RISPOND 2

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

RISPERIDONE

Available from:

UNIPHARM LTD, ISRAEL

ATC code:

N05AX08

Pharmaceutical form:

COATED TABLETS

Composition:

RISPERIDONE 2 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

UNIPHARM LTD, ISRAEL

Therapeutic area:

RISPERIDONE

Therapeutic indications:

Risperidone is indicated for the management of schizophrenia and manifestation of psychotic disorders. The antipsychotic efficacy of Risperidone was established in short-term (6 to 8-weeks) controlled trials of schizophrenic inpatients. Risperidone is also effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.Risperidone is indicated for the short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer’s dementia unresponsive to non-pharmacological approaches and when there is a risk of harm to self or others. Conduct and other disruptive disorders: Treatment of behavioral disorders expressed by impulse control disorders or self-alienated-aggressive or treatment-requiring behavioral disorders with reduced or substandard intelligence. Treatment should not be given to children under the age of 5 years.Risperidone is indicated for the treatment of mania in bipolar disorder. These episodes are characterized by symptoms such as elevated, expansive or irritable mood, inflated self-esteem, decreased need for sleep, pressured speech, racing thoughts, distractibility, or poor judgment, including disruptive or aggressive behaviors

Authorization date:

2021-05-31

Patient Information leaflet

PATIENT PACKAGE INSERT IN
ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with
a doctor’s prescription only
RISPOND 1, 2, 3, 4
FILM-COATED TABLETS
RISPOND SOLUTION
COMPOSITION:
RISPOND 1 TABLETS: each RISPOND 1 tablet
contains:
Risperidone 1 mg
RISPOND 2 TABLETS: each RISPOND 2 tablet
contains:
Risperidone 2 mg
RISPOND 3 TABLETS: each RISPOND 3 tablet
contains:
Risperidone 3 mg
RISPOND 4 TABLETS: each RISPOND 4 tablet
contains:
Risperidone 4 mg
RISPOND SOLUTION: each 1 ml contains:
Risperidone 1 mg
Inactive and allergenic ingredients in the
preparation – see section 2 “Important
information regarding some of the ingredients
of the medicine” and section 6 “Further
information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE
USING THE MEDICINE. This leaflet contains concise
information about the medicine. If you have further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed for the
treatment of your ailment. Do not pass it on to
others. It may harm them, even if it seems to you
that their ailment is similar.
1. WHAT IS THE MEDICINE INTENDED
FOR?
- For the treatment of schizophrenia and
symptoms of psychotic disorders.
- For treatment of state of mania in bipolar
disorder.
- For the treatment of psychotic manifestations
of moderate to severe Alzheimer’s dementia
(short-term treatment up to six weeks in cases
of consistent aggression) in patients who
are not responding to non-pharmacological
treatments and in whom there is concern that
they will harm themselves or others.
- For long-term treatment in order to maintain
the improvement in the state of the illness
in patients who have exhibited an initial
response.
- For the treatment of behavioral disorders
such as violence, impulsiveness and self-
aggression in children over 5 years of age
and in adolescents who are intellectually
disabled.
THERAPEUTIC GROUP: antipsychotic preparation.
Schizophrenia – a condition in which the
patient can see or feel things that are not the