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FLUPENTIXOL DECANOATE 20 MG/ML SOLUTION FOR INJECTION

Active substance(s): FLUPENTIXOL DECANOATE / FLUPENTIXOL DECANOATE

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Depixol® 20 mg/ml solution for
injection

2972
09.05.17[3]

(flupentixol decanoate)
PATIENT INFORMATION 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
- 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.
This medicine is available using the above name but will be referred to as
Depixol Injection throughout the leaflet.
What is in this leaflet:
1. What Depixol Injection is and what it is used for
2. What you need to know before Depixol Injection is given
3. How Depixol Injection is given
4. Possible side effects
5. How to store Depixol Injection
6. Contents of the pack and other information
1. WHAT DEPIXOL INJECTION IS AND WHAT IT IS USED FOR
The name of your medicine is Depixol 20 mg/ml solution for injection (called
Depixol Injection in this leaflet).
Depixol Injection contains the active substance flupentixol decanoate.
Depixol 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 Injection is used for the treatment of schizophrenia and other
psychoses.
Your doctor, however, may prescribe Depixol Injection for another purpose.
Ask your doctor if you have any questions about why Depixol Injection has
been prescribed for you.
2. WHAT YOU NEED TO KNOW BEFORE DEPIXOL INJECTION IS
GIVEN
Depixol 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 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
Children and adolescents
Depixol Injection is not recommended in these patients.
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 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 Injection
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
The following medicines should not be taken at the same time as Depixol
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 anti-depressants
- 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 Injection can reduce the effect of adrenaline (epinephrine) and
similar drugs.
Tell your doctor, dentist, surgeon or anaesthetist before any operation as
Depixol Injection can increase the effects of general anaesthetics, muscle
relaxing drugs and drugs used to prevent clots.
Depixol Injection with alcohol
Depixol Injection may increase the sedative effects of alcohol making you
drowsier. It is recommended not to drink alcohol during treatment with
Depixol Injection.
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.
Pregnancy
If you are pregnant or think you might be pregnant, tell your doctor. Depixol
Injection should not be used during pregnancy unless clearly necessary.
The following symptoms may occur in newborn babies, of mothers that have
used Depixol 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 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
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 INJECTION IS GIVEN
A small amount of Depixol 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.
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.
If you haven’t received an injection like Depixol 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 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.

The following information is intended for healthcare professionals
only:

Note: As with all oil-based injections it is important to ensure, by aspiration
before injection, that inadvertent intravascular entry does not occur.

Administration information for the healthcare professional

The maximum single dose at any one time is 400 mg.
For example, 800 mg every 2 weeks should not be given.

Depixol® 20 mg/ml solution for injection
Consult the Summary of Product Characteristics for full information
on this product
Depixol 20 mg/ml solution for injection should be administered by deep
intramuscular injection into the upper outer buttock or lateral thigh.

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.

Use in children
Depixol 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 feel that the effect of Depixol Injection is too strong or weak, talk to
your doctor.
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 Injection than you should
Your medicine will be given by your doctor or nurse.
In the unlikely event that you receive too much Depixol 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 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 taking Depixol and seek medical advice immediately if you have
any of the following allergic reactions:
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 immediately.

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
- Rashes or skin reactions (including sensitivity to sunlight)
- Stiff and floppy muscle
- 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 prolactin.
- Loss of control of blood sugar levels
- Breast enlargement in male
- Unexpected excretion of breast milk
- 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 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.

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 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

5. HOW TO STORE DEPIXOL 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
- Keep the ampoules in the original package in order to protect from light.
- If your medicines show any signs of deterioration or discolouration, you
should seek the advice of your pharmacist who will tell you what to do.

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)

The other ingredient is vegetable oil (medium chain triglycerides).

Other side effects:
Side effects are most pronounced in the beginning of the treatment and
most of them usually wear off during continued treatment.

Depixol Injection is available in: Glass ampoules containing 1 ml (20 mg) in
cartons of 10 ampoules.

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 frequency or amount)
- General weakness or pain, tiredness or feeling unwell

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 Injection contains
The active substance is flupentixol decanoate.
Each ml of solution contains 20 mg flupenthixol decanoate.

What Depixol Injection looks like and contents of the pack
Depixol Injection is a clear, colourless or pale-yellow liquid, practically free
from particles.

Manufacturer and Product Licence Holder
Manufactured by H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark.
Procured from within the EU by Product Licence holder:
Star Pharmaceuticals Ltd. 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2972

Leaflet revision and issue date (Ref) 09.05.17[3]
Depixol is a trademark of H. Lundbeck A/S.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8423 2111 to obtain the
leaflet in a format suitable for you.

Expand Transcript

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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