Haldol Decanoate 50mg/1ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Haloperidol decanoate

Available from:

Janssen-Cilag Ltd

ATC code:

N05AD01

INN (International Name):

Haloperidol decanoate

Dosage:

50mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020200; GTIN: 5012674035030

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

OBJECT 1
HALDOL DECANOATE
Summary of Product Characteristics Updated 09-Jun-2017 | Janssen-Cilag
Ltd
1. Name of the medicinal product
HALDOL Decanoate 50 mg/ml solution for injection
HALDOL Decanoate 100 mg/ml solution for injection
2. Qualitative and quantitative composition
Each 50 mg/ml ampoule contains 70.52 mg haloperiodol decanoate,
equivalent to 50 mg haloperidol base,
per millilitre.
Each 100 mg/ml ampoule contains 141.04 mg haloperiodol decanoate,
equivalent to 100 mg haloperidol
base, per millilitre.
3. Pharmaceutical form
Solution for injection.
Straw-coloured viscous solution for intramuscular injection.
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 a