DEPIXOL LOW VOLUME 200 MG/ML SOLUTION FOR INJECTION

Active substance: FLUPENTIXOL DECANOATE

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The following medicines should not be taken at the same
time as Depixol Low Volume Injection:

GB-067-60-200-13410 REG ver2

Package leaflet: Information for the user

Depixol® Low Volume 200 mg/ml solution for injection
flupentixol decanoate

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
• 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 of the 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 Depixol Low Volume Injection is and what it is
used for
2. What you need to know 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. Contents of the pack and other information
1. What Depixol Low Volume Injection is and what it is
used for

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The name of your medicine is Depixol Low Volume
200 mg/ml solution for injection (called Depixol Low
Volume Injection in this leaflet).
Depixol Low Volume Injection contains the active
substance flupentixol decanoate. 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.

• Medicines that change the heartbeat (quinidine,
amiodarone, sotalol, dofetilide, erythromycin,
moxifloxacin, cisapride, lithium)
• Other antipsychotic medicines
Tell your doctor or pharmacist if you are taking any of the
following medicines:
• 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 conditions)
• 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) betablockers, 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
Depixol Low Volume Injection can reduce the effect of
adrenaline (epinephrine) and similar drugs.
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.

Depixol Low Volume Injection is used for the treatment of
schizophrenia and other psychoses.

Depixol Low Volume Injection and 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.

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 you.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you might be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.

2. What you need to know before Depixol Low Volume
Injection is given

Pregnancy
If you are pregnant or think you might be pregnant, tell
your doctor. Depixol Low Volume Injection should not be
used during pregnancy unless clearly necessary.

Depixol Low Volume Injection is not given if you
• are allergic (hypersensitive) to flupentixol, other
thioxanthene drugs or antipsychotic drugs or any of the
other ingredients of this medicine (listed in section 6).
• are feeling less alert than usual or are drowsy or sleepy,
or have serious problems with your blood circulation
• are excited or agitated
Warnings and precautions
Talk to your doctor, pharmacist or nurse before Depixol
Low Volume Injection is given 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 kidney)
• 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
• are treated for cancer

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.
Breast-feeding
If you are breast-feeding, 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.
Fertility
Flupentixol may decrease your sexual activity and fertility.
These are not lasting effects. Please talk to your doctor
about any problems.
Driving and using machines
There is a risk of feeling drowsy and dizzy when being
treated with Depixol Low Volume 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.
3. How Depixol Low Volume Injection is given
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.

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.

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. If you need more than 2 ml of medicine it will
probably be divided between 2 injection sites.

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 Depixol Low Volume Injection
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

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 medicine.
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.
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.
Older patients (above 65 years)
Starting doses for older or frail patients are usually
reduced to a quarter or a half of the dosage range.
Use in children
Depixol Low Volume Injection is not recommended for
children.

The following information is intended for healthcare professionals only:
Administration information for the healthcare professional
Depixol Low Volume 200 mg/ml solution for injection
Consult the Summary of Product Characteristics for full information on this product
Depixol Low Volume 200 mg/ml solution for injection should be administered by deep intramuscular injection into the
upper outer buttock or lateral thigh.
Note: As with all oil-based injections it is important to ensure, by aspiration before injection, that inadvertent intravascular

entry does not occur.

Injection volumes greater than 2 ml should be distributed between two injection sites.
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.

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Children and adolescents
Depixol Low Volume Injection is not recommended in
these patients.

GB-067-60-200-13410 REG ver2

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 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 or 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, 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.
4. Possible side effects
Like all medicines, Depixol Low Volume Injection 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 Depixol and seek medical advice immediately if

• 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 decanoate (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 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, pharmacist
or nurse. 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 Depixol Low Volume Injection
Usually your doctor or nurse will store the medicine for
you. If you keep it at home:
• Keep this medicine out of the sight and reach of
children
• Do not use this medicine after the expiry date that is
printed on the label. The expiry date refers to the last
day of that month
• Do not store above 25°C
• Keep the ampoules in the outer carton in order to
protect from light.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to
protect the environment.

you have any of the following allergic reactions:

6. Contents of the pack and other information

• 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)

What Depixol Low Volume Injection contains
The active substance is flupentixol decanoate.
Each millilitre (ml) of Depixol Low Volume Injection
contains 200 mg flupentixol decanoate.

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.

The other ingredient is thin vegetable oil (purified from
coconut oil).

If you get any of the following symptoms you should
contact your doctor immediately as your dose may need to
be reduced or stopped:
• 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 treatment.
• 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
• Indigestion or stomach pain
• Flatulence (wind), constipation or diarrhoea
• Abnormal urination (such as a decrease in the
frequency or amount)
• Increased sweating or greasy skin
• Itching, rashes or skin reactions (including sensitivity
to sunlight)
• 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

What Depixol Low Volume Injection looks like and
contents of the pack
Depixol Low Volume Injection is a clear, colourless or paleyellow liquid.
Depixol Low Volume Injection is available in:
Glass ampoules containing 1 ml (200 mg) or 2 ml
(400 mg) in cartons of 5 ampoules. Single-packed vials of
5 ml (1000 mg).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
For any information about this medicine, please contact
the Marketing Authorisation holder:
Lundbeck Limited
Lundbeck House
Caldecotte Lake Business Park
Caldecotte
Milton Keynes MK7 8LG
UK
Manufacturer
H. Lundbeck A/S
Ottiliavej 9
DK-2500 Valby
Denmark
This leaflet was last revised in 05/2014
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 People.

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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.

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