ZUCLOPENTHIXOL 2MG TABLETSView full screen / Print PDF » Download PDF ⇩
Tablets/ Zuclopenthixol 2mg Tablets
Tablets/ Zuclopenthixol 10mg Tablets
This product is available using any of the above names but will be referred to as Clopixol
Tablets throughout this leaflet.
Clopixol is also available in 25 mg strength.
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm
• If any of the side effects are troubling, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Clopixol Tablets are and what they are used for
2. Before you take Clopixol Tablets
3. How to take Clopixol Tablets
4. Possible side effects
5. How to store Clopixol tablets
6. Further information
1. WHAT CLOPIXOL TABLETS ARE AND WHAT THEY ARE USED FOR
How do Clopixol Tablets work?
Clopixol Tablets belong to a group of medicines known as antipsychotics (also called
These medicines act on nerve pathways in specific areas of the brain and help to correct
certain chemical imbalances in the brain that are causing the symptoms of your illness.
What are Clopixol Tablets used for?
Clopixol Tablets are used for the treatment of schizophrenia and other psychoses.
Your doctor, however, may prescribe Clopixol Tablets for another purpose. Ask your doctor
if you have any questions about why Clopixol Tablets have been prescribed for you.
2. BEFORE YOU TAKE CLOPIXOL TABLETS
Do not take Clopixol Tablets
• If you are allergic (hypersensitive) to zuclopenthixol, other thioxanthine drugs or
antipsychotic drugs or any of the other ingredients of Clopixol Tablets (see What
Clopixol Tablets contain). Consult your doctor if you think you might be.
• If you are feeling less alert than usual, or are drowsy or sleepy or have serious
problems with your blood circulation.
Take special care with Clopixol Tablets
• If you have a heart condition, including an irregular heart beat (such as a slower heart
beat); have had a recent heart attack or have problems that cause ankle swelling or
shortness of breath
• If you have severe breathing problems (such as asthma or bronchitis)
• If you have liver, kidney or thyroid problems
• If you suffer from epilepsy, or have been told that you are at risk of having fits (for
example because of a brain injury or because of alcohol withdrawal)
• If you suffer from Parkinson’s disease, or myasthenia gravis (a condition causing
severe muscular weakness)
• If you have an enlarged prostate or suffer from a condition known as
phaeochromocytoma (a rare type of cancer of a gland near the kidney)
• If you suffer from glaucoma (raised pressure within the eye)
• If you have risk factors for stroke (e.g. smoking, hypertension)
• If you have too little potassium or magnesium in your blood or a family history of
irregular heart beats
• If you use other antipsychotic medicines
• If you suffer from diabetes
• If you or someone else in your family has a history of blood clots, as medicines like
these have been associated with formation of blood clots
Please talk to your doctor, even if these statements were applicable to you at any time in
Taking other medicines
The following medicines should not be taken at the same time as Clopixol tablets:
• Medicines that change the heartbeat (quinidine, amiodarone, sotalol, dofetilide,
erythromycin, moxifloxacin, cisapride, lithium)
• Other antipsychotic medicines
Medicines may affect the actions of other medicines and this can sometimes cause serious
adverse reactions. Please tell your doctor or pharmacist if you are taking, or have recently
taken, any other medicines, including medicines obtained without a prescription.
• Tricyclic antidepressants
• Barbiturates or other medicines that make you feel drowsy
• Anticoagulant drugs used to prevent blood clots (e.g. warfarin)
• Anticholinergic drugs (contained in some cold, allergy or travel sickness remedies as
well as other medicines)
• Metoclopramide (used to treat nausea and other stomach conditions)
• Piperazine (used to treat worm infections)
• Levodopa or other medicines used to treat Parkinson’s disease
• Sibutramine (used to reduce appetite)
• Digoxin (to control heart rhythm)
• Corticosteroids (e.g. prednisolone)
• Medicines used to lower the blood pressure such as hydralazine, alpha blockers (e.g.
doxazosin) beta-blockers, methyldopa, clonidine or guanethidine
• Medicines that cause a disturbed water or salt balance (too little potassium or
magnesium in your blood)
• Medicines known to increase the concentration of zuclopenthixol in your blood
• Medicines used to treat epilepsy
• Medicines used to treat diabetes
Clopixol tablets can reduce the effect of adrenaline (epinephrine) and similar drugs.
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
Do Clopixol Tablets interact with alcohol?
Clopixol tablets may increase the sedative effects of alcohol making you drowsier. It is
recommended not to drink alcohol during treatment with Clopixol tablets.
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant or think you may be pregnant, tell your doctor. Clopixol should not be
used during pregnancy, unless clearly necessary.
Your newborn baby might show side effects if this medicine is used.
