Haldol

Ülke: Malta

Dil: İngilizce

Kaynak: Medicines Authority

Aktif bileşen:

HALOPERIDOL

Mevcut itibaren:

Janssen-Cilag International NV Turnhoutsewes 30, B-2340 Beerse, Belgium

ATC kodu:

N05AD01

INN (International Adı):

HALOPERIDOL 5 mg

Farmasötik formu:

TABLET

Kompozisyon:

HALOPERIDOL 5 mg

Reçete türü:

POM

Terapötik alanı:

PSYCHOLEPTICS

Yetkilendirme durumu:

Withdrawn

Yetkilendirme tarihi:

2007-01-30

Bilgilendirme broşürü

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HALDOL 5 MG TABLETS
haloperidol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Haldol is and what it is used for
2.
What you need to know before you take Haldol
3.
How to take Haldol
4.
Possible side effects
5.
How to store Haldol
6.
Contents of the pack and other information
1.
WHAT HALDOL IS AND WHAT IT IS USED FOR
The name of your medicine is Haldol.
Haldol contains the active substance haloperidol. This belongs to a
group of medicines called
‘antipsychotics’.
Haldol is used in adults, adolescents and children for illnesses
affecting the way you think, feel or
behave. These include mental health problems (such as schizophrenia
and bipolar disorder) and
behavioural problems.
These illnesses may make you:
•
Feel confused (delirium)
•
See, hear, feel or smell things that are not there (hallucinations)
•
Believe things that are not true (delusions)
•
Feel unusually suspicious (paranoia)
•
Feel very excited, agitated, enthusiastic, impulsive or hyperactive
•
Feel very aggressive, hostile or violent.
In adolescents and children, Haldol is used to treat schizophrenia in
patients aged 13 to 17 years, and
to treat behavioural problems in patients aged 6 to 17 years.
Haldol is also used:
•
In adolescents and children aged 10 to 17 years and in adults for
movements or sounds you
can’t control (tics), for example in severe Tourette’s syndrome
•
In adults to help control movements in Huntington’s disease.
Haldol is sometimes used wh

Ürün özellikleri

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
HALDOL 5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5mg tablet contains 5mg of haloperidol.
Excipients with known effect:
Each 5mg tablet contains 69.4mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
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.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adult patients aged 18 years and above
•
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.
•
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.
Paediatric patients
Treatment of:
•
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 edu