CLOZARIL 100MG TABLETS

Active substance: CLOZAPINE

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Mockup code 369721_GB_LFT
Description:
LFT Clozaril tab 25/100mg GB
Line/Plant: CP
Proof No:
7
Date:
04 Apr 2013
Author: PA
Software:
InDesign CS6 (8)

T e m p l at e

180 x 594 L/S
SUBMISSION
Colours:
Black

Change to Variable Data/New Pack:
Change to Price/Addition of Price:
TVT compatible:

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Prior to this artwork’s use for printing
thePDF file must be PKI verified upon
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2. BEFORE YOU TAKE CLOZARIL

Do not 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.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– 
This medicine has been prescribed for you. Do not pass it on to others. It may
harm them, even if their symptoms are the same as yours.
–  any of the side effects gets serious, or if you notice any side effects not listed
If
in this leaflet, please tell your doctor or pharmacist.

In this leaflet:
1. What Clozaril is and what it is used for
2. Before you take Clozaril
3. How to take Clozaril
4. Possible side effects
5. How to store Clozaril
6. Further information

1. WHAT CLOZARIL IS AND WHAT IT IS USED FOR
Clozaril 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.

–  you are allergic (hypersensitive) to clozapine or any of the other ingredients
if
of Clozaril.
– if you are not able to have regular blood tests.
–  you have ever been told you have a low white blood cell count (e.g. leucopenia
if
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.
–  you suffer from bone marrow disease or have ever suffered from bone
if
marrow disease.
– 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.
–  you had to stop using Clozaril previously because of severe side effects (e.g.
if
agranulocytosis or heart problems).
– 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 myocarditis (an inflammation of the heart muscle).
– if you suffer from any other severe heart disease.
– if you suffer from any severe kidney disease.
–  you have symptoms of active liver disease such as jaundice (yellow colouring
if
of the skin and eyes, feeling sick and loss of appetite).
– if you suffer from any other severe liver disease.
– if you suffer from reduced consciousness and severe drowsiness.
–  you suffer from circulatory collapse which may occur as a result of
if
severe shock.
–  you suffer from paralytic ileus (your bowel does not work properly and you
if
have severe constipation).
–  you are being or have been treated with long-acting depot injections
if
of antipsychotics.
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.

Take special care with Clozaril
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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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.
–  you have had a heart disease or family history of abnormal conduction in the
if
heart called “prolongation of the QT interval”.
–  you are at risk for having a stroke, for example if you have high blood
if
pressure, cardiovascular problems or blood vessel problems in the brain.
Tell your doctor immediately before taking the next Clozaril tablet:
–  you get signs of a cold, fever, flu-like symptoms, sore throat or any other
if
infection. You will have to have an urgent blood test to check if your symptoms
are related to your medicine.
–  you have a sudden rapid increase in body temperature, rigid muscles
if
which may lead to unconsciousness (neuroleptic malignant syndrome) as you
may be experiencing a serious side effect which requires immediate treatment.
–  you have fast and irregular heart beat, even when you are at rest,
if
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.
–  you experience nausea (feeling sick), vomiting (being sick) and/or loss
if
of appetite. Your doctor will need to check your liver.
–  you have severe constipation. Your doctor will have to treat this in order to
if
avoid further complications.

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.
–  there is a decrease in the number of white blood cells, you will have to stop
If
Clozaril treatment immediately. Your white blood cells should then return
to normal.
–  will need to have blood tests for another 4 weeks after the end of
You
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)

Medical check-ups and blood tests

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.

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

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

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Taking other medicines
Before you start taking Clozaril, please tell your doctor if you are taking or have
recently taken 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 may affect how well other medicines work or they might
affect how well Clozaril works. Tell your doctor if you are taking any of the
following medicines:
−  edicines used to treat depression such as lithium, fluvoxamine, tricyclic
m
antidepressants, MAO inhibitors, citalopram, paroxetine, fluoxetine,
and sertraline.
− other antipsychotic medicines usued to treat mental illnesses.
−  enzodiazepines and other medicines used to treat anxiety or sleep
b
disturbances.
− narcotics and other medicines which can affect your breathing.
− medicines used to control epilepsy such as phenytoin and valproic acid.
−  edicines used to treat high or low blood pressure such as adrenaline and
m
noradrenaline.
− warfarin, a medicine used to prevent blood clots.
− antihistamines, medicines used for colds or allergies such as hay fever.
−  nticholinergic medicines, which are used to relieve stomach cramps, spasms
a
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.

A3+

C96 (CP1/2)
180 x 594 mm Landscape
Revision No. 1
18 May 2007
Fold code - CP1/CP2a

− some antibiotic medicines, such as erythromycin and rifampicin.
−  ome medicines used to treat fungal infections (such as ketoconazole) or viral
s
infections (such as protease inhibitors, used to treat HIV infections).
−  tropine, a medicine which may be used in some eye drops or cough and
a
cold preparations.
− adrenaline, a medicine used in emergency situations.
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
Tell your doctor before using Clozaril if you are pregnant or you think that you
might be pregnant. 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.