The following symptoms may occur in newborn babies, of mothers that have used Clopixol
tablets in the last trimester (last three months of their pregnancy): shaking, muscle stiffness
and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If
your baby develops any of these symptoms you may need to contact your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
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.
Driving and using machines
There is a risk of feeling drowsy and dizzy when using Clopixol tablets, especially at the
start of your treatment. If this happens do not drive or use any tools or machines until you
know you are not affected in this way.
Do not drive if you have blurred vision.
Important information about some of the ingredients in Clopixol Tablets
This product contains lactose. If your doctor has told you that you have intolerance to some
sugars, contact your doctor before taking this medicinal product.
Clopixol tablets contain hydrogenated castor oil which may cause stomach upset and
3. HOW TO TAKE CLOPIXOL TABLETS
Always take Clopixol tablets exactly as your doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
The dose varies and depends on the severity of the illness. The total amount of tablets you
need to take each day will be split into at least two doses (for example a morning and
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 20mg and 50 mg each day.
The maximum dosage per single dose is 40 mg.
If you have liver problems, the level of zuclopenthixol in your blood may be checked.
Elderly patients (above 65 years)
The initial dose is between a quarter and a half of the adult dose.
Clopixol tablets are not recommended for children.
It may take between four and six months before you feel better. Your doctor will decide the
duration of treatment.
If you feel that the effect of Clopixol tablets is too strong or weak, talk to your doctor or
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
Symptoms of overdose may include:
• Muscle movements or stiffness
• Low blood pressure, weak pulse, fast heart rate, pale skin, restlessness
• High or low body temperature
• Changes in heart beat including irregular heart beat or slow heart rate
If you forget to take Clopixol Tablets
If you forget to take a dose, take the next dose at the usual time. Do not take a double dose
to make up for a forgotten tablet.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Clopixol tablets can cause side effects, although not everybody gets
them. Elderly patients tend to be more likely to suffer from some of these effects than
younger patients and this may mean your treatment is supervised more closely.
Serious side effects
Stop taking Clopixol and seek medical advice immediately if you have any of the following
• Difficulty in breathing
• Swelling of the face, lips, tongue or throat which causes difficulty in swallowing or
• Severe itching of the skin (with raised lumps)
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 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
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.
• Loss of co-ordination or altered muscle movements (including unusual movements of
the mouth, tongue and eyeballs)
• 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
• Speech problems
• 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
• 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
6. FURTHER INFORMATION
What Clopixol Tablets contain
The active substance is zuclopenthixol dihydrochloride.
Each tablet contains 2 mg or 10 mg of zuclopenthixol.
The other ingredients are potato starch, lactose, microcrystalline cellulose, copolyvidone,
glycerol, talc, hydrogenated castor oil, magnesium stearate, methylhydroxypropyl
cellulose, macrogol 6000, titanium dioxide (E171) and the red iron oxide (E172).
What Clopixol Tablets looks like and contents of the pack
Description of Clopixol film-coated tablets: The 2 mg film-coated tablets are round, biconvex, pale pink with no markings. The 10 mg film-coated tablets are round, biconvex, pale
red with no markings.
Clopixol tablets are available in white plastic bottles containing 100 tablets.
Product Licence Holder and Manufacturer:
Clopixol Tablets are made by: H Lundbeck A/S, Ottilavej 9, DK-2500, Copenhagen,
Denmark. They are procured from within the EU by the Product Licence holder Swinghope
Ltd, Brandon House, Marlowe Way, Croydon CR0 4XS and repackaged by Interport Ltd,
Brandon House, Marlowe Way, Croydon CR0 4XS.
PL No: 10380/1035 2mg Tablets
PL No: 10380/1036 10mg Tablets
Leaflet revision date: 06/07/12.
Clopixol® is a registered trademark of H Lundbeck A/S, Denmark.
As with other medicines that work in a way similar to zuclopenthixol (the active ingredient
of Clopixol tablets), rare cases of the following side effects have been reported:
• Slow heartbeat and abnormal ECG heart tracing.
• Life threatening irregular heart beats
In rare cases irregular heart beats (arrhythmias) may have resulted in sudden death.
In elderly people with dementia, a small increase in the number of deaths has been
reported for patients taking antipsychotics compared with those not receiving antipsychotics.
If any of the side effects are troubling, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE CLOPIXOL TABLETS
Keep Clopixol Tablets out of the sight and reach of children.
Keep Clopixol Tablets in the original container protect from light and moisture.
Do not store above 25°C.
Do not use these tablets after the expiry date that is printed on the label. The expiry date
refers to the last day of that month.
If your medicine becomes discoloured or show signs of any deterioration, you should 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.
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.