Depixol Conc. 100mg/ml Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FLUPENTIXOL DECANOATE

Available from:

Lundbeck ( Ireland ) Limited

ATC code:

N05AF; N05AF01

INN (International Name):

FLUPENTIXOL DECANOATE

Dosage:

100 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Therapeutic area:

Thioxanthene derivatives; flupentixol

Authorization status:

Marketed

Authorization date:

1988-01-25

Patient Information leaflet

Package Leaflet: Information for the user
DEPIXOL CONC. 100 MG/ML SOLUTION FOR INJECTION
(cis(Z)-flupentixol decanoate) 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 DEPIXOL CONC. INJECTION IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DEPIXOL CONC. INJECTION
3.
HOW TO USE DEPIXOL CONC. INJECTION
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE DEPIXOL CONC. INJECTION
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT DEPIXOL CONC. INJECTION IS AND WHAT IT IS USED FOR
Depixol Conc. Injection contains the active substance flupentixol.
Depixol Conc. Injection belongs to a group of medicines known as
antipsychotics.
These medicines act on nerve pathways in specific areas of the brain
and help to correct
certain chemical imbalances in the brain that are causing the symptoms
of your illness.
This medicine
is used for the treatment of schizophrenia and other related
psychoses.
Ask your doctor if you have any questions about why this medicine has
been prescribed for
you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DEPIXOL CONC. INJECTION
DO NOT USE DEPIXOL CONC. INJECTION IF YOU:

are allergic to flupentixol or any of the other ingredients of this
medicine (listed in
Section 6). Consult your doctor if you think you might be

have a reduced level of alertness due to any cause (this includes
reduced alertness
after the consumption of alcohol or drugs such as opiates (e.g.
morphine) or
barbiturates)

are an older person who suffers from confusion

are receiv

Summary of Product characteristics

Health Products Regulatory Authority
24 November 2021
CRN00CN8J
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Depixol Conc. 100mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml ampoule contains 100 mg (10% w/v) cis(Z)-flupentixol
decanoate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection (injection)
Clear, yellowish to yellow oil, practically free from particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The management of schizophrenia and allied paranoid psychoses.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The usual dosage is between 50 mg every 4 weeks and 300 mg every two
weeks. Subsequent dosage can be adjusted on the
basis of the individual patient response and may reach 400mg weekly
before a reduction can be made to maintenance levels.
In patients who have not previously received depot neuroleptics,
treatment is usually started with a small dose (e.g. 20 mg) to
assess tolerability. An interval of at least one week should be
allowed before the second injection is given at a dose consistent
with the patients' condition.
Adequate control of severe psychotic symptoms may take up to 4 to 6
months at high enough dosage. Once stabilised lower
maintenance doses may be considered, but must be sufficient to prevent
relapse.
The appropriate presentation of Depixol should be selected to achieve
an injection volume which does not exceed 2 ml.
Volumes greater than 2 ml should be distributed between two injection
sites.
When transferring patients from oral to depot neuroleptic treatment,
the oral medication should not be discontinued
immediately but gradually withdrawn over a period of several days
after administering the first injection.
_Older people_
Older people should receive dosages in the lower end of the dosage
range.
_Reduced renal function_
Flupentixol decanoate can be given in usual doses to patients with
reduced renal function.
_Reduced hepatic function_
Dose reduction (re