Clozaril

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using CLOZARIL?

CLOZARIL contains the active ingredient clozapine. CLOZARIL is used to treat schizophrenia, which is a mental illness with disturbances in thinking, feelings and behaviour.
For more information, see Section 1. Why am I using CLOZARIL? in the full CMI.

2. What should I know before I use CLOZARIL?

Do not use if you have ever had an allergic reaction to clozapine or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use CLOZARIL? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with CLOZARIL and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use CLOZARIL?

The usual starting dose is half of a 25 mg tablet once or twice on the first day. The dose is usually increased to one 25 mg tablet once or twice on the second day. After that the dose can be slowly increased until the desired effect is achieved.
More instructions can be found in Section 4. How do I use CLOZARIL? in the full CMI.

5. What should I know while using [Medicine name]?

Things you should do
Remind any doctor, dentist or pharmacist you visit that you are using CLOZARIL.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking CLOZARIL.
You must have strict and regular blood tests while taking CLOZARIL.
Call your doctor straightaway if you develop a fever, signs and symptoms of an infection, changes to your bowel movements or become pregnant.
Things you should not do
Do not stop using this medicine suddenly OR lower the dosage, even if you are feeling better, without checking with your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how CLOZARIL affects you.
Drinking alcohol
Tell your doctor if you drink alcohol.
You should not drink alcohol while you are taking CLOZARIL.
Looking after your medicine
Keep your tablets in a cool dry place where the temperature stays below 30°C.
Keep it where children cannot reach it.
For more information, see Section 5. What should I know while using CLOZARIL? in the full CMI.

6. Are there any side effects?

Speak to your doctor if you have any of the following and they worry you: constipation or fewer bowel movements than normal, abdominal pain, nausea (feeling sick), vomiting, stomach discomfort especially after a meal, diarrhoea, dry mouth.
Call your doctor straight away or go straight to the Emergency Department at your nearest hospital if you notice any of the following: fever, sore throat, mouth ulcers, "flu-like" symptoms, a fast or irregular heartbeat, sudden signs of allergy, sudden increase in body temperature, muscle stiffness, stomach pain often accompanied by nausea, severe or prolonged constipation.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
WARNING:
Gastrointestinal hypomotility (reduced gastrointestinal movement) due to clozapine
Clozaril may cause slowing down or blockage of intestine function, resulting in reactions such as constipation; nausea with or without vomiting; tenderness or swelling of the abdomen, or bloating; stomach pains/spasms; leakage of diarrhoea or frequent and forceful bowel movements; bowel urges with no resulting movements; pain or pressure in the rectum and inflammation and bleeding of the bowels from the rectum. These can lead to severe outcomes. Your doctor must monitor bowel function before prescribing and during your therapy with Clozaril. It is extremely important to immediately advise your doctor, coordinator, pharmacist or any other healthcare professional, of any changes to your stool/bowel movements.
Myocarditis
CLOZARIL may cause myocarditis (inflammation of heart muscle), which may be fatal, or another heart condition. Your doctor will monitor you during treatment. If required, your doctor may want to refer you to a cardiologist for further tests.
Active ingredient(s): Clozapine

Full Consumer Medicine Information (CMI)

This leaflet provides important information about using CLOZARIL. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using CLOZARIL.
Where to find information in this leaflet:

1. Why am I using CLOZARIL?

CLOZARIL contains the active ingredient clozapine. CLOZARIL belongs to a group of medicines called antipsychotics. It helps to correct chemical imbalances in the brain which may cause mental illness.
CLO ZARIL is used to treat schizophrenia, which is a mental illness with disturb ances in thinking, feelings and behaviour.
CLOZARIL is only used to treat patients suffering with schizophrenia when other antipsychotic medicines either have not worked or have caused severe side effects.
Ask your doctor if you have any questions about why CLOZARIL has been prescribed for you.
Your doctor may have prescribed it for another reason.
CLOZARIL is available only with a doctor's prescription. There is no evidence that it is addictive.
CLOZARIL is not recommended for use in children or adolescents under the age of 16, as there is not enough information on its use in that age group.

