CLOPIXOL ACUPHASE INJECTION 100MG/2ML

Active substance: ZUCLOPENTHIXOL ACETATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Clopixol-Acuphase®
zuclopenthixol acetate
Read all of this leaflet carefully before you start taking
this medicine
• 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. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours
• If any of the side effects are troubling, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist
In this leaflet:
1.
2.
3.
4.
5.
6.

What Clopixol-Acuphase is and what it is used for
Before Clopixol-Acuphase is given
How Clopixol-Acuphase is given
Possible side effects
How to store Clopixol-Acuphase
Further information

1. WHAT CLOPIXOL-ACUPHASE IS AND WHAT IT IS USED FOR
How does Clopixol-Acuphase work?
Clopixol-Acuphase 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.

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What is Clopixol-Acuphase used for?
Clopixol-Acuphase is used for the initial treatment of short-term
psychoses including mania or increases in the severity of existing
psychoses.
2. BEFORE CLOPIXOL-ACUPHASE IS GIVEN
Clopixol-Acuphase is not given
• If you are allergic (hypersensitive) to zuclopenthixol, other
thioxanthine drugs or antipsychotic drugs or any of the other
ingredients of Clopixol-Acuphase (see What Clopixol-Acuphase
contains). Consult 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
Take special care with Clopixol-Acuphase
• 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 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 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.
Please talk to your doctor, even if these statements were
applicable to you at any time in the past.
Taking other medicines
The following medicines should not be taken at the same time as
Clopixol-Acuphase:
• Medicines that change the heartbeat (quinidine, amiodarone,
sotalol, dofetilide, erythromycin, moxifloxacin, cisapride,
lithium)
• Other antipsychotic medicines
Medicines may affect the actions of other medicines and this
can sometimes cause serious adverse reactions. Please tell your
doctor or pharmacist if you are taking, or have recently taken,
any other medicines, including medicines obtained without a
prescription.











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)

INFORMATION FOR THE HEALTHCARE PROFESSIONAL
CONSULT THE SUMMARY OF PRODUCT CHARACTERISTICS FOR
FULL INFORMATION ON THIS PRODUCT
NAME OF THE MEDICINAL PRODUCT
Clopixol-Acuphase.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zuclopenthixol acetate 5.0% w/v equivalent to 4.526% w/v of
zuclopenthixol base.
PHARMACEUTICAL FORM
Oily solution for deep intramuscular injection.
THERAPEUTIC INDICATIONS
For the initial treatment of acute psychoses including mania and
exacerbation of chronic psychoses, particularly where a duration
of effect of 2-3 days is desirable.
DOSAGE AND METHOD OF ADMINISTRATION
Adults
Dosage should be adjusted according to the severity of the
patient's illness. The usual dosage is 50-150 mg (1-3 ml),
repeated if necessary after 2 or 3 days. Some patients may need
an additional injection between 1 and 2 days after the first
injection.
Clopixol-Acuphase is not intended for long-term use and duration
of treatment should not be more than two weeks. The maximum
dosage should not exceed 400 mg and the number of injections
should not exceed four.
Elderly
The dosage may need to be reduced in the elderly owing to reduced
rates of metabolism and elimination. Maximum dosage per injection
should be 100 mg.
Children
Not recommended for children.
Reduced renal function
Clopixol-Acuphase can be given in usual doses to patients with
reduced renal function. Where there is renal failure dosage should
be reduced to half the normal dosage.
Reduced liver function
Use with caution in patients with hepatic disease. Patients
with compromised hepatic function should receive half the
recommended dosages. Serum-level monitoring is advised.
Maintenance Therapy:
Clopixol-Acuphase is not intended for long-term use.
A single injection of Clopixol-Acuphase has an onset of sedative
action shortly after injection and an antipsychotic action
persisting for 2 to 3 days. In this period, maintenance treatment
with tablets or a longer acting depot neuroleptic can be initiated.
The possible side-effects of long-term maintenance treatment with
a neuroleptic, including tardive dyskinesia, should be considered.
Maintenance treatment where required can be continued with
Clopixol tablets, Clopixol injection or Clopixol conc. injection,
according to the following guidelines:

• 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-Acuphase can reduce the effect of adrenaline
(epinephrine) and similar drugs.
Tell your doctor, dentist, surgeon or anaesthetist before any
operation as Clopixol-Acuphase can increase the effects of general
anaesthetics, muscle relaxing drugs and drugs used to prevent
clots.
Does Clopixol-Acuphase interact with alcohol?
Clopixol-Acuphase may increase the sedative effects of alcohol
making you drowsier. It is recommended not to drink alcohol
during treatment with Clopixol-Acuphase.
Pregnancy
Ask your doctor or pharmacist for advice before taking any
medicine.
If you are pregnant or think you might be pregnant, tell your
doctor.
Clopixol-Acuphase should not be used during pregnancy unless
clearly necessary.
Your newborn baby might show side effects if this medicine is
used during pregnancy.
The following symptoms may occur in newborn babies, of mothers
that have used Clopixol-Acuphase 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
Ask your doctor or pharmacist for advice before taking any
medicine.
If you are breastfeeding, ask your doctor for advice. ClopixolAcuphase should not be used when breast-feeding, as small
amounts of the medicine can pass into the breast milk.
Driving and using machines
There is a risk of feeling drowsy or dizzy, or suffering from blurred
vision when being treated with Clopixol-Acuphase, especially at
the start of your treatment. If this happens do not drive or use any
tools or machines.
3. HOW CLOPIXOL-ACUPHASE IS GIVEN
A small amount of Clopixol-Acuphase 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.
Adults
The usual dose lies between 50-150 mg (1-3 ml) repeated if
necessary after 2-3 days. Some patients may require an additional
dose 1 or 2 days after the first injection.
Treatment can continue for up to 2 weeks. In this time you may
receive a total of 4 injections up to a total dose of 400 mg (8 ml).
If further treatment is necessary, your doctor will prescribe
suitable medication immediately or shortly after the ClopixolAcuphase injections are stopped.
Elderly patients (above 65 years)
Elderly patients may need smaller doses. The maximum dose per
injection is 100 mg.
Children
Clopixol-Acuphase is not recommended for children.
Patients with Liver or Kidney Disease
If you have liver disease or severe kidney disease, half the usual
dose will be given.
If you have liver problems, the level of zuclopenthixol in your blood
may be checked.
If you feel that the effect of Clopixol-Acuphase 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.
If you get more Clopixol-Acuphase than you should
Your medicine will be given by your doctor/nurse.
In the unlikely event that you receive too much Clopixol-Acuphase
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

1.




2.






Introduce Clopixol tablets at a dosage of 20-60 mg/day in
divided doses, 2 to 3 days after the last injection of
Clopixol-Acuphase. If necessary, increase the tablet dosage
by 10-20 mg each day up to a maximum of 150 mg/day.
Or.
Concomitantly with the last injection of Clopixol-Acuphase,
administer 200-400 mg of Clopixol Injection or Clopixol Conc.
Injection by deep intramuscular injection and repeat the
Clopixol Injection or Clopixol Conc. Injection at intervals
of 2 to 4 weeks. Higher dosages or a shorter interval may be
necessary.

