Skip to Content

PSYTIXOL 20MG/ML INJECTION

Active substance(s): FLUPENTIXOL DECANOATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Psytixol 20 mg/ml, 100 mg/ml & 200 mg/ml injection
(flupentixol decanoate)
INFORMATION FOR THE HEALTHCARE PROFESSIONAL
CONSULT THE SUMMARY OF PRODUCT
CHARACTERISTICS FOR FULL
INFORMATION ON THIS PRODUCT
PHARMACEUTICAL FORM
Solution for injection.
A clear, colourless to pale yellow, oily
solution for deep intramuscular use.
THERAPEUTIC INDICATIONS
Psytixol is indicated for the treatment of
schizophrenia and other psychoses.
Use of flupentixol should be restricted to
those stabilised on oral therapy.
POSOLOGY AND METHOD
OF ADMINISTRATION
Adults - The recommended dosage of

lower maintenance doses may be
considered, but must be sufficient
to prevent relapse. The appropriate
presentation of Psytixol should be
selected to achieve an injection volume
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immediately, but gradually withdrawn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 - In accordance with
standard medical practice, initial dosage
may need to be reduced to a quarter or
half the normal starting dose in the frail
or older people.

weekly. Other patients may be adequately

Children - Psytixol is not indicated for
children.

who have not previously received depot
antipsychotic, treatment is usually started

Reduced renal function - Flupentixol has
not been studied in renal impairment.
Increased cerebral sensitivity to
antipsychotics has been noted in severe
renal impairment.

tolerability. An interval of at least one week
should be allowed before the second
injection is given at a dose consistent with
the patient’s condition.
Adequate control of severe psychotic
at high enough dosage. Once stabilized

Reduced hepatic function - Flupentixol
has not been studied in hepatic
impairment. It is extensively metabolised
by the liver and particular caution should
be used in this situation and serum level

PACKAGE LEAFLET: INFORMATION FOR THE USER

(flupentixol decanonate)

Psytixol throughout the leaflet.
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, or 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, or pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet:
1. What Psytixol is and what it is used for
2. What you need to know before you
are given Psytixol
3. How you are given Psytixol
4. Possible side effects
5. How to store Psytixol
6. Contents of the pack
and other information
1. What Psytixol is and what it is used
for
Psytixol 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.
Psytixol is used for the treatment of
schizophrenia and other psychoses.
Your doctor, however, may prescribe
Psytixol for another purpose. Ask your
doctor if you have any questions about
why Psytixol has been prescribed for you.
2. What you need to know before you
are given Psytixol
Psytixol is not given
• if you are allergic to flupentixol or the
oil it is dissolved in
• if you are feeling less alert than usual,
or are drowsy or sleepy, or have serious
problems with your blood circulation
• if you have taken an excess of alcohol,
barbiturates or opiate medicines such
as morphine
• if you are excited or agitated
Warnings and precautions
Talk to your doctor or pharmacist before
taking flupentixol:
• if you are allergic to similar
neuroleptic medicines
• if you suffer from kidney or liver disease
• if you have a heart condition, including
an irregular heartbeat (such as a slower
heart beat); have had a recent heart
attack or have problems that cause
ankle swelling or shortness of breath
• if you have risk factors for stroke
(e.g. smoking, hypertension)
• if you suffer from Parkinson's disease
• if you suffer from epilepsy, or have been
told that you are at risk of having fits (for
example because of a brain injury or
because of alcohol withdrawal)
• if you suffer from an over or under
active thyroid
• if you have severe breathing problems
(such as asthma or bronchitis)
• if you suffer from glaucoma (raised
pressure in the eye)
• if you suffer from a condition causing
severe muscular weakness
(myasthenia gravis)
• if you have a rare type of cancer of
the adrenal gland which sits near the
kidney (phaeochromocytoma)
• if you have an enlarged prostate
• if you have too little potassium or
magnesium in your blood or a family
history of irregular heart beats
• if you or someone else in your family has
a history of blood clots, as medicines
like these have been associated with
formation of blood clots
• if you suffer from diabetes
• if you use other antipsychotic medicines
Please talk to your doctor, even if these
statements were applicable to you at any
time in the past.
Thoughts of suicide and worsening of
your depression or anxiety disorder
Flupentixol is also available in tablet
form and at lower doses can be used to
treat depression. If you are depressed
and/or have anxiety disorders you can
sometimes have thoughts of harming or
killing yourself. These may be increased
when you first start taking your
medicine, since these medicines all take
time to work, usually about two weeks
but sometimes longer.
You may be more likely to think like this:
• If you have previously had thoughts
about killing or harming yourself.
• If you are a young adult. Information
from clinical trials has shown an
increased risk of suicidal behaviour
psychiatric conditions who were
treated with an antidepressant.
If you have thoughts of harming or
killing yourself at any time, contact your
doctor or go to a hospital straight away.
You may find it helpful to tell a relative
or close friend that you are depressed or
have an anxiety disorder, and ask them
to read this leaflet. You might ask them
to tell you if they think your depression
or anxiety is getting worse, or if they are
worried about changes in your behaviour.

