Clopixol Acuphase Injection

• 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-Acuphase is and what it is used for
2. What you need to know before you are given Clopixol-Acuphase
3. How Clopixol-Acuphase is given
4. Possible side effects
5. How to store Clopixol-Acuphase
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). Tell 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

Talk to your doctor, pharmacist or nurse before Clopixol-Acuphase 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 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 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-Acuphase is not recommended in 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-Acuphase:

• 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)
• 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-Acuphase can reduce the effect of adrenaline (epinephrine) and similar drugs.

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

Clopixol-Acuphase may increase the sedative effects of alcohol making you drowsier. It is recommended not to drink alcohol during treatment with Clopixol-Acuphase.

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-Acuphase should not be used during pregnancy unless clearly necessary.

The following symptoms may occur in newborn babies, of mothers that have used Clopixol-Acuphase 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-Acuphase 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 or dizzy, or suffering from blurred vision when being treated with Clopixol-Acuphase, especially at the start of your treatment. If this happens do not drive or use any tools or machines.

The usual dose lies between 50-150 mg (1-3 ml) repeated if necessary after 2-3 days.

Some patients may require an additional dose 1 or 2 days after the first injection.

Treatment can continue for up to 2 weeks. In this time you may receive a total of 4 injections up to a total dose of 400 mg (8 ml).

If further treatment is necessary, your doctor will prescribe suitable medication immediately or shortly after the Clopixol-Acuphase injections are stopped.

Older patients may need smaller doses. The maximum dose per injection is 100 mg.

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-Acuphase is not recommended for children.

Treatment with Clopixol-Acuphase can continue for up to 2 weeks. After this time if treatment is still needed it can be continued with Clopixol tablets, Clopixol injection or Clopixol Conc. injection.

If you feel that the effect of Clopixol-Acuphase 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-Acuphase 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 the day after the first treatment and usually wear off soon afterwards.

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 acetate.

Each millilitre (ml) of Clopixol-Acuphase contains 50 mg zuclopenthixol acetate.

The other ingredient is thin vegetable oil (purified from coconut oil).

Clopixol-Acuphase is an oily liquid.

Clopixol-Acuphase is available in glass ampoules containing 1 ml (50 mg) in cartons of 5 ampoules.