2. What should I know before I use CLOZARIL?

Warnings

Do not use CLOZARIL if:

you are allergic to clozapine, or any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, mouth and throat, as well as the tongue, which may be itchy or painful; or swelling of other parts of the body; rash, itching or hives on the skin.
If you think that you are allergic to CLOZARIL, ask your doctor for advice before taking this medicine."
Always check the ingredients to make sure you can use this medicine.
you have a low white blood cell count or have previously had a low white blood cell count caused by a medicine (except if it was following a treatment for cancer).
CLOZARIL can cause agranulocytosis (a condition with a reduced number of white blood cells).
These cells are needed to fight infections. If you have a low white blood cell count or have had one in the past, you must not take CLOZARIL.
if you are unable to have regular blood tests.
Before starting this medicine and during your therapy, checks will be required to monitor the levels of various components in your blood. Your doctor will tell you when these tests are needed.
CLOZARIL must not be given to anyone who is unconscious or in a coma, or who has an acute mental illness caused by alcohol or drugs.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

Do not take CLOZARIL if you have any of the following medical conditions:

any disease of the blood which causes a reduced number of red blood cells or platelets.
symptoms of active liver disease such as jaundice (yellow colour to the skin and eyes, feeling sick, loss of appetite) or any other severe liver disease.
severe kidney disease.
myocarditis (an inflammation of the heart muscle) or any other heart problems.
uncontrolled epilepsy (i.e. you still have some seizures).
paralytic ileus (your bowel does not work properly and you have severe constipation).
severe constipation, obstruction of the bowel, or any other condition which has affected your large bowel.
bone marrow disease.
problems with alcohol or drug abuse.

Check with your doctor if you:

take any medicines for any other condition.
smoke and how much coffee you drink. Sudden changes in your usual smoking or coffee drinking habits can also change the effects of CLOZARIL.
will be in a hot environment or you do a lot of vigorous exercise. CLOZARIL may make you sweat less, causing your body to overheat.
are lactose intolerant. This medicine contains lactose.
have allergies to other medicines or to any other substances such as foods, preservatives or dyes.

Tell your doctor if you have ever had any of the following medical conditions:

any form of heart disease or a family history of heart disease
family history of an abnormal conduction in the heart called "prolongation of the QT interval"
stroke
neuroleptic malignant syndrome, a reaction to some medicines with a sudden increase in body temperature, sweating, fast heartbeat, muscle stiffness and fluctuating blood pressure, which may lead to coma
tardive dyskinesia, a reaction to some medicines with uncontrolled movements of the tongue, face, mouth or jaw (such as puffing of the cheeks, puckering of the mouth or chewing movements).
problems with your liver or kidneys
glaucoma, a condition in which there is usually a build-up of fluid in the eye
enlargement of the prostate or prostate problems
epilepsy that is under control (i.e. you no longer have seizures)
diabetes or a family history of diabetes
chronic constipation, which needs to be treated before you start taking CLOZARIL. Your doctor must also monitor bowel function while you are on CLOZARIL.
dementia, a condition in which there is a decline in all areas of mental ability
any other serious medical condition.
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Experience with CLOZARIL in pregnancy is very limited. If you need to take this medicine during pregnancy, your doctor will discuss with you the benefits and risks of taking it.
Newborn babies of mothers taking antipsychotic drugs during the third trimester of pregnancy may have increased risk of developing stiff limbs, trembling, agitation, muscle stiffness, muscle flaccidity, drowsiness, short and shallow breathing, and feeding disorders following delivery. In some cases these symptoms may be self-limiting, in other cases, babies may require intensive care unit support or hospitalization.
You should not breast feed during CLOZARIL treatment. This medicine may pass into breast milk and may affect your baby.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and CLOZARIL may interfere with each other. These include:
medicines that decrease the number of blood cells produced by your body
other antipsychotic medicines used to treat mental illnesses
medicines used to control depression or mood swings
benzodiazepines and other medicines used to treat anxiety or to help you sleep
medicines used to control epilepsy, including phenytoin, carbamazepine and valproic acid
warfarin, a medicine used to prevent blood clots
strong pain killers such as morphine
St John's wort (Hypericum perforatum), an ingredient in many medicines that you can buy without a prescription from a pharmacy, health food shop or supermarket
antihistamines, medicines used for colds or allergies such as hay fever
anticholinergic medicines, which are used to relieve stomach cramps, spasms and travel sickness
medicines used to treat Parkinson's disease
medicines used to treat high blood pressure
digoxin, a medicine used to treat heart problems
medicines used to treat a fast or irregular heartbeat
some medicines used to treat stomach ulcers, including cimetidine, omeprazole, pantoprazole and lansoprazole
some antibiotic medicines, including erythromycin, clarithromycin, azithromycin, ciprofloxacin, norfloxacin and rifampicin
some medicines used to treat fungal or viral infections
nicotine in medicines used to help you quit smoking, such as nicotine patches or chewing gum
atropine, a medicine which may be used in some eye drops or cough and cold preparations
adrenaline, a drug used in emergency situations
birth-control tablets
These medicines may be affected by CLOZARIL or they may affect how well CLOZARIL works. You may need to take different amounts of your medicines or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking CLOZARIL.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect CLOZARIL.

