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Depixol® Low Volume Injection
cis (Z)-flupentixol decanoate
Read all of this leaflet carefully before you start taking
this medicine
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or
• This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours
• If any of the side effects are troubling, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist
In this leaflet:
1. What Depixol Low Volume Injection is and what it is used for
2. Before Depixol Low Volume Injection is given
3. How Depixol Low Volume Injection is given
4. Possible side effects
5. How to store Depixol Low Volume Injection
6. Further information

anxiety is getting worse, or if they are worried about changes in
your behaviour.
Taking other medicines
The following medicines should not be taken at the same time as Depixol
Low Volume Injection:
• Medicines that change the heartbeat (quinidine, amiodarone,
sotalol, dofetilide, erythromycin, moxifloxacin, cisapride,
• Other antipsychotic medicines
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, including medicines obtained without a

Tricyclic antidepressants
Barbiturates or other medicines that make you feel drowsy
Anticoagulant drugs used to prevent blood clots (e.g. warfarin)
Anticholinergic drugs (contained in some cold, allergy or travel
sickness remedies as well as other medicines)
Metoclopramide (used to treat nausea and other stomach
Piperazine (used to treat worm infections)
Levodopa or other medicines used to treat Parkinson’s disease
Sibutramine (used to reduce appetite)
Digoxin (to control heart rhythm)
Corticosteroids (e.g. prednisolone)
Medicines used to lower the blood pressure such as
hydralazine, alpha blockers (e.g. doxazosin) beta-blockers,
methyldopa, clonidine or guanethidine
Medicines that cause a disturbed water or salt balance (too
little potassium or magnesium in your blood)
Medicines known to increase the concentration of flupentixol in
your blood
Medicines used to treat epilepsy
Medicines used to treat diabetes

What is Depixol Low Volume Injection used for?
Depixol Low Volume Injection is used for the treatment of
schizophrenia and other psychoses.
Your doctor, however, may prescribe Depixol Low Volume Injection
for another purpose. Ask your doctor if you have any questions
about why Depixol Low Volume Injection has been prescribed for

Depixol Low Volume Injection can reduce the effect of adrenaline
(epinephrine) and similar drugs.


How does Depixol Low Volume Injection work?
Depixol Low Volume Injection 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.

Depixol Low Volume Injection is not given if you
• are allergic (hypersensitive) to flupentixol, other thioxanthine
drugs or antipsychotic drugs or any of the other ingredients of
Depixol Low Volume Injection (see What Depixol Low Volume
Injection contains). Consult your doctor if you think you might
• are feeling less alert than usual or are drowsy or sleepy, or
have serious problems with your blood circulation
• are excited or agitated
Take special care with Depixol Low Volume Injection if you
• have a heart condition, including an irregular heart beat (such
as a slower heart beat); have had a recent heart attack or have
problems that cause ankle swelling or shortness of breath
• have severe breathing problems (such as asthma or bronchitis)
• have liver, kidney or thyroid problems
• 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 Parkinson’s disease, or myasthenia gravis (a
condition causing severe muscular weakness)
• have an enlarged prostate or suffer from a condition known as
phaeochromocytoma (a rare type of cancer of a gland near the
• suffer from glaucoma (raised pressure within the eye)have risk
factors for stroke (e.g. smoking, hypertension)
• have too little potassium or magnesium in your blood or a
family history of irregular heart beats
• use other antipsychotic medicines
• suffer from diabetes
• or someone else in your family has a history of blood clots, as
medicines like these have been associated with formation of
blood clots.
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
If you are depressed and/or have anxiety disorders you can
sometimes have thoughts of harming or killing yourself. These
may be increased when first starting antidepressants, 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
• 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
Depixol® Low Volume Injection.

Tell your doctor, dentist, surgeon or anaesthetist before any
operation as Depixol Low Volume Injection can increase the
effects of general anaesthetics, muscle relaxing drugs and drugs
used to prevent clots.
Does Depixol Low Volume Injection interact with alcohol?
Depixol Low Volume Injection may increase the sedative effects of
alcohol making you drowsier. It is recommended not to drink
alcohol during treatment with Depixol Low Volume Injection.
Ask your doctor or pharmacist for advice before taking any
If you are pregnant or think you might be pregnant, tell your
Depixol Low Volume Injection should not be used during
pregnancy unless clearly necessary.
Your newborn baby might show side effects if this medicine is
used during pregnancy.
The following symptoms may occur in newborn babies, of mothers
that have used Depixol Low Volume Injection 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.
Ask your doctor or pharmacist for advice before taking any
If you are breastfeeding, ask your doctor for advice. Depixol Low
Volume Injection should not be used when breast-feeding, as
small amounts of the medicine can pass into the breast milk.
Driving and using machines
There is a risk of feeling drowsy and dizzy when being treated with
Depixol Injection, especially at the start of your treatment. If this
happens do not drive or use any tools or machines until you know
you are not affected in this way.
Do not drive if you have blurred vision.
A small amount of Depixol Low Volume Injection is drawn up into a
syringe and then injected 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 usual dose lies between 50 mg every 4 weeks to 300 mg every
2 weeks but some patients require 400 mg every week. If you
need more than 2 ml of medicine it will probably be divided
between 2 injection sites.
If you haven’t received an injection like Depixol Low Volume
Injection before, a small dose of 20 mg is usually given one week
before your normal dose to test how well you tolerate the
If you have been treated with Depixol tablets and you are being
transferred to Depixol Low Volume Injection you may be asked to
continue taking the tablets for several days after the first injection.

