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Package leaflet: Information for the user

Clopixol® 2 mg, 10 mg and 25 mg film-coated tablets
Zuclopenthixol (as dihydrochloride)
Read all of this leaflet carefully before you start taking 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
• 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 possible side effects not listed in this
leaflet. See section 4.
In this leaflet:
1. What Clopixol Tablets are and what they are used for
2. What you need to know before you take Clopixol Tablets
3. How to take Clopixol Tablets
4. Possible side effects
5. How to store Clopixol Tablets
6. Further information

1. What Clopixol Tablets are and what they are
used for
The name of your medicine is Clopixol 2 mg, 10 mg or 25 mg filmcoated tablets (called Clopixol Tablets in this leaflet). Clopixol
Tablets contain the active substance zuclopenthixol and belong to
a group of medicines known as antipsychotics (also called
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 Tablets are used for the treatment of schizophrenia and
other psychoses.
Your doctor, however, may prescribe Clopixol Tablets for another
purpose. Ask your doctor if you have any questions about why
Clopixol Tablets have been prescribed for you.

2. What you need to know before you take
Clopixol Tablets
Do not take Clopixol Tablets
• If you are allergic to zuclopenthixol, other thioxanthene drugs or
antipsychotic drugs or any of the other ingredients of this
medicine (listed in section 6).
• 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 of nurse before taking Clopixol
• 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
• 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
Children and adolescents
Clopixol is not recommended in these patients.
Other medicines and Clopixol Tablets
Tell your doctor or pharmacist if you are taking, have taken or might
take any other medicines.
The following medicines should not be taken at the same time as
Clopixol Tablets:
• 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 following
• 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
• 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 Tablets can reduce the effect of adrenaline (epinephrine)
and similar drugs.
Tell your doctor, dentist, surgeon or anaesthetist before any
operation as Clopixol Tablets can increase the effects of general
anaesthetics, muscle relaxing drugs and drugs used to prevent
Clopixol Tablets with food, drink and alcohol
Clopixol Tablets can be taken with or without food.
Clopixol Tablets may increase the sedative effects of alcohol
making you drowsier. It is recommended not to drink alcohol
during treatment with Clopixol Tablets.

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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 or pharmacist for
advice before taking this medicine.
If you are pregnant or think you may be pregnant, tell your doctor.
Clopixol should not be used during pregnancy, unless clearly
The following symptoms may occur in newborn babies, of mothers
that have used Clopixol Tablets 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 breast-feeding, ask your doctor for advice. Clopixol
Tablets 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


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Driving and using machines
There is a risk of feeling drowsy and dizzy when using Clopixol
Tablets, 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.
Clopixol Tablets contain lactose and hydrogenated castor oil
If your doctor has told you that you have intolerance to some
sugars, contact your doctor before taking this medicinal product.


Hydrogenated castor oil may cause stomach upset and diarrhoea.

3. How to take Clopixol Tablets
Always take Clopixol Tablets exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
The dose varies and depends on the severity of the illness. The
total amount of tablets you need to take each day will be split into
at least two doses (for example a morning and evening dose).
Daily doses of Clopixol Tablets range from 4 mg to 150 mg.
The daily dose at the start of treatment is usually 20 mg to 30 mg
each day.
This dose is then usually adjusted to between 20 mg and 50 mg
each day.
The maximum dosage per single dose is 40 mg.
If you have liver problems, the level of zuclopenthixol in your blood
may be checked.
Older patients (above 65 years of age)
The initial dose is between a quarter and a half of the adult dose.
Use in children
Clopixol Tablets are not recommended for children.
How to take Clopixol Tablets
Swallow the tablets with a drink of water. Do not chew them.
Duration of treatment
It may take between four and six months before you feel better.
Your doctor will decide the duration of treatment.
If you feel that the effect of Clopixol Tablets 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 take more Clopixol Tablets than you should
If you think that you or anyone else may have taken too many
Clopixol Tablets contact your doctor or nearest hospital casualty
department immediately. Do this even if there are no signs of
discomfort or poisoning. Take the Clopixol container with you if you
go to a doctor or hospital.
Symptoms of overdose may include:
• Drowsiness
• Unconsciousness
• Muscle movements or stiffness
• Fits
• Low blood pressure, weak pulse, fast heart rate, pale skin,
• High or low body temperature


• Changes in heart beat including irregular heart beat or slow heart
If you forget to take Clopixol Tablets
If you forget to take a dose, take the next dose at the usual time.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Clopixol Tablets
Your doctor will decide how and when to stop your treatment to
avoid any unpleasant symptoms that might occur if it is stopped
abruptly (eg difficulty in sleeping, muscle stiffness, feeling unwell).
If you have any further questions on the use of this product ask your
doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine 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 taking Clopixol Tablets 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
• 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 Tablets 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 in 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
• Increased sweating or greasy skin
• Itching, rashes or skin reactions (including sensitivity to
• 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 medicines that work in a way similar to zuclopenthixol
(the active ingredient of Clopixol Tablets), 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.
United Kingdom
Via the Yellow Card Scheme at:
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.
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D'Argens
GŻR-1368 Gżira

5. How to store Clopixol Tablets
• 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. The expiry date refers to the last day of that month.
• 2 mg tablets: Store in the original container in order to protect
from light.
• 10 mg and 25 mg tablets: These medicinal products do not
require any special storage conditions.
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 Tablets contain
The active substance is zuclopenthixol dihydrochloride.
Each tablet contains 2 mg, 10 mg or 25 mg of zuclopenthixol.
The other ingredients are potato starch, lactose, microcrystalline
cellulose, copolyvidone, glycerol, talc, hydrogenated castor oil,
magnesium stearate, methylhydroxypropyl cellulose, macrogol,
titanium dioxide (E171) and the red colour E172 (iron oxide).
What Clopixol Tablets look like and contents of the pack
Description of Clopixol Tablets:
The 2 mg tablets are round, biconvex, pale red.
The 10 mg tablets are round, biconvex, light red-brown.
The 25 mg tablets are round, biconvex, red-brown.
Clopixol Tablets are available in plastic containers or glass bottles
containing 100 tablets.
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
H. Lundbeck A/S
Ottiliavej 9
DK-2500 Valby
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 2 mg film-coated tablets
Clopixol 10 mg film-coated tablets
Clopixol 25 mg film-coated tablets

Product code number
PL 0458/0027
PL 0458/0028
PL 0458/0029

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



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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.