Clopixol Conc. Injection
(zuclopenthixol decanoate)
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 Conc. Injection is and what it is used for
2. Before Clopixol Conc. Injection is given
3. How Clopixol Conc. Injection is given
4. Possible side effects
5. How to store Clopixol Conc. Injection
6. Further information
What Clopixol Conc. Injection Is And What It Is Used For
How does Clopixol Conc. Injection work?
Clopixol Conc. Injection 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 Conc. Injection used for?
Clopixol Conc. Injection is used for the treatment of schizophrenia and other psychoses.
Your doctor, however, may prescribe Clopixol Conc. Injection for another purpose. Ask your doctor if you have any questions about why Clopixol Conc. Injection has been prescribed for you.
Before Clopixol Conc. Injection Is Given
Clopixol Conc. Injection is not given
- If you are allergic (hypersensitive) to zuclopenthixol, other thioxanthine drugs or antipsychotic drugs or any of the other ingredients of Clopixol Conc. Injection (see What Clopixol Conc. Injection 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 Conc. Injection
- 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.
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 Injection:
- Medicines that change the heartbeat (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 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.
Does Clopixol Conc. Injection interact with alcohol?
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.
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 Conc. Injection 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 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.
Driving and using machines
There is a risk of feeling drowsy and dizzy when being treated with Clopixol 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.
How Clopixol Conc. Injection Is Given
A small amount of Clopixol Conc. Injection 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, and how often to give it. The medicine is slowly released from the injection site so that a fairly constant amount of medicine gets into your blood during the period between each dose.
Adults
The usual dose lies between 200-500 mg every 1 to 4 weeks but some patients require 600 mg every week. 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.
If you have liver problems, the level of zuclopenthixol in your blood may be checked.
Elderly patients (above 65 years)
Starting doses for elderly or frail patients are usually reduced to a quarter or a half of the dosage range.
Children
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.
If you feel that the effect of Clopixol Conc. Injection 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 Conc. Injection than you should
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.
Possible Side Effects
Like all medicines, Clopixol Conc. Injection can cause side effects, although not everybody gets them. Elderly patients tend to be more likely to suffer from some of these effects than younger patients and this may mean your treatment is supervised more closely.
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
- 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)
- 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 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 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 Conc. Injection
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 Conc. Injection after the expiry date that is printed on the label. The expiry date refers to the last day of that month.
Store Clopixol Conc. Injection below 25°C.
Keep Clopixol Conc. Injection ampoules and vials 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 Conc. Injection contains
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.
What Clopixol Conc. Injection looks like and contents of the pack
Clopixol Conc. Injection is an oily liquid.
Clopixol Conc. Injection is available in
Glass ampoules containing 1 ml (500 mg) in boxes of 5 ampoules.
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 Conc Injection PL 0458/0060
This is a service provided by the Royal National Institute of Blind People.
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