PIL
FLUANXOL
®
_(FLU-ANK-SOL)_
_FLUANXOL_
_®_
_ DEPOT 20 MG/ML_
_FLUANXOL_
_®_
_ CONCENTRATED DEPOT 100 MG/ML_
_Flupenthixol decanoate (flu-PEN-thic-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 r
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SPC
Fluanxol PI 28/6/13 v1
Page 1
_ _
PRODUCT INFORMATION
FLUANXOL
DEPOT
FLUANXOL
CONCENTRATED DEPOT
NAME OF THE MEDICINE
Flupenthixol decanoate
Chemical name_: _
cis (z)-2-[4-[3-(2-(trifluoromethyl) thioxanthenylidene - (9)) propyl] - piperaziny - (1)]
ethanol - (1) decanoic acid ester
CAS number_: _
30909-51-4
Molecular formula_: _
C
33
H
43
F
3
N
2
O
2
S
Molecular weight_: _
588.82
Structural formula_: _
DESCRIPTION
Flupenthixol decanoate is insoluble in water, soluble in alcohol, ether and
chloroform.
Fluanxol Depot injection presents as a clear, colourless to slightly yellowish oil. It
contains the following excipient: coconut oil
– fractionated.
Fluanxol Concentrated Depot injection presents as a clear, yellowish to yellow oil. It
contains the following excipient: coconut oil
– fractionated.
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Page 2
_ _
PHARMACOLOGY
Pharmacological actions
Flupenthixol is a potent, relatively non-sedating, neuroleptic drug of the thioxanthene
class. In low to moderate dosages (up to 100 mg/2 weeks) Fluanxol is non-
sedating, while a sedative effect may be expected when higher doses are
administered. Flupenthixol shows antipsychotic effects in patients with
schizophrenia. It may be of benefit in patients with flat or depressed affect. In low
doses, Fluanxol possesses
disinhibiting and mood elevating properties.
Flupenthixol dose-dependently increases the serum prolactin
levels.
Pharmacokinetics
The decanoic acid esterification of flupenthixol results in the slow release of the drug
from the oily solution at the injection site with consequent prolongation
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