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CLOPIXOL CONC INJECTION (500MG/ML)

Active substance: ZUCLOPENTHIXOL DECANOATE

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Package leaflet: Information for the patient

Clopixol® Conc. 500 mg/ml solution for injection
zuclopenthixol 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, please 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 side effects not listed in this leaflet.
See section 4.
What is in this leaflet
1. What Clopixol Conc. Injection is and what it is used for
2. What you need to know before you are given Clopixol Conc.
Injection
3. How Clopixol Conc. Injection is given
4. Possible side effects
5. How to store Clopixol Conc. Injection
6. Contents of the pack and other information

1. What Clopixol Conc. Injection is and what it
is used for
The name of your medicine is Clopixol Conc. 500 mg/ml solution
for injection (called Clopixol Conc. Injection in this leaflet).
Clopixol Conc. Injection contains the active substance
zuclopenthixol. It 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.
Clopixol Conc. Injection is used for the treatment of schizophrenia
and other psychoses.












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) beta-blockers,
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
zuclopenthixol in your blood
Medicines used to treat epilepsy
Medicines used to treat diabetes

Clopixol Conc. Injection can reduce the effect of adrenaline
(epinephrine) and similar drugs.
Tell your doctor, dentist, surgeon or anaesthetist before any
operation as Clopixol Conc. Injection can increase the effects of
general anaesthetics, muscle relaxing drugs and drugs used to
prevent clots.
Clopixol Conc. Injection with alcohol
Clopixol Conc. Injection may increase the sedative effects of
alcohol making you drowsier. It is recommended not to drink
alcohol during treatment with Clopixol Conc. Injection.
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 for advice before
taking this medicine.
Pregnancy
If you are pregnant or think you might be pregnant, tell your
doctor. Clopixol Conc. Injection should not be used during
pregnancy unless clearly necessary.
The following symptoms may occur in newborn babies, of
mothers that have used Clopixol 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.

Your doctor, however, may prescribe Clopixol Conc. Injection for
another purpose. Ask your doctor if you have any questions
about why this medicine has been prescribed for you.

Breast-feeding
If you are breastfeeding, ask your doctor for advice. Clopixol Conc.
Injection should not be used when breast-feeding, as small
amounts of the medicine can pass into the breast milk.

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

Fertility
Zuclopenthixol may decrease your sexual activity and fertility.
These are not lasting effects. Please talk to your doctor about any
problems.

Clopixol Conc. Injection is not given
• If you are allergic (hypersensitive) to zuclopenthixol, other
thioxanthene drugs or antipsychotic drugs or any of the other
ingredients of this medicine (listed in section 6). Tell your
doctor if you think you might be
• If you are feeling less alert than usual, or are drowsy or sleepy
or have serious problems with your blood circulation

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Warnings and precautions
Talk to your doctor, pharmacist or nurse before Clopixol Conc.
Injection is given to you:
• 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
• If you have severe breathing problems (such as asthma or
bronchitis)
• If you have liver, kidney or thyroid problems
• If you 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)
• If you suffer from Parkinson’s disease, or myasthenia gravis (a
condition causing severe muscular weakness)
• If you have an enlarged prostate or suffer from a condition
known as phaeochromocytoma (a rare type of cancer of a gland
near the kidney)
• If you suffer from glaucoma (raised pressure within the eye)
• If you have risk factors for stroke (e.g. smoking, hypertension)
• If you have too little potassium or magnesium in your blood or
a family history of irregular heart beats
• If you use other antipsychotic medicines
• If you suffer from diabetes
• If you or someone else in your family has a history of blood
clots, as medicines like these have been associated with
formation of blood clots
• If you are being treated for cancer
Children and adolescents
Clopixol Conc. Injection is not recommended in these patients.
Other medicines and Clopixol Conc. 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
Clopixol 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)

The following information is intended for healthcare
professionals only:
Clopixol Conc. 500 mg/ml solution for injection
Administration information for the healthcare professional
Consult the Summary of Product Characteristics for full
information on this product
Clopixol Conc. 500 mg/ml solution for injection should be
administered by deep intramuscular injection into the upper
outer buttock or lateral thigh.

