Clopixol Conc. 500 mg/ml solution for injection

• Keep this leaflet. You may need to read it again
• If you have any further questions, please 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 Conc. Injection is and what it is used for
2. What you need to know before you are given Clopixol Conc. Injection
3. How Clopixol Conc. Injection is given
4. Possible side effects
5. How to store Clopixol Conc. Injection
6. Contents of the pack and other information

Talk to your doctor, pharmacist or nurse before Clopixol Conc. Injection is given to you:

• 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
• If you are being treated for cancer

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 Conc. Injection is not recommended this patient group.

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

The following medicines should not be taken at the same time as Clopixol Conc. Injection:

• 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 Conc. Injection can reduce the effect of adrenaline (epinephrine) and similar drugs.

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

Clopixol Conc. Injection may increase the sedative effects of alcohol making you drowsier.

It is recommended not to drink alcohol during treatment with Clopixol Conc. Injection.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

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

The following symptoms may occur in newborn babies, of mothers that have used Clopixol Conc. Injection 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 breastfeeding, ask your doctor for advice. Clopixol Conc. Injection 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 being treated with Clopixol Conc. Injection, 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.

The usual dose lies between 200-500 mg every 1 to 4 weeks but some patients require 600 mg every week. The maximum single dose at any one time is 600 mg. If you need more than 2 ml of medicine it will probably be divided between 2 injection sites.

If you haven’t received an injection like Clopixol Conc. Injection before, a small dose of 100 mg is usually given one week before your normal dose to test how well you tolerate the medicine.

If you have been treated with Clopixol tablets and you are being transferred to Clopixol Conc. Injection you may be asked to continue taking the tablets for several days after the first injection.

Your doctor may decide to adjust the amount given, or the interval between injections, from time to time.

Starting doses for older or frail patients are usually reduced to a quarter or a half of the dosage range.

If you have renal failure, your dosage should be reduced to half the usual dosage range. If you have liver problems, the level of zuclopenthixol in your blood may be checked. Patients with liver complaints normally receive doses at half the usual dosage range.

Clopixol Conc. Injection is not recommended for children.

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

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 feel that the effect of Clopixol Conc. Injection is too strong or weak, talk to your doctor or pharmacist.

Your medicine will be given by your doctor/nurse.

In the unlikely event that you receive too much Clopixol Conc. Injection you may experience some symptoms.

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

You will receive treatment for any of these symptoms from your doctor or nurse.

Stop using Clopixol 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 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)
• Skin reactions at injection site
• Changes in skin colour
• Decreased appetite, weight decreased
• Low blood pressure
• Hot flushes
• Reduced or increased body temperature (including fever)
• Abnormal liver function tests
• Lack of emotion or indifference to your surroundings (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), 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

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The active substance is zuclopenthixol decanoate.

Each millilitre (ml) of Clopixol Conc. Injection contains 500 mg zuclopenthixol decanoate.

The other ingredient is thin vegetable oil.

Clopixol Conc. Injection is an oily liquid.

Clopixol Conc. Injection is available in glass ampoules containing 1 ml (500 mg) in cartons of 5 ampoules.