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Important information about some of the ingredients of Clozaril
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. You should 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.
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 product, 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:
–  you get signs of a cold, fever, flu-like symptoms, sore throat or any other
if
infection. You will have to have an urgent blood test to check if your symptoms
are related to your medicine.
–  you have a sudden rapid increase in body temperature, rigid muscles
if
which may lead to unconsciousness (neuroleptic malignant syndrome) as you
may be experiencing a serious side effect which requires immediate treatment.
–  you experience crushing chest pain, sensation of chest tightness, pressure
if
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.
–  you have fast and irregular heart beat, even when you are at rest,
if
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.
–  you experience chest pressure, heaviness, tightness, squeezing, burning
if
or choking sensation (signs of insufficient blood flow and oxygen to the heart
muscle). Your doctor will need to check your heart.
–  you experience nausea (feeling sick), vomiting (being sick) and/or loss
if
of appetite. Your doctor will need to check your liver.
–  you have severe constipation. Your doctor will have to treat this in order to
if
avoid further complications.
–  you get signs of a respiratory tract infection or pneumonia such as fever,
if
coughing, difficulty breathing, wheezing.
–  you get signs of blood clots in the veins especially in the legs (symptoms
if
include swelling, pain and redness in the leg), which may travel through blood
vessels to the lungs causing chest pain and difficulty in breathing.
–  you experience profuse sweating, headache, nausea, vomiting and diarrhoea
if
(symptoms of cholinergic syndrome).
– if you experience severely decreased urine output (sign of kidney failure).
– if you experience seizures.
All possible side effects are listed under headings of frequency:
Very common (affects more than 1 in 10 people):
Drowsiness, dizziness, fast heart beat, constipation, increased production
of saliva.

Common (affects up to 1 in 10 people):
Low level of white blood cells (leukopenia), 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, seizures,
convulsions, jerks, abnormal movements, inability to initiate movement, inability
to remain motionless, 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), neuroleptic malignant syndrome
(disorder with high fever, impaired consciousness and muscle stiffness), 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), respiratory tract infection
and pneumonia, 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
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, persistent painful erection of the penis,
sudden unexplained death.

Unknown (frequency cannot be estimated from the available data)
Blood clots in the vein, profuse sweating, headache, nausea, vomiting and diarrhoea
(symptoms of cholinergic syndrome), crushing chest pain, shortness of breath
(symptoms of heart attack), chest pressure or heaviness (signs of insufficient
blood flow and oxygen to the heart muscle), severely decreased urine output (sign
of kidney failure), changes in brain waves machine (electroencephalogram/EEG),
diarrhoea, stomach discomfort, heartburn, stomach discomfort after a meal, muscle
weakness, muscle spasms, muscle pain, stuffy nose.
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.
If any of the side effects gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE CLOZARIL
– Keep out of the reach and sight of children.
–  not use Clozaril after the expiry date which is stated on the blister/bottle and
Do
the carton. The expiry date refers to the last day of that month.
– This medicinal product does not require any special storage conditions.
– 
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6. FURTHER INFORMATION
What Clozaril contains
–  active substance is clozapine. Each tablet contains 25 mg or 100 mg
The
clozapine.
–  other ingredients are magnesium stearate, anhydrous colloidal silica,
The
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.

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
Wimblehurst Road, Horsham, West Sussex, RH12 5AB
Novartis Pharmaceuticals UK Ltd
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR

These medicinal products are authorised in the Member States of
the EEA under the following names:
Austria
Leponex 25 mg and 100 mg Tabletten
Belgium 
Leponex 25 mg and 100 mg tabletten/ Leponex 25 mg and
100 mg Tabletten/ Leponex 25 mg and 100 mg comprimés
Denmark
Leponex
Finland
Leponex 25 mg and 100 mg tabletti
France
Leponex 25 mg and 100 mg comprimé sécable
Germany
Leponex 25 mg and 100 mg Tabletten
Greece
Leponex 25 mg and 100 mg Δισκία
Iceland
Leponex 25 mg and 100 mg töflur
Ireland
Clozaril 25 mg and 100 mg tablets
Italy
Leponex 25 mg and 100 mg compresse
Luxembourg
Leponex 25 mg and 100 mg
Netherlands
Leponex 25 mg and 100 mg, tabletten
Norway
Leponex 25 mg and 100 mg tabletter
Portugal
Leponex 25 mg and 100 mg comprimidos
Spain
Leponex 25 mg and 100 mg comprimidos
Sweden
Leponex 25 mg and 100 mg tabletter
United Kingdom
Clozaril 25 mg and 100 mg tablets

Not all pack sizes may be marketed.
This leaflet was last approved in 02/2013.
GB

Bottom

369721

SUBMISSION

Description:
LFT Clozaril TAB 25/100mg GB
Line/Plant: LF
Proof No:
6
Date:
04 Apr 2013
Author: PA
Software:
InDesign CS6 (8)

Colours:
Black

Change to Variable Data/New Pack:
Change to Price/Addition of Price:
TVT compatible

No
No
Yes

Prior to this artwork’s use for printing
thePDF file must be PKI verified upon
receipt.