Route of Administration:
Deep intramuscular injection, into the upper, outer buttock or
lateral thigh.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the
excipients.
Circulatory collapse, depressed level of consciousness due to any
cause (e.g. intoxication with alcohol, barbiturates or opiates),
coma.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Like other neuroleptics zuclopenthixol acetate should be used
with caution in patients with convulsive disorders or advanced
hepatic, renal or cardiovascular disease.
Zuclopenthixol is not suitable for patients who do not tolerate
oral neuroleptic drugs or for patients suffering from Parkinson's
disease.
The possibility of development of neuroleptic malignant syndrome
(hyperthermia, muscle rigidity, fluctuating consciousness,
instability of the autonomous nervous system) exists with any
neuroleptic. The risk is possibly greater with the more potent
agents. Patients with pre-existing organic brain syndrome, mental
retardation, opiate and alcohol abuse are over represented among
fatal cases.
Treatment: Discontinuation of the neuroleptic. Symptomatic
treatment and use of general supportive measures. Dantrolene
and bromocriptine may be helpful. Symptoms may persist for
more than a week after oral neuroleptics are discontinued and
somewhat longer when associated with the depot forms of the
drug.
Like other neuroleptics, zuclopenthixol should be used with
caution in patients with organic brain syndrome, convulsions or
advanced hepatic disease.
Blood dyscrasias have been reported rarely. Blood counts should
be carried out if a patient develops signs of persistent infection.
An approximately 3-fold increased risk of cerebrovascular adverse
events have been seen in randomised placebo controlled clinical
trials in the dementia population with some atypical antipsychotics.
The mechanism for this increased risk is not known. An increased
risk cannot be excluded for other antipsychotics or other patient
populations.
Zuclopenthixol should be used with caution in patients with risk
factors for stroke.

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GB-058-60-50-13410

GB-058-60-50-13410

You will receive treatment for any of these symptoms from your
doctor or nurse.

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

4. POSSIBLE SIDE EFFECTS

In rare cases irregular heart beats (arrhythmias) may have resulted
in sudden death.

• Changes in heart beat including irregular heart beat or slow
heart rate

Like all medicines, Clopixol-Acuphase can cause side effects,
although not everybody gets them.
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 "extrapyramidal" reaction
• Any yellowing of the skin and the white of the eyes (jaundice);
your liver may be affected
Other side effects:
Side effects are most pronounced the day after the first treatment
and usually wear off soon afterwards.
• 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
• 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 drugs belonging to the therapeutic class of
antipsychotics, zuclopenthixol may cause QT prolongation.
Persistently prolonged QT intervals may increase the risk of
malignant arrhythmias. Therefore, zuclopenthixol should be used with
caution in susceptible individuals (with hypokalaemia, hypomagnesia
or genetic predisposition) and inpatients with a history of
cardiovascular disorders, e.g. QT prolongation, significant bradycardia
(<50 beats per minute), a recent acute myocardial infarction,
uncompensated heart failure, or cardiac arrhythmia.
Cases of venous thromboembolism (VTE) have been reported with
antipsychotic drugs. Since patients treated with antipsychotics often
present with acquired risk factors for VTE, all possible risk factors for
VTE should be identified before and during treatment with Clopixol
and preventive measures undertaken.
Concomitant treatment with other antipsychotics should be avoided.
As described for other psychotropics zuclopenthixol may modify
insulin and glucose responses calling for adjustment of the
antidiabetic therapy in diabetic patients.
Increased Mortality in Elderly people with Dementia
Data from two large observational studies showed that elderly
people with dementia who are treated with antipsychotics are at
a small risk of death compared with those who are not treated.
There are insufficient data to give a firm estimate of the precise
magnitude of the risk and the cause of the increased risk is not
known.
Clopixol is not licensed for the treatment of dementia-related
behavioural disturbances.
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER
FORMS OF INTERACTION
In common with other antipsychotics, zuclopenthixol enhances
the response to alcohol, the effects of barbiturates and other
CNS depressants. Zuclopenthixol may potentiate the effects of
general anaesthetics and anticoagulants and prolong the action of
neuromuscular blocking agents.
The anticholinergic effects of atropine or other drugs with
anticholinergic properties may be increased. Concomitant use
of drugs such as metoclopramide, piperazine or antiparkinson
drugs may increase the risk of extrapyramidal effects such as
tardive dyskinesia. Combined use of antipsychotics and lithium
or sibutramine has been associated with an increased risk of
neurotoxicity.
Antipsychotics may enhance the cardiac depressant effects of
quinidine; the absorption of corticosteroids and digoxin. The
hypotensive effect of vasodilator antihypertensive agents such as
hydralazine and α-blockers (e.g. doxazosin), or methyl-dopa may
be enhanced.
Increases in the QT interval related to antipsychotic treatment may
be exacerbated by the co-administration of other drugs known to
significantly increase the QT interval. Co-administration of such
drugs should be avoided. Relevant classes include:
• class Ia and III antiarrhythmics (e.g. quinidine, amiodarone,
sotalol, dofetilide)
• some antipsychotics (e.g. thioridazine)
• some macrolides (e.g. erythromycin)
• some antihistamines
• some quinolone antibiotics (e.g. moxifloxacin)

