Depixol 20mg/ml Solution for Injection

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Ingredient activ:

FLUPENTIXOL DECANOATE

Disponibil de la:

Lundbeck (Ireland) Limited 4045 Kingwood Road Citywest, Business Park Citywest Co.Dublin, Ireland

Codul ATC:

N05AF01

INN (nume internaţional):

FLUPENTIXOL DECANOATE 20 mg/ml

Forma farmaceutică:

SOLUTION FOR INJECTION

Compoziție:

FLUPENTIXOL DECANOATE 20 mg/ml

Tip de prescriptie medicala:

POM

Zonă Terapeutică:

PSYCHOLEPTICS

Statutul autorizaţiei:

Authorised

Data de autorizare:

2006-04-18

Prospect

Package leaflet: Information for the user
DEPIXOL 20 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 INJECTION IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DEPIXOL INJECTION
3.
HOW TO USE DEPIXOL INJECTION
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE DEPIXOL INJECTION
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT
DEPIXOL INJECTION IS AND WHAT IT IS USED FOR
Depixol contains the active substance flupentixol.
Depixol 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 INJECTION
DO NOT USE DEPIXOL 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 receiving emergency treatment to support your blood circulation
•
are a

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Depixol 20 mg/ml Solution for Injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml ampoule contains 20 mg (2% w/v) cis (Z)-flupentixol
decanoate.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Solution for injection
Clear, colourless to slightly yellowish 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 20 to 40 mg every two to four weeks.
Larger doses may be used if necessary,
distributed between two injection sites.
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 (relative to the degree of hepatic impairment) should
be considered. If possible, where assay
facilities exist dosage should be adjusted according to serum levels.
_Childre