Fluanxol

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Flupentixol decanoate 20 mg/mL

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Flupentixol decanoate 20 mg/mL

Dosage:

20 mg/mL

Pharmaceutical form:

Injection (depot)

Composition:

Active: Flupentixol decanoate 20 mg/mL Excipient: Vegetable oil

Units in package:

Ampoule, glass, 1mL, 5 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

H Lundbeck A/S

Therapeutic indications:

Fluanxol injection is a depot neuroleptic preparation and is indicated in the treatment and maintenance of schizophrenic patients, especially those who are unreliable in taking the medicine prescribed for them.

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, 1mL - 5 dose units - 48 months from date of manufacture stored at or below 25°C - Ampoule, glass, 2mL - 10 dose units - 48 months from date of manufacture stored at or below 25°C

Authorization date:

1980-04-17

Patient Information leaflet

1
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

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Fluanxol v 1.0 December 2018
Page
1
of
11
1 NAME OF THE MEDICINE
Fluanxol
®
Depot 20 mg/mL solution for injection
Fluanxol
®
Concentrated Depot 100 mg/mL solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluanxol Depot Injection:
20 mg/mL Flupentixol decanoate.
Fluanxol Concentrated Depot Injection:
100 mg/mL Flupentixol decanoate.
For the full list of excipients, see Section 6.1 List of excipients
.
3 PHARMACEUTICAL FORM
Solution for injection.
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
FLUANXOL DEPOT INJECTION
Fluanxol injection is a depot neuroleptic preparation and is indicated
in the treatment and maintenance of
schizophrenic patients, especially those who are unreliable in taking
the medicine prescribed for them.
FLUANXOL CONCENTRATED DEPOT INJECTION
Fluanxol Concentrated injection is a depot neuroleptic preparation and
is indicated in the treatment of
moderate to severe schizophrenia and allied psychoses. Patients for
whom the drug is especially
appropriate are:
1.
Those believed by the physician to be unreliable in taking oral
medication.
2.
Patients who are already receiving treatment with Fluanxol injection
at high dose levels and who
may experience discomfort as a result of the large injection volume.
3.
Patients who hitherto could not receive effective treatment with depot
neuroleptics because of the
high doses, and hence large volumes, required to achieve satisfactory
therapeutic blood levels.
Features of the illness most likely to benefit are hallucinations,
paranoid delusions, apathy, inertia,
withdrawal and anxiety.
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 pre