Clopixol 2 mg film-coated tablets

• 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.

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

• 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

Talk to your doctor, pharmacist or 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

Movement disorders such as tremors and muscle spasm may occur, especially during the first few days after initiating therapy. Inform your doctor as the dose may need to be reduced.

Inform your doctor if symptoms of a constant urge to move are persistent, as these symptoms can be controlled by the appropriate medication. Inform your doctor if you experience uncontrolled movements of the face and jaw, as therapy discontinuation may be needed.

Difficulty in swallowing may occur as a secondary effect of extrapyramidal symptoms (such as tremors, muscle spasm or movement disorder), sedation (sleepiness), increased salivation, and/or neuroleptic malignant syndrome (a rare dangerous reaction with fever, rigid muscles, changing blood pressure and coma).

Clopixol is not recommended in this patient group.

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

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

• Medicines that change the heartbeat (quinidine, amiodarone, sotalol, dofetilide, erythromycin, moxifloxacin, cisapride, lithium
• Other antipsychotic medicines

Tell your doctor or pharmacist if you are taking any of the following medicines:

• Tricyclic antidepressants
• Barbiturates or other medicines that make you feel drowsy
• Anticoagulant drugs used to prevent blood clots (e.g. warfarin)
• Anticholinergic drugs (contained in some cold, allergy or travel sickness remedies as well as other medicines)
• Metoclopramide (used to treat nausea and other stomach conditions)
• Piperazine (used to treat worm infections)
• Levodopa or other medicines used to treat Parkinson’s disease
• Sibutramine (used to reduce appetite)
• Digoxin (to control heart rhythm)
• Corticosteroids (e.g. prednisolone)
• Medicines used to lower the blood pressure such as hydralazine, alpha blockers (e.g. doxazosin) beta-blockers, methyldopa, clonidine or guanethidine
• Medicines that cause a disturbed water or salt balance (too little potassium or magnesium in your blood)
• Medicines known to increase the concentration of zuclopenthixol in your blood
• Medicines used to treat epilepsy
• Medicines used to treat diabetes

Clopixol Tablets can reduce the effect of adrenaline (epinephrine) and similar drugs.

Tell your doctor, dentist, surgeon or anaesthetist before any operation as Clopixol Tablets can increase the effects of general anaesthetics, muscle relaxing drugs and drugs used to prevent clots.

Clopixol Tablets 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.

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 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.

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.

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

Hydrogenated castor oil may cause stomach upset and diarrhoea.

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.

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

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 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 a dose, take the next dose at the usual time.

Do not take a double dose to make up for a forgotten tablet.

Your doctor will decide when and how 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).

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:

Common (may affect more than 1 in 10 people):

• Unusual muscle movements such as stiffness, tremor and restlessness (for example difficulty in sitting or standing still) as these may be signs of a so-called “extra pyramidal” reaction

Uncommon (may affect up to 1 in 100 people):

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

Rare (may occur in up to 1 out of 1000 people):

• Difficulty in swallowing (see section 2)

Very rare (may affect up to 1 in 10,000 people):

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

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

Very common (may affect more than 1 in 10 people):

• Drowsiness
• Dry mouth
• Movement disorder (Extrapyramidal symptoms) – due to effects on a part of the brain that regulates movements which may result in tremors, muscle spasms or movement disorders (see section 2)

Common (may affect up to 1 in 10 people):

• Throbbing or fast heartbeats
• Tremor
• Dizziness or vertigo
• Headache
• Numbness or tingling in the arms and legs
• Poor concentration, loss of memory or confusion
• A changed walking pattern
• Stuffy nose
• Shortness of breath
• Increase in saliva
• Abnormal vision
• Feeling sick or vomiting
• Constipation or diarrhoea
• Abnormal urination (increases or decreases in the frequency or amount)
• Increased sweating
• Itching
• Muscle pain
• Increased appetite, weight increased
• General weakness or pain, tiredness or feeling unwell
• Insomnia, abnormal dreams or nightmares
• Depression or anxiety
• Nervousness or agitation
• Decreased sexual drive (libido decreased)

Uncommon (may affect up to 1 in 100 people):

• 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)
• Abnormal reflexes
• Rigidity of the whole body
• Fainting
• Migraine
• Speech problems
• Sensitive hearing or ringing in the ears (tinnitus)
• Enlarged pupils or blurred vision
• Indigestion or stomach pain
• Flatulence (wind)
• Greasy skin
• Rashes or skin reactions (including sensitivity to sunlight)
• Changes in skin colour
• Decreased appetite, weight decreased
• Low blood pressure
• Hot flushes
• Reduced or increased body temperature (including fever)
• Abnormal liver function tests
• Apathy
• Increased sexual drive (libido increased)
• 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
• Fits
• Bruising under the skin
• Increased thirsts

Rare (may affect up to 1 in 1,000 people):

• Reduction in blood platelets (which increases the risk of bleeding or bruising) and other blood cell changes
• Raised blood levels of glucose, lipids or the hormone prolactin
• Loss of control of blood sugar levels
• Unexpected excretion of breast milk

Very rare (may affect up to 1 in 10,000 people):

• Liver enlargement

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.

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

or search for MHRA Yellow Card in the Google Play or Apple App Store.

The active substance is zuclopenthixol dihydrochloride.

Each tablet contains 2 mg, 10 mg or 25 mg of zuclopenthixol.

The other ingredients are potato starch, lactose, microcrystalline cellulose, copolyvidone, glycerol, talc, hydrogenated castor oil, magnesium stearate, methylhydroxypropyl cellulose, macrogol, titanium dioxide (E171) and the red colour E172 (iron oxide).

Description of Clopixol Tablets:

The 2 mg tablets are round, biconvex, pale red.

The 10 mg tablets are round, biconvex, light red-brown.

The 25 mg tablets are round, biconvex, red-brown.

Clopixol Tablets are available in plastic containers or glass bottles containing 100 tablets.

Not all pack sizes may be marketed.