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DEPIXOL 3 MG FILM-COATED TABLETS

Active substance(s): FLUPENTIXOL DIHYDROCHLORIDE

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Package leaflet: Information for the user

Depixol® 3 mg film-coated tablets
flupentixol
Read all of this leaflet carefully before you start taking
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 or
pharmacist
• 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 or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.

What is in this leaflet:
1. What Depixol Tablets are and what they are used for
2. What you need to know before you take Depixol Tablets
3. How to take Depixol Tablets
4. Possible side effects
5. How to store Depixol Tablets
6. Contents of the pack and other information
1. What Depixol Tablets are and what they are used for
The name of your medicine is Depixol 3 mg film-coated
tablets (called Depixol Tablets in this leaflet).
Depixol Tablets contain the active substance flupentixol.
Depixol Tablets belong 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 Tablets are used for the treatment of schizophrenia
and other psychoses.
Your doctor, however, may prescribe Depixol Tablets for
another purpose. Ask your doctor if you have any questions
about why Depixol Tablets have been prescribed for you.
2. What you need to know before you take Depixol Tablets
Do not take Depixol Tablets:
• 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).
• If you are feeling less alert than usual, or are drowsy
or sleepy, or have serious problems with your blood
circulation
• If you are excited or agitated

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Warnings and precautions
Talk to your doctor or pharmacist before taking Depixol
Tablets 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
Children and adolescents
Depixol Tablets are 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

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 Tablets
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 Tablets:
• Medicines that change the heartbeat (quinidine,
amiodarone, sotalol, dofetilide, erythromycin,
moxifloxacin, cisapride, lithium)
• Other antipsychotic medicines
Tell your doctor 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 Tablets can reduce the effect of adrenaline
(epinephrine) and similar drugs.
Tell your doctor, dentist, surgeon or anaesthetist before
any operation as Depixol Tablets can increase the effects of
general anaesthetics, muscle relaxing drugs and drugs used
to prevent clots.
Depixol Tablets with food, drink and alcohol
Depixol Tablets can be taken with or without food.
Depixol Tablets may increase the sedative effects of alcohol
making you drowsier.
It is recommended not to drink alcohol during treatment with
Depixol Tablets.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may 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 Tablets should not be used during pregnancy
unless clearly necessary.
The following symptoms may occur in newborn babies, of
mothers that have used Depixol Tablets 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
Tablets 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 Tablets, 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.
Depixol Tablets contain lactose and sunset yellow (E110)
If your doctor has told you that you have intolerance to some
sugars, contact your doctor before taking this medicinal
product.
This product also contains the colouring agent sunset yellow
(E110), which may cause allergic reactions.
3. How to take Depixol Tablets
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
The dose varies and depends on the severity of the illness.
Adults
The usual dose is 1 to 3 tablets, twice a day. The maximum
daily dose is 6 tablets (18 mg).

If you have thoughts of harming or killing yourself at any time,
contact your doctor or go to a hospital straight away.

If you have liver problems, the level of flupentixol in your
blood may be checked.

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.

Older patients (above 65 years)
The initial dose is between a quarter and a half of the adult
dose.

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Use in children
Depixol Tablets are 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 Tablets 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.
Effects when treatment with Depixol Tablets is stopped
When you have completed your course of treatment, the dose
of Depixol Tablets is usually reduced gradually.
Stopping this medicine quickly may cause symptoms such as
dizziness, nausea, vomiting, sweating, difficulty in sleeping
or unusual muscle movements.
If you take more Depixol Tablets than you should
If you think that you or anyone else may have taken too
many Depixol Tablets contact your doctor or nearest hospital
casualty department immediately. Do this even if there are
no signs of discomfort or poisoning. Take the Depixol Tablets
container with you if you go to a doctor or hospital.
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
If you forget to take Depixol Tablets
If you forget to take a dose, take the next dose at the usual
time. Do not take a double dose to make up for a forgotten
tablet.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine 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 Tablets 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.

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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
Tablets 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 decrease in the frequency or
amount)
• Increased sweating or greasy skin
• Itching, rashes or skin reactions (including sensitivity to
sunlight)
• 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 Tablets), 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 Tablets
• 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.
• This medicinal product does not require any special
storage conditions
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 Tablets contain
The active substance is flupentixol (as dihydrochloride).
Each film-coated tablet contains 3 mg of flupentixol.
The other ingredients are betadex, lactose monohydrate,
maize starch, hydroxypropylcellulose, microcrystalline
cellulose, croscarmellose sodium, talc, hydrogenated
vegetable oil and magnesium stearate.
Coating and colour: macrogol 6000, polyvinyl alcohol,
macrogol 3350, talc, iron oxide yellow (E172), titanium
dioxide (E171), iron oxide red (E172) and sunset yellow
(E110).
What Depixol Tablets look like and contents of the pack
Depixol Tablets are round, slightly biconvex, ochre,
film-coated tablets marked FI and are available in plastic
containers containing 100 tablets.
Marketing Authorisation Holder
For any information about this medicine, please contact the
Marketing Authorisation holder:
Lundbeck Limited
Building K1
Timbold Drive
Kents Hill
Milton Keynes MK7 6BZ
UK
01908 638972
Manufacturer
H. Lundbeck A/S
Ottiliavej 9
DK-2500 Valby
Denmark
This leaflet was last revised in 03/2015
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 3 mg film-coated tablets PL 0458/0013R
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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