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CLOPIXOL 2MG FILM-COATED TABLETS

Active substance(s): ZUCLOPENTHIXOL DIHYDROCHLORIDE

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500669/PL1f
®

Clopixol 2 mg Film-Coated Tablets
(zuclopenthixol dihydrochloride)
Patient Information Leaflet
®
The name of your medicine is Clopixol 2 mg Film-Coated
Tablets, throughout this leaflet it will be referred to as
®
Clopixol Tablets. Other strengths are available. This leaflet
contains information about other strengths.
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.
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) Contents of the pack and other information
®

1) WHAT CLOPIXOL TABLETS ARE AND WHAT THEY
ARE USED FOR
®
The name of your medicine is Clopixol 2 mg film-coated
®
®
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 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.

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) betablockers, 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 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.
Breast-feeding
®
If you are breast-feeding, ask you 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 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.

Other medicines and Clopixol Tablets
Tell your doctor or pharmacist if you are taking, have taken or
might take any other medicines.

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).

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

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.

Continued overleaf

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, 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
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)
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 store above 25°C. Store in the original container.
Protect from light. Protect from moisture.
If you notice any sign of deterioration or discolouration of the
tablets consult your pharmacist.
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
Each tablet contains 2.36 mg of zuclopenthixol
dihydrochloride equivalent to 2 mg of zuclopenthixol.
The other (inactive) ingredients are potato starch, lactose
monohydrate, microcrystalline cellulose, copovidone, glycerol,
talc, hydrogenated castor oil, magnesium stearate,
hypromellose, macrogol 6000, titanium dioxide (E171) and
red iron oxide (E172).
®

What Clopixol Tablets looks like and contents of the
pack
®
Clopixol Tablets are round, bi-convex pink film-coated
tablets.
Each bottle contains 100 tablets.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd and repackager Ginova UK Ltd both at St James’ House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufactured by H Lundbeck A/S, Ottiliavej 9, DK-2500,
Copenhagen, Denmark.
®

Clopixol 2 mg Film-Coated Tablets
PL: 18067/0271

POM

th

This leaflet was last revised on 4 June 2015.
®

Clopixol is a registered trademark of H Lundbeck A/S.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172
500669/PL1f

500670/PL1f

Zuclopenthixol 2 mg Film-Coated Tablets
(zuclopenthixol dihydrochloride)
Patient Information Leaflet
The name of your medicine is Zuclopenthixol 2 mg FilmCoated Tablets, throughout this leaflet it will be referred to as
Zuclopenthixol Tablets. Other strengths are available. This
leaflet contains information about other strengths.
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.
In this leaflet:
1) What Zuclopenthixol Tablets are and what they are
used for
2) What you need to know before you take Zuclopenthixol
Tablets
3) How to take Zuclopenthixol Tablets
4) Possible side effects
5) How to store Zuclopenthixol Tablets
6) Contents of the pack and other information
1) WHAT ZUCLOPENTHIXOL TABLETS ARE AND WHAT
THEY ARE USED FOR
The name of your medicine is Zuclopenthixol 2 mg film-coated
tablets (called Zuclopenthixol Tablets in this leaflet).
Zuclopenthixol 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.
Zuclopenthixol Tablets are used for the treatment of
schizophrenia and other psychoses.
Your doctor, however, may prescribe Zuclopenthixol Tablets
for another purpose. Ask your doctor if you have any
questions about why Zuclopenthixol Tablets have been
prescribed for you.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ZUCLOPENTHIXOL TABLETS
Do not take Zuclopenthixol 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
Zuclopenthixol 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
Zuclopenthixol is not recommended in these patients.
Other medicines and Zuclopenthixol 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 Zuclopenthixol 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) betablockers, 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
Zuclopenthixol Tablets can reduce the effect of adrenaline
(epinephrine) and similar drugs.
Tell your doctor, dentist, surgeon or anaesthetist before any
operation as Zuclopenthixol Tablets can increase the effects
of general anaesthetics, muscle relaxing drugs and drugs
used to prevent clots.
Zuclopenthixol Tablets with food, drink and alcohol
Zuclopenthixol Tablets can be taken with or without food.
Zuclopenthixol Tablets may increase the sedative effects of
alcohol making you drowsier. It is recommended not to drink
alcohol during treatment with Zuclopenthixol 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.
Zuclopenthixol should not be used during pregnancy, unless
clearly necessary.
The following symptoms may occur in newborn babies, of
mothers that have used Zuclopenthixol 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 you doctor for advice.
Zuclopenthixol
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
Zuclopenthixol 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.
Zuclopenthixol 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 ZUCLOPENTHIXOL TABLETS
Always take Zuclopenthixol 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 Zuclopenthixol 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.

Continued overleaf

Older patients (above 65 years of age)
The initial dose is between a quarter and a half of the adult
dose.
Use in children
Zuclopenthixol Tablets are not recommended for children.
How to take Zuclopenthixol 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 Zuclopenthixol 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 Zuclopenthixol Tablets than you should
If you think that you or anyone else may have taken too many
Zuclopenthixol Tablets contact your doctor or nearest hospital
casualty department immediately. Do this even if there are no
signs of discomfort or poisoning. Take the Zuclopenthixol
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 Zuclopenthixol 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 Zuclopenthixol 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 Zuclopenthixol 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)

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)
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 Zuclopenthixol
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 ZUCLOPENTHIXOL 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.

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.

Do not store above 25°C. Store in the original container.
Protect from light. Protect from moisture.

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 Zuclopenthixol 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

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.

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

If you notice any sign of deterioration or discolouration of the
tablets consult your pharmacist.

6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Zuclopenthixol Tablets contain
Each tablet contains 2.36 mg of zuclopenthixol
dihydrochloride equivalent to 2 mg of zuclopenthixol.
The other (inactive) ingredients are potato starch, lactose
monohydrate, microcrystalline cellulose, copovidone, glycerol,
talc, hydrogenated castor oil, magnesium stearate,
hypromellose, macrogol 6000, titanium dioxide (E171) and
red iron oxide (E172).
What Zuclopenthixol Tablets looks like and contents of
the pack
Zuclopenthixol Tablets are round, bi-convex pink film-coated
tablets.
Each bottle contains 100 tablets.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd and repackager Ginova UK Ltd both at St James’ House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufactured by H Lundbeck A/S, Ottiliavej 9, DK-2500,
Copenhagen, Denmark.
Zuclopenthixol 2 mg Film-Coated Tablets
PL: 18067/0271
POM
th

This leaflet was last revised on 4 June 2015.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172
500670/PL1f

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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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