solvent for reconstitution _
Clear solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
OKEDI is indicated for the treatment of schizophrenia in adults
for whom tolerability and
effectiveness have been established with oral risperidone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
OKEDI should be administered every 28 days by intramuscular (IM)
injection.
OKEDI should be initiated according to the patient’s clinical
context:
_Patients with history of previous response to Risperidone who are
currently stabilised with oral _
_antipsychotics (mild to moderate psychotic symptoms) _
Patients stabilised with oral risperidone can be switched to OKEDI
without previous titration.
Patients stabilised on other oral antipsychotics (different from
risperidone) should be titrated with
oral risperidone before initiating treatment with OKEDI. The duration
of the titration period
should be sufficiently long (at least 6 days) to confirm the
tolerability and responsiveness to
risperidone.
_Patients never treated before with oral Risperidone _
Patients who are candidates to receive OKEDI and have NOT been
previously treated with
risperidone, the tolerability and responsiveness to risperidone must
be confirmed with a period
of oral risperidone t