Other medicines and Psytixol
Tell your doctor or pharmacist if you are
taking or have recently taken or might
take any other medicines.
The following medicines should not be
taken at the same time as flupentixol:
• treatments for an irregular heartbeat
such as quinidine, disopyramide,
amiodarone, sotalol, bretylium, dofetilide.
• antibiotics such as moxifloxacin,
erythromycin
• antimalarials such as quinine
and mefloquine
• antihistamines (for hay fever or allergies)
• treatments for gastroesophageal
reflux disease such as cisapride
• other medicines used to treat
schizophrenia and other mental
illness such as lithium, chlorpromazine,
haloperidol, pimozide, sertindole,
thioridazine
Medicines may affect the actions of other
medicines and this can sometimes cause
serious adverse reactions.
Please tell your doctor or pharmacist if
you are taking, or have recently taken,
any other medicines.
• antidepressants such as amitriptyline
• sleeping tablets or sedatives such as
barbiturates (e.g. amobarbital)
• piperazine (for treating worms)
• cough and cold remedies including
those bought over the counter
• medicines containing adrenaline,
flupentixol can reduce the effect of
adrenaline and similar drugs
• corticosteroids for inflammatory
conditions such as arthritis
e.g. prednisolone
• treatment for Parkinson's disease
such as levodopa
• metoclopramide (anti-sickness medicine)
• treatments for hypertension (high
blood pressure) such as guanethidine,
hydralazine, methyldopa or doxazosin
• digoxin to control heart rhythm
• treatments for epilepsy such as
phenytoin, carbamazepine
• anticoagulants such as warfarin, used
to prevent blood clots
• medicines for diabetes such as insulin or
metformin as the dose of your diabetic
medicine may need to be adjusted
• sibutramine used to reduce appetite
• medicines containing atropine (often
used for colic)
• medicines that cause a disturbed water
or salt balance (too little potassium or
magnesium in your blood) such
as diuretics for water retention
and hypertension
Tell your doctor, dentist, surgeon or
anaesthetist before any operation as
flupentixol can increase the effects of
general anaesthetics, muscle relaxing drugs
and drugs used to prevent blood clots.
Psytixol with food, drink and alcohol
You should not drink alcohol while being
treated with this medicine, because
it may increase the sedative effects of
alcohol making you drowsier.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your doctor
or pharmacist for advice before taking
this medicine.
Psytixol should not be given to pregnant
or breast-feeding mothers unless the
benefits to the mother outweigh the
risks to the baby. Ask your doctor for
advice before taking any medicine.
Tell your doctor if you are pregnant or
planning to become pregnant. Psytixol
should not be given to you in the first or
last three months of pregnancy as it can
affect the growth of your unborn baby
and may also affect your labour.
The following symptoms may occur
in newborn babies, of mothers
that have used Psytixol in the last
trimester (last three months of their
pregnancy): shaking, muscle stiffness
and/or weakness, sleepiness, agitation,
breathing problems, and difficulty in
feeding. If your baby develops any
of these symptoms you may need to
contact your doctor.
While you are being given Psytixol do
not breast-feed your baby, as small
amounts of flupentixol can pass into
breast milk.
Driving and using machines
Do not drive or operate machinery
during the early stages of treatment or if
you drink alcohol as Psytixol may reduce
your alertness. Do not drive if you have
blurred vision.
Talk to your doctor before you drive or
operate machinery.
3. How you are given Psytixol
Your doctor will usually give you this
injection deep into the muscle of your
buttock or thigh.
Your doctor will decide on the correct
amount of medicine to give, and how
often to give it. The medicine is slowly
released from the injection site so that
a fairly constant amount of medicine
gets into your blood during the period
between each dose.
The recommended dose lies between