4. How do I use CLOZARIL?

How much to take

The usual starting dose is half of a 25 mg tablet once or twice on the first day. The dose is usually increased to one 25 mg tablet once or twice on the second day. After that the dose can be slowly increased until the desired effect is achieved. Usually the total amount of CLOZARIL needed each day will be between 200 mg and 450 mg but some people will need higher doses. Once the maximum benefit is reached, the dose can often be decreased to between 150 mg and 300 mg each day.
If you have heart, kidney or liver disease, are prone to seizures (fits) or are elderly, your doctor may start you on a lower dose and increase it more gradually to prevent unwanted side effects.
Follow all directions given to you by your doctor and pharmacist carefully. They may different from the information contained in the leaflet.
If you do not understand the instructions on the label, ask your doctor or pharmacist for help.
Follow the instructions provided and use CLOZARIL until your doctor tells you to stop.
Your doctor will check your progress to make sure the medicine is working and will discuss with you how long your treatment should continue.

When to take CLOZARIL

Take your medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you remember when to take it.
The total daily amount of CLOZARIL is usually divided into 2 doses (morning and bedtime). But, if your total dose is 200 mg or less, your doctor may allow you to take the whole amount at once, usually in the evening.

How to take CLOZARIL

Swallow the tablets with a full glass of water or other liquid.
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

If you forget to take CLOZARIL

CLOZARIL should be taken regularly at the same time each day.
If you miss your dose and it is almost time for your next dose (within 4 hours), skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking it as you would normally.
Do not take a double dose to make up for the dose you missed.
This may increase the chance of you getting an unwanted side effect.
If you have forgotten to take CLOZARIL for more than 2 days, do not start taking it again before you contact your doctor.
To prevent unwanted side effects, your doctor will probably want you to restart CLOZARIL at a low dose and increase it gradually back to the amount you were taking before.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask you pharmacist for some hints.

If you use too much CLOZARIL

If you think that you have used too much CLOZARIL, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
The most common symptoms of an overdose include light headedness due to low blood pressure, too much saliva, difficulty breathing, fast or irregular heartbeat, drowsiness, confusion and unconsciousness.

