FLUANXOL DEPOT flupentixol decanoate 40mg/2mL injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

flupentixol decanoate, Quantity: 20 mg

Available from:

Lundbeck Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: fractionated coconut oil

Administration route:

Intramuscular

Units in package:

5 X 2mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Flupenthixol is indicated for the maintenance treatment of chronic schizophrenia and other related chronic psychoses, in patients intolerant of and/or refractory to other depot preparations. Flupenthixol is intended for maintenance therapy and not for short-term use ( less than 3 months).

Product summary:

Visual Identification: Clear, colourless to slightly yellowish oil, practically free from particles.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1994-01-10

Patient Information leaflet

FLUANXOL
®
_(FLU-ANK-SOL); FLUANXOL_
_®_
_ DEPOT 20 MG/ML; FLUANXOL_
_®_
_ CONCENTRATED DEPOT 100 MG/ML_
_Flupentixol decanoate (flu-PEN-tic-sol deck-can-OH-ate)_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet contains answers to some
common questions about Fluanxol.
It does not contain all the information
that is known about Fluanxol. It does
not take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risk of you using this medicine
against the benefits he/she expects it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT FLUANXOL IS USED
FOR
Fluanxol is used for the long-term
treatment of schizophrenia, a mental
illness with disturbances in thinking,
emotional reactions and behaviour,
and other chronic mental conditions.
Fluanxol belongs to a group of
medicines called thioxanthene
neuroleptics. It helps to correct
chemical imbalances in the brain,
which may cause mental illness.
Your doctor, however, may prescribe
it for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is only available with
a doctor's prescription.
Fluanxol is not addictive.
BEFORE YOU ARE GIVEN IT
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT USE FLUANXOL IF YOU ARE
ALLERGIC TO IT, TO ANY OTHER SIMILAR
MEDICINES (SUCH AS THIOXANTHENES
OR PHENOTHIAZINES), OR THE
INGREDIENT FRACTIONATED COCONUT OIL.
Symptoms of an allergic reaction
may include shortness of breath,
wheezing or difficulty breathing,
swelling of the face, lips, tongue or
other parts of the body, or rash,
itching or hives on the skin.
DO NOT USE FLUANXOL IF YOU HAVE:
•
diminished consciousness due to
any cause
•
collapse due to very low blood
pressure
•
brain damage
•
diseases of the blood with a
reduced number of red or white
blood cells or platelets
•
phaeochromocytoma, a rare
tumour of the adre

Summary of Product characteristics

FLUANXOL
®
(
flupentixol decanoate
)
1 of 15
AUSTRALIAN
PRODUCT
INFORMATION
–
FLUANXOL
®
DEPOT
AND
FLUANXOL
®
CONCENTRATED
DEPOT
SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Flupentixol decanoate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluanxol Depot
•
Solution for injection containing 20 mg/mL flupentixol decanoate.
Fluanxol Concentrated Depot
•
Concentrated injection containing 100 mg/mL flupentixol decanoate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Flupentixol decanoate is insoluble in water, soluble in alcohol, ether
and chloroform.
Fluanxol Depot injection presents as a clear, colourless to slightly
yellowish oil.
Fluanxol Concentrated Depot injection presents as a clear, yellowish
to yellow oil.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Flupentixol is indicated for the maintenance treatment of chronic
schizophrenia and other
related
chronic
psychoses,
in
patients
intolerant
of
and/or
refractory
to
other
depot
preparations.
Flupentixol is intended for maintenance therapy and not for short-term
use (less than 3
months).
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
Fluanxol (flupentixol decanoate) is administered by intramuscular
injection, in the gluteus
maximus. Fluanxol is NOT for intravenous use. It is not intended for
short-term therapy
(less than 3 months).
As a long-acting depot preparation, Fluanxol has been found useful in
the maintenance
treatment of non-agitated chronic schizophrenic patients who have been
stabilised with short-
acting neuroleptics and might benefit from transfer to a longer-acting
injectable medication.
FLUANXOL
®
(
flupentixol decanoate
)
2 of 15
The changeover of medication should aim at maintaining a clinical
outcome similar to or
better than that obtained with the previous therapy. To achieve and
maintain the optimum
dose, the changeover from other neuroleptic
medication should proceed gradually and
constant supervision is required during the period of dosage
adjustment in order to minimise
the risk of ov