RISPERDAL ORAL SOLUTION 1MG/ML

País: Malásia

Língua: inglês

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

Ingredientes ativos:

RISPERIDONE

Disponível em:

JOHNSON & JOHNSON SDN BHD

DCI (Denominação Comum Internacional):

RISPERIDONE

Unidades em pacote:

30ml mL; 100ml mL

Fabricado por:

JANSSEN PHARMACEUTICA N.V.

Folheto informativo - Bula

RISPERDAL
® TABLETS/ORAL SOLUTION
Risperidone (1 mg, 2 mg, 3 mg, 1 mg/ml)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What RISPERDAL
®
is used for
2.
How RISPERDAL
®
works
3.
Before you use RISPERDAL
®
4.
How to use RISPERDAL
®
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
RISPERDAL
®
8.
Product description
9.
Manufacturer and product registration
holder
10.
Date of revision
WHAT RISPERDAL
® IS USED FOR
RISPERDAL
is used to treat a group of
disorders called psychoses (e.g.
schizophrenia). These are brain function
disorders relating to thought, feeling
and/or action, such as confusion, impaired
perception (like hearing the voice of
someone who is not there), unusual
suspiciousness, alienation from society,
and being excessively introverted, as well
as the resulting disturbed mental state,
anxiety, and tension.
RISPERDAL may be taken for both
sudden (acute) and long-lasting (chronic)
psychotic disorders.
In addition, after symptoms have been
relieved, RISPERDAL is used to keep the
disorder under control, i.e. to prevent its
recurrence.
RISPERDAL is indicated for the treatment
of moderate to severe manic episodes
associated with bipolar disorders.
RISPERDAL is used to treat short-term
treatment (up to 6 weeks) of long-term
aggression in intellectually disabled
children (at least 5 years of age) and
adolescents with conduct disorder.
HOW RISPERDAL
® WORKS
RISPERDAL helps to correct the chemical
imbalance in the brain associated with
these conditions.
BEFORE YOU USE RISPERDAL
®
-
_When you must not use it _
Do not take RISPERDAL if you know
that you are oversensitive to Risperidone
or other ingredients listed at the end of
the leaflet. Oversensitivity can be
recognized for instance by skin rash,
itching, shortness of breath or swollen
face. If any of these occur, contact your
doctor right away.
-
_Before you start to use it _
Always inform your doctor or
pharmacist if you are using other
medicines because some medicines
should not be taken together.
Te

Características técnicas

1
RISPERDAL
®
DESCRIPTION
_Tablets: _
Each tablet contains 1 mg, 2 mg or 3 mg of risperidone.
_Oral Solution: _
_ _
The oral solution contains 1 mg/ml risperidone.
Excipients
For excipients, see List of Excipients.
PHARMACEUTICAL FORM
_Tablets: _
Film-coated tablets for oral use:
- 1 mg risperidone as white half-scored oblong biconvex tablets;
- 2 mg risperidone as orange half-scored oblong biconvex tablets;
- 3 mg risperidone as yellow half-scored oblong biconvex tablets;
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
_ _
_Oral Solution: _
The oral solution contains 1 mg/ml risperidone.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
RISPERDAL TABLET (1MG, 2MG & 3MG) AND RISPERDAL ORAL SOLUTION 1MG/ML
RISPERDAL
®
is 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. RISPERDAL
®
alleviates affective symptoms (such as depression, guilt
feelings, anxiety) associated with schizophrenia. RISPERDAL
®
is also effective in maintaining the
2
clinical improvement during continuation therapy in patients who have
shown an initial treatment
response.
RISPERDAL is indicated for the treatment of moderate to severe manic
episodes associated with bipolar
disorders.
RISPERDAL TABLETS (1MG) AND RISPERDAL ORAL SOLUTION 1MG/ML
RISPERDAL is indicated for the short-term symptomatic treatment (up to
6 weeks) of persistent
aggression in conduct disorder in children from the age of 5 years and
adolescents with subaverage
intellectual functioning or mental retardation diagnosed according to
DSM-IV criteria, in whom the
severity of aggressive or other disruptive behaviours require
pharmacologic treatment. Ph