If you have not received an injection
like flupentixol before, a small dose of

monitoring is advised. Psytixol should be
initiated at low doses orally to check for
tolerability before switching to the depot
formulation.
ROUTE OF ADMINISTRATION
Deep intramuscular injection into the
upper outer buttock or lateral thigh.
Dosage and dosage interval should
be adjusted according to the patient’s
symptoms and response to treatment.
Note: As with all oil based injections it is
important to ensure, by aspiration before
injection, that inadvertent intravascular
entry does not occur.
CONTRAINDICATIONS
Hypersensitivity to the active substance
or to any of the excipients.
Circulatory collapse, depressed level of
consciousness due to any cause (e.g.
intoxication with alcohol, barbiturates, or
opiates), coma.
Not recommended for excitable or
agitated patients.
SPECIAL WARNINGS AND PRECAUTIONS
FOR USE
Please consult the summary of product
characteristics for full information on
this product.
INTERACTION WITH OTHER MEDICINAL
PRODUCTS AND OTHER FORMS
OF INTERACTION
Please consult the summary of product
characteristics for full information on
this product.

OVERDOSAGE
Overdosage may cause somnolence,
or even coma, extrapyramidal
symptoms, convulsions, hypotension,
shock, hyper-or hypothermia. ECG
changes, QT prolongation, Torsades de
Pointes, cardiac arrest and ventricular
arrhythmias have been reported when
administered in overdose together with
drugs known to affect the heart.
Treatment is symptomatic and supportive,
with measures aimed at supporting the
respiratory and cardiovascular systems.
The following specific measures may be
employed if required.
- anticholinergic antiparkinson drugs if
extrapyramidal symptoms occur.
- sedation (with benzodiazepines) in
the unlikely event of agitation or
excitement or convulsions.
- noradrenaline in saline intravenous drip
if the patient is in shock. Adrenaline
must not be given.
PHARMACEUTICAL PRECAUTIONS
Do not store above 25°C. Store in the
original package. Psytixol should not be
mixed with any other injection fluids.
MARKETING AUTHORISATION HOLDER
Mylan, Station Close, Potters Bar,
Hertfordshire, EN6 1TL, United Kingdom.

834392

Date of revision: March 2016

your normal dose to test how well you
tolerate the medicine.
If you have been treated with flupentixol
tablets and you are being transferred to
flupentixol injection you may be asked
to continue taking the tablets for several
days after the first injection.
Your doctor may decide to adjust the
amount given, or the interval between
injections, from time to time.
If you have liver problems, the level of
flupentixol in your blood may be checked.
In older people or frail patients the
starting dose may be reduced to a
quarter or half the normal starting dose.
Children
Psytixol is not recommended for children.
It may take between four and six months
before you feel better. Your doctor will
decide the duration of treatment.
If you feel that the effect of flupentixol
injection is too strong or weak, talk to
your doctor or pharmacist.
It is important that you continue to receive
your medicine at regular intervals even if
you are feeling completely well, because
the underlying illness may persist for a
long time. If you stop your treatment too
soon your symptoms may return.
If you get more Psytixol than you should
Your medicine will be given by your
doctor/nurse.
In the unlikely event that you receive
too much Psytixol you may experience
some symptoms.
Symptoms of overdose may include:
- Drowsiness
- Unconsciousness
- Muscle movements or stiffness
- Fits
- Low blood pressure, weak pulse, fast
heart rate, pale skin, restlessness
- High or low body temperature
- Changes in heart beat including
irregular heart beat or slow heart rate
You will receive treatment for any of these
symptoms from your doctor or nurse.
If you stop your treatment with Psytixol
Even if you feel better after your treatment
has started you should see your doctor at
the time they ask for further treatment.
If you stop your treatment too soon your
illness may return over the course of several
weeks or months. Your doctor will decide
when it is possible to stop your treatment
and will gradually reduce the amount you
receive to avoid any unpleasant symptoms
that might occur if it is stopped abruptly
(e.g. unusual movements, feeling or being
sick, insomnia).
If you have any further questions on
the use of this medicine, ask your doctor
or pharmacist.
4. Possible side effects
Like all medicines, this medicine
can cause side effects, although not
everybody gets them.
Older patients tend to be more likely to
suffer from some of these effects than
younger patients and this may mean your
treatment is supervised more closely.
Serious side effects
Stop using Psytixol and seek medical
advice immediately if you have any of
the following:
• allergic reactions:
- Difficulty in breathing
- Swelling of the face, lips, tongue
or throat which causes difficulty in
swallowing or breathing
- Severe itching of the skin (with
raised lumps)
• blood clots in the veins especially in
the legs (symptoms include swelling,
pain and redness in the leg), which may
travel through blood vessels to the
lungs causing chest pain and difficulty
in breathing. If you notice any of these
symptoms seek medical
advice immediately.
If any of the following happen, tell
your doctor immediately or go to your
nearest hospital emergency department:
- High fever, unusual stiffness of the
muscles and changes in consciousness,
especially if occurring with sweating and
fast heart rate. These symptoms may
be signs of a rare but serious condition
called neuroleptic malignant syndrome
that has been reported with the use of
Psytixol and similar medicines
- Unusual movements of the mouth and
tongue as these may be early signs of a
condition known as tardive dyskinesia
- Unusual muscle movements (such
as circular movements of the eyes),
stiffness, tremor and restlessness (for
example difficulty in sitting or standing
still) as these may be signs of a socalled "extra-pyramidal" reaction
- In rare cases irregular heart beats
(arrhythmias) may have resulted in
sudden death
- Any yellowing of the skin and the
white in the eyes (jaundice); your liver
may be affected
If you suffer from these symptoms you
may need medical attention.
Other side effects
Side effects are most pronounced in
the beginning of the treatment and
most of them usually wear off during
continued treatment.
• Blood disorders such as lack of white
blood cells, which may be characterised
by fever or chills, sore throat, ulcerated
mouth or throat, or decrease in the
number of blood platelets which is
characterised by unusual bleeding or
unexplained bruising

