SAPHRIS 5 MG

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

ASENAPINE AS MALEATE

Commercializzato da:

MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL

Codice ATC:

N05AH05

Forma farmaceutica:

TABLETS SUBLINGUAL

Composizione:

ASENAPINE AS MALEATE 5 MG

Via di somministrazione:

PER OS

Tipo di ricetta:

Required

Prodotto da:

MERCK SHARP & DOHME CORP., USA

Gruppo terapeutico:

ASENAPINE

Area terapeutica:

ASENAPINE

Indicazioni terapeutiche:

Schizophrenia SAPHRIS is indicated for the treatment of schizophrenia in adults. The efficacy of SAPHRIS was established in two 6-week trials and one maintenance trial in adults Bipolar Disorder Monotherapy: SAPHRIS is indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder. Efficacy was established in two 3-week monotherapy trials in adults Adjunctive Therapy: SAPHRIS is indicated as adjunctive therapy with either lithium or valproate for the acute treatment of manic or mixed episodes associated with bipolar I disorder. Efficacy was established in one 3-week adjunctive trial in adults.

Data dell'autorizzazione:

2016-04-30

Foglio illustrativo

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS'
REGULATIONS (PREPARATIONS) - 1986
THE DISPENSING OF THIS MEDICINE REQUIRES A DOCTOR'S PRESCRIPTION.
READ THIS PACKAGE INSERT CAREFULLY IN ITS ENTIRETY BEFORE USING THIS
MEDICINE.
THE FORMAT OF THIS LEAFLET WAS DETERMINED BY THE MINISTRY OF HEALTH
AND ITS
CONTENT WAS CHECKED AND APPROVED IN NOVEMBER 2011.
SAPHRIS
® 5 MG SAPHRIS
® 10 MG
SUBLINGUAL TABLETS SUBLINGUAL TABLETS
COMPOSITION
Each sublingual tablet contains:
Saphris 5 mg: 5 mg of Asenapine
Saphris 10 mg: 10 mg of Asenapine
INACTIVE INGREDIENTS:_ _
Gelatin, Mannitol.
THERAPEUTIC GROUP: Antipsychotics
THERAPEUTIC ACTIVITY_ _
Saphris is used to treat schizophrenia and manic episodes associated
with bipolar I
disorder.
WHEN SHOULD THE PREPARATION NOT BE USED?
- Do not use this medicine if you are allergic to asenapine or any of
the other
ingredients.
- Do not take Saphris while you are pregnant, unless your doctor tells
you so. If you
are taking Saphris and you become pregnant or you plan to get
pregnant, ask your
doctor as soon as possible whether you may continue taking Saphris.
- Do not breast-feed when taking Saphris.
- Do not use this medicine if you have severe liver function problems.
- Do not use this medicine in elderly patients with dementia.
DO
NOT
TAKE
THIS
MEDICINE
WITHOUT
CONSULTING
A
DOCTOR
BEFORE STARTING TREATMENT

if you are breastfeeding

if you have ever been diagnosed with a condition whose symptoms
include high
body temperature and muscle stiffness (also known as Neuroleptic
Malignant
Syndrome)

if you have ever experienced abnormal movements of the tongue or face
(Tardive Dyskinesia)
You should be aware that both of these conditions may be caused by
this type of
medicine.

if you have a heart disease or heart disease treatment that makes you
prone to
low blood pressure

if you are diabetic or prone to diabetes

if you have epilepsy (seizures)

if you experience any difficulty in swallowing (dysphagia)

if you have difficulty controlling core body temper

Scheda tecnica

HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SAPHRIS
® (ASENAPINE) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR SAPHRIS.
SAPHRIS (ASENAPINE) SUBLINGUAL TABLETS
INITIAL U.S. APPROVAL: 2009
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS
WITH DEMENTIA-RELATED PSYCHOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. _
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS ARE AT AN INCREASED RISK OF DEATH. SAPHRIS IS
NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS. (5.1)
---------------------------RECENT MAJOR
CHANGES---------------------------
Indications and Usage, Schizophrenia (1.1)
09/2010
Indications and Usage, Bipolar Disorder (1.2)
09/2010
Dosage and Administration, Schizophrenia (2.2)
09/2010
Dosage and Administration, Bipolar Disorder (2.3)
09/2010
Contraindications (4)
08/2011
Warnings and Precautions, Hypersensitivity Reactions (5.7)
08/2011
---------------------------INDICATIONS AND
USAGE-----------------------------
SAPHRIS is an atypical antipsychotic indicated for:
•
Treatment of schizophrenia
in adults. (1.1)
Efficacy was established in two 6-week clinical trials and one
maintenance trial in patients with schizophrenia in adults. (14.1)
•
Acute treatment, as monotherapy or adjunctive therapy, of manic
or mixed episodes associated with bipolar I disorder. (1.2)
Efficacy was established in two 3-week monotherapy trials and in
one 3-week adjunctive trial in patients with manic or mixed
episodes associated with bipolar I disorder in adults. (14.2)
-------------------------DOSAGE AND
ADMINISTRATION----------------------
STARTING
DOSE
RECOMMENDED
DOSE
MAXIMUM
DOSE
Schizophrenia –
acute treatment in
adults (2.2)
5 mg
sublingually
twice daily
5 mg
sublingually
twice daily
10 mg
sublingually
twice daily
Schizophrenia –
maintenance
treatment in adults
(2.2)
5 mg
sublingually
twice daily
for one
week
10 mg
sublingually
twice daily
10 mg
sublingually
twice dai