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.

The treatment of schizophrenia and other psychoses.
Use of Depixol should be restricted to those stabilised on oral therapy.

The elderly require close supervision because they are specially prone to
experience such adverse effects as sedation, hypotension, confusion and
temperature changes.

Route of administration
Deep intramuscular injection into the upper outer buttock or lateral

The possibility of development of neuroleptic malignant syndrome
(hyperthermia, muscle rigidity, fluctuating consciousness, instability of the
autonomous nervous system) exists with any neuroleptic. The risk is
possibly greater with the more potent agents. Patients with pre-existing
organic brain syndrome, mental retardation, and opiate and alcohol abuse
are over-represented among fatal cases.

200 mg/ml (20 %w/v) cis (Z)-flupentixol decanoate in thin vegetable oil.
Ampoules 1 ml and 2 ml, and Vial 5 ml.

Dosage and dosage interval should be adjusted according to the
patients’ 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
The usual dosage of flupentixol decanoate lies between 50 mg every
4 weeks and 300 mg every 2 weeks, but some patients may require up
to 400 mg weekly. Other patients may be adequately maintained on
dosages of 20-40 mg flupentixol decanoate every 2-4 weeks.
In 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 patients’
Depixol Injection 20 mg/ml is not intended for use in patients requiring
doses of greater than 60 mg (3 ml) of flupentixol. Injection volumes of
2 - 3 ml should be distributed between two injection sites.
More concentrated solutions of flupentixol decanoate (Depixol Conc
Injection or Depixol Low Volume Injection) should be used if doses
greater than 3 ml (60 mg) are required.
The injection volumes selected for Depixol Conc Injection or Depixol Low
Volume Injection should not exceed 2 ml.
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
Depixol Low Volume Injection is not indicated for children.
Reduced Renal Function
Flupentixol has not been studied in renal impairment. Increased
cerebral sensitivity to antipsychotics has been noted in severe renal
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 monitoring is advised. Depixol should be
initiated at low doses orally to check for tolerability before switching to the
depot formulation.

Treatment: Discontinuation of the neuroleptic. Symptomatic treatment
and use of general supportive measures. Dantrolene and bromocriptine
may be helpful.
Symptoms may persist for more than a week after oral neuroleptics are
discontinued and somewhat longer when associated with the depot forms of
the drugs.
Blood dyscrasias, including thrombocytopenia, have been reported
rarely. Blood counts should be carried out if a patient develops signs of
persistent infection.
As described for other psychotropics flupentixol may modify insulin and
glucose responses calling for adjustment of the antidiabetic therapy in
diabetic patients.
Acute withdrawal symptoms, including nausea, vomiting, sweating and
insomnia have been described after abrupt cessation of antipsychotic
drugs. Recurrence of psychotic symptoms may also occur, and the
emergence of involuntary movement disorders (such as akathisia, dystonia
and dyskinesia) has been reported. The plasma concentrations of the
Depixol Injection gradually decrease over several weeks which makes
gradual dosage tapering unnecessary.
When transferring patients from oral to depot antipsychotic treatment, the
oral medication should not be discontinued immediately, but gradually
withdrawn over a period of several days after administering the first
An approximately 3-fold increased risk of cerebrovascular adverse events
have been seen in randomised placebo controlled clinical trials in the
dementia population with some atypical antipsychotics. The mechanism for
this increased risk is not known. An increased risk cannot be excluded for
other antipsychotics or other patient populations.
Flupentixol should be used with caution in patients with risk factors for
As with other drugs belonging to the therapeutic class of antipsychotics,
flupentixol may cause QT prolongation. Persistently prolonged QT intervals
may increase the risk of malignant arrhythmias. Therefore, flupentixol
should be used with caution in susceptible individuals (with
hypokalaemia, hypomagnesaemia or genetic predisposition) and in
patients with a history of cardiovascular disorders, e.g. QT prolongation,
significant bradycardia (<50 beats per minute), a recent acute myocardial
infarction, uncompensated heart failure, or cardiac arrhythmia.


Oily solution for deep intramuscular injection.

