RISPERIDONE GENERICHEALTH risperidone 2mg tablet blister pack

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

risperidone, Quantity: 2 mg

Disponibil de la:

Generic Health Pty Ltd

INN (nume internaţional):

Risperidone

Forma farmaceutică:

Tablet, film coated

Compoziție:

Excipient Ingredients: microcrystalline cellulose; colloidal anhydrous silica; pregelatinised maize starch; lactose monohydrate; sodium lauryl sulfate; purified talc; magnesium stearate; titanium dioxide; hypromellose; propylene glycol; sunset yellow FCF aluminium lake

Calea de administrare:

Oral

Unități în pachet:

60 tablets

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

? Risperidone tablets are indicated for the treatment of schizophrenia and related psychoses. ? Risperidone tablets are indicated for the short-term treatment of acute mania associated with bipolar 1 disorder (see Section 4.2 Dose and Method of Administration ? Bipolar mania)). ? Risperidone tablets are also indicated for the treatment (up to 12 weeks) of psychotic symptoms, or persistent agitation or aggression unresponsive to non-pharmacological approaches in patients with moderate to severe dementia of the Alzheimer type. (see Section 4.2 Dose and Method of Administration: Behavioural Disturbances in Dementia) ? Risperidone tablets are indicated in the treatment of conduct and other disruptive disorders in children (over 5 years), adolescents and adults with sub average intellectual functioning or mental retardation in whom destructive behaviours (eg. aggression, impulsivity and self-injurious behaviours) are prominent. (see Section 5.1 Pharmacodynamic Properties ? Clinical Trials for maintenance data). ? Risperidone tablets are indicated for the treatment of behavioural disorders associated with autism in children and adolescents (see Section 5.1 Pharmacodynamic Properties ? Clinical Trials)

Rezumat produs:

Visual Identification: Orange, capsule-shaped, biconvex film-coated tablet, debossed '2' on one side and break line on the other side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Statutul autorizaţiei:

Registered

Data de autorizare:

2008-07-07

Prospect

CONSUMER MEDICINE INFORMATION
RISPERIDONE GENERICHEALTH
(RISPERIDONE) FILM-COATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about
Risperidone generichealth.
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 TAKING THIS MEDICINE,
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 RISPERIDONE
GENERICHEALTH IS USED FOR
Risperidone generichealth
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.
Risperidone generichealth 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,
A

Caracteristicilor produsului

AUSTRALIAN PRODUCT INFORMATION – RISPERIDONE GENERICHEALTH
(RISPERIDONE) FILM COATED TABLET
1
NAME OF THE MEDICINE
Risperidone.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Risperidone generichealth tablet contains 1 mg, 2 mg, 3 mg or 4 mg of
risperidone.
List of excipients with known effects: lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Risperidone generichealth 1 mg tablets are white, capsule-shaped,
biconvex film-coated tablets,
debossed with ‘1’ on one side and scoreline on the other side.
Risperidone generichealth 2 mg tablets are orange, capsule-shaped,
biconvex film-coated tablets,
debossed with ‘2’ on one side and scoreline on the other side.
Risperidone generichealth 3 mg tablets are dark yellow,
capsule-shaped, biconvex film-coated tablets,
debossed with ‘3’ on one side and scoreline on the other side.
Risperidone generichealth 4 mg tablets are red brown, capsule-shaped,
biconvex film-coated tablets,
debossed with ‘4’ on one side and scoreline on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Risperidone tablets are indicated for the treatment of schizophrenia
and related psychoses.
Risperidone tablets are indicated for the short-term treatment of
acute mania associated with bipolar 1
disorder (see SECTION 4.2 DOSE AND METHOD OF ADMINISTRATION –
BIPOLAR MANIA).
Risperidone tablets are also indicated for the treatment (up to 12
weeks) of psychotic symptoms, or
persistent agitation or aggression unresponsive to non-pharmacological
approaches in patients with
moderate
to
severe
dementia
of
the
Alzheimer
type.
(see
SECTION
4.2
DOSE
AND
METHOD
OF
ADMINISTRATION: BEHAVIOURAL DISTURBANCES IN DEMENTIA)
Risperidone tablets are indicated in the treatment of conduct and
other disruptive disorders in children
(over 5 years), adolescents and adults with sub average intellectual
functioning or mental retardation in
whom destructive behaviours (eg. aggression, impulsivity and
self-injurious behaviours) are prominen