Information for patients and carers YOUR GUIDE TO CLOPINE® 25 mg 50 mg 100 mg 200 mg
WARNING: Gastrointestinal hypomotility (reduced gastrointestinal movement) Clozapine may cause slowing down of bowel (intestine) function, which may result in blockage, perforation or tissue damage and cause reactions such as constipation; nausea with or without vomiting; tenderness or swelling of the stomach, or bloating; gas/wind; foul-smelling breath; stomach pains/spasms; leakage of diarrhoea or frequent and forceful bowel movements (poo); bowel urges with no resulting movements; weight loss due to lack of appetite; lower back pain; pain or pressure in your bottom and bleeding from the bottom. These can lead to extremely severe outcomes. Your doctor must monitor bowel function before prescribing and during your therapy with CLOPINE. It is extremely important to immediately advise your doctor, coordinator, pharmacist, or any other health professional, of any changes to your bowel movements. Myocarditis/pericarditis/cardiomyopathy CLOPINE may cause myocarditis (inflammation of heart muscle) and/or cardiomyopathy (heart muscle disease), either of which may be fatal. Another heart condition, pericarditis (inflammation of the sac surrounding the heart) which may be severe has also been reported in patients on clozapine.Please advise your doctor if you have, or previously had, any heart problems. Your doctor will monitor you during treatment. If required, your doctor may want to refer you to a cardiologist for further tests. If you feel any symptoms such as chest pain, speak to your doctor immediately.
For further information about Clopine® or schizophrenia, please speak to the prescribing doctor CONTENTS Why has Clopine® been prescribed? 05 06 Before starting on Clopine® 07 Continuing on Clopine® 08 About blood tests 10 Important side effects 11 Dealing with constipation 12 Managing life with schizophrenia 14 SANE guide to healthy living Useful contacts 13 Smoking and caffeine 06
This booklet answers some common questions about Clopine®. For more detailed information on Clopine®, ask your doctor or pharmacist for the Clopine® Consumer Medicine Information (CMI). This booklet is intended to help patients and carers to participate in Clopine® treatment decisions alongside their healthcare team. If you have any questions or concerns about Clopine®, talk to your doctor or pharmacist. YOUR GUIDE TO CLOPINE® 04
WHY HAS CLOPINE® BEEN PRESCRIBED? What is Clopine®? Clopine® belongs to the group of medicines known as antipsychotics. This group of medicines is mainly used in the treatment of schizophrenia. Clopine® is thought to work by correcting chemical imbalances in the brain that may cause mental illness. What is Clopine® used for? Clopine® is used in patients with schizophrenia for whom other antipsychotic medicines have not worked or have caused severe side effects. A doctor may have prescribed it for another reason. Ask the prescribing doctor if you have any questions about why this medicine has been prescribed. What is schizophrenia? Schizophrenia is a mental illness that causes disturbances in thinking, feelings and behaviour. It is one of a group of mental illnesses called ‘psychotic disorders’. These disorders share similar symptoms, especially psychosis. A person experiencing psychosis finds it hard to tell what is real from what isn’t — they may see or hear things that other people cannot see or hear (hallucinations), and they may also hold beliefs that seem strange or are untrue (delusions). The main types of symptoms of schizophrenia are referred to as: • Positive symptoms - including delusions, hallucinations and disorganised thoughts. • Negative symptoms - including feeling unmotivated, not feeling any emotions, feeling less pleasure in everyday life, or difficulties with attention or memory. Schizophrenia is a potentially serious condition if it is left untreated. Antipsychotic medicines — such as Clopine® — can help to control the symptoms of schizophrenia. 05
BEFORE STARTING ON CLOPINE® Please tell your doctor if you: • Have a problem with your intestines or bowel, or severe constipation • Have a heart problem • Have circulatory (blood) or nervous system problems • Have uncontrolled epilepsy seizures • Have problems with alcohol or drug abuse • Have any other type of medical condition (including diseases of the bone marrow, blood, kidney or liver) • Have any allergies (including to clozapine or lactose) • Are unable to have blood tests • Have a history of low white blood cell counts • Are pregnant or plan to become pregnant • Are breastfeeding or plan to breastfeed • Will be in a hot environment or do a lot of vigorous exercise • Are taking any other medicines, vitamins or supplements (with or without a prescription) SMOKING AND CAFFEINE Do smoking and caffeine interfere with Clopine® treatment? Smoking and caffeine can have an impact on how Clopine® affects the body. A sudden change in usual smoking or coffee-drinking habits can also change the effects of Clopine®, as well as the dose required. • Before starting on Clopine®: please tell your doctor if you smoke and/or drink coffee. • During treatment with Clopine®: please tell your doctor if you are planning to stop smoking and/or change the number of caffeinated drinks consumed in a day. 06
