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ZUCLOPENTHIXOL 2MG FILM-COATED TABLETS

Active substance(s): ZUCLOPENTHIXOL / ZUCLOPENTHIXOL DIHYDROCHLORIDE / ZUCLOPENTHIXOL / ZUCLOPENTHIXOL

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S576 LEAFLET Clopixol 20170624

PACKAGE LEAFLET: INFORMATION FOR THE USER
®

CLOPIXOL 2mg TABLETS
(zuclopenthixol dihydrochloride)
Your medicine is known as Clopixol® 2mg Tablets but will be
referred to as Clopixol Tablets throughout the following leaflet.
Inforamtion for other strengths of Clopixol also may be present in
this leaflet.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.



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



Keep this leaflet. You may need to read it again





Medicines used to treat epilepsy

If you have any further questions, ask your doctor, pharmacist
or nurse.



Medicines used to treat diabetes



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

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

6. Further information

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.

1. WHAT CLOPIXOL TABLETS ARE AND WHAT THEY ARE
USED FOR

Pregnancy

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
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

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 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.

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

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.

Warnings and precautions
Talk to your doctor, pharmacist of nurse before taking Clopixol
Tablets:

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.



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)

Adults



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)

The daily dose at the start of treatment is usually 20 mg to 30 mg
each day.



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

Older patients (above 65 years of age)



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

The initial dose is between a quarter and a half of the adult dose.

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.

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.

Use in children
Children and adolescents

Clopixol Tablets are not recommended for children.

Clopixol is not recommended in these patients.

How to take Clopixol Tablets
Swallow the tablets with a drink of water. Do not chew them.

Other medicines and Clopixol Tablets

Duration of treatment

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

It may take between four and six months before you feel better.
Your doctor will decide the duration of treatment.

The following medicines should not be taken at the same time as
Clopixol Tablets:

If you feel that the effect of Clopixol Tablets is too strong or weak,
talk to your doctor or pharmacist.



Medicines that change the heartbeat (quinidine, amiodarone,
sotalol, dofetilide, erythromycin, moxifloxacin, cisapride, lithium)



Other antipsychotic medicines

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.

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)

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



Abnormal liver function tests



Low blood pressure, weak pulse, fast heart rate, pale skin,
restlessness



Liver enlargement





Unexpected excretion of breast milk

High or low body temperature





Insomnia, abnormal dreams or nightmares

Changes in heart beat including irregular heart beat or slow
heart rate



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)

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).

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

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 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.

(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.

Serious side effects

Reporting of side effects

Stop taking Clopixol Tablets and seek medical advice
immediately if you have any of the following allergic reactions:

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).



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

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
5. HOW TO STORE CLOPIXOL TABLETS


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Store your tablets between 15-25°C.



Store in the original container. Protect from light and moisture.



Do not use Clopixol Tablets after the expiry date printed on the
bottle label. The expiry date refers to the last day of that month.



Tablets should not be thrown in your bin or put down the drain.
If they are out of date, or no longer suitable for you, return them
to your pharmacist.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



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

6. FURTHER INFORMATION

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



Each tablet contains 2mg of the active ingredient zuclopenthixol
(as the dihydrochloride).



Clopixol Tablets also contain the following inactive ingredients:
potato starch, lactose, microcrystalline cellulose, copovidone,
glycerol, talc, castor oil hydrogenated, magnesium stearate,
hypromellose, macrogol 6000, titanium dioxide (E171) and red
iron oxide (E172).



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

What Clopixol Tablets contain



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)

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.



Dizziness or vertigo

Manufacturer



Headache or migraine



Numbness or tingling in the arms and legs

This product is manufactured by H Lundbeck A/S, Ottilavej 9, DK2500 Copenhagen-Valby, Denmark.



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)

What Clopixol Tablets look like and contents of the pack
Clopixol Tablets are unmarked, round, pale-red biconvex filmcoated tablets.
Clopixol Tablets are available in bottles containing 100 tablets.
Product Licence holder

POM

PL: 19488/0576

Leaflet revision date: 24 June 2017

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.
Clopixol is a registered trade mark of H Lundbeck A/S, Denmark.
S576 LEAFLET Clopixol 20170624



Piperazine (used to treat worm infections)

PACKAGE LEAFLET: INFORMATION FOR THE USER



Levodopa or other medicines used to treat Parkinson’s disease

ZUCLOPENTHIXOL 2mg TABLETS
(zuclopenthixol dihydrochloride)



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

S576 LEAFLET Zuclopenthixol Dihydrochloride 20170624

Your medicine is known as Zuclopenthixol 2mg Tablets but will be
referred to as Zuclopenthixol Tablets throughout the following
leaflet.
Inforamtion for other strengths of Zuclopenthixol also may be
present in this 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.

