Skip to Content


Active substance(s): FLUPENTIXOL DECANOATE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

Package leaflet: Information for the patient

Depixol® Conc.
100 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 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 Conc. Injection is and what it is used for
2. What you need to know before Depixol Conc. Injection
is given
3. How Depixol Conc. Injection is given
4. Possible side effects
5. How to store Depixol Conc. Injection
6. Contents of the pack and other information
1. What Depixol Conc. Injection is and what it is used for
The name of your medicine is Depixol Conc. 100 mg/ml
solution for injection (called Depixol Conc. Injection in this


Depixol Conc. Injection contains the active substance
flupentixol decanoate. Depixol Conc. 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.

The following medicines should not be taken at the same
time as Depixol Conc. Injection:
• 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
• Anticoagulant drugs used to prevent blood clots (e.g.
• 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
• Sibutramine (used to reduce appetite)
• Digoxin (to control heart rhythm)
• Corticosteroids (e.g. prednisilone)
• 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 Conc. Injection can reduce the effect of adrenaline
(epinephrine) and similar drugs.
Tell your doctor, dentist, surgeon or anaesthetist before
any operation as Depixol Conc. Injection can increase the
effects of general anaesthetics, muscle relaxing drugs and
drugs used to prevent clots.

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

Depixol Conc. Injection with alcohol
Depixol Conc. Injection may increase the sedative effects
of alcohol making you drowsier. It is recommended not
to drink alcohol during treatment with Depixol Conc.

Your doctor, however, may prescribe Depixol Conc.
Injection for another purpose. Ask your doctor if you have
any questions about why Depixol Conc. 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
for advice before taking this medicine.

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

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

Depixol Conc. 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
• are excited or agitated
Warnings and precautions
Talk to your doctor, pharmacist or nurse before Depixol
Conc. 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
• 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
Children and adolescents
Depixol Conc. Injection is not recommended in these
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 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
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
Other medicines and Depixol Conc. Injection
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

The following symptoms may occur in newborn babies, of
mothers that have used Depixol Conc. 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.
If you are breast-feeding, ask your doctor for advice.
Depixol Conc. Injection should not be used when breastfeeding, as small amounts of the medicine can pass into
the breast milk.
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 Conc. 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 Conc. Injection is given
A small amount of Depixol Conc. 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. 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.
If you haven’t received an injection like Depixol Conc.
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 Conc. Injection you may be
asked to continue taking the tablets for several days after
the 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 and a half of the dosage range.
Use in children
Depixol Conc. Injection 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.

The following information is intended for healthcare professionals only:
Administration information for the healthcare professional
Depixol Conc. 100 mg/ml solution for injection
Consult the Summary of Product Characteristics for full information on this product
Depixol Conc. 100 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.
The maximum single dose at any one time is 400 mg. For example, 800 mg every 2 weeks should not be given.
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.




If you feel that the effect of Depixol Conc. 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
If you get more Depixol Conc. Injection than you should
Your medicine will be given by your doctor or nurse.
In the unlikely event that you receive too much Depixol
Conc. 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.

• Rashes or skin reactions (including sensitivity to
• Stiff or floppy muscles
• Problems with ejaculation or erections in male
• Skin reactions at injection site
Rare: May affect up to 1 in 1,000 people
• 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)
• Reduction in blood platelets (which increases the risk
of bleeding or bruising) and other blood cell changes
• Raised blood levels of glucose or the hormone
• Loss of control of blood sugar levels
• Breast enlargement in male
• Unexpected excretion of breast milk
• Women may experience an absence of menstrual
As with other medicines that work in a way similar to
flupentixol decanoate (the active ingredient of Depixol
Conc. Injection), rare cases of the following side effects
have been reported:
• Slow heartbeat and abnormal ECG heart tracing
• Life threatening irregular heart beats

4. Possible side effects

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

Like all medicines, Depixol Conc. 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.

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 (see
details below).

Serious side effects
Stop using Depixol Conc. Injection and seek medical
advice immediately if you have any of the following
allergic reactions:

By reporting side effects you can help provide more
information on the safety of this medicine.

Not known: frequency cannot be estimated from the
available data
• 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
If you get any of the following symptoms you should
contact your doctor immediately as your dose may need
to be reduced or stopped:
Very rare: may affect up to 1 in 10,000 people
• 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 Injection and similar medicines
• Unusual movements of the mouth and tongue as
these may early signs of a condition known as tardive
• 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
Rare: may affect up to 1 in 1,000 people
• 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)
Other side effects
Side effects are most pronounced in the beginning of
the treatment and most of them usually wear off during
continued treatment.
Very common: may affect more than 1 in 10 people
• Drowsiness
• Dry mouth
• Muscle spasm
• Rigidity of the whole body
Common: may affect up to 1 in 10 people
• Changes in appetite or weight
• Insomnia
• Depression
• Nervousness or agitation
• Dizziness
• Headaches
• Reduction in your sex drive
• Poor concentration
• Blurred or abnormal vision
• Throbbing or fast heartbeats
• Shortness of breath
• Increase of saliva
• Vomiting
• Indigestion
• Diarrhoea
• Increased sweating or greasy skin
• Itching
• Muscle pain
• Tremor
• Abnormal urination (such as decrease in the frequency
or amount)
• General weakness or pain, tiredness or feeling unwell
Uncommon: may affect up to 1 in 100 people
• Confusion
• Loss of co-ordination or altered muscle movements
(including unusual movements of the mouth, tongue
and eyeballs)
• Speech problems
• Fits
• Low blood pressure
• Hot flushes
• Stomach pain
• Feeling sick
• Flatulence (wind) and constipation
• Abnormal liver function tests

United Kingdom
Via the Yellow Card Scheme at:
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D'Argens
GŻR-1368 Gżira
5. How to store Depixol Conc. 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
• Do not use Depixol Conc. Injection after the expiry date
that is printed on the label. The expiry date refers to the
last day of that month
• 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.
6. Contents of the pack and other information
What Depixol Conc. Injection contains
The active substance is flupentixol decanoate.
Each millilitre (ml) of Depixol Conc. Injection contains
100 mg flupentixol decanoate.
The other ingredient is thin vegetable oil (purified from
coconut oil).
What Depixol Conc. Injection looks like and contents of
the pack
Depixol Conc. Injection is a clear, colourless or pale-yellow
Depixol Conc. Injection is available in:
Glass ampoules containing 1 ml (100 mg) in cartons of 10
Marketing Authorisation Holder
For any information about this medicine, please contact
the Marketing Authorisation Holder.
Lundbeck Limited
2nd Floor
Building 3 Abbey View
Everard Close
St Albans
01908 638972
H. Lundbeck A/S
Ottiliavej 9
2500 Valby
This leaflet was last revised in 02/2017
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 Conc. Injection

PL 0458/0015R

This is a service provided by the Royal National Institute of
Blind People.

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.