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CLOPIXOL 2MG TABLETS

Active substance(s): ZUCLOPENTHIXOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Clopixol® 2mg Tablets
(zuclopenthixol 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,
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.
The name of your medicine is Clopixol 2mg Tablets but will be
referred to as Clopixol Tablets throughout this leaflet. Please
note that this leaflet also contains information about other
strengths such as Clopixol 10mg and Clopixol 25mg Tablets.
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. Content of the pack and other information

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.

1. What Clopixol Tablets are and what they are used for

Pregnancy

Clopixol Tablets belong to a group of medicines known as
antipsychotics (also called neuroleptics).

If you are pregnant or think you may be pregnant, tell your
doctor. Clopixol Tablets should not be used during pregnancy,
unless clearly necessary.

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.

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

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

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.

Do not take Clopixol Tablets

Fertility

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.

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.
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 4mg to 150mg.
The daily dose at the start of treatment is usually 20mg to
30mg each day.
This dose is then usually adjusted to between 20mg and 50mg
each day.
The maximum dosage per single dose is 40mg.

Children and adolescents

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

Clopixol is not recommended in these patients.

Older patients (above 65 years of age)

Other medicines and Clopixol Tablets

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

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 heart beat (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)

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 Tablets
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 (eg difficulty in sleeping, muscle stiffness,
feeling unwell).
If you have any further questions on the use of this product ask
your doctor, pharmacist or nurse.

4. Possible side effects

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 heart beat and abnormal ECG heart tracing
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.

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

Reporting of side effects

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 heart beats
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

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.
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
Do not store above 25ºC, keep it in dry place, protected
from light in the manufacturer’s original container.

Do not use after the expiry date stated on the carton label
or bottle label after ‘Exp’. The expiry date refers to the last
day of that month.
Keep out the sight and reach of the children.
if your doctor tells you to stop taking this medicine, return
any unused tablets to your pharmacist for safe disposal.
Only keep this medicine if your doctor tells you to.
If your tablets become discoloured or show any signs of
deterioration, seek the advice of your pharmacist.
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.

6. Content of the pack and other information
What Clopixol Tablets contain
The active ingredient in Clopixol is zuclopenthixol.
Each tablet contains 2mg of the active ingredient,
zuclopenthixol as the dihydrochloride.
The other ingredients are:
potato starch, lactose, microcrystalline cellulose, copolyvidone,
glycerol, talc, hydrogenated castor oil, magnesium stearate,
hypromellose , macrogol 6000, titanium dioxide (E171) and red
iron oxide (E172).

What Clopixol Tablets look like and contents of the
pack
Clopixol Tablets are in a pink round unmarked tablet.
Clopixol Tablets are available in bottle packs containing
100 tablets.

Manufactured by: H. Lundbeck A/S, Ottiliavej 9, DK-2500
Copenhagen-Valby, Denmark.

Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4, Bradfield
Road, Ruislip, Middlesex, HA4 0NU, UK.
Clopixol® 2mg Tablets,
PL No: 18799/2738
Leaflet date: 21.07.2015

POM

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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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