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KAWILON 25MG TABLETS

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Kawilon 25 mg Tablets
Kawilon 100 mg Tablets
Clozapine

Package leaflet: information for the user

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.
• 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.

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

1

WHAT KAWILON IS AND WHAT IT IS USED FOR

Kawilon is an antipsychotic (sometimes called neuroleptic) medicine and
belongs to a group of medicines known as dibenzodiazepines. Kawilon is
used to treat schizophrenia in people who have either tried at least two other
antipsychotic medicines to which they did not respond very well, or who
don’t tolerate other antipsychotics because of side effects.
Kawilon is also used to treat severe thought disturbances in patients with
Parkinson’s disease, when other treatments have not worked.

2

BEFORE YOU TAKE KAWILON

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

Take special care with Kawilon
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 Kawilon, tell your doctor if you suffer
from or have ever suffered from:
• blood clots or family history of blood clots, as medicines like these have
been associated with formation of blood clots
• glaucoma (increased pressure in the eye)
• diabetes. Elevated (sometimes considerably) blood sugar levels, has
occurred in patients with or without diabetes mellitus in their medical
history (see section 4)
• prostate problems or difficulty in urinating
• any heart, kidney or liver disease
• chronic constipation or if you are taking medicines which cause constipation
(such as anticholinergics)
• galactose intolerance, Lapp lactase deficiency or glucose-galactose
malabsorption
• controlled epilepsy
• large intestine diseases
• tell your doctor if you have ever had abdominal surgery
• if you have had a heart disease or family history of abnormal conduction
in the heart called “prolongation of the QT interval”
• if you are at risk for having a stroke, for example if you have high blood
pressure, cardiovascular problems or blood vessel problems in the brain.

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

Medical check-ups and blood Tests
Before you start taking Kawilon, 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 Kawilon.
• Your doctor will tell you exactly when and where to have the tests.
• Kawilon can cause a serious decrease in the number of white cells in your
blood (agranulocytosis). Only regular blood tests can tell the doctor if you
are at risk of developing agranulocytosis.
• During the first 18 weeks of treatment, tests are needed once a week.
Afterwards, tests are needed at least once a month.
• If there is a decrease in the number of white blood cells, you will have to
stop Kawilon treatment immediately. Your white blood cells should then
return to normal.
• You will need to have blood tests for another 4 weeks after the end of
Kawilon treatment.
Your doctor will also do a physical examination and may do an electrocardiogram (ECG) to check your heart, but only if these examinations are
necessary for you, or if you have any special concerns.
If Kawilon 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 Kawilon. 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 Kawilon as there is not
enough information on its use in that age group.

Elderly patients
Elderly patients may be more likely to have the following side effects during
treatment with Kawilon: 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 Kawilon, 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 take different medicines.

Do not take Kawilon 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
• cytotoxic 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 Kawilon may affect how well other medicines work or they
might affect how well Kawilon 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 used to treat mental illnesses
• benzodiazepine 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 hayfever
• 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 or pharmacist have more information
on medicines to be careful with or to avoid while taking Kawilon. They will
also know if the medicines you are taking belong to the listed groups. Speak
to them.

Taking Kawilon with food and drink
Food and drink do not affect Kawilon. Do not drink alcohol during treatment
with Kawilon.
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 Kawilon.

Pregnancy and breast-feeding
There are only limited data on the safe use of Kawilon during pregnancy.
Always inform your doctor if you are pregnant or if you are planning to get
pregnant. He will decide for you if you can take Kawilon.
The following symptoms may occur in newborn babies, of mothers that
have used Kawilon 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 Kawilon. This means you should
use effective contraception.
You should not breast-feed while taking Kawilon as it can pass to your baby
through your milk.

Driving and using machines
Kawilon 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 Kawilon
Kawilon 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
Kawilon.