1. WHAT CLOZARIL IS AND WHAT IT IS USED FOR

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.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– 
This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
–  any of the side effects gets serious, or if you notice any side effects not listed in
If
this leaflet, please tell your doctor or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.
369726

T e m p l at e

Mockup code 369726_GB_LFT

GB

Pharma Code to be read and run in this direction
XXX

148 x 594 L/S

What Clozaril is and what it is used for
Before you take Clozaril
How to take Clozaril
Possible side effects
How to store Clozaril
Further information

Clozaril 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.

2. BEFORE YOU TAKE CLOZARIL
Do not take Clozaril
–  you are allergic (hypersensitive) to clozapine or any of the other ingredients
if
of Clozaril.
– if you are not able to have regular blood tests.
–  you have ever been told you have a low white blood cell count (e.g. leucopenia or
if
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.
–  you suffer from bone marrow disease or have ever suffered from bone
if
marrow disease.
– 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.
–  you had to stop using Clozaril previously because of severe side effects (e.g.
if
agranulocytosis or heart problems).
– 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 myocarditis (an inflammation of the heart muscle).
– if you suffer from any other severe heart disease.
– if you suffer from any severe kidney disease.
–  you have symptoms of active liver disease such as jaundice (yellow colouring of
if
the skin and eyes, feeling sick and loss of appetite).
– if you suffer from any other severe liver disease.
– if you suffer from reduced consciousness and severe drowsiness.
– if you suffer from circulatory collapse which may occur as a result of severe shock.
–  you suffer from paralytic ileus (your bowel does not work properly and you have
if
severe constipation).

Top
–  you are being or have been treated with long-acting depot injections of antipsychotics.
if
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.

Take special care with Clozaril
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.
–  you have had a heart disease or family history of abnormal conduction in the heart
if
called “prolongation of the QT interval”.
–  you are at risk for having a stroke, for example if you have high blood pressure,
if
cardiovascular problems or blood vessel problems in the brain.
Tell your doctor immediately before taking the next Clozaril tablet:
–  you get signs of a cold, fever, flu-like symptoms, sore throat or any other
if
infection. You will have to have an urgent blood test to check if your symptoms are
related to your medicine.
–  you have a sudden rapid increase in body temperature, rigid muscles which
if
may lead to unconsciousness (neuroleptic malignant syndrome) as you may be
experiencing a serious side effect which requires immediate treatment.
–  you have fast and irregular heart beat, even when you are at rest, palpitations,
if
breathing problems, chest pain or unexplained tiredness. Your doctor will need
to check your heart and if necessary refer you to a cardiologist immediately.

Bottom

–  you experience nausea (feeling sick), vomiting (being sick) and/or loss of
if
appetite. Your doctor will need to check your liver.
–  you have severe constipation. Your doctor will have to treat this in order to avoid
if
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.
–  there is a decrease in the number of white blood cells, you will have to stop Clozaril
If
treatment immediately. Your white blood cells should then return to normal.
–  will need to have blood tests for another 4 weeks after the end of Clozaril treatment.
You
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.

Taking other medicines
Before you start taking Clozaril, please tell your doctor if you are taking or have recently
taken 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 may affect how well other medicines work or they might
affect how well Clozaril works. Tell your doctor if you are taking any of the
following medicines:
−  edicines used to treat depression such as lithium, fluvoxamine, tricyclic
m
antidepressants, MAO inhibitors, citalopram, paroxetine, fluoxetine, and sertraline.
− other antipsychotic medicines usued to treat mental illnesses.
− 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.
−  edicines used to treat high or low blood pressure such as adrenaline
m
and noradrenaline.
− warfarin, a medicine used to prevent blood clots.

A3+

Loose Fill Line
148 x 594 mm Landscape
Revision No. 6
7 Mar 2011
Fold code - LFg

− antihistamines, medicines used for colds or allergies such as hay fever.
−  nticholinergic medicines, which are used to relieve stomach cramps, spasms and
a
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.
−  ome medicines used to treat fungal infections (such as ketoconazole) or viral
s
infections (such as protease inhibitors, used to treat HIV infections).
−  tropine, a medicine which may be used in some eye drops or cough and
a
cold preparations.
− adrenaline, a medicine used in emergency situations.
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
Tell your doctor before using Clozaril if you are pregnant or you think that you might be
pregnant. 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.

Top
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.

Important information about some of the ingredients of Clozaril
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. You should 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.
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 product, ask your doctor
or pharmacist.

All possible side effects are listed under headings of frequency:
Very common (affects more than 1 in 10 people):
Drowsiness, dizziness, fast heart beat, constipation, increased production of saliva.

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:
–  you get signs of a cold, fever, flu-like symptoms, sore throat or any other
if
infection. You will have to have an urgent blood test to check if your symptoms are
related to your medicine.
–  you have a sudden rapid increase in body temperature, rigid muscles which
if
may lead to unconsciousness (neuroleptic malignant syndrome) as you may be
experiencing a serious side effect which requires immediate treatment.
–  you experience crushing chest pain, sensation of chest tightness, pressure or
if
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.
–  you have fast and irregular heart beat, even when you are at rest, palpitations,
if
breathing problems, chest pain or unexplained tiredness. Your doctor will need
to check your heart and if necessary refer you to a cardiologist immediately.
–  you experience chest pressure, heaviness, tightness, squeezing, burning or choking
if
sensation (signs of insufficient blood flow and oxygen to the heart muscle). Your
doctor will need to check your heart.
–  you experience nausea (feeling sick), vomiting (being sick) and/or loss of
if
appetite. Your doctor will need to check your liver.
–  you have severe constipation. Your doctor will have to treat this in order to avoid
if
further complications.
–  you get signs of a respiratory tract infection or pneumonia such as fever,
if
coughing, difficulty breathing, wheezing.
–  you get signs of blood clots in the veins especially in the legs (symptoms include
if
swelling, pain and redness in the leg), which may travel through blood vessels to
the lungs causing chest pain and difficulty in breathing.
–  you experience profuse sweating, headache, nausea, vomiting and diarrhoea
if
(symptoms of cholinergic syndrome).
–  you experience severely decreased urine output (sign of kidney failure).
if
–  you experience seizures.
if

Bottom

Common (affects up to 1 in 10 people):
Low level of white blood cells (leukopenia), 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, seizures,
convulsions, jerks, abnormal movements, inability to initiate movement, inability to
remain motionless, 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), neuroleptic malignant syndrome (disorder
with high fever, impaired consciousness and muscle stiffness), 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), respiratory tract infection and pneumonia, 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 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, persistent painful erection of
the penis, sudden unexplained death.
Unknown (frequency cannot be estimated from the available data)
Blood clots in the vein, profuse sweating, headache, nausea, vomiting and diarrhoea
(symptoms of cholinergic syndrome), crushing chest pain, shortness of breath
(symptoms of heart attack), chest pressure or heaviness (signs of insufficient blood
flow and oxygen to the heart muscle), severely decreased urine output (sign of kidney
failure), changes in brain waves machine (electroencephalogram/EEG), diarrhoea,
stomach discomfort, heartburn, stomach discomfort after a meal, muscle weakness,
muscle spasms, muscle pain, stuffy nose.
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.
If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE CLOZARIL
– Keep out of the reach and sight of children.
–  not use Clozaril after the expiry date which is stated on the blister/bottle and the
Do
carton. The expiry date refers to the last day of that month.
– This medicinal product does not require any special storage conditions.
– 
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will
help to protect the environment.

6. FURTHER INFORMATION
What Clozaril contains
– The active substance is clozapine. Each tablet contains 25 mg or 100 mg clozapine.
–  other ingredients are magnesium stearate, anhydrous colloidal silica, povidone
The
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
Wimblehurst Road, Horsham, West Sussex, RH12 5AB
Novartis Pharmaceuticals UK Ltd
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR

These medicinal products are authorised in the Member States of the
EEA under the following names:
Austria
Leponex 25 mg and 100 mg Tabletten
Belgium 
Leponex 25 mg and 100 mg tabletten/ Leponex 25 mg and
100 mg Tabletten/ Leponex 25 mg and 100 mg comprimés
Denmark
Leponex
Finland
Leponex 25 mg and 100 mg tabletti
France
Leponex 25 mg and 100 mg comprimé sécable
Germany
Leponex 25 mg and 100 mg Tabletten
Greece
Leponex 25 mg and 100 mg Δισκία
Iceland
Leponex 25 mg and 100 mg töflur
Ireland
Clozaril 25 mg and 100 mg tablets
Italy
Leponex 25 mg and 100 mg compresse
Luxembourg
Leponex 25 mg and 100 mg
Netherlands
Leponex 25 mg and 100 mg, tabletten
Norway
Leponex 25 mg and 100 mg tabletter
Portugal
Leponex 25 mg and 100 mg comprimidos
Spain
Leponex 25 mg and 100 mg comprimidos
Sweden
Leponex 25 mg and 100 mg tabletter
United Kingdom
Clozaril 25 mg and 100 mg tablets

This leaflet was last approved in 02/2013.
GB

369726

1234 laetus_1-0

2. BEFORE YOU TAKE CLOZARIL
Do not 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.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– 
This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
–  any of the side effects gets serious, or if you notice any side effects not listed in this
If
leaflet, please tell your doctor or pharmacist.

In this leaflet:
1.  hat Clozaril is and what it is used for
W
2. Before you take Clozaril
3. How to take Clozaril
4. Possible side effects
5. How to store Clozaril
6. Further information

1. WHAT CLOZARIL IS AND WHAT IT IS USED FOR
Clozaril 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.

–  you are allergic (hypersensitive) to clozapine or any of the other ingredients
if
of Clozaril.
– if you are not able to have regular blood tests.
–  you have ever been told you have a low white blood cell count (e.g. leucopenia or
if
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.
–  you suffer from bone marrow disease or have ever suffered from bone
if
marrow disease.
– 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.
–  you had to stop using Clozaril previously because of severe side effects (e.g.
if
agranulocytosis or heart problems).
– 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 myocarditis (an inflammation of the heart muscle).
– if you suffer from any other severe heart disease.
– if you suffer from any severe kidney disease.
–  you have symptoms of active liver disease such as jaundice (yellow colouring of the
if
skin and eyes, feeling sick and loss of appetite).
– if you suffer from any other severe liver disease.
– if you suffer from reduced consciousness and severe drowsiness.
–  you suffer from circulatory collapse which may occur as a result of severe shock.
if
–  you suffer from paralytic ileus (your bowel does not work properly and you have severe
if
constipation).
–  you are being or have been treated with long-acting depot injections
if
of antipsychotics.
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.

1234 laetus_1-0
– 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.
–  you have had a heart disease or family history of abnormal conduction in the heart
if
called “prolongation of the QT interval”.
–  you are at risk for having a stroke, for example if you have high blood pressure,
if
cardiovascular problems or blood vessel problems in the brain

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

Medical check-ups and blood tests

Take special care with Clozaril
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 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.

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.
–  there is a decrease in the number of white blood cells, you will have to stop Clozaril
If
treatment immediately. Your white blood cells should then return to normal.
–  will need to have blood tests for another 4 weeks after the end of
You
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.

Taking other medicines
Before you start taking Clozaril, please tell your doctor if you are taking or have recently
taken 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 may affect how well other medicines work or they might
affect how well Clozaril works. Tell your doctor if you are taking any of the
following medicines:
−  edicines used to treat depression such as lithium, fluvoxamine, tricyclic
m
antidepressants, MAO inhibitors, citalopram, paroxetine, fluoxetine, and sertraline.
− other antipsychotic medicines usued to treat mental illnesses.
−  enzodiazepines and other medicines used to treat anxiety or sleep disturbances.
b
− narcotics and other medicines which can affect your breathing.
−  edicines used to control epilepsy such as phenytoin and valproic acid.
m
−  edicines used to treat high or low blood pressure such as adrenaline
m
and noradrenaline.
− warfarin, a medicine used to prevent blood clots.
− antihistamines, medicines used for colds or allergies such as hay fever.
−  nticholinergic medicines, which are used to relieve stomach cramps, spasms and
a
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.
−  ome medicines used to treat stomach ulcers, such as omeprazole or cimetidine.
s
− some antibiotic medicines, such as erythromycin and rifampicin.
−  ome medicines used to treat fungal infections (such as ketoconazole) or viral infections
s
(such as protease inhibitors, used to treat HIV infections).
−  tropine, a medicine which may be used in some eye drops or cough and
a
cold preparations.
−  drenaline, a medicine used in emergency situations.
a
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
Tell your doctor before using Clozaril if you are pregnant or you think that you might be
pregnant. 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.

Important information about some of the ingredients of Clozaril
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. You should 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.
GB

1234 laetus_1-0

1234 laetus_1-0

Leaflet_CLOZARIL_TAB_1X100_GB
680209_GB
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contract manufacturer:
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Sandoz LEK
Clozaril_v9
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TVT compatible
yes
no

X

165 x 620 mm
T e m p l at e

680209_GB.indd 1

680209

LEK
165 x 620 mm Landscape
Revision No. 2
18 Dec 2012
Fold code - CP1/CP2a

Treatment of schizophrenia

If you forget to take Clozaril

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, lightheaded 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 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 product, 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:
–  you get signs of a cold, fever, flu-like symptoms, sore throat or any other
if
infection. You will have to have an urgent blood test to check if your symptoms are
related to your medicine.
–  you have a sudden rapid increase in body temperature, rigid muscles which may
if
lead to unconsciousness (neuroleptic malignant syndrome) as you may be experiencing
a serious side effect which requires immediate treatment.
–  you experience crushing chest pain, sensation of chest tightness, pressure or
if
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.
–  you have fast and irregular heart beat, even when you are at rest, palpitations,
if
breathing problems, chest pain or unexplained tiredness. Your doctor will need to
check your heart and if necessary refer you to a cardiologist immediately.
–  you experience chest pressure, heaviness, tightness, squeezing, burning or choking
if
sensation (signs of insufficient blood flow and oxygen to the heart muscle). Your doctor
will need to check your heart.

–  you experience nausea (feeling sick), vomiting (being sick) and/or loss of
if
appetite. Your doctor will need to check your liver.
–  you have severe constipation. Your doctor will have to treat this in order to avoid
if
further complications.
–  you get signs of a respiratory tract infection or pneumonia such as fever,
if
coughing, difficulty breathing, wheezing.
–  you get signs of blood clots in the veins especially in the legs (symptoms include
if
swelling, pain and redness in the leg), which may travel through blood vessels to the
lungs causing chest pain and difficulty in breathing.
–  you experience profuse sweating, headache, nausea, vomiting and diarrhoea
if
(symptoms of cholinergic syndrome).
–  you experience severely decreased urine output (sign of kidney failure).
if
–  you experience seizures.
if
All possible side effects are listed under headings of frequency:
Very common (affects more than 1 in 10 people):
Drowsiness, dizziness, fast heart beat, constipation, increased production of saliva.
Common (affects up to 1 in 10 people):
Low level of white blood cells (leukopenia), 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, seizures, convulsions, jerks,
abnormal movements, inability to initiate movement, inability to remain motionless, 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), neuroleptic malignant syndrome (disorder
with high fever, impaired consciousness and muscle stiffness), 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), respiratory tract infection and pneumonia, 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 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, persistent
painful erection of the penis, sudden unexplained death.
Unknown (frequency cannot be estimated from the available data)
Blood clots in the vein, profuse sweating, headache, nausea, vomiting and diarrhoea
(symptoms of cholinergic syndrome), crushing chest pain, shortness of breath
(symptoms of heart attack), chest pressure or heaviness (signs of insufficient blood flow
and oxygen to the heart muscle), severely decreased urine output (sign of kidney failure),
changes in brain waves machine (electroencephalogram/EEG), diarrhoea, stomach
discomfort, heartburn, stomach discomfort after a meal, muscle weakness, muscle
spasms, muscle pain, stuffy nose.
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.
If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

6. FURTHER INFORMATION
What Clozaril contains
–  active substance is clozapine. Each tablet contains 25 mg or 100 mg clozapine.
The
–  other ingredients are magnesium stearate, anhydrous colloidal silica, povidone K30,
The
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
Wimblehurst Road, Horsham, West Sussex, RH12 5AB
Novartis Pharmaceuticals UK Ltd
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR

These medicinal products are authorised in the Member1234 laetus_1-0the
States of
EEA under the following names:
Austria
Leponex 25 mg and 100 mg Tabletten
Belgium 
Leponex 25 mg and 100 mg tabletten
Leponex 25 mg and 100 mg Tabletten
Leponex 25 mg and 100 mg comprimés
Denmark
Leponex
Finland
Leponex 25 mg and 100 mg tabletti
France
Leponex 25 mg and 100 mg comprimé sécable
Germany
Leponex 25 mg and 100 mg Tabletten
Greece
Leponex 25 mg and 100 mg Δισκία
Iceland
Leponex 25 mg and 100 mg töflur
Ireland
Clozaril 25 mg and 100 mg tablets
Italy
Leponex 25 mg and 100 mg compresse
Luxembourg
Leponex 25 mg and 100 mg
Netherlands
Leponex 25 mg and 100 mg, tabletten
Norway
Leponex 25 mg and 100 mg tabletter
Portugal
Leponex 25 mg and 100 mg comprimidos
Spain
Leponex 25 mg and 100 mg comprimidos
Sweden
Leponex 25 mg and 100 mg tabletter
United Kingdom
Clozaril 25 mg and 100 mg tablets

This leaflet was last approved in February 2013.

5. HOW TO STORE CLOZARIL
– Keep out of the reach and sight of children.
–  not use Clozaril after the expiry date which is stated on the blister/bottle and the
Do
carton. The expiry date refers to the last day of that month.
– 
This medicinal product does not require any special storage conditions.
– 
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.

GB

1234 laetus_1-0
15.04.13 14:48:22

680209_GB.indd 2

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2. proof
3. proof
4. proof
5. proof
6. proof

14.02.2013 sw
10.04.2013 sw
15.04.2013 sw

TVT compatible
yes
no

X

165 x 620 mm
T e m p l at e

Leaflet_CLOZARIL_TAB_1X100_GB
680209_GB
Novartis
N/A
Order File
GB
680475_MJ
1234
contract manufacturer:
620 x 165 mm
Sandoz LEK
Clozaril_v9
Page 2 of 2
Sec. Edge Marks N/A
Typopharma # 104097

Product
Material No.
Replaced No.
Country
Code No.
Dimension
Drawing No.

680209

LEK
165 x 620 mm Landscape
Revision No. 2
18 Dec 2012
Fold code - CP1/CP2a

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.

2. BEFORE YOU TAKE CLOZARIL

PACKAGE LEAFLET: INFORMATION FOR THE USER

Do not take Clozaril

CLOZARIL®
Clozaril 25 mg tablets
Clozaril 100 mg tablets
clozapine

Read all of this leaflet carefully before you start taking this medicine.
– 
Keep this leaflet. You may need to read it again.
–  you have any further questions, ask your doctor or pharmacist.
If
– 
This medicine has been prescribed for you. Do not pass it on to others. It may
harm them, even if their symptoms are the same as yours.
–  any of the side effects gets serious, or if you notice any side effects not listed
If
in this leaflet, please tell your doctor or pharmacist.

In this leaflet:
1. What Clozaril is and what it is used for
2. Before you take Clozaril
3. How to take Clozaril
4. Possible side effects
5. How to store Clozaril
6. Further information

1. WHAT CLOZARIL IS AND WHAT IT IS USED FOR
Clozaril 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.

–  you are allergic (hypersensitive) to clozapine or any of the other ingredients
if
of Clozaril.
–  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
if
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.
–  you suffer from bone marrow disease or have ever suffered from bone marrow
if
disease.
–  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
–  you had to stop using Clozaril previously because of severe side effects
if
(e.g. agranulocytosis or heart problems).
–  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 myocarditis (an inflammation of the heart muscle).
if
–  you suffer from any other severe heart disease.
if
–  you suffer from any severe kidney disease.
if
–  you have symptoms of active liver disease such as jaundice (yellow colouring
if
of the skin and eyes, feeling sick and loss of appetite).
–  you suffer from any other severe liver disease.
if
–  you suffer from reduced consciousness and severe drowsiness.
if
–  you suffer from circulatory collapse which may occur as a result of severe
if
shock.
–  you suffer from paralytic ileus (your bowel does not work properly and you
if
have severe constipation).
–  you are being or have been treated with long-acting depot injections of
if
antipsychotics.
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.

682648 GB.indd 1

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Leaflet CLOZARIL TAB 25/100MG GB

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11.04.2013

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This information was compiled with utmost care and on completion was subjected to strict internal checks. However, the
handling of data always involves a certain degree of risk and the impossibility of error cannot be guaranteed. Therefore
we would ask you to check the proof thoroughly. Pharma print design GmbH assumes no liability for errors identified
only after print approval has been given.

3. Proof

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.
–  heart, kidney or liver disease.
any
– 
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.
–  your doctor if you have ever had abdominal surgery.
tell
–  you have had a heart disease or family history of abnormal conduction in the
if
heart called “prolongation of the QT interval”.
–  you are at risk for having a stroke, for example if you have high blood
if
pressure, cardiovascular problems or blood vessel problems in the brain
Tell your doctor immediately before taking the next Clozaril tablet:
–  you get signs of a cold, fever, flu-like symptoms, sore throat or any other
if
infection. You will have to have an urgent blood test to check if your symptoms
are related to your medicine.
–  you have a sudden rapid increase in body temperature, rigid muscles which
if
may lead to unconsciousness (neuroleptic malignant syndrome) as you may be
experiencing a serious side effect which requires immediate treatment.
–  you have fast and irregular heart beat, even when you are at rest,
if
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.
–  you experience nausea (feeling sick), vomiting (being sick) and/or loss
if
of appetite. Your doctor will need to check your liver.

–  you have severe constipation. Your doctor will have to treat this in order to
if
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.
–  there is a decrease in the number of white blood cells, you will have to stop
If
Clozaril treatment immediately. Your white blood cells should then return to normal.
–  will need to have blood tests for another 4 weeks after the end of Clozaril
You
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.

Taking other medicines
Before you start taking Clozaril, please tell your doctor if you are taking or have
recently taken 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 may affect how well other medicines work or they might
affect how well Clozaril works. Tell your doctor if you are 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 usued to treat mental illnesses.
– 
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.
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
Tell your doctor before using Clozaril if you are pregnant or you think that you might
be pregnant. 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
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of Clozaril, may pass into your milk and affect your baby.

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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.

Important information about some of the ingredients of Clozaril
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. You should 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 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

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.

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.

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If you have any further questions on the use of this product, 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:
–  you get signs of a cold, fever, flu-like symptoms, sore throat or any other
if
infection. You will have to have an urgent blood test to check if your symptoms
are related to your medicine.
–  you have a sudden rapid increase in body temperature, rigid muscles which
if
may lead to unconsciousness (neuroleptic malignant syndrome) as you may be
experiencing a serious side effect which requires immediate treatment.
–  you experience crushing chest pain, sensation of chest tightness, pressure or
if
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.
–  you have fast and irregular heart beat, even when you are at rest, palpitations,
if
breathing problems, chest pain or unexplained tiredness. Your doctor will need
to check your heart and if necessary refer you to a cardiologist immediately.
–  you experience chest pressure, heaviness, tightness, squeezing, burning or
if
choking sensation (signs of insufficient blood flow and oxygen to the heart
muscle). Your doctor will need to check your heart.
–  you experience nausea (feeling sick), vomiting (being sick) and/or loss
if
of appetite. Your doctor will need to check your liver.
–  you have severe constipation. Your doctor will have to treat this in order to
if
avoid further complications.
–  you get signs of a respiratory tract infection or pneumonia such as fever,
if
coughing, difficulty breathing, wheezing.
–  you get signs of blood clots in the veins especially in the legs (symptoms
if
include swelling, pain and redness in the leg), which may travel through blood
vessels to the lungs causing chest pain and difficulty in breathing.
–  you experience profuse sweating, headache, nausea, vomiting and diarrhoea
if
(symptoms of cholinergic syndrome).
–  you experience severely decreased urine output (sign of kidney failure).
if
–  you experience seizures.
if

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Leaflet CLOZARIL TAB 25/100MG GB

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All possible side effects are listed under headings of frequency:
Very common (affects more than 1 in 10 people):
Drowsiness, dizziness, fast heart beat, constipation, increased production of saliva.
Common (affects up to 1 in 10 people):
Low level of white blood cells (leukopenia), 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, seizures,
convulsions, jerks, abnormal movements, inability to initiate movement, inability to
remain motionless, 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), neuroleptic malignant syndrome
(disorder with high fever, impaired consciousness and muscle stiffness), 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), respiratory tract infection and pneumonia, 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
t
­ riglycerides 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, persistent painful erection of the penis,
sudden unexplained death.
Unknown (frequency cannot be estimated from the available data)
Blood clots in the vein, profuse sweating, headache, nausea, vomiting and
diarrhoea (symptoms of cholinergic syndrome), crushing chest pain, shortness of
breath (symptoms of heart attack), chest pressure or heaviness (signs of
insufficient blood flow and oxygen to the heart muscle), severely decreased urine
output (sign of kidney failure), changes in brain waves machine
(
­ electroencephalogram/EEG), diarrhoea, stomach discomfort, heartburn, stomach
discomfort after a meal, muscle weakness, muscle spasms, muscle pain, stuffy nose.
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.
If any of the side effects gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE CLOZARIL
– 
Keep out of the reach and sight of children.
–  not use Clozaril after the expiry date which is stated on the blister/bottle and
Do
the carton. The expiry date refers to the last day of that month.
– 
This medicinal product does not require any special storage conditions.
– 
Medicines should not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6. FURTHER INFORMATION
What Clozaril contains

–  active substance is clozapine. Each tablet contains 25 mg or 100 mg clozapine.
The
–  other ingredients are magnesium stearate, anhydrous colloidal silica,
The
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
Wimblehurst Road, Horsham, West Sussex, RH12 5AB
Novartis Pharmaceuticals UK Ltd
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
These medicinal products are authorised in the Member States of the EEA
under the following names:
Austria
Leponex 25 mg and 100 mg Tabletten
Belgium
Leponex 25 mg and 100 mg tabletten

Leponex 25 mg and 100 mg Tabletten

Leponex 25 mg and 100 mg comprimés
Denmark
Leponex
Finland
Leponex 25 mg and 100 mg tabletti
France
Leponex 25 mg and 100 mg comprimé sécable
Germany
Leponex 25 mg and 100 mg Tabletten
Greece
Leponex 25 mg and 100 mg Δισκία
Iceland
Leponex 25 mg and 100 mg töflur
Ireland
Clozaril 25 mg and 100 mg tablets
Italy
Leponex 25 mg and 100 mg compresse
Luxembourg
Leponex 25 mg and 100 mg
Netherlands
Leponex 25 mg and 100 mg, tabletten
Norway
Leponex 25 mg and 100 mg tabletter
Portugal
Leponex 25 mg and 100 mg comprimidos
Spain
Leponex 25 mg and 100 mg comprimidos
Sweden
Leponex 25 mg and 100 mg tabletter
United Kingdom
Clozaril 25 mg and 100 mg tablets

This leaflet was last approved in February 2013.

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11.04.13 09:17

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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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