CLOPIXOL INJECTION 200MG/ML

Active substance: ZUCLOPENTHIXOL DECANOATE

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GB-056-60-200-13409

PACKAGE LEAFLET: INFORMATION FOR THE USER

Clopixol® Injection
zuclopenthixol decanoate
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. What Clopixol Injection is and what it is used for
2. Before Clopixol Injection is given
3. How Clopixol Injection is given
4. Possible side effects
5. How to store Clopixol Injection
6. Further information
1. WHAT CLOPIXOL INJECTION IS AND WHAT IT IS USED FOR
How does Clopixol Injection work?
Clopixol Injection 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.
What is Clopixol Injection used for?
Clopixol Injection is used for the treatment of schizophrenia and
other psychoses.

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Your doctor, however, may prescribe Clopixol Injection for another
purpose. Ask your doctor if you have any questions about why
Clopixol Injection has been prescribed for you.
2. BEFORE CLOPIXOL INJECTION IS GIVEN
Clopixol Injection is not given
• If you are allergic (hypersensitive) to zuclopenthixol, other
thioxanthine drugs or antipsychotic drugs or any of the other
ingredients of Clopixol Injection (see What Clopixol Injection
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 Injection
• 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.
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 Injection:
• Medicines that change the heartbeat (quinidine, amiodarone,
sotalol, dofetilide, erythromycin, moxifloxacin, cisapride,
lithium)
• Other antipsychotic 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.
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.
Does Clopixol Injection interact 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
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 Injection 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 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.
Breast-feeding
Ask your doctor or pharmacist for advice before taking any
medicine.
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.
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.
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.
Elderly patients (above 65 years)
Starting doses for elderly or frail patients are usually reduced to a
quarter or a half of the dosage range.

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.

Children
Clopixol Injection is not recommended for children.






If you feel that the effect of Clopixol Injection is too strong or weak,
talk to your doctor or pharmacist.

sickness remedies as well as other medicines)

INFORMATION FOR THE HEALTHCARE PROFESSIONAL
CONSULT THE SUMMARY OF PRODUCT CHARACTERISTICS FOR
FULL INFORMATION ON THIS PRODUCT
NAME OF THE MEDICINAL PRODUCT
Clopixol Injection.

It is important that you continue to receive your medicine at
regular intervals even if you are feeling completely well, because

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.

PHARMACEUTICAL FORM
Solution for Injection.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Caution should be exercised in patients having: liver disease; cardiac
disease, or arrhythmias; severe respiratory disease; renal failure;
epilepsy (and conditions predisposing to epilepsy, e.g. alcohol
withdrawal or brain damage); Parkinson’s disease; narrow angle
glaucoma; prostatic hypertrophy; hypothyroidism; hyperthyroidism;
myasthenia gravis; phaeochromocytoma and patients who have
shown hypersensitivity to thioxanthenes or other antipsychotics.

THERAPEUTIC INDICATIONS
The maintenance treatment of schizophrenia and paranoid
psychoses.

The elderly require close supervision because they are especially
prone to experience such adverse effects as sedation, hypotension,
confusion and temperature changes.

DOSAGE AND METHOD OF ADMINISTRATION
Route of administration
By deep intramuscular injection into the upper outer buttock or
lateral thigh.

When transferring patients from oral to depot antipsychotic
treatment, the oral medication should not be discontinued
immediately, but gradually withdrawn over a period of several days
after administering the first injection.

Note: As with all oil based injections it is important to ensure, by
aspiration before injection, that inadvertent intravascular entry
does not occur.

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 and opiate and alcohol abuse are over-represented
among fatal cases.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Zuclopenthixol Decanoate 20.0% w/v (equivalent to zuclopenthixol
base 14.445% w/v).

Adults
Dosage and dosage interval should be adjusted according to the
patient’s symptoms and response to treatment.
The usual dosage range of zuclopenthixol decanoate is
200-500 mg every one to four weeks, depending on response, but
some patients may require up to 600 mg per week. In patients who
have not previously received depot antipsychotics, treatment is
usually started with a small dose (e.g. 100 mg) to assess tolerance.
An interval, of at least one week should be allowed before the
second injection is given at a dose consistent with the patient’s
condition.
Adequate control of severe psychotic symptoms may take up to
4 to 6 months at high enough dosage. Once stabilised lower
maintenance doses may be considered, but must be sufficient to
prevent relapse.
Injection volumes of greater than 2 ml should be distributed between
two injection sites.
Elderly
In accordance with standard medical practice initial dosage may
need to be reduced to a quarter or half the normal starting dose in
the frail or elderly.
Children
Not indicated for children.
Dosage in reduced renal function
Clopixol 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.
Dosage in reduced hepatic function
Use with caution in patients with liver disease. Patients with
compromised hepatic function should receive half the recommended
dosages. Serum-level monitoring is advised.

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 drugs.
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.
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,
hypomagnesaemia or genetic predisposition) and in patients 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.

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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

It may take between four and six months before you feel better.
Your doctor will decide the duration of treatment.

GB-056-60-200-13409

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 Injection than you should
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. Elderly 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 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

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 methyldopa may
be enhanced.
Concomitant use of zuclopenthixol and drugs known to cause QT
prolongation or cardiac arrhythmias, such as tricyclic
antidepressants or other antipsychotics should be avoided.
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)
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



















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 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 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 INJECTION
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 Injection after the expiry date that is
printed on the label. The expiry date refers to the last day of
that month
• Store Clopixol Injection below 25°C
• Keep Clopixol Injection ampoules and vials 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 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.
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 boxes of 10
ampoules and single-packed vials of 10 ml.
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 8LFG
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 Injection

PL 0458/0017

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

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
Overdosage may cause somnolence or even 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 is symptomatic and supportive, with measures aimed at
supporting the respiratory and cardiovascular systems. The following
specific measures may be employed if required.
- Anticholinergic antiparkinson drugs if extrapyramidal symptoms
occur
- Sedation (with benzodiazepines) in the unlikely event of agitation or
excitement or convulsions
- Noradrenaline in saline intravenous drip if the patient is in shock.
Adrenaline must not be given.
LIST OF EXCIPIENTS
Thin vegetable oil
INCOMPATABILITIES
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.
SPECIAL PRECAUTIONS FOR STORAGE
Store at or below 25°C. Protect from light.
SPECIAL PRECAUTIONS FOR DISPOSAL
Nil.
MARKETING AUTHORISATION HOLDER
Lundbeck Limited
Lundbeck House
Caldecotte Lake Business Park
Caldecotte
Milton Keynes
MK7 8LG
MARKETING AUTHORISATION NUMBER
PL 0458/0017.

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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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