LOZAPINE 100 MG

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE

PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986

The medicine is dispensed with a doctor’s prescription only

Instructions for issuing this preparation:

During the first 18 weeks:

Perform a blood test once a week during the first 18 weeks.

The local pharmacy will dispense the medicine for one week of

treatment only, according to a doctor’s prescription, provided that it

carries a stamp as follows:

“White blood cell test has been conducted and results are normal”.

Starting from week 19 of treatment:

A blood test must be conducted at least once a month.

The local pharmacy will dispense the medicine for one month of

treatment only, according to a doctor’s prescription, provided that it

carries a stamp as follows:

“White blood cell test has been conducted and results are normal”.

Lozapine 25 mg Tablets

Lozapine 100 mg Tablets

Active ingredient and quantity:

Active ingredient and quantity:

Each tablet contains:

Each tablet contains:

Clozapine 25 mg

Clozapine 100 mg

For a list of inactive ingredients, please refer to section 6.

Read this leaflet carefully in its entirety before using the medicine.

This leaflet contains concise information about the medicine. If you have

further questions, refer to the doctor or pharmacist.

This medicine has been prescribed for the treatment of your ailment. Do

not pass it on to others. It may harm them, even if it seems to you that

their ailment is similar.

This medicine is not intended for infants and children below the age of 16,

as there is not enough information on its use in this age group.

Prior to starting treatment with Lozapine, you must perform a blood test to

ensure that you may take the medicine.

Since the medicine may cause a decrease in the number of white

blood cells, a white blood cell count and a differential blood count

must be performed prior to beginning treatment. The treatment may

be started only if the blood count is found to be normal.

A white blood cell count should be performed every week for the

first 18 weeks of treatment, and then, at least every 4 weeks, as

long as the patient is taking Lozapine.

If an infection is found and/or the blood count is below 3500/mm

, or

is significantly lower than the baseline (even if the count is above

3500/mm

differential

blood

count

must

performed

immediately.

this

test

confirms that

white

blood

cell

count

between

3500/mm

3000/mm

and/or

shows

absolute

count

neutrophil

granulocytes

between

2000/mm

1500/mm

leukocytes and granulocytes must be checked twice a week.

If the white blood cell count is below 3000/mm

and an absolute

count of neutrophil granulocytes is below 1500/mm

, stop treatment

with Lozapine immediately and continue conducting white blood cell

counts for 4 weeks after stopping the medicine.

white

blood

cell

count

below

2000/mm

and/or

neutrophil

granulocytes are less than 1000/mm

, consult a hematologist about

suitable

treatment,

possible

transfer

patient

hematological department.

If treatment was stopped due to the decrease in white blood cell

count below 3000/mm

and absolute count of neutrophils below

1500/mm

, do not resume patient's treatment with Lozapine.

1.

WHAT IS THIS MEDICINE INTENDED FOR?

For the treatment of schizophrenia when there is no response to

other medicines or when other medicines are causing intolerable side

effects.

Therapeutic group:

Atypical Antipsychotics.

2.

BEFORE USING THE MEDICINE:

.X. Do not use the medicine:

If you are sensitive (allergic) to the active ingredient (clozapine) or to

any of the other ingredients of the medicine listed in section 6

"Further information".

If you are breastfeeding.

If you are unable to have regular blood tests.

If you have previously been told that you have a low white blood cell

count (for instance: leukopenia or agranulocytosis), especially if this

was caused by medicinal treatment (excluding chemotherapy).

If you suffer or have ever suffered from bone marrow disease, or if

you take medicines that suppress bone marrow activity.

If you take medicines that reduce the number of white cells in your

blood.

If you had to stop taking Lozapine previously because of severe side

effects (e.g., agranulocytosis or heart problems).

If you suffer from uncontrolled epilepsy (seizures or fits).

If you have a severe mental illness caused by alcohol or medicines

(e.g., narcotics).

If you suffer from an inflammation of the heart muscle (myocarditis)

or if you suffer from some other severe heart disease.

If you suffer from any severe kidney disease.

If you have symptoms of an active liver disease such as jaundice

(yellowing of the skin and eyes, nausea, and loss of appetite), or if

you suffer from any other severe liver disease or from liver failure.

If you suffer from reduced consciousness and severe drowsiness.

If you suffer from circulatory collapse which may occur as a result of

severe shock and/or central nervous system suppression for any

reason.

If you suffer or have previously suffered from severe constipation,

paralytic ileus (your bowel does not work properly and you have

severe constipation) or any other condition affecting the bowel.

If you are being or have been treated in the past with long-acting

injections of antipsychotics.

