Haloperidol 10mg tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Haloperidol

זמין מ:

Teva UK Ltd

קוד ATC:

N05AD01

INN (שם בינלאומי):

Haloperidol

כמות:

10mg

טופס פרצבטיות:

Oral tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 04020100; GTIN: 5017007110422

עלון מידע

BLACK
ZINC Ref:
EAS4769D LEA HALOPERIDOL 1.5MG 5MG 10MG TAB TUK DEB
13 OCTOBER 2021
Version:
1
Colours Used:
Length:
Width:
Depth:
550 MM
160 MM
-
TEMPLATE
UK & Ireland Artwork Department
HALOPERIDOL 1.5 MG, 5 MG, AND 10 MG
TABLETS
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.
1. WHAT HALOPERIDOL IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
HALOPERIDOL
3. HOW TO TAKE HALOPERIDOL
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE HALOPERIDOL
6. CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT HALOPERIDOL IS AND WHAT IT IS USED
FOR
Haloperidol belongs to a group of medicines called
‘antipsychotics’.
Haloperidol 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, Haloperidol is used to
treat schizophrenia in patients aged 13 to 17 years,
and to treat behavioural problems in patients aged 6
to 17 years.
Haloperidol 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

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Haloperidol 10 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of haloperidol.
For a full list of excipients, see 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Pink, biconvex tablet, embossed 5S2 on one side.
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 educational, psychological
and other
pharmacological treatments have failed.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
A low initial dose is recommended, which subsequently may be adjusted
according to the
patient’s response. Patients must always be m