• Allergic reactions
• High prolactin levels in the blood
• An increase or decrease in appetite,
increase or decrease in weight
• Raised blood levels of glucose, loss of
control of blood sugar levels
• Difficulty in sleeping
• Depression
• Feeling nervous, agitated, confused or
mentally dull or slowed down
• Sleepiness, sedation
• Restlessness or difficulty in
standing still
• Unusually overactive
• Reduced or slow body movements
• Tremor, uncontrollable muscle spasms
affecting the eyes, head, neck and
body, uncontrollable twitching, jerking
or writhing movements
• Dizziness
• Headache
• Lack of concentration
• Disorder of the central nervous system,
seen usually in older persons, in which
there is muscle weakness, trembling,
sweating and slowing of movements
(parkinsonism), speech disorder, fits
• Higher (hyperthermia) or lower
(hypothermia) body temperature
than normal
• Blurred eyesight
• Fast heartbeat, changes in the electrical
tracing of the heart (ECG), irregular or
abnormal heart rhythm and heart block
have been reported for this type
of medicine
• A fall in blood pressure, which may
make you feel dizzy and unwell,
especially when you stand quickly
• Hot flush
• Shortness of breath
• Dry mouth, increase in the amount of
saliva produced
• Constipation, being sick (vomiting),
indigestion, diarrhoea, stomach pain,
feeling sick (nausea), wind
• Abnormal liver enzyme tests
• Increased sweating, itching
• Skin rashes or increased sensitivity to
sunlight, redness, pain or painful lumps
at the site of injection
• Muscle pain and muscle stiffness
• Passing urine when you do not mean
to, passing urine more often than usual
or inability to pass urine
• Fluid retention (oedema)
• Feeling tired, unusual weakness
• Irregular or complete disappearance
of periods
• Enlargement of the breasts in men
and production of milk in both men
and women
• Loss of sex drive, difficulty in getting
and keeping an erection and difficulty
in ejaculation
• In older people with dementia, a small
increase in the number of deaths has
been reported for patients taking
antipsychotics compared with those
not receiving antipsychotics
Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. You can also report side effects
directly via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help
provide more information on the safety
of this medicine.
5. How to store Psytixol
Keep this medicine out of the sight and
reach of children.
Your doctor will not use Psytixol after the
expiry date, which is stated on the carton
after EXP. The expiry date refers to the
last day of that month.
Your doctor will store this medicine
below 25°C and in the original package.
Medicines should not be disposed of
via wastewater or household waste.
Your doctor will dispose of medicines
no longer required. These measures will
help protect the environment.
6. Contents of the pack and other
information
What Psytixol contains
The active substance is flupentixol
decanoate.
The other ingredient is medium
chain triglycerides.
What Psytixol looks like and contents
of the pack
Your medicine is in the form of an oily
solution for deep intramuscular injection.
Psytixol is supplied in amber glass
ampoules and is available in the
following strengths and pack sizes:




Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Mylan, Station Close, Potters Bar, Herts,
Manufacturer:
Haupt Pharma Wülfing GmbH,
Bethelner Landstraβe 18,
31028 Gronau/Leine,
Germany

Date of revision:
March 2016

834392
22515034

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide