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CLOZARIL 25MG TABLETS

Active substance(s): CLOZAPINE

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2. What you need to know before you take Clozaril
Do not take Clozaril

–– chronic constipation or if you are taking medicines which cause constipation (such as
anticholinergics).
–– galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
–– controlled epilepsy.
–– large intestine diseases.
–– tell your doctor if you have ever had abdominal surgery.
–– if you have had a heart disease or family history of abnormal conduction in the heart
called “prolongation of the QT interval”.
–– if you are at risk for having a stroke, for example if you have high blood pressure,
cardiovascular problems or blood vessel problems in the brain.

–– You will need to have blood tests for another 4 weeks after the end of Clozaril treatment.
Your doctor will also do a physical examination before starting treatment. Your doctor may
do an electrocardiogram (ECG) to check your heart, but only if this is necessary for you, or
if you have any special concerns.

Tell your doctor immediately before taking the next Clozaril tablet:
–– if you get signs of a cold, fever, flu-like symptoms, sore throat or any other infection.
You will have to have an urgent blood test to check if your symptoms are related to your
medicine.
–– if you have a sudden rapid increase in body temperature, rigid muscles which may
lead to unconsciousness (neuroleptic malignant syndrome) as you may be experiencing
a serious side effect which requires immediate treatment.
–– if you have fast and irregular heart beat, even when you are at rest, palpitations,
breathing problems, chest pain or unexplained tiredness. Your doctor will need to
check your heart and if necessary refer you to a cardiologist immediately.
–– if you experience nausea (feeling sick), vomiting (being sick) and/or loss of appetite.
Your doctor will need to check your liver.
–– if you have severe constipation. Your doctor will have to treat this in order to avoid
further complications.

If Clozaril makes you feel light-headed, dizzy or faint, be careful when getting up from a
sitting or lying position.

Medical check-ups and blood tests

Tell your doctor or pharmacist if you suffer from a condition called dementia.

1. What Clozaril is and what it is used for
2. What you need to know before you take Clozaril
3. How to take Clozaril
4. Possible side effects
5. How to store Clozaril
6. Contents of the pack and other information

–– if you are allergic (hypersensitive) to clozapine or any of the other ingredients of Clozaril
(listed in section 6).
–– if you are not able to have regular blood tests.
–– if you have ever been told you have a low white blood cell count (e.g. leucopenia or
agranulocytosis), especially if this was caused by medicines. This does not apply if you
have had low white blood cell count caused by previous chemotherapy.
–– if you had to stop using Clozaril previously because of severe side effects
(e.g. agranulocytosis or heart problems).
–– if you are being or have been treated with long-acting depot injections of antipsychotics.
–– if you suffer from bone marrow disease or have ever suffered from bone marrow disease.
–– if you suffer from uncontrolled epilepsy (seizures or fits).
–– if you have an acute mental illness caused by alcohol or drugs (e.g. narcotics).
–– if you suffer from reduced consciousness and severe drowsiness.
–– if you suffer from circulatory collapse which may occur as a result of severe shock.
–– if you suffer from any severe kidney disease.
–– if you suffer from myocarditis (an inflammation of the heart muscle).
–– if you suffer from any other severe heart disease.
–– if you have symptoms of active liver disease such as jaundice (yellow colouring of the
skin and eyes, feeling sick and loss of appetite).
–– if you suffer from any other severe liver disease.
–– if you suffer from paralytic ileus (your bowel does not work properly and you have
severe constipation).
–– if you use any medicine that stops your bone marrow from working properly.
–– if you use any medicine that reduces the number of white cells in your blood.
If any of the above applies to you, tell your doctor and do not take Clozaril.
Clozaril must not be given to anyone who is unconscious or in a coma.

1. What Clozaril is and what it is used for

Warnings and Precautions

Before you start taking Clozaril, your doctor will ask about your medical history and do a
blood test to ensure that your white blood cells count is normal. It is important to find this
out, as your body needs white blood cells to fight infections.

Before you start treatment with Clozaril, tell your doctor if you suffer from or have ever
suffered from:
–– blood clots or family history of blood clots, as medicines like these have been associated
with formation of blood clots.
–– glaucoma (increased pressure in the eye).
–– diabetes. Elevated (sometimes considerably) blood sugar levels, has occurred in
patients with or without diabetes mellitus in their medical history (see section 4).
–– prostate problems or difficulty in urinating.
–– any heart, kidney or liver disease.

Make sure that you have regular blood tests before you start treatment, during
treatment and after you stop treatment with Clozaril.
–– Your doctor will tell you exactly when and where to have the tests. Clozaril may only be
taken if you have a normal blood count.
–– Clozaril can cause a serious decrease in the number of white cells in your blood
(agranulocytosis). Only regular blood tests can tell the doctor if you are at risk of
developing agranulocytosis.
–– During the first 18 weeks of treatment, tests are needed once a week. Afterwards, tests
are needed at least once a month.
–– If there is a decrease in the number of white blood cells, you will have to stop Clozaril
treatment immediately. Your white blood cells should then return to normal.

Package Leaflet: Information for the user

CLOZARIL

®

Clozaril 25 mg tablets
Clozaril 100 mg tablets
clozapine

Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.

–– 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 only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
–– If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.

What is in this leaflet:

The active ingredient of Clozaril is clozapine which belongs to a group of medicines called
antipsychotics (medicines that are used to treat specific mental disorders such as
psychosis).
Clozaril is used to treat people with schizophrenia in whom other medicines have not
worked. Schizophrenia is a mental illness which affects how you think, feel and behave.
You should only use this medicine if you have already tried at least two other antipsychotic
medicines, including one of the newer atypical antipsychotics, to treat schizophrenia, and
these medicines did not work, or caused severe side effects that cannot be treated.
Clozaril is also used to treat severe disturbances in the thoughts, emotions and behaviour
of people with Parkinson’s disease in whom other medicines have not worked.

The safety measures mentioned in this section are very important. You must comply
with them to minimise the risk of serious life-threatening side effects.

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Clozaril may cause alteration in blood lipids. Clozaril may cause weight gain. Your doctor
may monitor your weight and blood lipid level.

If you have to undergo surgery or if for some reason you are unable to walk around for a
long time, discuss with your doctor the fact that you are taking Clozaril. You may be at risk
of thrombosis (blood clotting within a vein).

Children and adolescents under 16 years

If you are under 16 years of age you should not use Clozaril as there is not enough
information on its use in that age group.

Older people (aged 60 years and over)

Older people (aged 60 years and over) may be more likely to have the following side effects
during treatment with Clozaril: faintness or light-headedness after changing position,
dizziness, fast heart beat, difficulty in passing urine, and constipation.

Other medicines and Clozaril

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. This includes medicines obtained without a prescription or herbal therapies. You
might need to take different amounts of your medicines or to take different medicines.
Do not take Clozaril together with medicines that stop the bone marrow from working
properly and/or decrease the number of blood cells produced by the body, such as:
–– carbamazepine, a medicine used in epilepsy.
–– certain antibiotics: chloramphenicol, sulphonamides such as co-trimoxazole.
–– certain painkillers: pyrazolone analgesics such as phenylbutazone.
–– penicillamine, a medicine used to treat rheumatic joint inflammation.
–– cytoxic agents, medicines used in chemotherapy.
–– long-acting depot injections of antipsychotic medicines.
These medicines increase your risk of developing agranulocytosis (lack of white blood cells).

Taking Clozaril with food and drink

Do not drink alcohol during treatment with Clozaril.
Tell your doctor if you smoke and how often you have drinks containing caffeine (coffee,
tea, cola). Sudden changes in your smoking habits or caffeine drinking habits can also
change the effects of Clozaril.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor for advice before taking this medicine. Your doctor will discuss with
you the benefits and possible risks of using this medicine during pregnancy. Tell your
doctor immediately if you become pregnant during treatment with Clozaril.

The following symptoms may occur in newborn babies, of mothers that have used Clozaril
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.
Some women taking some medicines to treat mental illnesses have irregular or no periods.
If you have been affected in this way, your periods might return when your medicine is
changed to Clozaril. This means you should use effective contraception.
Do not breast-feed during treatment with Clozaril. Clozapine, the active substance of
Clozaril, may pass into your milk and affect your baby.

Driving and using machines

Clozaril might cause tiredness, drowsiness and seizures, especially at the beginning of
treatment. You should not drive or operate machines while you have these symptoms.

Clozaril contains lactose.

If you have been told by your doctor that you have an intolerance to some sugars, discuss
this with your doctor before taking Clozaril.

3. How to take Clozaril

In order to minimise the risk of low blood pressure, seizures and drowsiness it is necessary
that your doctor increases your dose gradually. Always take Clozaril tablets exactly as your
doctor has told you. Check with your doctor or pharmacist if you are not sure.
It is important that you do not change your dose or stop taking Clozaril without asking your
doctor first. Continue taking the tablets for as long as your doctor tells you. If you are
60 years or older, your doctor may start you on a lower dose and increase it more gradually
because you might be more likely to develop some unwanted side effects (see section 2
“Before you take Clozaril”).
If the dose you are prescribed cannot be achieved with this strength tablet, other strengths
of this medicinal product are available to achieve the dose.

Treatment of schizophrenia

The usual starting dose is 12.5 mg (one half of a 25 mg tablet) once or twice on the first
day followed by 25 mg once or twice on the second day. Swallow the tablet with water. If
tolerated well, your doctor will then gradually increase the dose in steps of 25-50 mg over
the next 2-3 weeks until a dose up to 300 mg per day is reached. Thereafter, if necessary,
the daily dose may be increased in steps of 50 to 100 mg half-weekly or, preferably, at
weekly intervals.
The effective daily dose is usually between 200 mg and 450 mg, divided into several single
doses per day. Some people might need more. A daily dose of up to 900 mg is allowed.
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If you have a liver disorder you will have regular liver function tests as long as you continue
to take Clozaril. If you suffer from high levels of sugar in the blood (diabetes) your doctor
may regularly check your level of sugar in the blood.

Taking Clozaril at the same time as another medicine may affect how well Clozaril
and/or the other medicine works. Tell your doctor if you plan to take, if you are
taking (even if the course of treatment is about to end) or if you have recently had to
stop taking any of the following medicines:
–– medicines used to treat depression such as lithium, fluvoxamine, tricyclic
antidepressants, MAO inhibitors, citalopram, paroxetine, fluoxetine, and sertraline.
–– other antipsychotic medicines used to treat mental illnesses such as perazine.
–– benzodiazepines and other medicines used to treat anxiety or sleep disturbances.
–– narcotics and other medicines which can affect your breathing.
–– medicines used to control epilepsy such as phenytoin and valproic acid.
–– medicines used to treat high or low blood pressure such as adrenaline and noradrenaline.
–– warfarin, a medicine used to prevent blood clots.
–– 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.
–– digoxin, a medicine used to treat heart problems.
–– medicines used to treat a fast or irregular heart beat.
–– some medicines used to treat stomach ulcers, such as omeprazole or cimetidine.
–– some antibiotic medicines, such as erythromycin and rifampicin.
–– some medicines used to treat fungal infections (such as ketoconazole) or viral infections
(such as protease inhibitors, used to treat HIV infections).
–– atropine, a medicine which may be used in some eye drops or cough and cold preparations.
–– adrenaline, a medicine used in emergency situations.
–– hormonal contraceptives (birth-control tablets).
This list is not complete. Your doctor and pharmacist have more information on medicines
to be careful with or to avoid while taking Clozaril. They will also know if the medicines you
are taking belong to the listed groups. Speak to them.

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Increased side effects (in particular seizures) are possible at daily doses over 450 mg.
Always take the lowest effective dose for you. Most people take part of their dose in the
morning and part in the evening. Your doctor will tell you exactly how to divide your daily
dose. If your daily dose is only 200 mg, then you can take this as a single dose in the
evening. Once you have been taking Clozaril with successful results for some time, your
doctor may try you on a lower dose. You will need to take Clozaril for at least 6 months.

Treatment of severe thought disturbances in patients with Parkinson’s
disease

The usual starting dose is 12.5 mg (one half of a 25 mg tablet) in the evening. Swallow the
tablet with water. Your doctor will then gradually increase the dose in steps of 12.5 mg, not
faster than two steps a week, up to a maximum dose of 50 mg by the end of the second
week. Increases in the dosage should be stopped or postponed if you feel faint,
light-headed or confused. In order to avoid such symptoms your blood pressure will be
measured during the first weeks of treatment.
The effective daily dose is usually between 25 mg and 37.5 mg, taken as one dose in the
evening. Doses of 50 mg per day should only be exceeded in exceptional cases. The
maximum daily dose is 100 mg. Always take the lowest effective dose for you.

If you take more Clozaril than you should

If you think that you may have taken too many tablets, or if anyone else takes any of your
tablets, contact a doctor immediately or call for emergency medical help.
The symptoms of overdose are:
Drowsiness, tiredness, lack of energy, unconsciousness, coma, confusion, hallucinations,
agitation, incoherent speech, stiff limbs, trembling hands, seizures (fits), increased
production of saliva, widening of the black part of the eye, blurred vision, low blood
pressure, collapse, fast or irregular heart beat, shallow or difficult breathing.

If you forget to take Clozaril

If you forget to take a dose, take it as soon as you remember. If it is almost time for your
next dose, leave out the forgotten tablets and take the next dose at the right time. Do not
take a double dose to make up for a forgotten dose. Contact your doctor as soon as
possible if you have not taken any Clozaril for more than 48 hours.

If you stop taking Clozaril

Do not stop taking Clozaril without asking your doctor, because you might get withdrawal
reactions. These reactions include sweating, headache, nausea (feeling sick), vomiting
(being sick) and diarrhoea. If you have any of the above signs, tell your doctor straight
away. These signs may be followed by more serious side effects unless you are
treated immediately. Your original symptoms might come back. A gradual reduction in

dose in steps of 12.5 mg over one to two weeks is recommended, if you have to stop
treatment. Your doctor will advise you on how to reduce your daily dose. If you have to stop
Clozaril treatment suddenly, you will have to be checked by your doctor.
If your doctor decides to re-start the treatment with Clozaril and your last dose of Clozaril
was over two days ago, this will be with the starting dose of 12.5 mg.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

4. Possible side effects

Like all medicines, Clozaril can cause side effects, although not everybody gets them.
Some side effects can be serious and need immediate medical attention:
Tell your doctor immediately before taking the next Clozaril tablet:
Very common (affects more than 1 in 10 people):
–– if you have severe constipation. Your doctor will have to treat this in order to avoid
further complications.
Common (affects up to 1 in 10 people):
–– if you get signs of a cold, fever, flu-like symptoms, sore throat or any other
infection. You will have to have an urgent blood test to check if your symptoms are
related to your medicine.
–– if you experience seizures.
Uncommon (affects up to 1 in 100 people):
–– if you have a sudden rapid increase in body temperature, rigid muscles which may lead
to unconsciousness (neuroleptic malignant syndrome) as you may be experiencing a
serious side effect which requires immediate treatment.
Rare (affects up to 1 in 1,000 people):
–– if you get signs of a respiratory tract infection or pneumonia such as fever, coughing,
difficulty breathing, wheezing.
–– if you experience nausea (feeling sick), vomiting (being sick) and/or loss of
appetite. Your doctor will need to check your liver.
Rare (affects up to 1 in 1,000 people) or very rare (affects up to 1 in 10,000 people):
–– if you have fast and irregular heart beat, even when you are at rest, palpitations,
breathing problems, chest pain or unexplained tiredness. Your doctor will need to
check your heart and if necessary refer you to a cardiologist immediately.
Very rare (affects up to 1 in 10,000 people):
–– if you are a man and experience persistent painful erection of the penis. This is called
priapism. If you have an erection which lasts more than 4 hours immediate medical
treatment may be needed in order to avoid further complications.

Unknown (frequency cannot be estimated from the available data)
–– if you experience crushing chest pain, sensation of chest tightness, pressure or squeezing
(chest pain may radiate to the left arm, jaw, neck and upper abdomen), shortness of
breath, sweating, weakness, light headedness, nausea, vomiting and palpitations
(symptoms of heart attack). You should seek emergency medical treatment immediately.
–– if you experience chest pressure, heaviness, tightness, squeezing, burning or choking
sensation (signs of insufficient blood flow and oxygen to the heart muscle). Your doctor
will need to check your heart.
–– if you get signs of 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 experience profuse sweating, headache, nausea, vomiting and diarrhoea
(symptoms of cholinergic syndrome).
–– if you experience severely decreased urine output (sign of kidney failure).
–– if you experience an allergic reaction (swelling mainly of the face, mouth and throat, as
well as, the tongue, which may be itchy or painful).
If any of the above apply to you, please tell your doctor immediately before taking the next
Clozaril tablet.

Other side effects:

Very common (affects more than 1 in 10 people):
Drowsiness, dizziness, fast heart beat, increased production of saliva.
Common (affects up to 1 in 10 people):
High level of white blood cells (leukocytosis), high level of a specific type of white blood
cell (eosinophilia), weight gain, blurred vision, headache, trembling, stiffness,
restlessness, convulsions, jerks, abnormal movements, inability to initiate movement,
inability to remain motionless, changes in ECG heart machine, high blood pressure,
faintness or light-headedness after changing position, sudden loss of consciousness,
nausea (feeling sick), vomiting (being sick), loss of appetite, dry mouth, minor
abnormalities in liver function tests, loss of bladder control, difficulty in passing urine,
tiredness, fever, increased sweating, raised body temperature, speech disorders
(e.g. slurred speech).
Uncommon (affects up to 1 in 100 people):
Lack of white blood cells (agranulocytosis), speech disorders (e.g. stuttering).
Rare (affects up to 1 in 1,000 people):
Low level of red blood cells (anaemia), restlessness, agitation, confusion, delirium,
circulatory collapse, irregular heart beat, inflammation of the heart muscle (myocarditis) or
the membrane surrounding the heart muscle (pericarditis), fluid collection around the heart
(pericardial effusion), difficulty in swallowing (e.g. food going down the wrong way), high
level of sugar in the blood, diabetes mellitus, blood clot in the lungs (thromboembolism),

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Very rare (affects up to 1 in 10,000 people):
Increase in numbers of blood platelets with possible clotting in the blood vessels, decrease
in numbers of blood platelets, uncontrollable movements of mouth/tongue and limbs,
obsessive thoughts and compulsive repetitive behaviours (obsessive compulsive
symptoms), skin reactions, swelling in front of the ear (enlargement of saliva glands),
difficulty in breathing, complications due to uncontrolled blood sugar (e.g. coma or
ketoacidosis), very high levels of triglycerides or cholesterol in the blood, disorder of the
heart muscle (cardiomyopathy), stopped heart beat (cardiac arrest), severe constipation
with abdominal pain and stomach cramps caused by obstruction of the bowel (paralytic
ileus), swollen abdomen, abdominal pain, severe liver damage (fulminant hepatic
necrosis), inflammation of the kidneys, sudden unexplained death.
Unknown (frequency cannot be estimated from the available data)
Liver disorders including fatty liver disease, death of liver cells, liver toxicity/injury, liver
disorders that involve replacement of normal liver tissue with scar tissue leading to loss of
liver function, including those liver events leading to life-threatening consequences such as
liver failure (which may lead to death), liver injury (injury of liver cells, bile duct in the liver,
or both) and liver transplant, changes in brain waves machine (electroencephalogram/EEG),
diarrhoea, stomach discomfort, heartburn, stomach discomfort after a meal, muscle
weakness, muscle spasms, muscle pain, stuffy nose, nocturnal bedwetting, sudden,
uncontrollable increase in blood pressure (pseudophaeochromocytoma), uncontrolled
bending of the body to one side (pleurothotonus), ejaculatory disorder if you are a male, in
which semen enters the bladder instead of ejaculating through the penis (dry orgasm or
retrograde ejaculation), rash, purplish-red spots, fever or itching due to inflammation of
blood vessel, inflammation of the colon resulting in diarrhoea, abdominal pain, fever,
change in skin colour, “butterfly” facial rash, joint pain, muscle pain, fever and fatigue
(lupus erythematous).
In elderly people with dementia, a small increase in the number of people dying has been
reported for patients taking antipsychotics compared with those not taking antipsychotics.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly (see below).
By reporting side effects, you can help provide more information on the safety of this
medicine.
United Kingdom

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

5. How to store Clozaril

–– Keep this medicine out of the sight and reach of children.
–– Do not use Clozaril after the expiry date which is stated on the blister/bottle and the
carton. The expiry date refers to the last day of that month.
–– This medicinal product does not require any special storage conditions.
–– Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will help
protect the environment.

6. Contents of the pack and other information
What Clozaril contains

–– The active substance is clozapine. Each tablet contains 25 mg or 100 mg clozapine.
–– The other ingredients are magnesium stearate, anhydrous colloidal silica, povidone K30,
talc, maize starch, lactose monohydrate.

What Clozaril looks like and contents of the pack

Clozaril tablets are available in PVC/PVDC/Aluminium or PVC/PE/PVDC/Aluminium blister
packs containing 7, 14, 20, 28, 30, 40, 50, 60, 84, 98, 100, 500 (10x50) or 5000 (100x50)
tablets, and in amber glass bottles (class III) containing 100 or 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Novartis Pharmaceuticals UK Ltd
Trading as Sandoz Pharmaceuticals
Frimley Business Park
Frimley, Camberley
Surrey
GU16 7SR
Manufacturer:
Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley
Camberley
Surrey
GU16 7SR

Date of revision: 12/2015
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inflammation of the liver (hepatitis), liver disease causing yellowing of the skin/dark
urine/itching, inflammation of the pancreas leading to severe upper stomach pain, raised
levels of an enzyme called creatinine phosphokinase in the blood.

Matt Batch

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2. What you need to know before you take Clozaril
Package Leaflet: Information for the user

CLOZARIL®
Clozaril 25 mg tablets
Clozaril 100 mg tablets
clozapine
Read all of this leaflet carefully before you start taking this medicine because
it contains important information for you.
- 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 only. Do not pass it on to others. It
may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Clozaril is and what it is used for
2. What you need to know before you take Clozaril
3. How to take Clozaril
4. Possible side effects
5. How to store Clozaril
6. Contents of the pack and other information
1. What Clozaril is and what it is used for
The active ingredient of Clozaril is clozapine which belongs to a group of medicines
called antipsychotics (medicines that are used to treat specific mental disorders
such as psychosis).
Clozaril is used to treat people with schizophrenia in whom other medicines have
not worked. Schizophrenia is a mental illness which affects how you think, feel and
behave. You should only use this medicine if you have already tried at least two
other antipsychotic medicines, including one of the newer atypical antipsychotics,
to treat schizophrenia, and these medicines did not work, or caused severe side
effects that cannot be treated.
Clozaril is also used to treat severe disturbances in the thoughts, emotions and
behaviour of people with Parkinson’s disease in whom other medicines have not
worked.

Do not take Clozaril
- if you are allergic (hypersensitive) to clozapine or any of the other ingredients of
Clozaril (listed in section 6).
- if you are not able to have regular blood tests.
- if you have ever been told you have a low white blood cell count (e.g. leucopenia
or agranulocytosis), especially if this was caused by medicines. This does
not apply if you have had low white blood cell count caused by previous
chemotherapy.
- if you had to stop using Clozaril previously because of severe side effects (e.g.
agranulocytosis or heart problems).
- if you are being or have been treated with long‑acting depot injections of
antipsychotics.
- if you suffer from bone marrow disease or have ever suffered from bone marrow
disease.
- if you suffer from uncontrolled epilepsy (seizures or fits).
- if you have an acute mental illness caused by alcohol or drugs (e.g. narcotics).
- if you suffer from reduced consciousness and severe drowsiness.
- if you suffer from circulatory collapse which may occur as a result of severe
shock.
- if you suffer from any severe kidney disease.
- if you suffer from myocarditis (an inflammation of the heart muscle).
- if you suffer from any other severe heart disease.
- if you have symptoms of active liver disease such as jaundice (yellow colouring
of the skin and eyes, feeling sick and loss of appetite).
- if you suffer from any other severe liver disease.
- if you suffer from paralytic ileus (your bowel does not work properly and you
have severe constipation).
- if you use any medicine that stops your bone marrow from working properly.
- if you use any medicine that reduces the number of white cells in your blood.
If any of the above applies to you, tell your doctor and do not take Clozaril.
Clozaril must not be given to anyone who is unconscious or in a coma.
Warnings and Precautions
The safety measures mentioned in this section are very important. You
must comply with them to minimise the risk of serious life-threatening side
effects.

Before you start treatment with Clozaril, tell your doctor if you suffer from or
have ever suffered from:
- blood clots or family history of blood clots, as medicines like these have been
associated with formation of blood clots.
- glaucoma (increased pressure in the eye).
- diabetes. Elevated (sometimes considerably) blood sugar levels, has occurred in
patients with or without diabetes mellitus in their medical history (see section
4).
- prostate problems or difficulty in urinating.
- any heart, kidney or liver disease.
- chronic constipation or if you are taking medicines which cause constipation
(such as anticholinergics).
- galactose intolerance, Lapp lactase deficiency or glucose-galactose
malabsorption.
- controlled epilepsy.
- large intestine diseases.
- tell your doctor if you have ever had abdominal surgery.
- if you have had a heart disease or family history of abnormal conduction in the
heart called “prolongation of the QT interval”.
- if you are at risk for having a stroke, for example if you have high blood pressure,
cardiovascular problems or blood vessel problems in the brain.
Tell your doctor immediately before taking the next Clozaril tablet:
- if you get signs of a cold, fever, flu‑like symptoms, sore throat or any other
infection. You will have to have an urgent blood test to check if your symptoms
are related to your medicine.
- if you have a sudden rapid increase in body temperature, rigid muscles
which may lead to unconsciousness (neuroleptic malignant syndrome) as you
may be experiencing a serious side effect which requires immediate treatment.
- if you have fast and irregular heart beat, even when you are at rest,
palpitations, breathing problems, chest pain or unexplained tiredness. Your
doctor will need to check your heart and if necessary refer you to a cardiologist
immediately.
- if you experience nausea (feeling sick), vomiting (being sick) and/or loss of
appetite. Your doctor will need to check your liver.
- if you have severe constipation. Your doctor will have to treat this in order to
avoid further complications.
Medical check‑ups and blood tests
Before you start taking Clozaril, your doctor will ask about your medical history and
do a blood test to ensure that your white blood cells count is normal. It is important
to find this out, as your body needs white blood cells to fight infections.

Make sure that you have regular blood tests before you start treatment,
during treatment and after you stop treatment with Clozaril.
- Your doctor will tell you exactly when and where to have the tests. Clozaril may
only be taken if you have a normal blood count.
- Clozaril can cause a serious decrease in the number of white cells in your blood
(agranulocytosis). Only regular blood tests can tell the doctor if you are at risk of
developing agranulocytosis.
- During the first 18 weeks of treatment, tests are needed once a week.
Afterwards, tests are needed at least once a month.
- If there is a decrease in the number of white blood cells, you will have to stop
Clozaril treatment immediately. Your white blood cells should then return to
normal.
- You will need to have blood tests for another 4 weeks after the end of Clozaril
treatment.
Your doctor will also do a physical examination before starting treatment. Your
doctor may do an electrocardiogram (ECG) to check your heart, but only if this is
necessary for you, or if you have any special concerns.
If you have a liver disorder you will have regular liver function tests as long as
you continue to take Clozaril. If you suffer from high levels of sugar in the blood
(diabetes) your doctor may regularly check your level of sugar in the blood.
Clozaril may cause alteration in blood lipids. Clozaril may cause weight gain. Your
doctor may monitor your weight and blood lipid level.
If Clozaril makes you feel light‑headed, dizzy or faint, be careful when getting up
from a sitting or lying position.
If you have to undergo surgery or if for some reason you are unable to walk around
for a long time, discuss with your doctor the fact that you are taking Clozaril. You
may be at risk of thrombosis (blood clotting within a vein).
Children and adolescents under 16 years
If you are under 16 years of age you should not use Clozaril as there is not enough
information on its use in that age group.
Older people (aged 60 years and over)
Older people (aged 60 years and over) may be more likely to have the following side
effects during treatment with Clozaril: faintness or light-headedness after changing
position, dizziness, fast heart beat, difficulty in passing urine, and constipation.
Tell your doctor or pharmacist if you suffer from a condition called dementia.

Other medicines and Clozaril
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This includes medicines obtained without a prescription or
herbal therapies. You might need to take different amounts of your medicines or to
take different medicines.
Do not take Clozaril together with medicines that stop the bone marrow from
working properly and/or decrease the number of blood cells produced by
the body, such as:
− carbamazepine, a medicine used in epilepsy.
− certain antibiotics: chloramphenicol, sulphonamides such as co-trimoxazole.
− certain painkillers: pyrazolone analgesics such as phenylbutazone.
− penicillamine, a medicine used to treat rheumatic joint inflammation.
− cytoxic agents, medicines used in chemotherapy.
− long‑acting depot injections of antipsychotic medicines.
These medicines increase your risk of developing agranulocytosis (lack of white
blood cells).
Taking Clozaril at the same time as another medicine may affect how well
Clozaril and/or the other medicine works. Tell your doctor if you plan to
take, if you are taking (even if the course of treatment is about to end) or if
you have recently had to stop taking any of the following medicines:
− medicines used to treat depression such as lithium, fluvoxamine, tricyclic
antidepressants, MAO inhibitors, citalopram, paroxetine, fluoxetine, and
sertraline.
− other antipsychotic medicines used to treat mental illnesses such as perazine.
− benzodiazepines and other medicines used to treat anxiety or sleep
disturbances.
− narcotics and other medicines which can affect your breathing.
− medicines used to control epilepsy such as phenytoin and valproic acid.
− medicines used to treat high or low blood pressure such as adrenaline and
noradrenaline.
− warfarin, a medicine used to prevent blood clots.
− 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.
− digoxin, a medicine used to treat heart problems.
− medicines used to treat a fast or irregular heart beat.
− some medicines used to treat stomach ulcers, such as omeprazole or cimetidine.
− some antibiotic medicines, such as erythromycin and rifampicin.

− some medicines used to treat fungal infections (such as ketoconazole) or viral
infections (such as protease inhibitors, used to treat HIV infections).
− atropine, a medicine which may be used in some eye drops or cough and cold
preparations.
− adrenaline, a medicine used in emergency situations.
− hormonal contraceptives (birth-control tablets).
This list is not complete. Your doctor and pharmacist have more information on
medicines to be careful with or to avoid while taking Clozaril. They will also know if
the medicines you are taking belong to the listed groups. Speak to them.
Taking Clozaril with food and drink
Do not drink alcohol during treatment with Clozaril.
Tell your doctor if you smoke and how often you have drinks containing caffeine
(coffee, tea, cola). Sudden changes in your smoking habits or caffeine drinking
habits can also change the effects of Clozaril.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning
to have a baby, ask your doctor for advice before taking this medicine. Your doctor
will discuss with you the benefits and possible risks of using this medicine during
pregnancy. Tell your doctor immediately if you become pregnant during treatment
with Clozaril.
The following symptoms may occur in newborn babies, of mothers that have used
Clozaril 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.
Some women taking some medicines to treat mental illnesses have irregular or no
periods. If you have been affected in this way, your periods might return when your
medicine is changed to Clozaril. This means you should use effective contraception.
Do not breast‑feed during treatment with Clozaril. Clozapine, the active substance
of Clozaril, may pass into your milk and affect your baby.
Driving and using machines
Clozaril might cause tiredness, drowsiness and seizures, especially at the
beginning of treatment. You should not drive or operate machines while you have
these symptoms.
Clozaril contains lactose.
If you have been told by your doctor that you have an intolerance to some sugars,
discuss this with your doctor before taking Clozaril.
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3. How to take Clozaril
In order to minimise the risk of low blood pressure, seizures and drowsiness it
is necessary that your doctor increases your dose gradually. Always take Clozaril
tablets exactly as your doctor has told you. Check with your doctor or pharmacist if
you are not sure.
It is important that you do not change your dose or stop taking Clozaril without
asking your doctor first. Continue taking the tablets for as long as your doctor
tells you. If you are 60 years or older, your doctor may start you on a lower dose
and increase it more gradually because you might be more likely to develop some
unwanted side effects (see section 2 “Before you take Clozaril”).
If the dose you are prescribed cannot be achieved with this strength tablet, other
strengths of this medicinal product are available to achieve the dose.
Treatment of schizophrenia
The usual starting dose is 12.5 mg (one half of a 25 mg tablet) once or twice on the
first day followed by 25 mg once or twice on the second day. Swallow the tablet with
water. If tolerated well, your doctor will then gradually increase the dose in steps
of 25‑50 mg over the next 2‑3 weeks until a dose up to 300 mg per day is reached.
Thereafter, if necessary, the daily dose may be increased in steps of 50 to 100 mg
half‑weekly or, preferably, at weekly intervals.
The effective daily dose is usually between 200 mg and 450 mg, divided into several
single doses per day. Some people might need more. A daily dose of up to 900 mg
is allowed. Increased side effects (in particular seizures) are possible at daily
doses over 450 mg. Always take the lowest effective dose for you. Most people take
part of their dose in the morning and part in the evening. Your doctor will tell you
exactly how to divide your daily dose. If your daily dose is only 200 mg, then you can
take this as a single dose in the evening. Once you have been taking Clozaril with
successful results for some time, your doctor may try you on a lower dose. You will
need to take Clozaril for at least 6 months.
Treatment of severe thought disturbances in patients with Parkinson’s
disease
The usual starting dose is 12.5 mg (one half of a 25 mg tablet) in the evening.
Swallow the tablet with water. Your doctor will then gradually increase the dose
in steps of 12.5 mg, not faster than two steps a week, up to a maximum dose of
50 mg by the end of the second week. Increases in the dosage should be stopped or
postponed if you feel faint, light‑headed or confused. In order to avoid such symptoms
your blood pressure will be measured during the first weeks of treatment.
The effective daily dose is usually between 25 mg and 37.5 mg, taken as one dose in
the evening. Doses of 50 mg per day should only be exceeded in exceptional cases.
The maximum daily dose is 100 mg. Always take the lowest effective dose for you.

If you take more Clozaril than you should
If you think that you may have taken too many tablets, or if anyone else takes any
of your tablets, contact a doctor immediately or call for emergency medical help.

Common (affects up to 1 in 10 people):
- if you get signs of a cold, fever, flu‑like symptoms, sore throat or any other
infection. You will have to have an urgent blood test to check if your symptoms
are related to your medicine.
- if you experience seizures.

- if you experience severely decreased urine output (sign of kidney failure).
- if you experience an allergic reaction (swelling mainly of the face, mouth and
throat, as well as, the tongue, which may be itchy or painful).

abdominal pain and stomach cramps caused by obstruction of the bowel (paralytic
ileus), swollen abdomen, abdominal pain, severe liver damage (fulminant hepatic
necrosis), inflammation of the kidneys, sudden unexplained death.

If any of the above apply to you, please tell your doctor immediately before taking
the next Clozaril tablet.

Uncommon (affects up to 1 in 100 people):
- if you have a sudden rapid increase in body temperature, rigid muscles which
may lead to unconsciousness (neuroleptic malignant syndrome) as you may be
experiencing a serious side effect which requires immediate treatment.

Other side effects:

If you forget to take Clozaril
If you forget to take a dose, take it as soon as you remember. If it is almost time for
your next dose, leave out the forgotten tablets and take the next dose at the right
time. Do not take a double dose to make up for a forgotten dose. Contact your doctor
as soon as possible if you have not taken any Clozaril for more than 48 hours.

Rare (affects up to 1 in 1,000 people):
- if you get signs of a respiratory tract infection or pneumonia such as fever,
coughing, difficulty breathing, wheezing.
- if you experience nausea (feeling sick), vomiting (being sick) and/or loss of
appetite. Your doctor will need to check your liver.

If you stop taking Clozaril
Do not stop taking Clozaril without asking your doctor, because you might get
withdrawal reactions. These reactions include sweating, headache, nausea (feeling
sick), vomiting (being sick) and diarrhoea. If you have any of the above signs,
tell your doctor straight away. These signs may be followed by more serious
side effects unless you are treated immediately. Your original symptoms might
come back. A gradual reduction in dose in steps of 12.5 mg over one to two weeks
is recommended, if you have to stop treatment. Your doctor will advise you on how
to reduce your daily dose. If you have to stop Clozaril treatment suddenly, you will
have to be checked by your doctor.

Rare (affects up to 1 in 1,000 people) or very rare (affects up to 1 in
10,000 people):
- if you have fast and irregular heart beat, even when you are at rest,
palpitations, breathing problems, chest pain or unexplained tiredness. Your
doctor will need to check your heart and if necessary refer you to a cardiologist
immediately.

Common (affects up to 1 in 10 people):
High level of white blood cells (leukocytosis), high level of a specific type of
white blood cell (eosinophilia), weight gain, blurred vision, headache, trembling,
stiffness, restlessness, convulsions, jerks, abnormal movements, inability to
initiate movement, inability to remain motionless, changes in ECG heart machine,
high blood pressure, faintness or light-headedness after changing position,
sudden loss of consciousness, nausea (feeling sick), vomiting (being sick), loss
of appetite, dry mouth, minor abnormalities in liver function tests, loss of bladder
control, difficulty in passing urine, tiredness, fever, increased sweating, raised body
temperature, speech disorders (e.g. slurred speech).

Unknown (frequency cannot be estimated from the available data)
Liver disorders including fatty liver disease, death of liver cells, liver toxicity/
injury, liver disorders that involve replacement of normal liver tissue with scar
tissue leading to loss of liver function, including those liver events leading to
life-threatening consequences such as liver failure (which may lead to death),
liver injury (injury of liver cells, bile duct in the liver, or both) and liver transplant,
changes in brain waves machine (electroencephalogram/EEG), diarrhoea, stomach
discomfort, heartburn, stomach discomfort after a meal, muscle weakness, muscle
spasms, muscle pain, stuffy nose, nocturnal bedwetting, sudden, uncontrollable
increase in blood pressure (pseudophaeochromocytoma), uncontrolled bending
of the body to one side (pleurothotonus), ejaculatory disorder if you are a male,
in which semen enters the bladder instead of ejaculating through the penis (dry
orgasm or retrograde ejaculation), rash, purplish-red spots, fever or itching due
to inflammation of blood vessel, inflammation of the colon resulting in diarrhoea,
abdominal pain, fever, change in skin colour, “butterfly” facial rash, joint pain,
muscle pain, fever and fatigue (lupus erythematous).

The symptoms of overdose are:
Drowsiness, tiredness, lack of energy, unconsciousness, coma, confusion,
hallucinations, agitation, incoherent speech, stiff limbs, trembling hands, seizures
(fits), increased production of saliva, widening of the black part of the eye, blurred
vision, low blood pressure, collapse, fast or irregular heart beat, shallow or difficult
breathing.

If your doctor decides to re‑start the treatment with Clozaril and your last dose of
Clozaril was over two days ago, this will be with the starting dose of 12.5 mg.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.
4. Possible side effects
Like all medicines, Clozaril can cause side effects, although not everybody gets
them.
Some side effects can be serious and need immediate medical attention:
Tell your doctor immediately before taking the next Clozaril tablet:
Very common (affects more than 1 in 10 people):
- if you have severe constipation. Your doctor will have to treat this in order to
avoid further complications.

Very rare (affects up to 1 in 10,000 people):
- if you are a man and experience persistent painful erection of the penis. This
is called priapism. If you have an erection which lasts more than 4 hours
immediate medical treatment may be needed in order to avoid further
complications.
Unknown (frequency cannot be estimated from the available data)
- if you experience crushing chest pain, sensation of chest tightness, pressure
or squeezing (chest pain may radiate to the left arm, jaw, neck and upper
abdomen), shortness of breath, sweating, weakness, light headedness,
nausea, vomiting and palpitations (symptoms of heart attack). You should seek
emergency medical treatment immediately.
- if you experience chest pressure, heaviness, tightness, squeezing, burning
or choking sensation (signs of insufficient blood flow and oxygen to the heart
muscle). Your doctor will need to check your heart.
- if you get signs of 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 experience profuse sweating, headache, nausea, vomiting and diarrhoea
(symptoms of cholinergic syndrome).

Very common (affects more than 1 in 10 people):
Drowsiness, dizziness, fast heart beat, increased production of saliva.

Uncommon (affects up to 1 in 100 people):
Lack of white blood cells (agranulocytosis), speech disorders (e.g. stuttering).
Rare (affects up to 1 in 1,000 people):
Low level of red blood cells (anaemia), restlessness, agitation, confusion, delirium,
circulatory collapse, irregular heart beat, inflammation of the heart muscle
(myocarditis) or the membrane surrounding the heart muscle (pericarditis), fluid
collection around the heart (pericardial effusion), difficulty in swallowing (e.g. food
going down the wrong way), high level of sugar in the blood, diabetes mellitus,
blood clot in the lungs (thromboembolism), inflammation of the liver (hepatitis),
liver disease causing yellowing of the skin/dark urine/itching, inflammation of the
pancreas leading to severe upper stomach pain, raised levels of an enzyme called
creatinine phosphokinase in the blood.
Very rare (affects up to 1 in 10,000 people):
Increase in numbers of blood platelets with possible clotting in the blood
vessels, decrease in numbers of blood platelets, uncontrollable movements
of mouth/tongue and limbs, obsessive thoughts and compulsive repetitive
behaviours (obsessive compulsive symptoms), skin reactions, swelling in front
of the ear (enlargement of saliva glands), difficulty in breathing, complications
due to uncontrolled blood sugar (e.g. coma or ketoacidosis), very high levels
of triglycerides or cholesterol in the blood, disorder of the heart muscle
(cardiomyopathy), stopped heart beat (cardiac arrest), severe constipation with

In elderly people with dementia, a small increase in the number of people dying has
been reported for patients taking antipsychotics compared with those not taking
antipsychotics.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. You can also report side effects
directly (see below). By reporting side effects, you can help provide more
information on the safety of this medicine.
United Kingdom

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

6. Contents of the pack and other information
What Clozaril contains
- The active substance is clozapine. Each tablet contains 25 mg or 100 mg
clozapine.
- The other ingredients are magnesium stearate, anhydrous colloidal silica,
povidone K30, talc, maize starch, lactose monohydrate.
What Clozaril looks like and contents of the pack
Clozaril tablets are available in PVC/PVDC/Aluminium or PVC/PE/PVDC/
Aluminium blister packs containing 7, 14, 20, 28, 30, 40, 50, 60, 84, 98, 100, 500
(10x50) or 5000 (100x50) tablets, and in amber glass bottles (class III) containing
100 or 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Novartis Pharmaceuticals UK Ltd
Trading as Sandoz Pharmaceuticals
Frimley Business Park
Frimley, Camberley
Surrey
GU16 7SR
Manufacturer:
Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley
Camberley
Surrey
GU16 7SR
Date of revision: 12/2015

5. How to store Clozaril
- Keep this medicine out of the sight and reach of children.
- Do not use Clozaril after the expiry date which is stated on the blister/bottle and
the carton. The expiry date refers to the last day of that month.
- This medicinal product does not require any special storage conditions.
- Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures
will help protect the environment.
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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