Zuclopenthixol 2mg Film-Coated Tablets

Leaflet

Document: leaflet MAH BRAND_PLPI 18067-0271 change

500669/PL1g

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.

1) WHAT CLOPIXOL	® TABLETS ARE AND WHAT THEY\|
ARE USED FOR^H

2) WHAT YOU NEED	) TO KNOW BEFORE YOU TAKE
CLOPIXOL® TABLETS

Do not take Clopixol® Tablets

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.

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

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.

• 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.

Other medicines and Clopixol® 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 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 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 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.

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 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.

|4) POSSIBLE SIDE EFFECTS|

Keep out of the sight and reach of children.

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.

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

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.

Store in the original container in order to protect from light.

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 mg of zuclopenthixol (as dihydrochloride).

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|

This leaflet was last revised on 20^th June 2016.

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/PL1g

|3) HOW TO TAKE ZUCLOPENTHIXOL TABLETS|

500670/PL1g

Zuclopenthixol 2 mg Film-Coated Tablets

(zuclopenthixol dihydrochloride)

Patient Information Leaflet

The name of your medicine is Zuclopenthixol 2 mg Film-Coated 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

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^^^^^^^^^^^H

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) 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

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 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.

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.

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.

|4) POSSIBLE SIDE EFFECTS|

|5) HOW TO STORE ZUCLOPENTHIXOL TABLETS|

|6) CONTENTS OF THE PACK AND OTHER INFORMATION

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.

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

If you have any further questions on the use of this product ask your doctor, pharmacist or nurse.

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)

If you get any of the following symptoms you should contact your doctor immediately as your dose may need to be reduced or stopped:

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

• 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 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

By reporting side effects you can help provide more information on the safety of this medicine.

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.

Store in the original container in order to protect from light.

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.

What Zuclopenthixol Tablets contain

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

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.