SAPHRIS SUBLINGUAL TABLET 10MG

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

ASENAPINE MALEATE

Boleh didapati daripada:

ORGANON MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

ASENAPINE MALEATE

Unit dalam pakej:

60Tablet Tablets; 20Tablet Tablets

Dikeluarkan oleh:

Catalent UK Swindon Zydis Limited

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
SAPHRIS
® SUBLINGUAL TABLET
Asenapine (5mg, 10mg)
1
Copyright 2021 Organon group of companies. All rights reserved.
WHAT IS IN THIS LEAFLET
1.
What SAPHRIS SUBLINGUAL
TABLET is used for
2.
How SAPHRIS SUBLINGUAL
TABLET works
3.
Before you take SAPHRIS
SUBLINGUAL TABLET
4.
How to take SAPHRIS
SUBLINGUAL TABLET
5.
While you are taking SAPHRIS
SUBLINGUAL TABLET
6.
Side effects
7.
Storage and Disposal of
SAPHRIS SUBLINGUAL
TABLET
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT SAPHRIS SUBLINGUAL
TABLET IS USED FOR
SAPHRIS SUBLINGUAL
TABLET belongs to a group of
medicines called antipsychotics.
SAPHRIS SUBLINGUAL
TABLET is used to treat
schizophrenia, acute treatment of
manic or mixed episodes associated
with bipolar I disorder.
Schizophrenia is a disease with
symptoms such as hearing things,
seeing or sensing things that are not
there, mistaken beliefs, unusual
suspiciousness, becoming
withdrawn, incoherent speech and
behaviour, and emotional flatness.
People with this disease may also
feel depressed, anxious, guilty or
tense.
Manic episodes associated with
bipolar I disorder is a condition with
symptoms such as feeling "high",
having excessive amounts of
energy, needing much less sleep
than usual, talking very quickly with
racing ideas and sometimes severe
irritability.
HOW SAPHRIS SUBLINGUAL
TABLET WORKS
SAPHRIS SUBLINGUAL
TABLET is thought to work by
blocking receptors in the brain for
treatment of schizophrenia and
bipolar I disorder.
BEFORE YOU TAKE SAPHRIS
SUBLINGUAL TABLET
_When you must not take it _
−
if you are allergic
(hypersensitive) to asenapine or
any of the other ingredients.
−
If you have diabetes or risk
factors for diabetes, such as
being overweight or a family
history of diabetes, your blood
sugar should be tested at the
beginning of and throughout
treatment with SAPHRIS
SUBLINGUAL TABLET.
−
If you are pregnant or
breastfeeding, unless your doctor
tells you so.
−
If you are below 18 years o

Ciri produk

Copyright 2021 Organon group of companies. All rights reserved.
SAPHRIS SUBLINGUAL TABLET
LPC-SB-T-102017a
SAPHRIS (ASENAPINE) SUBLINGUAL TABLET
FULL
PRESCRIBING
INFORMATION
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. ANALYSES OF 17 PLACEBO-CONTROLLED
TRIALS (MODAL
DURATION OF 10 WEEKS), LARGELY IN PATIENTS TAKING ATYPICAL
ANTIPSYCHOTIC DRUGS, REVEALED A
RISK OF DEATH IN THE DRUG-TREATED PATIENTS OF BETWEEN 1.6 TO 1.7 TIMES
THAT SEEN IN
PLACEBO-TREATED PATIENTS. OVER THE COURSE OF A TYPICAL 10-WEEK
CONTROLLED TRIAL, THE RATE OF
DEATH IN DRUG-TREATED PATIENTS WAS ABOUT 4.5%, COMPARED TO A RATE OF
ABOUT 2.6% IN THE
PLACEBO GROUP. ALTHOUGH THE CAUSES OF DEATH WERE VARIED, MOST OF THE
DEATHS APPEARED
TO BE EITHER CARDIOVASCULAR (E.G., HEART FAILURE, SUDDEN DEATH) OR
INFECTIOUS (E.G.,
PNEUMONIA) IN NATURE. OBSERVATIONAL STUDIES SUGGEST THAT, SIMILAR TO
ATYPICAL
ANTIPSYCHOTIC DRUGS, TREATMENT WITH CONVENTIONAL ANTIPSYCHOTIC DRUGS
MAY INCREASE
MORTALITY. THE EXTENT TO WHICH THE FINDINGS OF INCREASED MORTALITY IN
OBSERVATIONAL STUDIES
MAY BE ATTRIBUTED TO THE ANTIPSYCHOTIC DRUG AS OPPOSED TO SOME
CHARACTERISTIC(S) OF THE
PATIENTS IS NOT CLEAR. SAPHRIS
®
(ASENAPINE) IS NOT APPROVED FOR THE TREATMENT OF PATIENTS
WITH DEMENTIA-RELATED PSYCHOSIS
_[SEE WARNINGS AND PRECAUTIONS (7.1)]_
.
1.
NAME OF THE MEDICINAL PRODUCT
Copyright 2021 Organon group of companies. All rights reserved.
Saphris Sublingual Tablet 5mg
Saphris Sublingual Tablet 10mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Saphris 5 mg sublingual tablet contains 5mg asenapine (Asenapine
maleate 7.03mg equivalent to asenapine 5mg)
Each Saphris 10mg sublingual tablet contains 10mg asenapine (Asenapine
maleate 14.06mg equivalent to asenapine 10mg)
List of excipients:
Gelatin
Mannitol (E421)
3
INDICATIONS AND USAGE
3.1
SCHIZOPHRENIA
SAPHRIS is indicated for the treatment of schizophrenia. The efficacy
of SAPHR