Depixol Conc. 100mg/ml Solution for Injection

País: Malta

Idioma: anglès

Font: Medicines Authority

ingredients actius:

FLUPENTIXOL DECANOATE

Disponible des:

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

Codi ATC:

N05AF01

Designació comuna internacional (DCI):

FLUPENTIXOL DECANOATE 100 mg/ml

formulario farmacéutico:

SOLUTION FOR INJECTION

Composición:

FLUPENTIXOL DECANOATE 100 mg/ml

tipo de receta:

POM

Área terapéutica:

PSYCHOLEPTICS

Estat d'Autorització:

Authorised

Data d'autorització:

2006-04-18

Informació per a l'usuari

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

Fitxa tècnica

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Depixol Conc. 100 mg/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.
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 as
sess 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.
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_Reduced hepatic function _
Dose reduction (relative to the degree of hepatic impairment) should
be