5. What should I know while using CLOZARIL?

Things you should do

Continue taking CLOZARIL as long as your doctor tells you. If you have questions about how long to take CLOZARIL, talk to your doctor or pharmacist.
You must have strict and regular blood tests while taking CLOZARIL.
CLOZARIL can cause agranulocytosis. This is a condition where the number of white blood cells in your body is reduced. White blood cells are needed to fight infection.
There is no way of knowing who is at risk of developing agranulocytosis.
Deaths have occurred in severe cases of agranulocytosis. However, with regular blood tests, the problem can be detected early. If CLOZARIL is stopped as soon as possible, the white blood cell numbers should return to normal.
You must have a blood test at least once a week for the first 18 weeks after starting CLOZARIL.
This is the time when the risk of agranulocytosis is greatest. These tests can tell the doctor whether the white blood cell count is dropping.
After 18 weeks, you must have a blood test at least every 4 weeks for as long as you are taking CLOZARIL and for a month after stopping the medicine.
There are some situations where you may need to have blood tests more often (e.g. twice a week). Your doctor will explain this to you.
If the number of white blood cells falls below a critical level, CLOZARIL will be stopped immediately and you must never take CLOZARIL again.
If you suffer from a high level of sugar in the blood (diabetes) your doctor may regularly check your level of sugar in the blood.
Watch for important side effects. If you develop a fast or irregular heartbeat that is present even when you are resting, accompanied by rapid breathing, shortness of breath, swelling of the feet or legs, dizziness or light headedness, or chest pain, contact your doctor immediately as these may cause death .
These symptoms could be signs of myocarditis, an inflammation of the heart muscle, or another heart condition. Your doctor may want to refer you to a cardiologist for further tests.
Make sure you use a contraceptive to prevent pregnancy during treatment with CLOZARIL.
Some women taking some antipsychotic medications have irregular or no periods. If you are female and you have been affected in this way, your periods may return when your medication is changed to CLOZARIL.

Call your doctor straight away if you:

develop a fever.
Some patients develop a fever in the first few weeks of taking CLOZARIL. You must be checked carefully to make sure that you do not have agranulocytosis, myocarditis or neuroleptic malignant syndrome, a reaction to some medicines with a sudden increase in body temperature.
develop a sour throat, mouth ulcers, flu-like symptoms or any other sign of a cold or infection.
Your doctor will check your blood to decide if your symptoms are an early sign of agranulocytosis. Flu-like symptoms may also be a sign of myocarditis.
notice any uncontrolled movements of the tongue, face, mouth or jaw, such as puffing of the cheeks, puckering of the mouth or chewing move me nts.
These are symptoms of a very rare condition called tardive dyskinesia which may develop in people taking antipsychotic medicines. This condition is more likely to happen during long-term treatment, especially in elderly women. In very rare cases, it may be permanent. However, if detected early, these symptoms are usually reversible.
Be mindful of any changes to your gastrointestinal (stomach/intestine) function. CLOZARIL may slow down or block intestinal function causing reactions such as constipation, nausea with or without vomiting, tenderness or swelling of the abdomen, leakage of diarrhoea or frequent and forceful bowel movements, bowel urges with no resulting movements, lower back pain, pain or pressure in the rectum and bleeding from the rectum. These can lead to extremely severe outcomes.
Your doctor must monitor intestine function before prescribing and during your therapy with CLOZARIL. If you develop any of these symptoms, you must tell your doctor, coordinator, pharmacist or any other healthcare professional of any changes to your bowel movements.
become pregnant while taking this medicine.
Newborn babies of mothers taking antipsychotic drugs during the third trimester of pregnancy may have increased risk of developing stiff limbs, trembling, agitation, muscle stiffness, muscle flaccidity, drowsiness, short and shallow breathing, and feeding disorders following delivery. In some cases these symptoms may be self-limiting, in other cases, babies may require intensive care unit support or hospitalization.
Your doctor can discuss with you the risks of taking it while you are pregnant.
Remind any doctor, dentist or pharmacist you visit that you are using CLOZARIL or if you are about to be started on any new medicine.
If you plan to have surgery, tell your doctor that you are taking CLOZARIL.

Things you should not do

Do not stop using this medicine or lower the dosage, even if you are feeling better, without checking with your doctor.
If you stop taking CLOZARIL suddenly, your condition may worsen or you may have unwanted side effects such as excessive sweating, headache, nausea (feeling sick), vomiting and diarrhoea. If this medicine is stopped for any reason, your doctor will reduce the dose gradually, over a one-to-two-week period, to avoid side effects, before stopping the medicine completely.
Do not take CLOZARIL to treat any other complaints unless your doctor tells you to.
Do not give this medicine to anyone else, even if their condition seems similar to yours.

