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 Clopixol (clo-PIK-sol) Clopixol Tablets 10 mg Clopixol Acuphase Injection 50 mg/mL Clopixol Depot Injection 200 mg/mL Zuclopenthixol hydrochloride (zoo-clo-PEN-thic-sol high-dro-CLOR-ride) Zuclopenthixol (zoo-clo-PEN-thic-sol AS-se-tate) Zuclopenthixol decanoate (zoo-clo-PEN-thic-sol deck-can-OH-ate)

Consumer Medicine Information (CMI)

What is in this leaflet Clopixol Acuphase injection is used ingredients listed at the end of this for the initial treatment of acute leaflet. This leaflet contains answers to episodes of mental disorders. It is Symptoms of an allergic reaction may some common questions about also used to treat mania (a mental include shortness of breath, wheezing Clopixol. condition characterised by episodes or difficulty breathing, swelling of the of overactivity, elation or irritability) face, lips, tongue or other parts of the It does not contain all the and used in case of worsening of body, or rash, itching or hives on the information that is known about chronic mental conditions. skin. Clopixol. It does not take the place of talking to your doctor or Clopixol Depot injection is usually Do not use Clopixol if you have: pharmacist. used to prevent further episodes of ⋅ collapse due to very low blood your illness. pressure All medicines have risks and ⋅ diminished consciousness due to benefits. Your doctor has weighed Clopixol belongs to a group of any cause the risk of you using this medicine medicines called against the benefits he/she expects it neuroleptics. It helps to correct ⋅ brain damage will have for you. chemical imbalances in the brain, ⋅ diseases of the blood with which may cause mental illness. abnormal or reduced number of red If you have any concerns about or white blood cells or platelets using this medicine, ask your Your doctor, however, may prescribe doctor or pharmacist. it for another purpose. ⋅ phaeochromocytoma, a rare tumour of the adrenal gland which sits near Ask your doctor if you have any Keep this leaflet with the the kidney. medicine. questions about why it has been You may need to read it again. prescribed for you. Do not give Clopixol to anyone who currently has poisoning, or This medicine is only available with poisoning with medicines used to a doctor’s prescription. produce calmness or to help you Clopixol is not addictive. sleep, or medicines used to treat What Clopixol is epilepsy or strong pain. used for Do not give Clopixol to anyone who is unconscious or in a coma. Clopixol tablets are used for the Before you use it acute and long-term treatment of Do not use it after the expiry date printed on the pack. and other mental When you must not use it If you use it after the expiry date has illnesses with disturbances in passed, it may not work as well. The thinking, emotional reactions and Do not use Clopixol if you are expiry date refers to the last day of the behaviour. allergic to it, to any other similar month. medicines (such as It is also used to treat the manic or ), or any of the phase of manic depressive illness. A Do not use it if the packaging is torn or shows signs of tampering. manic phase is a mood of excitement, over-activity and uninhibited behaviour.

