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DEPIXOL CONC. 100MG/ML SOLUTION FOR INJECTION

Active substance(s): FLUPENTIXOL DECANOATE

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Patient Information Leaflet
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
leaflet).









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 patients.

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. Injection.

Pregnancy
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.

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.

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

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
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)

Administration information for the healthcare professional

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.

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

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 circulation

are excited or agitated

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.

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.

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.

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

The following information is intended for healthcare
professionals only:

Thoughts of suicide and worsening of your depression or
anxiety disorder

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.

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.

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

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 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. 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

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.
Breast-feeding
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.
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 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.
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 return.

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 400mg. 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.

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 400mg. If you need
more than 2 ml of medicine it will probably be divided between 2
injection sites.

If you get any of the following symptoms you should contact your
doctor immediately as your dose may need to be reduced or
stopped:

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:






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.





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 heartbeats (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 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.

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

Men may experience breast enlargement or problems with
ejaculation or erections

Women may experience an absence of menstrual periods

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.
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.
4. Possible side effects
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.
Serious side effects
Stop using Depixol Conc. Injection 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.

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 (see details
below).
By reporting side effects you can help provide more information
on the safety of this medicine.
Via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Alternatively you can call Freephone 0808 100 3352
(available between 10am-2pm Monday – Friday) or fill in a
paper form available from your local pharmacy.
5. How to store Depixol Conc. Injection
Usually your doctor or nurse will store the medicine for you.
If you keep it at home:
Do not store above 25°C.
Keep this medicine out of the sight and reach of children
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
The active substance is flupentixol decanoate.
Each millilitre (ml) of Depixol Conc. Injection contains 100 mg
flupentixol decanoate.
Depixol Conc. Injection is a clear, colourless or pale-yellow liquid.
The other ingredient is thin vegetable oil (triglycerides, medium
chain).
What Depixol Conc. Injection looks like and contents of the
pack
Depixol Conc. Injection is available in:
Glass ampoules containing 1 ml (100 mg) in cartons of 10
ampoules.
Manufactured by: H.Lundbeck A/S Ottiliavej 9 2500 Valby
Denmark. Procured from within the EU. Product Licence Holder:
Quadrant Pharmaceuticals Ltd, Lynstock House, Lynstock Way,
Lostock, Bolton BL6 4SA. Repackaged by Maxearn Ltd, Bolton
BL6 4SA.
PL 20774/1456

Depixol Conc. 100 mg/ml solution for
injection
POM

Depixol Conc is a registered trademark of Lundbeck A/S
Date of preparation 24th May 2016

PP1/1456/V3

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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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