Caution should be exercised in patients having: liver disease; cardiac
disease or arrhythmias; severe respiratory disease; renal failure; epilepsy
(and conditions predisposing to epilepsy e.g. alcohol withdrawal or brain
damage); Parkinson’s disease; narrow angle glaucoma; prostatic
hypertrophy; hypothyroidism; hyperthyroidism; myasthenia gravis;
phaeochromocytoma and patients who have shown hypersensitivity to
thioxanthenes or other antipsychotics.


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.
Elderly patients (above 65 years)
Starting doses for elderly or frail patients are usually reduced to a
quarter or a half of the dosage range.
Depixol Low Volume Injection 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 Depixol Low Volume 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 Depixol Low Volume Injection than you should
Your medicine will be given by your doctor/nurse.
In the unlikely event that you receive too much Depixol Low
Volume Injection 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,
• High or low body temperature
• Changes in heart beat including irregular heart beat or slow
heart rate

• Indigestion or stomach pain
• Flatulence (wind), constipation or diarrhoea
• Abnormal urination (such as a decrease in the frequency or
• Increased sweating or greasy skin
• Itching, rashes or skin reactions (including sensitivity to
• Skin reactions at injection site
• Muscle pain
• Raised blood levels of glucose or the hormone prolactin
• Loss of control of blood sugar levels
• Changes in appetite or weight
• Low blood pressure
• Hot flushes
• General weakness or pain, tiredness or feeling unwell
• Abnormal liver function tests
• Unexpected excretion of breast milk
• Insomnia
• Depression
• Nervousness or agitation
• Reduction in your sex drive
• Men may experience breast enlargement or problems with
ejaculation or erections
• Women may experience an absence of menstrual periods
As with other medicines that work in a way similar to flupentixol
(the active ingredient of Depixol Low Volume Injection), rare cases
of the following side effects have been reported:
• Slow heartbeat and abnormal ECG heart tracing
• Life threatening irregular heart beats
In elderly people with dementia, a small increase in the number of
deaths has been reported for patients taking antipsychotics
compared with those not receiving antipsychotics.
If any of the side effects are troubling, or if you notice any side
effects not listed in this leaflet, please tell your doctor or

You will receive treatment for any of these symptoms from your doctor
or nurse.



Usually your doctor or nurse will store the medicine for you. If you
keep it at home:

Like all medicines, Depixol Low Volume Injection can cause side
effects, although not everybody gets them. Elderly 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
Serious side effects
Stop using Depixol 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 you get any of the following symptoms you should contact your
doctor immediately as your dose may need to be reduced or
• 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 Depixol 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
• Throbbing or fast heartbeats
• Reduction in blood platelets (which increases the risk of
bleeding or bruising) and other blood cell changes
• Drowsiness
• Loss of co-ordination or altered muscle movements (including
unusual movements of the mouth, tongue and eyeballs)
• Tremor
• Stiff or floppy muscles
• Dizziness
• Headache
• Poor concentration or confusion
• Rigidity of the whole body
• Speech problems
• Fits
• Blurred or abnormal vision
• Shortness of breath
• Dry mouth or increase in saliva
• Feeling sick or vomiting
Cases of venous thromboembolism (VTE) have been reported with
antipsychotic drugs. Since patients treated with antipsychotics often
present with acquired risk factors for VTE, all possible risk factors for VTE
should be identified before and during treatment with Depixol and
preventive measures undertaken.
Concomitant treatment with other antipsychotics should be avoided.
Suicide/suicidal thoughts or clinical worsening
Depression is associated with an increased risk of suicidal thoughts,
self harm and suicide (suicide-related events). This risk persists until
significant remission occurs. As improvement may not occur during the
first few weeks or more of treatment, patients should be closely
monitored until such improvement occurs.
It is general clinical experience that the risk of suicide may increase in
the early stages of recovery. Other psychiatric conditions for which
flupentixol is prescribed can also be associated with an increased risk
of suicide-related events. In addition, these conditions may be
co-morbid with major depressive disorder. The same precautions
observed when treating patients with major depressive disorder should
therefore be observed when treating patients with other psychiatric
disorders. Patients with a history of suicide-related events, or those
exhibiting a significant degree of suicidal ideation prior to
commencement of treatment are known to be at greater risk of suicidal
thoughts or suicide attempts, and should receive careful monitoring
during treatment. A meta-analysis of placebo-controlled clinical trials of
antidepressant drugs in adult patients with psychiatric disorders
showed an increased risk of suicidal behaviour with antidepressants
compared to placebo in patients less than 25 years old.
Close supervision of patients and in particular those at high risk should
accompany drug therapy especially in early treatment and following
dose changes. Patients (and caregivers of patients) should be alerted
about the need to monitor for any clinical worsening, suicidal behaviour
or thoughts and unusual changes in behaviour and to seek medical
advice immediately if these symptoms present.
Increased Mortality in Elderly people with Dementia
Data from two large observational studies showed that elderly people
with dementia who are treated with antipsychotics are at a small
increased risk of death compared with those who are not treated. There
are insufficient data to give a firm estimate of the precise magnitude of
the risk and the cause of the increased risk is not known.
Depixol is not licensed for the treatment of dementia-related behavioural
In common with other antipsychotics, flupentixol enhances the
response to alcohol, the effects of barbiturates and other CNS
Flupentixol may potentiate the effects of general anaesthetics and
anticoagulants and prolong the action of neuromuscular blocking
The anticholinergic effects of atropine or other drugs with anticholinergic
properties may be increased. Concomitant use of drugs such as
metoclopramide, piperazine or antiparkinson drugs may increase the risk
of extrapyramidal effects such as tardive dyskinesia. Combined use of
antipsychotics and lithium or sibutramine has been associated with an
increased risk of neurotoxicity.
Antipsychotics may enhance the cardiac depressant effects of
quinidine; the absorption of corticosteroids and digoxin.
The hypotensive effect of vasodilator antihypertensive agents such as
hydralazine and α-blockers (e.g. doxazosin), or methyl-dopa may be
Increases in the QT interval related to antipsychotic treatment may be
exacerbated by the co-administration of other drugs known to
significantly increase the QT interval. Co-administration of such drugs
should be avoided. Relevant classes include:

