Depixol Conc. Injection

Country: Malta

Lingwa: Ingliż

Sors: Medicines Authority

Ingredjent attiv:

FLUPENTIXOL DECANOATE

Disponibbli minn:

Lundbeck Limited

Kodiċi ATC:

N05AF01

INN (Isem Internazzjonali):

FLUPENTIXOL DECANOATE

Għamla farmaċewtika:

SOLUTION FOR INJECTION

Kompożizzjoni:

FLUPENTIXOL DECANOATE 100 mg/ml

Tip ta 'preskrizzjoni:

POM

Żona terapewtika:

PSYCHOLEPTICS

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2006-04-18

Fuljett ta 'informazzjoni

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DEPIXOL® CONC. 100 MG/ML SOLUTION FOR INJECTION
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 DEPIXOL CONC. INJECTION IS GIVEN
3. HOW DEPIXOL CONC. INJECTION IS GIVEN
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
The name of your medicine is Depixol Conc. 100 mg/ml solution for
injection (called Depixol Conc.
Injection in this leaflet).
Depixol Conc. Injection contains the active substance flupentixol
decanoate. Depixol Conc. Injection
belongs to a group of medicines known as antipsychotics (also called
neuroleptics).
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.
Depixol Conc. Injection is used for the treatment of schizophrenia and
other psychoses.
Your doctor, however, may prescribe Depixol Conc. Injection for
another purpose. Ask your doctor if you
have any questions about why Depixol Conc. Injection has been
prescribed for you.
2. WHAT YOU NEED TO KNOW BEFORE DEPIXOL CONC. INJECTION IS GIVEN
DEPIXOL CONC. INJECTION IS NOT GIVEN IF YOU

are allergic (hypersensitive) to flupentixol, other thioxanthene drugs
or antipsychotic drugs or any of the
other ingredients of this medicine (

Karatteristiċi tal-prodott

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Depixol® 20 mg/ml solution for injection
Depixol® Conc. 100 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Depixol Injection:
20 mg/ml flupentixol decanoate in thin vegetable oil.
Depixol Conc. Injection:
100 mg/ml flupentixol decanoate in thin vegetable oil.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Depixol Injection:
Clear, colourless to slightly yellowish oil, practically free from
particles.
Depixol Conc. Injection:
Clear, yellowish to yellow oil, practically free from particles.
Oily solution for deep intramuscular injection.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The treatment of schizophrenia and other psychoses.
Use of Depixol should be restricted to those stabilised on oral
therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
The usual dosage of flupentixol decanoate lies between 50 mg every 4
weeks and 300 mg every 2 weeks, but
some patients may require up to 400 mg weekly. The maximum single dose
at any one time is 400 mg. For
example, 800 mg ever 2 weeks should not be given.
Other patients may be adequately maintained on dosages of 20-40 mg
flupentixol decanoate every 2-4
weeks. In patients who have not previously received depot
antipsychotic, 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.
Depixol Injection 20 mg/ml is not intended for use in patients
requiring doses of greater than 60 mg (3 ml) of
flupentixol. Injection volumes of 2 – 3 ml should be distributed
between two injection sites.
More concentrated solutions of flupentixol decanoate (Depixol Conc
Injection or Depixol Low Volume
Injection) should be used if doses greater than 3 ml (60 mg) are
required.
The injection volumes selected for Depixol Conc Injection or Depixol
Low Volume Injection sh