1 Before you start to use it ⋅ glaucoma, a condition in If you have not told your doctor which there is usually a build- about any of the above, tell them Tell your doctor if: up of pressure in the eye before you use Clopixol. 1. you have allergies to any ⋅ heart and blood vessel other substances such as problems foods, preservatives or dyes. Taking other medicines ⋅ kidney problems 2. you are pregnant or intend to Tell your doctor if you are taking ⋅ problems become pregnant. any other medicines, including any ⋅ low potassium and/or low Clopixol may affect your that you buy without a prescription magnesium levels in the fertility. If you are intending to from your pharmacy, supermarket blood start a family, ask your doctor or health food shop. for advice. ⋅ organic brain syndrome Some medicines and Clopixol may interfere with each other. These Like most medicines of this ⋅ , a disease of the include: kind, Clopixol is not brain affecting movement recommended for use during ⋅ risk factors for stroke ⋅ and pregnancy unless clearly ⋅ tardive dyskinesia, a reaction lithium, medicines used to treat necessary. The general to some medicines with depression or mood swings condition of your baby might be worm-like movements of the ⋅ medicines used to treat strong pain affected by the use of this tongue, or other uncontrolled ⋅ medicines used to produce medicine. movements of the mouth, calmness or to help you sleep The following symptoms may tongue, cheeks or jaw which ⋅ medicines used to treat high blood occur in newborn babies of may progress to the arms and pressure (hypertension), such as mothers who have used legs. guanethidine Clopixol in the last three months ⋅ treatment for cancer ⋅ levodopa, a medicine used to treat of their pregnancy: shaking, ⋅ if you or someone else in your Parkinson’s disease muscle stiffness and/or family has a history of blood ⋅ medicines which stimulate the weakness, sleepiness, agitation, clots, as medicines like these body, getting it ready for action, breathing problems and have been associated with such as formation of blood clots difficulty in feeding. If your ⋅ , a medicine used baby develops any of these ⋅ sleep apnoea (a sleep disorder to relieve nausea and vomiting symptoms you should contact where your breathing is ⋅ , a medicine used to treat your doctor. interrupted during sleep). worm infections 3. you are breast-feeding or Also tell your doctor if you will be ⋅ medicines known to inhibit the planning to breast-feed. in a hot environment or you do a activity of certain liver enzymes lot of vigorous exercise. It is not recommended that you ⋅ medicines used to treat changes in Clopixol may make you sweat less, breast-feed while using the rhythm or rate of the heart beat, causing your body to overheat. Clopixol. Its active ingredient e.g. , amiodarone, passes into breast milk and Tell your doctor if you are exposed and dofetilide therefore there is a possibility to pesticides that contain ⋅ , a class of medicines that your baby might be phosphorus. used to treat certain mental and affected. The risk of you experiencing a side emotional conditions, e.g. effect may be increased. 4. you have, or have had, the following medical conditions: If you are lactose intolerant, ⋅ certain medicines used to treat ⋅ arteriosclerosis, a disease contact your doctor before taking infections, such as erythromycin, affecting the arteries Clopixol tablets. gatifloxacin and moxifloxacin Clopixol tablets contain lactose. ⋅ convulsions, fits or seizures ⋅ medicines used to relieve the ⋅ decreased blood supply to Do not give Clopixol to a child or symptoms of allergy, including the brain adolescent. and ⋅ diabetes, a disorder of There is no experience with its use in ⋅ , used to treat stomach metabolism in which the children or adolescents under problems amount of sugar in the blood 18 years old. ⋅ medicines that disturb or salt is too high balance e.g. thiazide diuretics, also ⋅ feeling lethargic, indifferent, called fluid or water tablets lost or remote

