CLOPIXOL INJECTION 200MG/ML

GB-056-60-200-13409

PACKAGE LEAFLET: INFORMATION FOR THE USER

Clopixol Injection zuclopenthixol decanoate
Read all of this leaflet carefully before you start taking this medicine Keep this leaflet. You may need to read it again If you have any further questions, 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 Injection is and what it is used for 2. Before Clopixol Injection is given 3. How Clopixol Injection is given 4. Possible side effects 5. How to store Clopixol Injection 6. Further information 1. WHAT CLOPIXOL INJECTION IS AND WHAT IT IS USED FOR How does Clopixol Injection work? Clopixol 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 Injection used for? Clopixol Injection is used for the treatment of schizophrenia and other psychoses.

Metoclopramide (used to treat nausea and other stomach conditions) Piperazine (used to treat worm infections) Levodopa or other medicines used to treat Parkinsons 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 Injection can reduce the effect of adrenaline (epinephrine) and similar drugs. Tell your doctor, dentist, surgeon or anaesthetist before any operation as Clopixol Injection can increase the effects of general anaesthetics, muscle relaxing drugs and drugs used to prevent clots. Does Clopixol Injection interact with alcohol? Clopixol Injection may increase the sedative effects of alcohol making you drowsier. It is recommended not to drink alcohol during treatment with Clopixol 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 Injection should not be used during pregnancy unless clearly necessary. Your newborn baby might show side effects if this medicine is used during pregnancy. The following symptoms may occur in newborn babies, of mothers that have used Clopixol 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 Ask your doctor or pharmacist for advice before taking any medicine. If you are breastfeeding, ask your doctor for advice. Clopixol 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. 3. HOW CLOPIXOL INJECTION IS GIVEN A small amount of Clopixol Injection is drawn up into a syringe and then injected into 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 havent received an injection like Clopixol 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 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 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 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

2. BEFORE CLOPIXOL INJECTION IS GIVEN Clopixol 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 Injection (see What Clopixol 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 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 Parkinsons 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)

INFORMATION FOR THE HEALTHCARE PROFESSIONAL CONSULT THE SUMMARY OF PRODUCT CHARACTERISTICS FOR FULL INFORMATION ON THIS PRODUCT NAME OF THE MEDICINAL PRODUCT Clopixol Injection. QUALITATIVE AND QUANTITATIVE COMPOSITION Zuclopenthixol Decanoate 20.0% w/v (equivalent to zuclopenthixol base 14.445% w/v). PHARMACEUTICAL FORM Solution for Injection. THERAPEUTIC INDICATIONS The maintenance treatment of schizophrenia and paranoid psychoses. DOSAGE AND METHOD OF ADMINISTRATION Route of administration By deep intramuscular injection into the upper outer buttock or lateral thigh. Note: As with all oil based injections it is important to ensure, by aspiration before injection, that inadvertent intravascular entry does not occur. Adults Dosage and dosage interval should be adjusted according to the patients symptoms and response to treatment. The usual dosage range of zuclopenthixol decanoate is 200-500 mg every one to four weeks, depending on response, but some patients may require up to 600 mg per week. In patients who have not previously received depot antipsychotics, treatment is usually started with a small dose (e.g. 100 mg) to assess tolerance. An interval, of at least one week should be allowed before the second injection is given at a dose consistent with the patients condition. Adequate control of severe psychotic symptoms may take up to 4 to 6 months at high enough dosage. Once stabilised lower maintenance doses may be considered, but must be sufficient to prevent relapse. Injection volumes of greater than 2 ml should be distributed between two injection sites. Elderly In accordance with standard medical practice initial dosage may need to be reduced to a quarter or half the normal starting dose in the frail or elderly. Children Not indicated for children. Dosage in reduced renal function Clopixol can be given in usual doses to patients with reduced renal function. Where there is renal failure dosage should be reduced to half the normal dosage. Dosage in reduced hepatic function Use with caution in patients with liver disease. Patients with compromised hepatic function should receive half the recommended dosages. Serum-level monitoring is advised.

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Your doctor, however, may prescribe Clopixol Injection for another purpose. Ask your doctor if you have any questions about why Clopixol Injection has been prescribed for you.

CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients. Circulatory collapse, depressed level of consciousness due to any cause (e.g. intoxication with alcohol, barbiturates or opiates), coma. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Caution should be exercised in patients having: liver disease; cardiac disease, or arrhythmias; severe respiratory disease; renal failure; epilepsy (and conditions predisposing to epilepsy, e.g. alcohol withdrawal or brain damage); Parkinsons disease; narrow angle glaucoma; prostatic hypertrophy; hypothyroidism; hyperthyroidism; myasthenia gravis; phaeochromocytoma and patients who have shown hypersensitivity to thioxanthenes or other antipsychotics. The elderly require close supervision because they are especially prone to experience such adverse effects as sedation, hypotension, confusion and temperature changes. When transferring patients from oral to depot antipsychotic treatment, the oral medication should not be discontinued immediately, but gradually withdrawn over a period of several days after administering the first injection. The possibility of development of neuroleptic malignant syndrome (hyperthermia, muscle rigidity, fluctuating consciousness, instability of the autonomous nervous system) exists with any neuroleptic. The risk is possibly greater with the more potent agents. Patients with pre-existing organic brain syndrome, mental retardation and opiate and alcohol abuse are over-represented among fatal cases. Treatment: Discontinuation of the neuroleptic. Symptomatic treatment and use of general supportive measures. Dantrolene and bromocriptine may be helpful. Symptoms may persist for more than a week after oral neuroleptics are discontinued and somewhat longer when associated with the depot forms of the drugs. Like other neuroleptics, zuclopenthixol should be used with caution in patients with organic brain syndrome, convulsions or advanced hepatic disease. Blood dyscrasias have been reported rarely. Blood counts should be carried out if a patient develops signs of persistent infection. An approximately 3-fold increased risk of cerebrovascular adverse events have been seen in randomised placebo controlled clinical trials in the dementia population with some atypical antipsychotics. The mechanism for this increased risk is not known. An increased risk cannot be excluded for other antipsychotics or other patient populations. Zuclopenthixol should be used with caution in patients with risk factors for stroke. As with other drugs belonging to the therapeutic class of antipsychotics, zuclopenthixol may cause QT prolongation. Persistently prolonged QT intervals may increase the risk of malignant arrhythmias. Therefore, zuclopenthixol should be used with caution in susceptible individuals (with hypokalaemia, hypomagnesaemia or genetic predisposition) and in patients with a history of cardiovascular disorders, e.g. QT prolongation, significant bradycardia (<50 beats per minute), a recent acute myocardial infarction, uncompensated heart failure, or cardiac arrhythmia.

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GB-056-60-200-13409

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 Injection than you should Your medicine will be given by your doctor/nurse. In the unlikely event that you receive too much Clopixol 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 the heartbeat including irregular heartbeat or slow heart rate You will receive treatment for any of these symptoms from your doctor or nurse. 4. POSSIBLE SIDE EFFECTS Like all medicines, Clopixol 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 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 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) 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. 5. HOW TO STORE CLOPIXOL 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 Injection after the expiry date that is printed on the label. The expiry date refers to the last day of that month Store Clopixol Injection below 25C Keep Clopixol 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. 6. FURTHER INFORMATION What Clopixol Injection contains The active substance is zuclopenthixol decanoate. Each millilitre (ml) of Clopixol Injection contains 200 mg zuclopenthixol decanoate. The other ingredient is thin vegetable oil. What Clopixol Injection looks like and contents of the pack Clopixol Injection is an oily liquid. Clopixol Injection is available in Glass ampoules containing 1 ml (200 mg) in boxes of 10 ampoules and single-packed vials of 10 ml. Not all pack sizes may be marketed. This injection is manufactured by: H. Lundbeck A/S Ottiliavej 9 DK-2500 Valby Denmark For any information about this medicine, please contact the Marketing Authorisation holder: Lundbeck Limited Lundbeck House Caldecotte Lake Business Park Caldecotte Milton Keynes MK7 8LFG UK This leaflet was last approved in 10/2011. 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 Clopixol Injection Product code number PL 0458/0017

This is a service provided by the Royal National Institute of Blind People.

Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Clopixol and preventive measures undertaken. Concomitant treatment with other antipsychotics should be avoided. As described for other psychotropics zuclopenthixol may modify insulin and glucose responses calling for adjustment of the antidiabetic therapy in diabetic patients Increased Mortality in Elderly people with Dementia Data from two large observational studies showed that elderly people with dementia who are treated with antipsychotics are at a small risk of death compared with those who are not treated. There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known. Clopixol is not licensed for the treatment of dementia-related behavioural disturbances. INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION In common with other antipsychotics, zuclopenthixol enhances the response to alcohol, the effects of barbiturates and other CNS depressants. Zuclopenthixol may potentiate the effects of general anaesthetics and anticoagulants and prolong the action of neuromuscular blocking agents. The anticholinergic effects of atropine or other drugs with anticholinergic properties may be increased. Concomitant use of drugs such as metoclopramide, piperazine or antiparkinson drugs may increase the risk of extrapyramidal effects such as tardive dyskinesia. Combined use of antipsychotics and lithium or sibutramine has been associated with an increased risk of neurotoxicity. Antipsychotics may enhance the cardiac depressant effects of quinidine; the absorption of corticosteroids and digoxin. The hypotensive effect of vasodilator antihypertensive agents such as hydralazine and -blockers (e.g. doxazosin), or methyldopa may be enhanced. Concomitant use of zuclopenthixol and drugs known to cause QT prolongation or cardiac arrhythmias, such as tricyclic antidepressants or other antipsychotics should be avoided. Increases in the QT interval related to antipsychotic treatment may be exacerbated by the co-administration of other drugs known to significantly increase the QT interval. Co-administration of such drugs should be avoided. Relevant classes include: class Ia and III antiarrhythmics (e.g. quinidine, amiodarone, sotalol, dofetilide) some antipsychotics (e.g. thioridazine) some macrolides (e.g. erythromycin) some antihistamines some quinolone antibiotics (e.g., moxifloxacin) The above list is not exhaustive and other individual drugs known to significantly increase QT interval (e.g. cisapride, lithium) should be avoided. Drugs known to cause electrolyte disturbances such as thiazide diuretics (hypokalaemia) and drugs known to increase the plasma

concentration of zuclopenthixol should also be used with caution as they may increase the risk of QT prolongation and malignant arrythmias. Antipsychotics may antagonise the effects of adrenaline and other sympathomimetic agents, and reverse the antihypertensive effects of guanethidine and similar adrenergic-blocking agents. Antipsychotics may also impair the effect of levodopa, adrenergic drugs and anticonvulsants. The metabolism of tricyclic antidepressants may be inhibited and the control of diabetes may be impaired. Since zuclopenthixol is partly metabolised by CYP2D6 concomitant use of drugs known to inhibit this enzyme may lead to to higher than expected plasma concentrations of zuclopenthixol, increasing the risk of adverse effects and cardiotoxicity. OVERDOSE Overdosage may cause somnolence or even coma, extrapyramidal symptoms, convulsions, hypotension, shock, hyper or hypothermia. ECG changes, QT prolongation, Torsade de Pointes, cardiac arrest and ventricular arrhythmias have been reported when administered in overdose together with drugs known to affect the heart. Treatment is symptomatic and supportive, with measures aimed at supporting the respiratory and cardiovascular systems. The following specific measures may be employed if required. - Anticholinergic antiparkinson drugs if extrapyramidal symptoms occur - Sedation (with benzodiazepines) in the unlikely event of agitation or excitement or convulsions - Noradrenaline in saline intravenous drip if the patient is in shock. Adrenaline must not be given. LIST OF EXCIPIENTS Thin vegetable oil INCOMPATABILITIES This product may be mixed in the same syringe with other products in the Clopixol Injection range, including Clopixol Acuphase Injection (zuclopenthixol acetate 50 mg/ml). It should not be mixed with any other injection fluids. SPECIAL PRECAUTIONS FOR STORAGE Store at or below 25C. Protect from light. SPECIAL PRECAUTIONS FOR DISPOSAL Nil. MARKETING AUTHORISATION HOLDER Lundbeck Limited Lundbeck House Caldecotte Lake Business Park Caldecotte Milton Keynes MK7 8LG MARKETING AUTHORISATION NUMBER PL 0458/0017.