Things to be careful of

Sudden unexplained death and heart attacks that may lead to death have been reported with CLOZARIL.
Be careful when taking pain relievers, sleeping tablets or antihistamines (medicines for colds or allergies such as hay fever) while you are taking CLOZARIL.
CLOZARIL can increase the drowsiness caused by medicines that affect your nervous system.
CLOZARIL may cause alteration in blood lipids. It may also cause weight gain. Your doctor may monitor your weight and blood lipid levels.
CLOZARIL can cause sleepiness, and remaining in bed for prolonged duration in combination with weight gain may lead to the formation of blood clots in some patients.
If CLOZARIL makes you feel light-headed, dizzy or faint, be careful when getting up from a sitting or lying position.
CLOZARIL may lower your blood pressure, especially at the start of treatment. These symptoms can usually be prevented by getting up slowly and flexing your leg muscles and toes to get the blood flowing. When getting out of bed, dangle your legs over the side for a minute or two before standing up.
Make sure you keep cool in hot weather and keep warm in cool weather.
As with other antipsychotic medicines, CLOZARIL may affect the way your body reacts to temperature changes. It may prevent sweating, even during heatwaves. You may feel dizzy or faint if you are too hot.
To stay cool in hot weather, try to do the following:
- wear light clothing
- spend time in air-conditioned environments (or keep windows open and use electric fans)
- drink plenty of water
- take cool baths or showers and avoid hot baths and saunas
- try to restrict exercise or heavy work to cool parts of the day.
Inform your doctor if you stop smoking or change the number of caffeine-containing drinks that you have in one day. These changes can affect the levels of this medicine in your blood.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how CLOZARIL affects you.
CLOZARIL may cause tiredness, drowsiness, dizziness, light-headedness, fainting or seizures (fits) in some people, especially at the start of treatment. Seizures, drowsiness, fainting, muscle weakness may lead to falls.

Drinking alcohol

Tell your doctor if you drink alcohol.
You should not drink alcohol while you are taking CLOZARIL.
CLOZARIL may enhance the effects of alcohol.

Looking after your medicine

Keep your tablets in the pack until it is time to take them. If you take the tablets out of the pack they may not keep well.
Keep your tablets in a cool dry place where the temperature stays below 30°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.
Do not use this medicine after the expiry date.
Remember that you must still have your blood tested for a month after stopping this medicine.

6. Are there any side effects?

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking CLOZARIL, even if you do not think it is connected with the medicine.
All medicines can have side effects. Sometimes they are serious, but most of the time they are not. You may need medical treatment if you get some of the side effects. Some of the side effects of CLOZARIL can be relieved by changing the dose.
If you are over 65 years old, you should be especially careful while taking this medicine. Report any side effects promptly to your doctor.
You may be more likely to get some of the side effects of CLOZARIL, such as rapid heartbeat, dizziness or light- headedness due to low blood pressure, constipation and difficulty urinating.
Do not be alarmed by this list of possible side effects.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects
What to do
constipation or fewer bowel movements than normal (if it seems to be getting worse, check with your doctor immediately)
abdominal pain
nausea (feeling sick), vomiting
stomach discomfort, especially after a meal
diarrhoea
dry mouth
too much saliva
difficulty in swallowing
heartburn
tiredness, drowsiness
dizziness or light headedness when standing up
headache
agitation, confusion, disorientation, vivid dreams
blurred vision, difficulty in reading
weight gain, especially excessive weight gain
changes in sexual function
painful menstrual periods
repetitive and ritualised behaviour (obsessive compulsive symptoms)
obsessive thoughts
stuttering in speech
problems in passing or holding urine
dark urine
excessive urination
for males, dry orgasm (retrograde ejaculation) where very little or no semen is ejaculated as it enters the bladder instead. Urine will appear cloudy after an orgasm
nocturnal bedwetting
increased or decreased sweating
skin reactions or change in skin colour
swelling of the glands in the cheeks
rash, purplish-red spots, fever or itching
"butterfly" rash, joint pain, muscle pain, fever and fatigue
stuffy nose
sudden, uncontrollable increase in blood pressure
uncontrolled bending of the body to one side
a strong urge to move the legs (restless legs syndrome) with an unpleasant feeling in the legs
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects
What to do
fainting or loss of consciousness
falls due to seizure, drowsiness, fainting, muscle weakness
crushing chest pain or chest pain
fever, sore throat, mouth ulcers, "flu-like" symptoms (chills, aching joints, swollen glands, lack of energy) or any other signs of infection
a fast or irregular heartbeat that is present even when you are resting, accompanied by rapid breathing, shortness of breath, swelling of the feet or legs, dizziness or light headedness, or chest pain
sudden signs of allergy such as rash, itching or hives on the skin; swelling of the face, lips, tongue or other parts of the body; wheezing or troubled breathing
symptoms of neuroleptic malignant syndrome, with a sudden increase in body temperature, sweating, fast heartbeat, muscle stiffness and fluctuating blood pressure, which may lead to coma
seizures (fits)
pain in the stomach, often accompanied by nausea with or without vomiting, leakage of diarrhoea or frequent and forceful bowel movements; bowel urges with no resulting movements.
severe or prolonged constipation, which may be accompanied by abdominal pain and bloating
signs of loss of blood sugar control (diabetes) such as excessive thirst, drinking or eating large amounts, weakness, passing large amounts of urine, dry mouth and skin, as CLOZARIL may cause or worsen diabetes
spontaneous bleeding or bruising more easily than normal
signs that blood clots may have formed, such as sudden severe headache, sudden loss of coordination, blurred vision or sudden loss of vision, slurred speech, numbness in an arm or leg
yellowing of the skin and/or eyes, sometimes accompanied by feeling sick and loss of appetite
difficulty in passing urine (water) or blood in the urine
loss of bladder control
muscle stiffness, muscle weakness, muscle spasms, or muscle pain
muscle spasms, fever, red-brown urine
rigidity or stiffness in the arms and legs, shaking or tremor, feeling unable to sit still
abnormal movements, inability to initiate movement, inability to remain motionless, inner feeling restlessness, stiff limbs, trembling hands
symptoms of tardive dyskinesia (uncontrolled involuntary purposeful movements of the tongue, face, mouth or jaw such as puffing of the cheeks, puckering of the mouth, chewing movements, grimacing, lip-smacking, rapid eye blinking)
persistent painful erection or prolonged erection
signs of respiratory tract infection or pneumonia such as fever, coughing, difficulty breathing, wheezing
signs of sepsis such as shivering, fever, rapid breathing and heart rate, a change in your mental state such as confusion or disorientation
chest pain, cough, hiccups, rapid breathing
varying degrees of pain in the chest and abdomen
pauses in breathing or periods of shallow breathing during sleep.
The above are serious side effects that need medical attention.
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.
Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What CLOZARIL contains

Active ingredient
Clozapine
Other ingredients
(inactive ingredients)
colloidal anhydrous silica
purified talc
magnesium stearate
lactose monohydrate
maize starch
povidone
Potential allergens
Sugars as lactose
Do not take this medicine if you are allergic to any of these ingredients.

What CLOZARIL looks like

CLOZARIL 25mg: circular, flat, yellow, bevelled edged tablets. Approximately 6.3 mm diameter, coded “CLOZ” on one side, and “L/O” and angle score on the reverse. Container of 100 tablets. (AUST R 50510)
CLOZARIL 100 mg: circular, flat, yellow, bevelled edged tablets. Approximately 10 mm diameter, coded “CLOZ” on one side, and “Z/A” and angle score on the reverse. Container of 100 tablets. (AUST R 50511)
The quantity of tablets provided to you will be determined by your doctor.

Who distributes CLOZARIL

Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
 
For medical enquiries phone 1800 931 383
 
This leaflet was prepared in April 2023.
 
CLOZARIL® is a Viatris company trade mark.
 
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