RISPERIDEX TABLET 4MG

Riik: Singapur

keel: inglise

Allikas: HSA (Health Sciences Authority)

Toimeaine:

RISPERIDONE

Saadav alates:

APEX PHARMA MARKETING PTE. LTD.

ATC kood:

N05AX08

Annus:

4.0MG

Ravimvorm:

TABLET, FILM COATED

Koostis:

RISPERIDONE 4.0MG

Manustamisviis:

ORAL

Retsepti tüüp:

Prescription Only

Valmistatud:

DEXCEL LIMITED

Volitamisolek:

ACTIVE

Loa andmise kuupäev:

2013-10-22

Toote omadused

QUALITATIVE AND QUANTITATIVE COMPOSITION
The tablets contain 0.5mg, 1mg, 2mg or 4mg risperidone.
DOSAGE FORM
Film-coated tablets for oral use:
RISPERIDEX 0.5MG TABLETS are red, film-coated, round tablets, scored
on one side.
RISPERIDEX 1MG TABLETS are white, film-coated, round tablets, scored
on one side.
RISPERIDEX 2MG TABLETS are white, film-coated, capsule shaped tablets.
RISPERIDEX 4MG TABLETS are white, film-coated, capsule shaped tablets.
The tablets of 0.5 mg and 1 mg can be divided into equal halves.
FOR EXCIPIENTS, SEE _LIST OF EXCIPIENTS._
CLINICAL INFORMATION
INDICATIONS
Risperidex Tablets are indicated for the treatment of a broad range of
patients with
schizophrenia,
including
first
episode
psychoses,
acute
schizophrenic
exacerbations,
chronic schizophrenia, and other psychotic conditions, in which
positive symptoms (such as
hallucinations, delusions, thought disturbances, hostility,
suspiciousness), and/or negative
symptoms (such as blunted affect, emotional and social withdrawal,
poverty of speech)
are prominent. Risperidex Tablets alleviate affective symptoms (such
as depression, guilt
feelings, anxiety) associated with schizophrenia. Risperidex Tablets
are also effective
in maintaining the clinical improvement during continuation therapy in
patients who have
shown an initial treatment response.
Risperidex Tablets are indicated for the short-term treatment of
persistent aggression in
patients with moderate to severe dementia of the Alzheimer’s type
unresponsive to non-
pharmacological approaches and when there is a risk of harm to self or
others.
Risperidex Tablets are indicated for the treatment of behavioural
disorders associated
with
autism
(eg
irritability,
social
withdrawal,
stereotypic
behaviour,
hyperactivity
and
inappropriate speech) in children and adolescents.
Risperidex Tablets are also indicated for bipolar mania.
_ADJUNCTIVE THERAPY:_ Risperidex Tablets are indicated as adjunctive
therapy to mood
stabilizers in the treatment of manic episodes associated with bipolar
disorders. These