In elderly people with dementia, a small increase in the number
of deaths has been reported for patients taking antipsychotics
compared with those not receiving antipsychotics.
If any of the side effects are troubling, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.
5. HOW TO STORE CLOPIXOL-ACUPHASE
Usually your doctor or nurse will store the medicine for you. If you
keep it at home:
Keep out of the reach and sight of children.
Do not use Clopixol-Acuphase after the expiry date that is printed
on the label. The expiry date refers to the last day of that month.
Store Clopixol-Acuphase at or below 25°C (room temperature).
Keep Clopixol-Acuphase ampoules in the box, so they are
protected from light.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Clopixol-Acuphase contains
The active substance is zuclopenthixol acetate.
Each millilitre (ml) of Clopixol-Acuphase contains 50 mg
zuclopenthixol acetate.
The other ingredient is thin vegetable oil (purified from coconut
oil).
What Clopixol-Acuphase looks like and contents of the pack
Clopixol-Acuphase is an oily liquid.
Clopixol-Acuphase is available in glass ampoules containing 1 ml
(50 mg) or 2 ml (100 mg) in boxes of 5 ampoules.
Not all pack sizes may be marketed.
This injection is manufactured by:
H. Lundbeck A/S
Ottiliavej 9
DK-2500 Valby
Denmark
For any information about this medicine, please contact the
Marketing Authorisation holder:
Lundbeck Limited
Lundbeck House
Caldecotte Lake Business Park
Caldecotte
Milton Keynes MK7 8LG
UK
This leaflet was last approved in 10/2011.
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

Clopixol-Acuphase

PL 0458/0063

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

The above list is not exhaustive and other individual drugs known
to significantly increase QT interval (e.g. cisapride, lithium) should
be avoided.
Drugs known to cause electrolyte disturbances such as thiazide
diuretics (hypokalaemia) and drugs known to increase the plasma
concentration of zuclopenthixol should also be used with caution
as they may increase the risk of QT prolongation and malignant
arrythmias.
Antipsychotics may antagonise the effects of adrenaline and
other sympathomimetic agents, and reverse the antihypertensive
effects of guanethidine and similar adrenergic-blocking agents.
Antipsychotics may also impair the effect of levodopa, adrenergic
drugs and anticonvulsants.
The metabolism of tricyclic antidepressants may be inhibited and
the control of diabetes may be impaired.
Since zuclopenthixol is partly metabolised by CYP2D6
concomitant use of drugs known to inhibit this enzyme may
lead to to higher than expected plasma concentrations of
zuclopenthixol, increasing the risk of adverse effects and
cardiotoxicity.
OVERDOSE
Symptoms: somnolence, coma, extrapyramidal symptoms,
convulsions, hypotension, shock, hyper or hypothermia. ECG
changes, QT prolongation, Torsade de Pointes, cardiac arrest and
ventricular arrhythmias have been reported when administered in
overdose together with drugs known to affect the heart.
Treatment: treatment is symptomatic and supportive. Measures
aimed at supporting the respiratory and cardiovascular systems
should be instituted. Adrenaline (epinephrine) must not be used
in these patients.
There is no specific antidote.
LIST OF EXCIPIENTS
Thin vegetable oil (derived from coconuts).
INCOMPATIBILITIES
Zuclopenthixol acetate should not be mixed with other injection
fluids.
SPECIAL PRECAUTIONS FOR STORAGE
Store at or below 25°C. Protect from light.
SPECIAL PRECAUTIONS FOR DISPOSAL
Nil.
MARKETING AUTHORISATION HOLDER
Lundbeck Ltd
Lundbeck House
Caldecotte Lake Business Park
Caldecotte, Milton Keynes, MK7 8LG
MARKETING AUTHORISATION NUMBER: PL 0458/0063.

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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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