2 ⋅ medicines known to increase the Clopixol Depot injection same effects on your illness, although concentration of Clopixol in The usual dose is 200 to 400 mg they last for different lengths of time. your blood (1 to 2 mL) every second to fourth Clopixol tablets ⋅ medicines used to relieve week. Clopixol tablets only work for a short stomach cramps or spasms, to Your doctor will decide what dose time, so they need to be taken every prevent travel sickness and to you will receive. This depends on day. treat Parkinson’s disease, such your condition and other factors, Take Clopixol tablets once a day at as atropine or related medicines. such as your weight and your about the same time. ⋅ medicines used to treat cancer response to the medicine. Generally, Taking them at the same time each day your doctor will start you on smaller will also help you remember when to doses which will be gradually These medicines may be affected by take the tablets. Clopixol, or may affect how well it increased until a dose is reached works. You may need to use where Clopixol works best for you. Take Clopixol tablets before or after food. different amounts of your Your doctor may have prescribed a medicines, or take different different dose. Clopixol injections medicines. Your doctor will advise Clopixol Acuphase injection has to be you. Ask your doctor or pharmacist if given every 2 - 3 days, while Clopixol you are unsure of the correct dose Depot injection lasts several weeks, so Your doctor or pharmacist has more for you. Follow the instructions it is given once every 2 - 4 weeks. information on medicines to be they give you. careful with or avoid while using They will tell you exactly how much Your doctor will advise you. Clopixol. you will be given. Elderly patients How long to use it The dosage of Clopixol may need to Continue taking your tablets and/or be reduced in elderly patients. How to use it having your injections for as long as your doctor tells you to. How to use it Clopixol helps control your condition, How much to use but does not cure it. Therefore, you Clopixol tablets Clopixol tablets will need regular treatment. The usual dose is 10 to 50 mg per Swallow the tablets whole with a full glass of water. day. If you forget to use it Ask your doctor or pharmacist if Clopixol tablets you are unsure of the correct dose To open this child resistant bottle, for you. please hold, twist and turn the bottle If it is almost time for your next They will tell you exactly how much as per the diagram below. dose, skip the dose you missed and take the next dose when you are to take. meant to. Follow the instructions they give Do not take a double dose to make you. up for the dose you have missed. If you take the wrong dose, Clopixol may not work as well and If there is still a long time to go before your next dose, take it as your condition may not improve. soon as you remember, and then go Clopixol Acuphase injection back to taking it as you would The usual dose is 50 to 150 mg normally. (1 to 3 mL) every 2 to 3 days or as Clopixol injections instructed by your doctor. If you are not sure what to do, ask Clopixol is given as an injection into your doctor or pharmacist. The duration of the treatment a large muscle where it is slowly should not be more than 2 weeks. released over time. The injection should only be given by a doctor, The maximum dose should not be nurse or other trained person. more than 400 mg and the total number of injections should not be more than 4 per course of treatment. When to use it You may be given Clopixol tablets or injections which both have the

3 If you have trouble remembering If you are about to be started on If your skin appears to be burning, when to take your medicine, ask any new medicine, remind your tell your doctor. your pharmacist for hints. doctor and pharmacist that you Clopixol may cause your skin to be are using Clopixol. much more sensitive to sunlight than it Clopixol injections is normally. This could cause skin If you forget to keep an Tell any other doctors, dentists rash, itching, redness, or severe appointment, contact your doctor and pharmacists who treat you sunburn. as soon as you remember, so that that you are using this medicine. you can make another one. If you become pregnant while Keep all of your doctor’s using Clopixol, tell your doctor appointments so that your progress Overdose immediately. can be checked. Your doctor may do some blood and Immediately telephone your Tell your doctor immediately if liver tests from time to time, you notice any worm-like doctor, or the Poisons particularly during the first months of movements of the tongue, or other Information Centre (Tel: 0800 therapy, to make sure the medicine is 764 766 for New Zealand), or go uncontrolled movements of the tongue, mouth, cheeks or jaw working and to prevent unwanted side to Accident and Emergency at effects. your nearest hospital, if which may progress to the arms ⋅ you think you or anyone else and legs. These are symptoms of a condition may have taken too many Things you must not do called tardive dyskinesia, which may Clopixol tablets. Do this even develop in people taking similar Do not give your medicine to anyone if there are no signs of medicines, including Clopixol. else, even if they have the same discomfort or poisoning. condition as you. ⋅ you experience any side effects This condition is more likely to Do not use Clopixol to treat any after being given Clopixol occur during long-term treatment other complaints unless your doctor injections. with Clopixol, especially in elderly women. In very rare cases, this may tells you to. You may need urgent medical be permanent. However, if detected attention. Do not take any medicines that early, these symptoms are usually cause drowsiness while you are As Clopixol injections are given reversible. using Clopixol, unless recommended to you under the supervision of by your doctor. your doctor, it is very unlikely Also tell your doctor if you notice that you will receive too much. any soreness of the mouth, gums, Do not stop using Clopixol, or lower throat or other flu-like symptoms. the dosage, without checking with Symptoms of an overdose may your doctor. include sleepiness, coma, cramps, Talk to your doctor or mental health professional if you are Do not miss any injections, even if convulsions, low blood pressure and you feel better. extremely high or low body thinking or talking about death, suicide, self-harm or harm to Clopixol helps control your condition, temperature. Uncontrollable others. but does not cure it. Therefore, you movements may develop, and will need regular injections. collapse due to very low blood These may be signs of changes or pressure may occur. Changes in the worsening in your mental illness. Do not stop using Clopixol suddenly. rhythm or rate of the heart beat have If Clopixol is stopped suddenly, you If you are going to have surgery, may experience symptoms such as been seen in Clopixol overdose tell the surgeon or anaesthetist nausea, vomiting, loss of appetite, when medicines known to affect the that you are using this medicine. diarrhoea, runny nose, sweating, heart have also been taken. Clopixol may affect other medicines aching muscles, pins and needles, used during surgery. sleeplessness, restlessness, anxiety, or If you are about to have any blood agitation. tests, tell your doctor that you are Your doctor may want to gradually While you are using it using this medicine. reduce the amount you are using It may interfere with the results of before stopping completely. Things you must do some tests.