• Keep out of the reach and sight of children
• Do not use Depixol Low Volume Injection after the expiry date
that is printed on the label. The expiry date refers to the last day
of that month
• Store Depixol Low Volume Injection at or below 25°C
• Keep Depixol Low Volume Injection ampoules and vials in the
box, so they are protected from light
Medicines should not be disposed of via wastewater or household
Ask your pharmacist how to dispose of medicines no longer
These measures will help to protect the environment.
What Depixol Low Volume Injection contains
The active substance is cis(Z)-flupentixol decanoate.
Each millilitre (ml) of Depixol Low Volume Injection contains
200 mg cis (Z)-flupentixol decanoate.
The other ingredient is thin vegetable oil (purified from coconut
What Depixol Low Volume Injection looks like and contents of
the pack
Depixol Low Volume Injection is a clear, colourless or pale-yellow
Depixol Low Volume Injection is available in:
Glass ampoules containing 1 ml (200 mg) or 2 ml (400 mg) in
boxes of 5 ampoules. Single-packed vials of 5 ml (1000 mg).
Not all pack sizes may be marketed.
This injection is manufactured by:
H. Lundbeck A/S
Ottiliavej 9
DK-2500 Valby
For any information about this medicine, please contact the
Marketing Authorisation holder:
Lundbeck Limited
Lundbeck House
Caldecotte Lake Business Park
Milton Keynes MK7 8LG
This leaflet was last approved in 10/2011.
To request a copy of this leaflet in braille, large print or audio
please call free of charge:

0800 198 5000

Please be ready to give the following information:
Product name

Product code number

Depixol Low Volume Injection

PL 0458/0065

This is a service provided by the Royal National Institute of Blind
• class Ia and III antiarrhythmics (e.g. quinidine, amiodarone,
sotalol, dofetilide)
• some antipsychotics (e.g. thioridazine)
• some macrolides (e.g. erythromycin)
• some antihistamines
• some quinolone antibiotics (e.g. moxifloxacin)
The above list is not exhaustive and other individual drugs known to
significantly increase QT interval (e.g. cisapride, lithium) should be
Drugs known to cause electrolyte disturbances such as thiazide
diuretics (hypokalaemia) and drugs known to increase the plasma
concentration of flupentixol should also be used with caution as they
may increase the risk of QT prolongation and malignant arrhythmias.
Antipsychotics may antagonise the effects of adrenaline and other
sympathomimetic agents, and reverse the antihypertensive effects of
guanethidine and similar adrenergic-blocking agents.
Antipsychotics may also impair the effect of levodopa, adrenergic drugs
and anticonvulsants.
The metabolism of tricyclic antidepressants may be inhibited and the
control of diabetes may be impaired.
Overdosage may cause somnolence, or even coma, extrapyramidal
symptoms, convulsions, hypotension, shock, hyper-or hypothermia. ECG
changes, QT prolongation, Torsade 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
- 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.
Thin vegetable oil (fractionated coconut oil).
This product may be mixed in the same syringe with other products in
the Depixol Injection range. It should not be mixed with any other
injection fluids.
Store at or below 25°C. Protect from light.
Lundbeck Limited
Lundbeck House
Caldecotte Lake Business Park
Caldecotte, Milton Keynes, MK7 8LG
PL 0458/0065.
® Trademark
Depixol Low Volume Injection is made by H Lundbeck A/S, Denmark.

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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.