Clopixol Acuphase Injection
(zuclopenthixol acetate)
Read all of this leaflet carefully before you start using this medicine
- Keep this leaflet. You may need to read it again
- If you have further questions, please ask your doctor or pharmacist
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours
- 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 Acuphase is and what it is used for
2. Before Clopixol Acuphase is given
3. How Clopixol Acuphase is given
4. Possible side effects
5. How to store Clopixol Acuphase
6. Further information
What Clopixol Acuphase Is And What It Is Used For
How does Clopixol Acuphase work?
Clopixol Acuphase belongs 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.
What is Clopixol Acuphase used for?
Clopixol Acuphase is used for the initial treatment of short-term psychoses including mania or increases in the severity of existing psychoses.
Before Clopixol Acuphase Is Given
Clopixol Acuphase is not given
- If you are allergic (hypersensitive) to zuclopenthixol, other thioxanthine drugs or antipsychotic drugs or any of the other ingredients of Clopixol Acuphase (see What Clopixol Acuphase contains). 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 Acuphase
- 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.
Please talk to your doctor, even if these statements were applicable to you at any time in the past.
Taking 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
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 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.
Does Clopixol Acuphase interact with alcohol?
Clopixol Acuphase may increase the sedative effects of alcohol making you drowsier. It is recommended not to drink alcohol during treatment with Clopixol Acuphase.
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant or think you might be pregnant, tell your doctor. Clopixol Acuphase should not be used during pregnancy unless clearly necessary.
Your newborn baby might show side effects if this medicine is used during pregnancy.
Breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
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.
Driving and using machines
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.
How Clopixol Acuphase Is Given
A small amount of Clopixol Acuphase is drawn up into a syringe and then injected into the muscle of your buttock or thigh.
Your doctor will decide on the correct amount of medicine to give.
Adults
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.
Elderly patients (above 65 years)
Elderly patients may need smaller doses. The maximum dose per injection is 100 mg.
Children
Clopixol Acuphase is not recommended for children.
Patients with Liver or Kidney Disease
If you have liver disease or severe kidney disease, half the usual dose will be given.
If you have liver problems, the level of zuclopenthixol in your blood may be checked.
If you feel that the effect of Clopixol Acuphase 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 get more Clopixol Acuphase than you should
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.
Possible Side Effects
Like all medicines, Clopixol Acuphase can cause side effects, although not everybody gets them.
Serious side effects
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:
- 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 of the eyes (jaundice); your liver may be affected
Other side effects:
Side effects are most pronounced the day after the first treatment and usually wear off soon afterwards.
- Throbbing or fast heart beats
- 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)
- Skin reactions at injection site
- 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), rare cases of the following side effects have been reported:
- Slow heart beat 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.
How To Store Clopixol Acuphase
Usually your doctor or nurse will store the medicine for you. If you keep it at home:
Keep out of the reach and sight of children.
Do not use Clopixol Acuphase after the expiry date that is printed on the label. The expiry date refers to the last day of that month.
Store Clopixol Acuphase below 25°C (room temperature).
Keep Clopixol Acuphase ampoules in the box, so they are protected from light.
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.
Further Information
What Clopixol Acuphase contains
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).
What Clopixol Acuphase looks like and contents of the pack
Clopixol Acuphase is an oily liquid.
Clopixol Acuphase is available in glass ampoules containing 1 ml (50 mg) or 2 ml (100 mg) in boxes of 5 ampoules.
Not all pack sizes may be marketed.
This injection is manufactured by:
For any information about this medicine, please contact the Marketing Authorisation holder:
This leaflet was last approved in January 2010.
To request a copy of this leaflet in braille, large print or audio please call free of charge:
0800 198 5000
Please be ready to give the following information:
Product name Product code number
Clopixol Acuphase PL 0458/0063
This is a service provided by the Royal National Institute of Blind People
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