Driving and using machines
There is a risk of feeling drowsy and dizzy when being treated
with Clopixol 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 Clopixol Conc. Injection is given
A small amount of Clopixol 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.
Adults
The usual dose lies between 200-500 mg every 1 to 4 weeks but
some patients require 600 mg every week. 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 Clopixol Conc. Injection
before, a small dose of 100 mg is usually given one week before
your normal dose to test how well you tolerate the medicine.
If you have been treated with Clopixol tablets and you are being
transferred to Clopixol Conc. 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.
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.
Patients with special risks
If you have renal failure, your dosage should be reduced to half
the usual dosage range. If you have liver problems, the level of
zuclopenthixol in your blood may be checked. Patients with liver
complaints normally receive doses at half the usual dosage
range.
Use in children
Clopixol 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.
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.

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 of 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 Clopixol Injection range, including Clopixol
Acuphase Injection (zuclopenthixol acetate 50 mg/ml).
It should not be mixed with any other injection fluids.

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If you feel that the effect of Clopixol Conc. Injection is too strong
or weak, talk to your doctor or pharmacist.
If you are given too much Clopixol Conc. Injection
Your medicine will be given by your doctor/nurse.
In the unlikely event that you receive too much Clopixol 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, Clopixol Conc. Injection can cause side
effects, although not everybody gets them. Older people tend to
be more likely to suffer from some of these effects than younger
people and this may mean your treatment is supervised more
closely.
Serious side effects
Stop using Clopixol 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.
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 Clopixol 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.
• Any yellowing of the skin and the white of the eyes (jaundice);
your liver may be affected.

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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 (including stiff jaw and neck muscles)
• Dizziness or vertigo
• Headache or migraine
• Numbness or tingling in the arms and legs
• Poor concentration, loss of memory or confusion
• A changed walking pattern
• Abnormal reflexes
• Rigidity of the whole body
• Fainting
• Speech problems
• Fits
• Enlarged pupils or blurred, abnormal vision
• Sensitive hearing or ringing in the ears (tinnitus)
• Stuffy nose
• Shortness of breath
• Dry mouth or increase in saliva
• Feeling sick or vomiting
• Indigestion or stomach pain
• Flatulence (wind), constipation or diarrhoea
• Abnormal urination (increases or decreases in the frequency or
amount)
• Increased sweating or greasy skin
• Itching, rashes or skin reactions (including sensitivity to
sunlight)
• Skin reactions at injection site
• Changes in skin colour
• Bruising under the skin
• Muscle pain
• Raised blood levels of glucose, lipids 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
• Increased thirst
• Reduced or increased body temperature (including fever)
• Abnormal liver function tests
• Liver enlargement
• Unexpected excretion of breast milk








Insomnia, abnormal dreams or nightmares
Depression or anxiety
Nervousness or agitation
Lack of emotion or indifference to your surroundings (apathy)
Changes to your sex drive
Men may experience breast enlargement or problems with
ejaculation or erections (including prolonged erections)
• Women may experience an absence of menstrual periods,
vaginal dryness or problems with orgasms
As with other medicines that work in a way similar to
zuclopenthixol (the active ingredient of Clopixol), rare cases of
the following side effects have been reported:
• Slow heartbeat and abnormal ECG heart tracing
• Life threatening irregular heart beats
In rare cases irregular heart beats (arrhythmias) may have
resulted in sudden death.
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.
United Kingdom
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.
Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D'Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt

5. How to store Clopixol 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 children.
• Do not use this medicine after the expiry date that is printed on
the label and carton after EXP. 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 Clopixol Conc. Injection contains
The active substance is zuclopenthixol decanoate.
Each millilitre (ml) of Clopixol Conc. Injection contains 500 mg
zuclopenthixol decanoate.
The other ingredient is thin vegetable oil.
What Clopixol Conc. Injection looks like and contents of the
pack
Clopixol Conc. Injection is an oily liquid.
Clopixol Conc. Injection is available in glass ampoules containing
1 ml (500 mg) in cartons of 5 ampoules.
Marketing Authorisation Holder
For any information about this medicine, please contact the
Marketing Authorisation holder:
Lundbeck Limited
Building K1
Timbold Drvie
Kents Hill
Milton Keynes
MK7 6BZ
UK
Manufacturer
H. Lundbeck A/S
Ottiliavej 9
DK-2500 Valby
Denmark
This leaflet was last revised in 04/2015
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
Clopixol Conc. Injection

Product code number
PL 0458/0060

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

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GB-MT-056-60-500-13410 REG ver 2

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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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