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PSYTIXOL 20MG/ML INJECTION

Active substance(s): FLUPENTIXOL DECANOATE

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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 usual dosage of Psytixol is
between 50 mg every 4 weeks and 300 mg
every 2 weeks. However, some patients
may require up to 400 mg weekly. The
maximum single dose at any one time
is 400 mg. For example, 800 mg every
2 weeks should not be given. Other
patients may be adequately maintained
on dosages of 20-40 mg Psytixol every
2-4 weeks. For 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
patient’s condition.

Adequate control of severe psychotic
symptoms may take up to 4 to 6 months
at high enough dosage. Once stabilized,
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 which does
not exceed 2 ml. Volumes greater than
2 ml should be distributed 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withdrawn over a period of several days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.
Elderly - 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.
Paediatric population - Psytixol is not
indicated for children due to lack of clinical
experience.
Renal impairment - Flupentixol has
not been studied in renal impairment.
Increased cerebral sensitivity to
antipsychotics has been noted in severe
renal impairment.

Package leaflet: information for the user

Psytixol 20 mg/ml,
100 mg/ml and 200 mg/ml Injection
(flupentixol decanoate)

Psytixol 20 mg/ml, 100 mg/ml and
200 mg/ml injection are referred to as
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, pharmacist or nurse.
• 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 Psytixol is and what it is used for
2. What you need to know before you are
given Psytixol
3. How Psytixol is given
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 contains the active substance
Flupentixol decanoate. 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
You must not be given Psytixol if you
• are allergic to flupentixol or the oil it is
dissolved in (listed in section 6)
• are feeling less alert than usual, or
are drowsy or sleepy, or have serious
problems with your blood circulation
• have taken an excess of alcohol,
barbiturates or opiate medicines such
as morphine
• are excited or agitated

Warnings and precautions

Talk to your doctor, pharmacist or nurse
before you are given Psytixol if you:
• are allergic to similar neuroleptic
medicines
• suffer from kidney or liver disease
• 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
• have risk factors for stroke (e.g. smoking,
hypertension)
• suffer from Parkinson's disease
• 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)
• suffer from an over or under active thyroid
• have severe breathing problems (such as
asthma or bronchitis)
• suffer from glaucoma (raised pressure in
the eye)
• suffer from a condition causing severe
muscular weakness (myasthenia gravis)
• have a rare type of cancer of the adrenal
gland which sits near the kidney
(phaeochromocytoma)
• have an enlarged prostate
• have too little potassium or magnesium
in your blood or a family history of
irregular heart beats
• or someone else in your family has a
history of blood clots, as medicines
like these have been associated with
formation of blood clots
• suffer from diabetes
• use other antipsychotic medicines
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
in adults aged less than 25 years with
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, pharmacist or nurse if you
are taking, have recently taken or might
take any other medicines.

Flupenthixol Decanoate 200 mg / ml,20 mg / ml,

Description 100 mg / ml all

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, pharmacist
or nurse if you are taking, any of the
following 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 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.
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 Psytixol is given
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.

Adults

The usual dose lies between 50 mg every
4 weeks to 300 mg every 2 weeks but
some patients require 400 mg every week.
The maximum single dose at any one time
is 400 mg. If you need more than 2 ml
of medicine it will probably be divided
between 2 injection sites.

Date: 13 Sep 2016

Component Type Leaflet

Pharma Code 192

No. of colours

Affiliate Item Code 979294

SAP No. N/A

Colours

Superceded Affiliate Item Code 834392
TrackWise PR No. 979294
MA No. 04569/0393,
0394, 0395

Packing Site/Printer N/A
Supplier Code 22515036

Vendor Job No. 289646
Trackwise Proof No. 3
Glams Proof No. N/A
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

1

Time: 17:26
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 128 x 600 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v1/May 2015

Hepatic impairment - 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 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.
Date of revision: August 2016.
979294

If you have not received an injection like
Psytixol before, a small dose of 20 mg
is usually given one week before 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
Psytixol 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.

Patients with liver problems:

If you have liver problems, the level of
flupentixol in your blood may be checked.

Elderly patients (above 65 years)

In older or frail patients, the starting dose
may be reduced to a quarter or half the
normal starting dose.

Use in children

Psytixol is not recommended for children.

Duration of treatment

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 Psytixol
injection is too strong or weak, talk to your
doctor, pharmacist or nurse.
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
or nurse.
In the unlikely event that you receive too
much Psytixol, you may experience some
symptoms of overdose such as:
• 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, difficulty
sleeping).
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

mouth or throat, or decrease in the
number of blood platelets which is
characterised by unusual bleeding or
unexplained bruising
• High prolactin levels in the blood
• An increase or decrease in appetite,
increase in weight
• Raised blood levels of glucose, loss of
control of blood sugar levels
• Difficulty in sleeping
• Depression
• Feeling nervous, agitated
• Decreased sexual drive
• 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 the elderly , 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 (seen in a
blood test)
• 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
unable 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 elderly patients 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

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.

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.

Serious side effects

5. How to store Psytixol

4. Possible 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 so-called
"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

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

Flupenthixol Decanoate 200 mg / ml,20 mg / ml,

Description 100 mg / ml all

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:
• Psytixol 20 mg/ml injection is supplied
in packs of 1, 5 or 10 ampoules. Each
ampoule contains 1 or 2 ml of solution.
• Psytixol 100 mg/ml injection is supplied
in packs of 1, 5 or 10 ampoules. Each
ampoule contains 0.5 or 1 ml of solution.
• Psytixol 200 mg/ml injection supplied in
packs of 5 or 10 ampoules where each
ampoule contains 1 ml of solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Mylan,
Station Close,
Potters Bar, Herts, EN6 1TL, UK

Manufacturer:

Haupt Pharma Wülfing GmbH,
Bethelner Landsraβe 18,
31028 Gronau/Leine,
Germany
Date of last revision: August 2016.
979294
22515036

Date: 13 Sep 2016

Component Type Leaflet

Pharma Code 192

No. of colours

Affiliate Item Code 979294

SAP No. N/A

Colours

Superceded Affiliate Item Code 834392
TrackWise PR No. 979294
MA No. 04569/0393,
0394, 0395

Packing Site/Printer N/A
Supplier Code 22515036

Vendor Job No. 289646
Trackwise Proof No. 3
Glams Proof No. N/A
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

1

Time: 17:26
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 128 x 600 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v1/May 2015

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.

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