Risperdal

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Risperidone 2mg;  ;  

Disponible depuis:

Janssen-Cilag (New Zealand) Ltd

DCI (Dénomination commune internationale):

Risperidone 2 mg

Dosage:

2 mg

forme pharmaceutique:

Film coated tablet

Composition:

Active: Risperidone 2mg     Excipient: Colloidal silicon dioxide Hypromellose   Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose Propylene glycol Purified talc Sodium laurilsulfate Sunset yellow FCF Titanium dioxide

Unités en paquet:

Blister pack, 1 x 60, 60 tablets

classe:

Prescription

Type d'ordonnance:

Prescription

Fabriqué par:

Janssen Pharmaceutical Sciences Unlimited Company (JPSUC)

indications thérapeutiques:

RISPERDAL is indicated for the treatment of schizophrenia and other psychotic disorders. These include 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 effect, emotional and social withdrawal, poverty of speech) are prominent.

Descriptif du produit:

Package - Contents - Shelf Life: Blister pack, 1 x 60 - 60 tablets - 36 months from date of manufacture stored at or below 25°C protect from light

Date de l'autorisation:

1992-07-13

Notice patient

RISPERDAL
®
(211014)NZCMI
1
RISPERDAL
®
_TABLETS; ORAL SOLUTION _
_Risperidone _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about
RISPERDAL. It does not contain all
of the available information. It does
not take the place of talking to your
doctor or pharmacist.
IF YOU HAVE ANY CONCERNS ABOUT
USING RISPERDAL, ASK YOUR
DOCTOR OR PHARMACIST.
Your doctor and pharmacist have
more information.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT RISPERDAL IS
USED FOR
RISPERDAL belongs to a group of
medicines called antipsychotic agents
which improve the symptoms of
certain types of mental illness.
It is used for:
•
treatment of sudden (acute) and
long-term (chronic) schizophrenia
and other types of related
psychoses. These are disorders
related to thought, feeling and/or
action,
•
short term treatment of acute
mania associated with bipolar 1
disorder. This condition is
characterised by symptoms such
as elevated, expansive or irritable
mood, inflated self-esteem,
decreased need for sleep,
pressured speech, racing
thoughts, distractibility or poor
judgement including disruptive or
aggressive behaviours,
•
treatment of behavioural
problems in patients with a
decline in mental ability
(dementia) caused by Alzheimer's
disease. These problems include:
aggression through words or
action, morbid suspiciousness,
agitation or wandering,
•
treatment of conduct and other
disruptive behaviours such as
aggression, impulsiveness and
self-injury in children (over 5
years old), adolescents and adults
who are intellectually disabled,
•
treatment of behavioural
symptoms of autism in children
and adolescent.
RISPERDAL helps to correct a
chemical imbalance in the brain
associated with these conditions.
This medicine has been approved for
the uses mentioned above. However,
your doctor may prescribe it for
another use. It is only available with
a doctor's prescription.
IF YOU WANT MORE INFORMATION, ASK
YOUR DOCTOR.
RISPERDAL is not addictive.

Résumé des caractéristiques du produit

CCDS200407ver21
Page 1 of 24
RISPERDAL TABS ORAL (211014) ADS
RISPERDAL
®
RISPERIDONE
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
RISPERDAL
®
0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg film-coated tablets
RISPERDAL
®
1 mg/mL oral solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
RISPERDAL FILM-COATED TABLETS
Each film-coated tablet contains 0.5 mg, 1mg, 2 mg, 3 mg or 4 mg of
risperidone.
_Excipients with known effect: _
Sugars as lactose. Each 0.5 mg, 1mg, 2 mg, 3 mg or 4 mg film-coated
tablet contains 91 mg,
131 mg, 130 mg, 195 mg or 260 mg lactose monohydrate, respectively.
For the full list of excipients, see SECTION 6.1.
RISPERDAL ORAL SOLUTION
1 ml oral solution contains 1 mg of risperidone
_Excipients with known effect: _
Benzoates.
For the full list of excipients, see SECTION 6.1.
3. PHARMACEUTICAL FORM
FILM-COATED TABLETS
0.5 mg: brownish-red, film-coated biconvex, half-scored oblong tablets
(marked on the grooved side with “Ris 0.5” and “JANSSEN” on
the other side)
1 mg:
white, film-coated, half-scored, oblong tablets
(marked on the grooved side with "Ris 1")
2 mg:
orange, film-coated, half-scored, oblong tablets
(marked on the grooved side with "Ris 2")
3 mg:
yellow, film-coated, half-scored, oblong tablets
(marked on the grooved side with "Ris 3")
4 mg:
green, film-coated, half-scored, oblong tablets
(marked on the grooved side with "Ris 4")
ORAL SOLUTION
1mg/mL: clear colourless solution
CCDS200407ver21
Page 2 of 24
RISPERDAL TABS ORAL(211014) ADS
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
RISPERDAL is indicated for the treatment of schizophrenia and other
psychotic disorders. These
include 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 effect,
emotional and social withdrawal, poverty of speech) are prominent.
RISPERDAL is also indicated for the treatment and long term control