3

HOW TO TAKE KAWILON

Always take Kawilon 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 Kawilon
without asking your doctor first. Continue taking the tablets for as long as
your doctor tells you. If you are elderly, 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
Kawilon”).
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
Treatment starts with one half of a 25 mg tablet (12.5 mg) 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 the
lowest effective dose is reached. It may be necessary to further increase the
dose in steps of 50 or 100 mg weekly or half-weekly.
The usual daily dose of Kawilon is between 200 mg and 450 mg. The maximum
dose is 900 mg per day. Increased side effects (in particular seizures) are
possible at daily doses over 450 mg. Always take the lowest effective dose
for you.
You may take Kawilon in unevenly divided doses during the day, with a
larger dose at bedtime. If your daily dose does not exceed 200 mg, you
should take it once daily in the evening. Once you have been taking Kawilon
with successful results for some time, your doctor may try you on a lower
dose. You will need to take Kawilon for at least 6 months.

Treatment of severe thought disturbances in patients with Parkinson’s
disease
The treatment starts with one half of a 25 mg tablet (12.5 mg) in the evening.
Swallow the tablet with water. Your doctor will then gradually increase the
dose in steps of 12.5 mg, with no more than two steps in one week, until
the lowest effective dose is reached. Your doctor will monitor your blood
pressure during the first weeks of treatment, to decide if increasing your
dose would be safe.
The usual daily dose of Kawilon is between 25 mg and 37.5 mg. This dose
is carefully built up in 2 weeks. The maximum dose is 100 mg per day.
Always take the lowest effective dose for you. You should take Kawilon as
one single dose in the evening.

If you take more Kawilon 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. Take this leaflet and any remaining tablets with you to show
them.
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 Kawilon
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
Kawilon for more than 48 hours.

If you stop taking Kawilon
Do not stop taking Kawilon without asking your doctor, because you might
get withdrawal reactions. These reactions include sweating, headache, nausea
(feeling sick), vomiting (being sick) and diarrhoea. 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
Kawilon suddenly, you will have to be checked by your doctor. If your doctor
decides to re-start the treatment with Kawilon and your last dose of Kawilon
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, Kawilon can cause side effects, although not everybody
gets them.












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 creatine 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 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.
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 KAWILON

Some side effects can be serious and need immediate medical attention:
Tell your doctor immediately before taking the next Kawilon tablet:

Keep out of the reach and sight of children.

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

Do not use Kawilon after the expiry date [EXP] which is stated on the outer
carton box and on each blister or on the label of the container. The first two
digits indicate the month and the last four digits indicate the year. The expiry
date refers to the last day of that month.

All possible side effects are listed under headings of frequency:
Very common (affects more than 1 in 10 people):






Drowsiness
Dizziness
Fast heartbeat
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
A feeling of inner restlessness or the urge to move
Seizures
Convulsions
Jerks
Abnormal movements
High blood pressure
Faintness or light-headedness after changing position
Sudden loss of consciousness
Nausea (feeling sick)
Vomiting (being sick)

Kawilon should be stored in its original package below 25°C.
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 Kawilon contains
Each tablet contains either 25 or 100 mg of the active substance clozapine.
The other ingredients are: lactose monohydrate, povidone, pregelatinised
starch, maize starch, talc, colloidal anhydrous silica, magnesium stearate.

What Kawilon looks like and contents of the pack
The tablets are yellow and round, scored with a division mark on both sides
and debossed with “CPN 25” or “CPN 100” on one side. They are supplied
in blister packs of 28, 30, 60, 84, 90 and 300 tablets or in plastic containers
containing 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Leyden Delta B.V.
Neerbosscheweg 620
6544 LL Nijmegen
The Netherlands
Manufacturer(s):
Synthon Hispania S.L.
Castello, 1
Poligono Las Salinas
08830 Sant Boi de Llobregat
Spain
National registration number:
Kawilon 25 mg Tablets PL 32553/0001
Kawilon 100 mg Tablets PL 32553/0002

This leaflet was last revised in December 2013

Leyden Delta BV (NL)
Market
Patient Leaflet

UK
Kawilon 25 mg Tablets
Kawilon 100 mg Tablets
Clozapine

Dimensions

260 x 480 mm.

Laetus Code
Item Code
Software Application

QuarkXPress PP 9.5

Artwork

Eugène de Leeuw - 3.0

Date

DEC 2013

Printing Color

Black
Pantone 2716 U
Key-Lines

Typefont settings

Univers Condensed: 9.5 pnts.

Expand Transcript

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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