CLOPIXOL INJECTION 200MG/ML
Active substance(s): ZUCLOPENTHIXOL DECANOATE / ZUCLOPENTHIXOL DECANOATE / ZUCLOPENTHIXOL DECANOATE
Clopixol® 200 mg/ml solution for injection
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
• 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 Injection is and what it is used for
2. What you need to know before Clopixol Injection is given
3. How Clopixol Injection is given
4. Possible side effects
5. How to store Clopixol Injection
6. Contents of the pack and other information
1. What Clopixol Injection is and what it is
The name of your medicine is Clopixol 200 mg/ml solution for
injection (called Clopixol Injection in this leaflet). Clopixol 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 Injection is used for the treatment of schizophrenia and
Your doctor, however, may prescribe Clopixol Injection for another
purpose. Ask your doctor if you have any questions about why
this medicine has been prescribed for you.
2. What you need to know before Clopixol
Injection is given
Clopixol 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
Warnings and precautions
Talk to your doctor, pharmacist or nurse before Clopixol 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
• 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 Injection is not recommended in these patients.
Other medicines and Clopixol 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
• Medicines that change the heartbeat (quinidine, amiodarone,
sotalol, dofetilide, erythromycin, moxifloxacin, cisapride,
• Other antipsychotic medicines
Tell your doctor or pharmacist if you are taking any of the
• 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
• Piperazine (used to treat worm infections)
• Levodopa or other medicines used to treat Parkinson’s disease
The following information is intended for healthcare
Clopixol 200 mg/ml solution for injection
Administration information for the healthcare professional
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 Injection can reduce the effect of adrenaline
(epinephrine) and similar drugs.
Tell your doctor, dentist, surgeon or anaesthetist before any
operation as Clopixol Injection can increase the effects of general
anaesthetics, muscle relaxing drugs and drugs used to prevent clots.
Clopixol Injection with alcohol
Clopixol Injection may increase the sedative effects of alcohol
making you drowsier. It is recommended not to drink alcohol
during treatment with Clopixol 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.
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 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.
If you are breastfeeding, ask your doctor for advice. Clopixol
Injection should not be used when breast-feeding, as small
amounts of the medicine can pass into the breast milk.
Zuclopenthixol may decrease your sexual activity and fertility.
These are not lasting effects. Please talk to your doctor about any
Driving and using machines
There is a risk of feeling drowsy and dizzy when being treated
with Clopixol 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 Injection is given
A small amount of Clopixol Injection is drawn up into a syringe
and then injected into 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.
The usual dose lies between 200-500 mg every 1 to 4 weeks but
some patients require 600 mg every week. The maximum single
dose at any one time is 600 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 Clopixol 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 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 zuclopenthixol in your
blood may be checked.
Older patients (above 65 years of age)
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 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.
If you feel that the effect of Clopixol Injection is too strong or
weak, talk to your doctor or pharmacist.
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 600 mg. For
example, 1200 mg every 2 weeks should not be given.
Consult the Summary of Product Characteristics for full
information on this product
Injection volumes of greater than 2 ml should be distributed
between two injection sites.
Clopixol 200 mg/ml solution for injection is a clear, yellowish oil,
practically free from particles. It should be administered by deep
intramuscular injection into the upper outer buttock or lateral thigh.
This product may be mixed in the same syringe with other
products in the Clopixol Injection range, including ClopixolAcuphase Injection (zuclopenthixol acetate 50 mg/ml).
It should not be mixed with any other injection fluids.
If you are given too much Clopixol Injection
Your medicine will be given by your doctor/nurse.
In the unlikely event that you receive too much Clopixol Injection
you may experience some symptoms.
Symptoms of overdose may include:
• Muscle movements or stiffness
• Low blood pressure, weak pulse, fast heart rate, pale skin,
• High or low body temperature
• Changes in the heartbeat including irregular heartbeat or slow
You will receive treatment for any of these symptoms from your
doctor or nurse.
4. Possible side effects
Like all medicines, Clopixol 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 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
If you get any of the following symptoms you should contact your
doctor immediately as your dose may need to be reduced or
• 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
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.
• Loss of co-ordination or altered muscle movements (including
unusual movements of the mouth, tongue and eyeballs)
• 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
• Speech problems
• 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
• Increased sweating or greasy skin
• Itching, rashes or skin reactions (including sensitivity to
• 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.
Via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
The Medicines Authority
Sir Temi Zammit Buildings
Malta Life Sciences Park
San Gwann SGN 300
5. How to store Clopixol 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
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 Injection contains
The active substance is zuclopenthixol decanoate.
Each millilitre (ml) of Clopixol Injection contains 200 mg
The other ingredient is thin vegetable oil.
What Clopixol Injection looks like and contents of the pack
Clopixol Injection is an oily liquid.
Clopixol Injection is available in glass ampoules containing 1 ml
(200 mg) in cartons of 10 ampoules and single-packed vials of
Not all pack sizes may be marketed.
Marketing Authorisation Holder
For any information about this medicine, please contact the
Marketing Authorisation holder:
Building 3 Abbey View
H. Lundbeck A/S
This leaflet was last revised in 12/2016
To request a copy of this leaflet in braille, large print or audio
please call free of charge:
0800 198 5000
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Product code number
This is a service provided by the Royal National Institute of Blind
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.