HALDOL 5 MG

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

HALOPERIDOL

Tilgjengelig fra:

J-C HEALTH CARE LTD

ATC-kode:

N05AD01

Legemiddelform:

TABLETS

Sammensetning:

HALOPERIDOL 5 MG

Administreringsrute:

PER OS

Resept typen:

Required

Produsert av:

JANSSEN PHARMACEUTICA N.V.,BELGIUM

Terapeutisk gruppe:

HALOPERIDOL

Terapeutisk område:

HALOPERIDOL

Indikasjoner:

HALDOL is indicatedin adult patients aged 18 years and above for:• Treatment of schizophrenia and schizoaffective disorder.• Acute treatment of delirium when non-pharmacological treatments have failed.• Treatment of moderate to severe manic episodes associated with bipolar I disorder when other treatments cannot be used.• Treatment of acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder.• Treatment of persistent aggression and psychotic symptoms in patients with moderate to severe Alzheimer’s dementia and vascular dementia when non-pharmacological treatments have failed and when there is a risk of harm to self or others.• Treatment of tic disorders, including Tourette’s syndrome, in patients with severe impairment after educational, psychological and other pharmacological treatments have failed.• Treatment of mild to moderate chorea in Huntington’s disease, when other medicinal products are ineffective or not tolerated.In paediatric patients for:• Schizophrenia in adolescents aged 13 to 17 years when other pharmacological treatments have failed or are not tolerated.• Persistent, severe aggression in children and adolescents aged 6 to 17 years with autism or pervasive developmental disorders, when other treatments have failed or are not tolerated. • Tic disorders, including Tourette’s syndrome, in children and adolescents aged 10 to 17 years with severe impairment after educational, psychological and other pharmacological treatments have failed.

Autorisasjon dato:

2022-04-30

Informasjon til brukeren

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS
REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor s prescription only
HALDOL
®
5 mg
Tablets
Active ingredient
Each tablet contains haloperidol 5 mg.
Inactive ingredients and allergens in the preparation – See section
2
Important
information regarding some of the ingredients of the medicine and
section 6 Further
information .
Read the 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 to treat 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?
Haldol is indicated in adult patients aged 18 years and above for:
•
Treatment of schizophrenia and schizoaffective disorder.
•
Acute
treatment
of
severe
confusion
(delirium)
when
non-pharmacological
treatments have failed.
•
Treatment of moderate to severe manic episodes associated with bipolar
I
disorder when other treatments cannot be used.
•
Treatment of acute psychomotor agitation associated with psychotic
disorder or
manic episodes of bipolar I disorder.
•
Treatment of persistent aggression and psychotic symptoms in patients
with
moderate
to
severe
Alzheimers
dementia
and
vascular
dementia
when
non-pharmacological treatments have failed and when there is a risk of
harm to
self or others.
•
Treatment of tic disorders, including Tourettes syndrome, in patients
with severe
impairment
after
educational,
psychological
and
other
pharmacological
treatments have failed.
•
Treatment of mild to moderate chorea in Huntingtons disease, when
other
medicinal products are ineffective or not tolerated.
In pediatric patients for:
•
Treatment of schizophrenia in adolescents aged 13 to 17 years when
other
pharmacological treatments have failed or are not tolerated.
•
Treatment of severe, persistent aggression in chi

Preparatomtale

N1
Haldol Tabs_Drops-PI_2-2023
1.
NAME OF THE MEDICINAL PRODUCT
HALDOL 5 mg
HALDOL 2 mg/ml Drops
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mg tablet contains 5 mg of haloperidol.
Oral solution - Drops
–
Dropper container:
Each drop of the oral solution contains 0.1 mg of haloperidol (each ml
contains 2 mg of haloperidol).
Excipients with known effect:
Each 5 mg tablet contains 69.4 mg of lactose monohydrate
Each ml of the oral solution contains 1.9 mg of methyl
parahydroxybenzoate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Oral solution.
5 mg tablets:
Blue, circular, biconvex tablet, cross-scored on one side and with the
inscription
“JANSSEN”
on the
other side.
The score lines are only to facilitate breaking for ease of swallowing
and not to divide into equal
doses.
Oral solution:
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HALDOL is indicated
in adult patients aged 18 years and above for:
• Treatment of schizophr
enia and schizoaffective disorder.
• Acute treatment of delirium when non
-pharmacological treatments have failed.
• Treatment of moderate to severe manic episode
s associated with bipolar I disorder when other
treatments cannot be used.
• Treatment of acute
psychomotor agitation associated with psychotic disorder or manic
episodes
of bipolar I disorder.
• Tre
atment of persistent aggression and psychotic symptoms in patients
with moderate to severe
Alzheimer’s dementia and vascular dementia when non
-pharmacological treatments have failed
2
Haldol Tabs_Drops-PI_2-2023
and when there is a risk of harm to self or others.
• Treatment
of tic disorders,
including Tourette’s syndrome, in patients with s
evere impairment
after educational, psychological and other pharmacological treatments
have failed.
• Treatment of mild to moderate chorea in Huntington’s disease,
when other medicinal prod
ucts
are ineffective or not tolerated.
In paediatric patients for:
• S
chizophrenia in adolescents aged 13 to 1