CONTINUING ON CLOPINE® Clopine® helps to control schizophrenia, but is not a cure. It is important to keep taking Clopine® as prescribed, even if symptoms become less noticeable. Please contact your doctor, nurse or pharmacist if you’re not sure what to do. What is the starting dose for Clopine®? To provide time to get used to Clopine®, the starting dose is usually half a tablet taken once or twice on the first day; this dose will then be gradually increased over time to achieve the right dose. The right dose of Clopine® will be determined in consultation with the prescribing doctor. What steps should be taken following a missed dose of Clopine®? • If it is almost time for the next dose (within four hours): skip the missed dose, then take the next dose as normal. • At any other time: take the missed dose as soon as you remember, then return to normal dosing. It is important NOT to take a double dose of Clopine® If Clopine® treatment is missed for more than two days, it should NOT be started again without contacting the prescribing doctor first. A lower dose may be needed on re-starting to prevent side effects. 07
ABOUT BLOOD TESTS Are blood tests needed? Everyone who takes clozapine (regardless of the brand) is required to have regular blood tests. The prescribing doctor will talk to you about this. Why are blood tests needed? In a small number of people (less than 1 in 100), clozapine can lower the number of blood cells that are needed to fight infections in the body. These blood cells will be monitored by the prescribing doctor via regular blood tests. How often are blood tests needed? After starting on Clopine®, weekly blood tests are needed for the first 18 weeks. Blood tests will then continue every 4 weeks thereafter for as long as Clopine® treatment continues. These blood tests must be taken no earlier than 48 hours before review or prescribing. There may be times when the prescribing doctor will ask for blood tests more often. Unfortunately, it may be necessary to stop Clopine® treatment if a blood test reveals a white blood cell count that is too low. Some additional blood tests will still be required after this to check for a return to normal blood cell count. If Clopine® is stopped for any other reason, blood tests are still needed for a month after the last dose. If switching from other clozapine brands to Clopine®, blood tests are still needed, but it’s not necessary to start at the beginning of the blood test monitoring program. If any signs of infection develop during treatment with Clopine®, such as a sore throat, mouth ulcers, fever or flu-like symptoms, contact the prescribing doctor immediately. 08
Are other tests needed? The prescribing doctor may ask for some other tests to help ensure general wellness. These may include blood tests for changes to heart muscle (for cardiomyopathy or myocarditis), and/or glucose levels (for diabetes). Why test for changes to heart muscle? Changes to heart muscle may occur with clozapine treatment, which can lead to conditions called cardiomyopathy and myocarditis. • Cardiomyopathy is very rare, affecting less than 1 in 10,000 people taking clozapine. • Pericarditis is rare, affecting between 1 in 10,000 and 1 in 1,000 people taking clozapine in Australia. • Myocarditis is uncommon, affecting between 1 in 1000, and 1 in 100 people taking clozapine in Australia. To learn more about these conditions, please speak to the prescribing doctor. Why test for glucose levels? People with schizophrenia are more likely to be overweight or obese. They may also be at an increased risk for type 2 diabetes (2 to 4 times greater than the rest of the population). A well-balanced diet and regular exercise may help to minimise the risk of diabetes. The prescribing doctor will manage any diabetes risk as needed. Some strategies for helping to ensure general wellness include keeping appointments, having tests done and talking to the prescribing doctor about how treatment is going. 09