Protect your skin when you are in the sun, especially between 10am Things to be careful of and 3pm. If you are outdoors, wear protective clothing and use a 30+ sunscreen.

4 Be careful driving or operating ⋅ headaches ⋅ bleeding or bruising more easily machinery until you know how ⋅ nasal congestion than normal, nosebleeds Clopixol affects you. ⋅ dry mouth ⋅ yellowing of the skin and/or eyes, It may cause drowsiness, tiredness, ⋅ constipation or diarrhoea also called jaundice sleepiness or blurred vision in some ⋅ increased salivation or increased ⋅ severe pain in the stomach with people. If you have any of these bloating, gut cramps and vomiting. symptoms, do not drive, operate sweating ⋅ Blood clots in the veins especially machinery, or do anything else that ⋅ nausea, vomiting, dyspepsia in the legs (symptoms include could be dangerous. ⋅ weight and appetite changes swelling, pain and redness in the ⋅ change in your menstrual periods Be careful when drinking alcohol leg), which may travel through while you are using this medicine. ⋅ impaired sexual function blood vessels to the lungs causing If you drink alcohol, drowsiness or ⋅ swelling of hands, ankles or feet chest pain and difficulty in sleepiness may be worse. ⋅ skin rash, itching. breathing. If you notice any of these symptoms seek medical If you feel light-headed, dizzy or ⋅ abnormal sensations, such as faint when getting out of bed or burning or prickling advice immediately. standing up, get up slowly. ⋅ changes in attention and memory ⋅ In elderly people with dementia, a small increase in the number of Standing up slowly will help your ⋅ dizziness or spinning sensation body get used to the change in deaths has been reported for ⋅ painful or weak muscles position and blood pressure. If this patients taking antipsychotics problem continues or gets worse, ⋅ pain at the injection site compared with those not receiving talk to your doctor. ⋅ feeling generally unwell antipsychotics. Tell your doctor immediately if you notice any of the following: These may be serious side effects of ⋅ sudden onset of unusual Clopixol. You may need urgent Side effects movements, including trembling medical attention. and shaking of the hands and fingers, twisting movements of Tell your doctor immediately, or go All medicines may have some to Accident and Emergency at your the body, or shuffling walk and unwanted side effects. Sometimes nearest hospital, if you notice any of stiffness of the arms and legs they are serious, but most of the the following: time they are not. Your doctor has ⋅ worm-like movements of the ⋅ serious allergic reaction weighed the risks of using this tongue or other uncontrolled (symptoms of an allergic reaction medicine against the benefits he/she movements of the mouth, tongue, may include swelling of the face, expects it will have for you. cheeks or jaws, which may lips, mouth or throat which may progress to the arms and legs cause difficulty in swallowing or Tell your doctor or pharmacist as ⋅ inability to keep still soon as possible if you do not feel breathing, or hives) well while you are using Clopixol. ⋅ increased, slowed or unusual ⋅ sudden increase in body It helps most people with mental muscle movements temperature, unusual stiffness of illness, but it may have unwanted ⋅ feeling dizzy when standing up the muscles and changes in side effects in a few people. ⋅ irregular heart beat and changes consciousness, especially in conjunction with fast heart rate and If you are over 65 years of age you in heart rate and blood pressure sweating. This may be due to a may have an increased chance of ⋅ fainting very rare condition called getting side effects. ⋅ blurred vision or difficulty neuroleptic malignant syndrome, focusing Tell your doctor if you notice any which has been reported with of the following and they worry ⋅ difficulty passing urine various medicines. you: ⋅ increased urination or other These are very serious side effects. ⋅ drowsiness, sleepiness urinary disorder You may need urgent medical attention ⋅ inability to sleep ⋅ high pressure in the eye or hospitalisation. ⋅ abnormal dreams ⋅ unusual secretion of breast milk These side effects are generally rare. ⋅ headache ⋅ breast enlargement in men Tell your doctor if you notice ⋅ fatigue ⋅ difficult or painful breathing anything else that is making you feel ⋅ depressed mood ⋅ frequent infections such as fever, unwell. ⋅ anxiousness severe chills, sore throat or Other side effects not listed above may ⋅ nervousness, agitation mouth ulcers occur in some people.

