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CLOPIXOL 25MG FILM-COATED TABLETS

Active substance(s): ZUCLOPENTHIXOL DIHYDROCHLORIDE

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Patient Information Leaflet

Clopixol® 10 mg film-coated tablets
Clopixol® 25 mg film-coated tablets
(zuclopenthixol dihydrochloride)
Your medicine is available in any of the above two names, but will be
referred to as Clopixol Tablets throughout the remainder of the leaflet.
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
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 possible side effects not listed in this leaflet. See
section 4.
Your medicine is also available in the following strength 2mg film-coated
Tablets
What is 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
Clopixol Tablets contain the active substance zuclopenthixol and 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.
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 Tablets:

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
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, 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 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 clots.
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.
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.
Pregnancy
If you are pregnant or think you may be pregnant, tell your doctor. Clopixol
should not be used during pregnancy, unless clearly necessary.
The following symptoms may occur in new-born 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.
Breast-feeding
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.
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 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
If your doctor has told you that you have intolerance to some sugars,
contact your doctor before taking this medicinal product.
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).
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.
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.

PP1/1460/61/V2

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,
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.
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 (e.g.
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 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 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


































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)
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 via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. How to store Clopixol Tablets
Keep 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.
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. Further information
Each tablet contains 10 mg or 25 mg of zuclopenthixol (as
dihydrochloride).
Also contains: potato starch, lactose monohydrate, microcrystalline
cellulose, copolyvidone, glycerol 85%, talc, hydrogenated castor oil,
magnesium stearate, hypromellose 5, macrogol 6000, titanium dioxide
(E171) and the red colour E172 (iron oxide).
The 10 mg tablets are round, biconvex, light red-brown with no markings.
The 25 mg tablets are round, biconvex, red-brown with no markings.

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

Clopixol Tablets are available in plastic containers containing 100 tablets.
Manufactured by: H.Lundbeck A/S, Ottiliavej 9 DK-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 20774/1460
PL 20774/1461

Clopixol 10mg film-coated tablets
Clopixol 25mg film-coated tablets

POM

Clopixol is a registered trademark of Lundbeck A/S
th

Date of preparation 6 January 2016

PP1/1460/61/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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