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.

In this leaflet:
1. What Zuclopenthixol Tablets are and what they are used for

Zuclopenthixol Tablets with food, drink and alcohol

2. What you need to know before you take Zuclopenthixol
Tablets

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

3. How to take Zuclopenthixol Tablets
4. Possible side effects
5. How to store Zuclopenthixol Tablets
6. Further information
1. WHAT ZUCLOPENTHIXOL TABLETS ARE AND WHAT
THEY ARE USED FOR
The name of your medicine is Zuclopenthixol 2 mg, 10 mg or 25 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

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 your 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.

Warnings and precautions

Zuclopenthixol Tablets contain lactose

Talk to your doctor, pharmacist of nurse before taking
Zuclopenthixol Tablets:

If your doctor has told you that you have intolerance to some
sugars, contact your doctor before taking this medicinal product.



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

3. HOW TO TAKE ZUCLOPENTHIXOL TABLETS



If you have severe breathing problems (such as asthma or
bronchitis)

Always take Zuclopenthixol Tablets exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not sure.



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)

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).



If you suffer from Parkinson’s disease, or myasthenia gravis (a
condition causing severe muscular weakness)

Adults



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)

The daily dose at the start of treatment is usually 20 mg to 30 mg
each day.



If you suffer from glaucoma (raised pressure within the eye)

This dose is then usually adjusted to between 20 mg and 50 mg
each day.



If you have risk factors for stroke (e.g. smoking, hypertension)

The maximum dosage per single dose is 40 mg.



If you have too little potassium or magnesium in your blood or a
family history of irregular heart beats

If you have liver problems, the level of zuclopenthixol in your blood
may be checked.



If you use other antipsychotic medicines



If you suffer from diabetes

Older patients (above 65 years of age)



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

The initial dose is between a quarter and a half of the adult dose.

Daily doses of Zuclopenthixol Tablets range from 4 mg to 150 mg.

Use in children
Zuclopenthixol Tablets are not recommended for children.

Children and adolescents

How to take Zuclopenthixol Tablets

Zuclopenthixol is not recommended in these patients.

Swallow the tablets with a drink of water. Do not chew them.
Duration of treatment

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)

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



Increased thirst



Fits



Reduced or increased body temperature (including fever)



Low blood pressure, weak pulse, fast heart rate, pale skin,
restlessness



Abnormal liver function tests





Liver enlargement

High or low body temperature





Unexpected excretion of breast milk

Changes in heart beat including irregular heart beat or slow
heart rate



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

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 (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.

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

4. POSSIBLE SIDE EFFECTS



Life threatening irregular heart beats

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.

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.

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)

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.

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
5. HOW TO STORE ZUCLOPENTHIXOL TABLETS


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Store your tablets between 15-25°C.



Store in the original container. Protect from light and moisture.



Do not use Zuclopenthixol Tablets after the expiry date printed
on the bottle label. The expiry date refers to the last day of that
month.



Unusual movements of the mouth and tongue as these may be
early signs of a condition known as tardive dyskinesia

Tablets should not be thrown in your bin or put down the drain.
If they are out of date, or no longer suitable for you, return them
to your pharmacist.





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

If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

6. FURTHER INFORMATION



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

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

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

What Zuclopenthixol Tablets contain


Each tablet contains 2mg of the active ingredient zuclopenthixol
(as the dihydrochloride).



Zuclopenthixol Tablets also contain the following inactive
ingredients: potato starch, lactose, microcrystalline cellulose,
copovidone, glycerol, talc, castor oil hydrogenated, magnesium
stearate, hypromellose, macrogol 6000, titanium dioxide (E171)
and red iron oxide (E172).



Throbbing or fast heartbeats



Reduction in blood platelets (which increases the risk of
bleeding or bruising) and other blood cell changes

What Zuclopenthixol Tablets look like and contents of the pack



Drowsiness



Loss of co-ordination or altered muscle movements (including
unusual movements of the mouth, tongue and eyeballs)

Zuclopenthixol Tablets are unmarked, round, pale-red biconvex
film-coated tablets.



Tremor



Stiff or floppy muscles (including stiff jaw and neck muscles)



Dizziness or vertigo



Headache or migraine

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.



Numbness or tingling in the arms and legs

Manufacturer



Poor concentration, loss of memory or confusion



A changed walking pattern

This product is manufactured by H Lundbeck A/S, Ottilavej 9, DK2500 Copenhagen-Valby, Denmark.



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

Zuclopenthixol Tablets are available in bottles containing 100
tablets.
Product Licence holder

POM

PL: 19488/0576

Leaflet revision date: 24 June 2017

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.
S576 LEAFLET Zuclopenthixol Dihydrochloride 20170624

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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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