NOUMED RISPERIDONE risperidone 2 mg film-coated tablet blister pack

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

risperidone, Quantity: 2 mg

Fáanlegur frá:

AVALLON PHARMACEUTICALS PTY LTD

INN (Alþjóðlegt nafn):

Risperidone

Lyfjaform:

Tablet, film coated

Samsetning:

Excipient Ingredients: magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica; pregelatinised maize starch; iron oxide yellow; iron oxide red; lactose monohydrate; titanium dioxide; hypromellose; macrogol 4000

Stjórnsýsluleið:

Oral

Einingar í pakka:

60 tablets

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

Treatment of schizophrenia and related psychoses. Short-term treatment of acute mania associated with bipolar I disorder. Treatment of behavioural disturbances in dementia. 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 (e.g. aggression, impulsivity and self-injurious behaviours) are prominent (see Clinical Trials for maintenance data). Treatment of behavioural disorders associated with autism in children and adolescents (see Clinical Trials).

Vörulýsing:

Visual Identification: apricot coated, oval, scored tablet, coded "2" on one side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Leyfisstaða:

Licence status A

Leyfisdagur:

2017-06-06

Upplýsingar fylgiseðill

NOUMED RISPERIDONE
1
NOUMED RISPERIDONE
_risperidone _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Noumed
Risperidone.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT NOUMED
RISPERIDONE IS USED
FOR
Noumed Risperidone contains the
active ingredient risperidone.
Risperidone 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. Symptoms of this
condition include 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). 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 (> 5 years),
adolescents and adults who are
intellectually disabled.
•
Treatment of behavioural
symptoms of autism in children
and adolescents.
This medicine helps to correct a
chemical imbalance in the brain
associated with the conditions
mentioned above.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY NOUMED
RISPERIDONE WAS PRESCRIBED FOR
YOU.
Your doctor may have prescribed

Vara einkenni

Product Information - Australia
Page 1 of 27
AUSTRALIAN PRODUCT INFORMATION – NOUMED
RISPERIDONE TABLETS
(RISPERIDONE)
1. NAME OF THE MEDICINE
Risperidone
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
NOUMED RISPERIDONE tablets contain 0.5 mg, 1 mg, 2 mg, 3 mg or 4 mg of
risperidone.
List of excipients with known effect: sugars (as lactose).
For the full list of excipients, see _section 6.1 list of
excipients_._ _
3. PHARMACEUTICAL FORM
NOUMED RISPERIDONE 0.5mg tablets - Red, oval shaped tablets with a
breaking notch.
NOUMED RISPERIDONE 1mg tablets - White coated, oval, scored tablets,
coded “1” on one side.
NOUMED RISPERIDONE 2mg tablets - Apricot coated, oval, scored tablets,
coded “2” on one side.
NOUMED RISPERIDONE 3mg tablets - Yellow coated, oval, scored tablets,
coded “3” on one side.
NOUMED RISPERIDONE 4mg tablets - Green coated, oval, scored tablets,
coded “4” on one side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of schizophrenia and related psychoses.
Short-term treatment of acute mania associated with bipolar I
disorder.
Treatment of behavioural disturbances in dementia.
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 (e.g. aggression, impulsivity
and self-injurious behaviours) are prominent (see _ section 5.1
Pharmacodynamic Properties: Clinical Trials for _
_maintenance data_).
Treatment of behavioural disorders associated with autism in children
and adolescents (see _ section 5.1 _
_Pharmacodynamic Properties: Clinical Trials_).
4.2 DOSE AND METHOD OF ADMINISTRATION
SCHIZOPHRENIA
Studies
on
the
efficacy and
safety of
risperidone
have
been
performed, predominantly in
patients
with
schizophrenia. The pivotal studies lasted up to eight weeks, but more
than 600 patients have been treated for at
least 12 months.
_SWITCHING FROM OTHER ANTIPSYCHOTICS _
When medically appropriate, gradual discontinuation of the previous
tr