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CLOPIXOL 200MG/ML SOLUTION FOR INJECTION

Active substance(s): ZUCLOPENTHIXOL DECANOATE

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Patient Information Leaflet



Clopixol® 200 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, 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 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 used for
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
other psychoses.
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
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 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
Clopixol 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)

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 Injection can reduce the effect of adrenaline
(epinephrine) and similar drugs.

Breast-feeding
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.

The following information is intended for healthcare
professionals only:

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

Administration information for the healthcare professional

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.

Clopixol 200 mg/ml solution for injection is clear, yellowish oil,
practically free from particles. It should be administered by
deep intramuscular injection into the upper outer buttock or
lateral thigh.

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.
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 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.

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.

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.

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.

Use in children
Clopixol Injection is not recommended for children.

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
Your new-born baby might show side effects if this medicine is
used during pregnancy.
The following symptoms may occur in new-born 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.

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.

Clopixol 200 mg/ml solution for injection

Consult the Summary of Product Characteristics for full
information on this product

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 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:

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 the heartbeat including irregular heartbeat 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 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
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

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

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.
Do not store above 25°C.
Keep the ampoules in the outer carton in order to protect from
light.
If the oil shows any signs of discolouration or deterioration consult
your pharmacist for advice.
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
zuclopenthixol decanoate.
The other ingredient is thin vegetable oil (triglycerides, medium
chain)
What Clopixol Injection looks like and contents of the pack
Clopixol Injection is a clear yellowish oil, practically free from
particles.
Clopixol Injection is available in Glass ampoules containing 1 ml
(200 mg) in cartons of 10 ampoules.
Manufactured by: H.Lundbeck A/S Ottiliavej 9 2500 Valby
Denmark. Procured from within the EU. Product Licence Holder:
Quadrant Pharmaceuticals Ltd, Lynstock House, Lynstock Way,
Lostock, Bolton BL6 4SA. Repackaged by Maxearn Ltd, Bolton
BL6 4SA.
PL 20774/1465

Clopixol 200 mg/ml solution for injection
POM

Clopixol is a registered trademark of Lundbeck A/S
Date of preparation 12th May 2016

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 heartbeats (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
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.

PP1/1465/V2

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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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