Skip to Content

CLOPIXOL-ACUPHASE 50 MG/ML SOLUTION FOR INJECTION

Active substance(s): ZUCLOPENTHIXOL ACETATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the patient

Clopixol-Acuphase® 50 mg/ml solution for injection
zuclopenthixol acetate

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
• If you get any side effects talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in
this leaflet. See section 4.
What is in this leaflet:
1. What Clopixol-Acuphase is and what it is used for
2. What you need to know before Clopixol-Acuphase is given
3. How Clopixol-Acuphase is given
4. Possible side effects
5. How to store Clopixol-Acuphase
6. Contents of the pack and other information

1. What Clopixol-Acuphase is and what it is
used for
The name of your medicine is Clopixol-Acuphase 50 mg/ml
solution for injection (called Clopixol-Acuphase in this leaflet).
Clopixol-Acuphase contains the active substance
zuclopenthixol. 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.
Clopixol-Acuphase is used for the initial treatment of short-term
psychoses including mania or increases in the severity of
existing psychoses.

2. What you need to know before ClopixolAcuphase is given
Clopixol-Acuphase 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 ClopixolAcuphase 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 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
Children and adolescents
Clopixol-Acuphase is not recommended in these patients
Other medicines and Clopixol-Acuphase
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.

135926

The following medicines should not be taken at the same time
as Clopixol-Acuphase:
• Medicines that change the heart beat (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)

The following information is intended for healthcare
professionals only:
Clopixol-Acuphase 50 mg/ml solution for injection
Administration information for the healthcare professional
Consult the Summary of Product Characteristics for full
information on this product
Clopixol-Acuphase 50 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.
REG_00064484 v.3.0

• 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.
Clopixol-Acuphase 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.

GB-MT-058-60-50-13412 / 135926
0645

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-Acuphase should not be used during pregnancy
unless clearly necessary.
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
If you are breast-feeding, 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.
Fertility
Zuclopenthixol may decrease your sexual activity and fertility.
These are not lasting effects. Please talk to your doctor about
any problems.
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

190x450
926180

GB-MT-058-60-50-13411/128477

Black

135926

GB-MT-058-60-50-13412

2015-08-13.13:03.SSB

2
3

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.
Older patients (above 65 years of age)
Older patients may need smaller doses. The maximum dose per
injection is 100 mg.
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-Acuphase is not recommended for children
Duration of treatment
Treatment with Clopixol-Acuphase can continue for up to 2 weeks.
After this time if treatment is still needed it can be continued
with Clopixol tablets, Clopixol injection or Clopixol Conc.
injection
If you feel that the effect of Clopixol-Acuphase is too strong or
weak, talk to your doctor or pharmacist.
If you are given too much Clopixol-Acuphase
Your medicine will be given by your doctor/nurse.
In the unlikely event that you receive too much ClopixolAcuphase 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.

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.
It should not be mixed with any other injection fluids.

135926

4. Possible side effects
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 “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 the day after the first
treatment and usually wear off soon afterwards.

135926

• Throbbing or fast heart beats
• 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 heart beat and abnormal ECG heart tracing
• Life threatening irregular heart beats
In rare cases irregular heart beats (arrhythmias) may have
resulted in sudden death.

REG_00064484 v.3.0

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-Acuphase
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-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 cartons of 5 ampoules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
For any information about this medicine, please contact the
Marketing Authorisation holder:
Lundbeck Limited
Building K1
Timbold Drive
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-Acuphase

Product code number
PL 0458/0063

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

135926

GB-MT-058-60-50-13412

Expand view ⇕

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.

Hide