Haldol Decanoate 100mg/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:

100 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Therapeutic area:

Butyrophenone derivatives; haloperidol

Authorization status:

Marketed

Authorization date:

1994-08-03

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HALDOL
® DECANOATE 50 MG/ML SOLUTION FOR INJECTION
HALDOL
® DECANOATE 100 MG/ML SOLUTION FOR INJECTION
haloperidol
Haldol is a registered trademark
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, 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 effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
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 effects
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 affecting 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

Summary of Product characteristics

Health Products Regulatory Authority
27 April 2020
CRN009Q6P
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Haldol Decanoate 100mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 141.04 mg of haloperidol decanoate,
equivalent to 100 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 decanoate dose will be 25
to150 mg for most patients.
CONTINUATION OF TREATMENT

It is recommended to adjust the haloperidol decanoate dose by up to 50
mg every 4 weeks (based on individual
patient response) until an optimal therapeutic effect is obtained.

The most effective dose is expected to range between 50 and 200 mg.

It is recommended to