CLOPIXOL TABLETS 10MG

Active substance: ZUCLOPENTHIXOL DIHYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Clopixol® Tablets 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
• 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 Tablets are and what they are used for
2. 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
How do Clopixol Tablets work?
Clopixol tablets belong 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 are Clopixol Tablets used for?
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. BEFORE YOU TAKE CLOPIXOL TABLETS
Do not take Clopixol Tablets
• If you are allergic (hypersensitive) to zuclopenthixol, other
thioxanthine drugs or antipsychotic drugs or any of the other
ingredients of Clopixol Tablets (see What Clopixol Tablets
contain). 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 Tablets

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• 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 tablets:
• Medicines that change the heartbeat (quinidine,
amiodarone, sotalol, dofetilide, erythromycin,
moxifloxacin, cisapride, lithium)
• Other antipsychotic medicines
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.
• 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 tablets can reduce the effect of adrenaline
(epinephrine) and similar drugs.

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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 clots.
Do Clopixol Tablets interact with alcohol?

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Clopixol tablets may increase the sedative effects of
alcohol making you drowsier. It is recommended not to
drink alcohol during treatment with Clopixol tablets.
Pregnancy
Ask your doctor or pharmacist for advice before taking any
medicine.
If you are pregnant or think you may be pregnant, tell your
doctor. Clopixol should not be used during pregnancy,
unless clearly necessary.
Your newborn baby might show side effects if this
medicine is used.
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.

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Breast-feeding
Ask your doctor or pharmacist for advice before taking any
medicine.
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.
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.
Important information about some of the ingredients in
Clopixol Tablets
This product contains lactose. If your doctor has told you
that you have intolerance to some sugars, contact your
doctor before taking this medicinal product.
Clopixol tablets contain hydrogenated castor oil which may
cause stomach upset and diarrhoea.
3. HOW TO TAKE CLOPIXOL TABLETS
Always take Clopixol tablets exactly as your doctor has told
you. You should 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).
Adults
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.
Elderly patients (above 65 years)
The initial dose is between a quarter and a half of the adult
dose.
Children
Clopixol tablets are not recommended for children.
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.

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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, restlessness
• High or low body temperature
• Changes in heart beat including irregular heart beat or
slow heart rate
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Clopixol tablets 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 taking 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:

• 
Raised blood levels of glucose, lipids or the hormone
prolactin
• 
Loss of control of blood sugar levels
• 
Changes in appetite or weight
•  blood pressure
Low
• Hot flushes
• 
General weakness or pain, tiredness or feeling unwell
• Increased thirst
•  educed or increased body temperature (including fever)
R
• 
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
•  en may experience breast enlargement or problems with
M
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 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 TABLETS
Keep this medicine out of the sight and reach of children.
Do not use these tablets 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.
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.

Other side effects

What Clopixol Tablets look like and contents of the pack

Side effects are most pronounced in the beginning of the
treatment and most of them usually wear off during
continued treatment.

Description of Clopixol film-coated tablets:
The 2 mg film-coated tablets are round, biconvex, pale red.
The 10 mg film-coated tablets are round, biconvex, light
red-brown.
The 25 mg film-coated tablets are round, biconvex, redbrown.

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• 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 "extrapyramidal" reaction
• Any yellowing of the skin and the white in the eyes
(jaundice); your liver may be affected

• 
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
•  changed walking pattern
A
• 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
•  mouth or increase in saliva
Dry
• 
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)
• 
Changes in skin colour
• 
Bruising under the skin
• Muscle pain

6. FURTHER 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).

Clopixol tablets are available in plastic containers or glass
bottles containing 100 tablets.
These tablets are 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 8LG
UK
This leaflet was last revised in 02/2014.
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 Tablets 2 mg PL 0458/0027
Clopixol Tablets 10 mg PL 0458/0028
Clopixol Tablets 25 mg PL 0458/0029
This is a service provided by the Royal National Institute of
Blind People.

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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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