Haldol Decanoate 50mg/ml Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Haloperidol

Available from:

Janssen Sciences Ireland UC

ATC code:

N05AD; N05AD01

INN (International Name):

Haloperidol

Dosage:

50 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Therapeutic area:

Butyrophenone derivatives; haloperidol

Authorization status:

Marketed

Authorization date:

1993-10-10

Patient Information leaflet

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READ ALL OF THIS LEAFL ET CAREFULLY
BEFORE YOU START USING THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
• Keep this leafl et. You may need to read it again.
• If you have any further questions, ask your
doctor, pharmacist or nurse.
• 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 eff ects, talk to your doctor,
pharmacist or nurse. This includes any possible
side eff ects not listed in this leafl et. See section 4.
WHAT IS IN THIS LEAFL ET
1
WHAT HALDOL DECANOATE IS AND WHAT IT IS
USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU ARE
GIVEN HALDOL DECANOATE
3
HOW TO USE HALDOL DECANOATE
4
POSSIBLE SIDE EFF ECTS
5
HOW TO STORE HALDOL DECANOATE
6
CONTENTS OF THE PACK AND OTHER INFORMATION
1 WHAT HALDOL DECANOATE IS AND WHAT IT IS USED FOR
The name of your medicine is Haldol Decanoate.
Haldol Decanoate contains the active substance
haloperidol (as haloperidol decanoate). This belongs
to a group of medicines called ‘antipsychotics’.
Haldol Decanoate is used in adults whose
condition has previously been treated with
haloperidol taken by mouth. It is used for illnesses
aff ecting the way you think, feel or behave.
These include mental health problems (such as
schizophrenia). 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.
2 WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN
HALDOL DECANOATE
DO NOT USE HALDOL DECANOATE IF:
• You are allergic to haloperidol or any of the other
ingredients of this medicine (listed in section 6)
• You are allergic to sesame oil. Haldol Decanoate
contains sesame oil. See ‘Haldol Decanoate
contains’ below
• You are less aware of things around you or

Summary of Product characteristics

HealthProductsRegulatoryAuthority
10June2019
CRN008JQQ
Page1of15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
HaldolDecanoate50mg/mlSolutionforInjection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Eachmlofsolutioncontains70.52
mgofhaloperidoldecanoate,equivalentto50
mgofhaloperidolbase.
Excipientswithknowneffect:
Eachmlofsolutioncontains15
mgofbenzylalcoholandupto1 mlofsesameoil.
Forthefulllistofexcipients,seesection 6.1.
3 PHARMACEUTICAL FORM
Solutionforinjection.
Slightlyamber,slightlyviscoussolution,freefromvisibleforeignmaterial.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
HALDOLDecanoateisindicatedforthemaintenancetreatmentofschizophreniaandschizoaffectivedisorderinadultpatients
currentlystabilisedwithoralhaloperidol(seesection
5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatmentinitiationanddosetitrationmustbecarriedoutundercloseclinicalsupervision.
Posology
Theindividualdosewilldependonboththeseverityofthesymptomsandthecurrentoralhaloperidoldose.Patientsmust
alwaysbemaintainedonthelowesteffectivedose.
Astheinitialdoseofhaloperidoldecanoateisbasedonamultipleofthedailyoralhaloperidoldose,specificguidanceon
switchingfromotherantipsychoticscannotbeprovided(seesection
5.1).
_Adults aged 18 years and above_
TABLE 1: HALOPERIDOL DECANOATE DOSE RECOMMENDATIONS FOR ADULTS AGED 18
YEARS AND ABOVE
TRANSITION FROM ORAL HALOPERIDOL

Ahaloperidoldecanoatedoseof10to15
timesthepreviousdailydoseoforalhaloperidolisrecommended.

Basedonthisconversion,thehaloperidol