5 pharmacist what to do with any Do not be alarmed by this list of Inactive ingredients (tablets): possible side effects. that is left over. ⋅ hydrogenated castor oil You may not experience any of Return any unused medicine to them. your pharmacist. ⋅ microcrystalline cellulose ⋅ glycerol

⋅ hypromellose Product description ⋅ iron oxide red After using it ⋅ lactose monohydrate What it looks like ⋅ macrogol 6000 Storage Clopixol comes as tablets and in two ⋅ magnesium stearate Keep Clopixol in the pack until it types of injections: ⋅ copovidone is time to use it. ⋅ Clopixol 10 mg film-coated ⋅ potato starch If you take the tablets or the tablets - light red brown, round ⋅ purified talc ampoules out of the pack they may biconvex tablets ⋅ titanium dioxide. not keep well. ⋅ Clopixol Acuphase 50 mg/mL Clopixol tablets do not contain gluten, Keep Clopixol away from solution for injection - clear, sucrose, tartrazine or any other azo sunlight. yellowish oil dyes. ⋅ Clopixol Depot 200 mg/mL Keep the medicine in a cool dry Inactive ingredient (injections): place where the temperature solution for injection - clear, stays below 25°C. yellowish oil. ⋅ fractionated . The tablets are available in bottles of Do not store it or any other 100 tablets and the injections come medicine in the bathroom, near a Manufacturer/Sponsor sink, or on a window-sill. in boxes of 5 ampoules. Clopixol is made by H. A/S, Do not leave it in the car. Ingredients Denmark. Heat and damp can destroy some medicines. Active ingredient(s): Distributed in New Zealand by: Pharmacy Retailing t/a Healthcare ⋅ Clopixol 10 mg tablets - 10 mg Keep it where children cannot Logistics reach it. zuclopenthixol (as 58 Richard Pearse Drive A locked cupboard at least one-and- hydrochloride) per tablet Mangere a-half metres above the ground is a ⋅ Clopixol Acuphase 50 mg/mL Auckland 2022 good place to store medicines. injection - 50 mg zuclopenthixol acetate per 1 mL or 100 mg Ph: 0800 540 555 Disposal zuclopenthixol acetate per 2 mL This leaflet was prepared on 18 June ⋅ Clopixol Depot 200 mg/mL 2020. If your doctor tells you to stop injection - 200 mg using this medicine, or the expiry zuclopenthixol decanoate per date has passed, ask your 1 mL. “Clopixol” is the registered trademark of H. Lundbeck A/S.

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