RISPERDAL CONSTA 25 MG

País: Israel

Idioma: inglés

Fuente: Ministry of Health

Ingredientes activos:

RISPERIDONE

Disponible desde:

J-C HEALTH CARE LTD

Código ATC:

N05AX08

formulario farmacéutico:

POWDER FOR SUSPENSION FOR INJECTION

Composición:

RISPERIDONE 25 MG/VIAL

Vía de administración:

I.M

tipo de receta:

Required

Fabricado por:

CILAG AG, SWITZERLAND

Grupo terapéutico:

RISPERIDONE

Área terapéutica:

RISPERIDONE

indicaciones terapéuticas:

Risperdal consta is indicated for the treatment of schizophrenia and schizoaffective disorders.Risperdal consta is indicated as monotherapy for the maintenance treatment of bipolar I disorder to delay occurrence of mood episodes.Risperdal consta is indicated for adjunctive maintenance treatment to delay occurrence of mood episodes in patients with frequently relapsing bipolar disorder.

Fecha de autorización:

2022-12-31

Información para el usuario

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor s prescription only
Risperdal Consta
®
25 mg
Risperdal Consta
®
37.5 mg
Risperdal Consta
®
50 mg
Powder for preparation of suspension for injection
Active ingredient
Risperdal Consta 25 mg contains:
Risperidone 25 mg/vial
Risperdal Consta 37.5 mg contains:
Risperidone 37.5 mg/vial
Risperdal Consta 50 mg contains:
Risperidone 50 mg/vial
Inactive ingredients
and allergens in the
preparation
–
see
section
6
Further
Information .
Read this leaflet carefully in its entirety before using the medicine.
This leaflet
contains concise information about the medicine. If you have further
questions, refer
to the doctor or pharmacist.
This medicine has been prescribed to treat you. Do not pass it on to
others. It may
harm them even if it seems to you that their medical condition is
similar.
WARNING:
Increased
mortality
in
elderly
patients
with
psychosis-related
dementia.
Elderly
patients
with
psychosis-related
dementia
treated
with
antipsychotic
medicines are at an increased risk of death. Risperdal Consta is not
approved for the
treatment of patients with psychosis-related dementia.
1. WHAT IS THE MEDICINE INTENDED FOR?
Risperdal Consta is indicated for the treatment of schizophrenia and
schizoaffective
disorders.
Risperdal Consta is indicated as monotherapy for the maintenance
treatment of
bipolar disorder to delay occurrence of mood episodes.
Risperdal
Consta
is
indicated
for
adjunctive
maintenance
treatment
to
delay
occurrence of mood episodes in patients with frequently relapsing
bipolar disorder.
Therapeutic group: atypical antipsychotics.
2. BEFORE USING THE MEDICINE
Do not use the preparation if:
You are sensitive (allergic) to the active ingredient (risperidone) or
its metabolite
(paliperidone) or to any of the additional ingredients contained in
the medicine (see
section
6
Further
Information ).
Hypersensitivity
reactions,
including
anaphylactic
reaction and angioedema, have be

Ficha técnica

1
RISPERDAL
CONSTA
®
25 MG, 37.5 MG AND 50 MG
POWDER AND SOLVENT FOR PROLONGED RELEASE SUSPENSION FOR INTRAMUSCULAR
INJECTION
1
THERAPEUTIC INDICATION
1.1
SCHIZOPHRENIA
RISPERDAL
CONSTA
®
(risperidone) is indicated for the treatment of schizophrenia
and
schizoaffective disorders.(
_see Clinical _
s
_tudies (14_
))
1.2
BIPOLAR DISORDER
RISPERDAL CONSTA
®
is indicated as monotherapy for the maintenance treatment of bipolar I
disorder to
delay occurrence of mood episodes.
RISPERDAL CONSTA® is indicated for adjunctive maintenance treatment
to delay
occurrence of mood episodes in patients with frequently relapsing
bipolar disorder.
2
DOSAGE AND ADMINISTRATION
For patients who have never taken oral RISPERDAL
®
, it is recommended to establish tolerability
with oral RISPERDAL
®
prior to initiating treatment with RISPERDAL CONSTA
®
.
RISPERDAL CONSTA
®
should be administered every 2 weeks by deep intramuscular (IM)
deltoid or gluteal injection. Each injection should be administered by
a health care professional
using the appropriate enclosed safety needle
_[see Dosage and Administration_
(2.8)
_]_
. For deltoid
administration, use the 1-inch needle alternating injections between
the two arms. For gluteal
administration, use the 2-inch needle alternating injections between
the two buttocks. Do not
administer intravenously.
2.1
SCHIZOPHRENIA
The recommended dose for the treatment of schizophrenia is 25 mg IM
every 2 weeks. Although
dose response for effectiveness has not been established for RISPERDAL
CONSTA
®
, some
patients not responding to 25 mg may benefit from a higher dose of
37.5 mg or 50 mg. The
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-
RELATED
PSYCHOSIS
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS ARE AT AN INCREASED RISK OF DEATH. RISPERDAL
®
CONSTA
®
(RISPERIDONE) IS NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS. [_SEE WARNINGS AND PRECAUTIONS (5.1)_]
2
maximum dose should not exceed 50 mg RISPERDAL CONSTA
®
ever