10 • Stomach pain (particularly if it occurs together with nausea or constipation) • Abdominal pain or chest pain • Heart discomfort • Muscle stiffness • Flu-like symptoms • Sore throat IMPORTANT SIDE EFFECTS All medicines have side effects. Some people may experience side effects from taking Clopine®, while others may not. It may be helpful to write down any side effects in a diary and take this list along to medical appointments. Please speak to the prescribing doctor if any of the following symptoms occur and they are a cause for concern: • Nausea (feeling sick) • Stomach discomfort (especially after a meal) For a more detailed list of possible side effects, please refer to the Clopine® Consumer Medicine Information (CMI), available from your healthcare professional. Are some side effects more serious than others? Please note that some side effects can be a sign of an allergy to the medication, or another serious medical condition, such as a heart problem, blood clot, pneumonia (lung infection) or sepsis (a serious infection). Some of these symptoms include: • Constipation (particularly if it seems to be getting worse - see next page) • Signs of allergic reaction • A fast or irregular heartbeat • A sudden increase in body temperature • Fever • Mouth ulcers If you experience any of the symptoms listed above, please call 000 or go to your nearest hospital emergency department. • Vomiting • Diarrhoea • Dry mouth
DEALING WITH CONSTIPATION Constipation is a fairly common side effect of clozapine treatment. In most people it’s usually mild; however, in some cases it can be serious if left untreated. If constipation does occur, Clopine® should not be stopped unless this has been discussed with the prescribing doctor. How is constipation identified? Some of the more obvious symptoms of constipation include: • Stomach pain or swelling • Bloating • Straining • Difficulty passing gas • Runny stools that may not feel ‘finished’ afterwards • Hard, dry stools However, sometimes constipation may not be obvious, or it can occur without the symptoms listed above, so it can be a good idea to keep a record of how often bowel movements are occurring. If there are any changes, please advise your doctor, nurse or case manager. It’s also important to advise if an iron or calcium supplement is being taken. How can constipation be prevented? Some simple things that can help to prevent constipation include: • Eating foods high in fibre, such as fruits and vegetables • Drinking plenty of water - aim to drink one glass before every meal • Exercising regularly - try going for a walk, or taking the stairs instead of a lift or escalator 11
MANAGING LIFE WITH SCHIZOPHRENIA People living with schizophrenia can benefit from self-care strategies, medication, psychological therapies, and community support. Some find that the following strategies can help prevent episodes of psychosis, help them feel better in between episodes, or feel more in control: • Learning more about schizophrenia • Looking after physical health including getting regular check-ups • Improving sleep • Developing a support network of trusted family or friends • Accessing peer support • Learning strategies to minimise stress • Developing a relapse prevention plan including identifying early warning signs, what to do when these occur, and who to contact Talk to your doctor and case manager about available programs and creating a treatment plan This information is based on the SANE Schizophrenia factsheet. Visit www.sane.org for more information. 12
Healthy living is about more than just the things you ‘should’ be doing; it can also be helpful to recognise the small steps you’re already taking. Use the checklist below to track your progress. Eating fresh fruit and vegetables Walking to catch public transport Going to the dentist for a check-up Walking up stairs instead of taking the lift Getting 7–9 hours of sleep per night Eating breakfast Eating a sugar-free snack instead of smoking Drinking 2–8 glasses of water per day Taking medication as prescribed by the doctor Making a meal instead of buying take-aways Going for a walk to the park Smiling at someone, or greeting or chatting with them Boiling or baking food instead of frying it Using a condom during sex Having a regular medical test (for example, Pap test, breast screen or cholesterol check) Putting on sunscreen when going outside Wearing a jacket on a cold day For more information, visit www.sane.org and search ‘healthy living’. SANE GUIDE TO HEALTHY LIVING 13
14 SANE Australia – Phone 1800 187 263 www.sane.org Contact SANE for information and support in relation to mental illness. Quitline – Phone 13 78 48 www.quit.org.au Contact Quitline for assistance with giving up smoking. Mind Australia - Phone 1300 286 463 www.mindaustralia.org.au Contact Mind Australia for support and services in relation to mental illness. USEFUL CONTACTS 14
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Copyright © 2024. All rights reserved. Clopine® is a registered trade mark of Douglas Pharmaceuticals Limited and sold by Douglas Pharmaceuticals Australia Pty Ltd under licence. Melbourne, Australia. www.douglas.com.au. Medical Information Department: medinfo@douglas.com.au or call +61 3 7054 1243 AUS-CLO-0001-MARCH 2026 25 mg 50 mg 100 mg 200 mg
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