In persons who are unconscious or in a coma.

In any of the aforementioned situations, inform your doctor and do

not take Lozapine.

Special warnings regarding the use of the medicine:

Lozapine may cause dizziness or fainting, especially in the beginning

of treatment due to a decrease in your blood pressure.

If you experience dizziness or fainting caused by Lozapine, be careful

when standing up from a lying or sitting position.

If you must have surgery, or if for any reason, you are unable to walk

for long time, you must tell your doctor that you are taking Lozapine.

You may be at risk of thrombosis (a blood clot in the veins).

Older

persons

(age

have

greater

chance

experiencing the following side effects during treatment: fainting or

dizziness after changing position, dizziness, rapid heartbeat, difficulty

urinating, and constipation.

If you are older (age 60 and up), tell the doctor if you have dementia

or psychotic states resulting from dementia.

If you experience any of the following symptoms, inform your doctor

immediately:

Consult your doctor immediately upon appearance of the first

sign of cold, flu, fever, sore throat, white spots on the lips, ulcers in

the oral cavity or any other infection. Lozapine may reduce the

number of white blood cells and lead to high susceptibility to

infection. Your doctor may examine your blood count and take

additional measures if required.

Consult your doctor immediately if you experience rapid and

irregular heart beat that persist at rest, possibly accompanied by

shortness of breath and swelling of the feet or legs. These effects

may occur, in particular in the beginning of treatment, and your

doctor may be required to take additional measures.

Potentially fatal heart attacks have been reported for Lozapine.

Lozapine may cause drowsiness and prolonged stay in bed,

accompanied by weight gain, which may result in blood clots in

certain patients.

.!. Before beginning treatment with Lozapine, tell the doctor if:

you suffer, or have suffered in the past from blood clots or have a

family history of blood clots, as medicines from this type have been

associated with formation of blood clots in the past.

you suffer, or have suffered in the past from glaucoma (increased

intra-ocular pressure).

you suffer, or have suffered in the past from diabetes. High levels of

sugar in the blood (sometimes, considerably high) have occurred in

patients with or without medical history of diabetes (see section 4

“Side effects”).

you suffer, or have suffered in the past from problems with your

prostate gland, or difficulty urinating.

you suffer, or have suffered in the past from any heart, and/or blood

vessel, kidney/urinary system or liver disease.

you suffer, or have suffered in the past from chronic constipation, or if

taking

medicines

that

cause

constipation

(such

anticholinergics).

you suffer, or have suffered in the past from galactose intolerance,

Lapp-lactase deficiency, or glucose-galactose malabsorption.

you suffer, or have suffered in the past from controlled epilepsy.

you suffer, or have suffered in the past from colon diseases.

you have undergone abdominal surgery in the past.

you have had heart disease in the past or have a family history of

abnormal conduction in the heart called 'prolongation of the QT

interval'.

You have had a stroke or are at risk of stroke, for instance, if you

have high blood pressure, cardiovascular problems, or problems with

the blood vessels in the brain.

you are sensitive to any food or medicine.

.!.

If

you

are

taking,

or

have

recently

taken,

other

medicines,

including non-prescription medicines and nutritional supplements,

tell the doctor or pharmacist.

Do not take Lozapine with medicines that suppress bone marrow activity

and/or reduce the number of blood cells generated by the body, for

instance:

carbamazepine to treat epilepsy.

certain

antibiotics:

chloramphenicol,

sulphonamides,

such

trimoxazole.

certain painkillers: pyrazolone analgesics such as phenylbutazone.

penicillamine, a medicine used to treat rheumatoid arthritis.

cytotoxic agents - chemotherapeutic medicines.

long-acting injections of antipsychotic medicines.

These medicines increase the risk of developing agranulocytosis (lack of

white blood cells).

Taking Lozapine may affect how other medicines work or they might affect

how Lozapine works. Tell your doctor or pharmacist if you are taking:

medicines used to treat depression such as: lithium, fluvoxamine,

tricyclic

antidepressants,

inhibitors,

citalopram,

paroxetine,

fluoxetine, and sertraline.

other antipsychotic medicines used to treat mental illnesses.

benzodiazepines and other medicines used to treat anxiety and sleep

disturbances.

narcotics and other medicines which can affect your breathing.

medicines for epilepsy such as phenytoin and valproic acid.

medicines

used

treat

high

blood

pressure

such

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

used

relieve

abdominal

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 heartbeat.

Certain medicines used to treat stomach ulcers, such as omeprazole

or cimetidine.

some antibiotics, such as erythromycin and rifampicin.

some

medicines

used

treat

fungal

infections

(such

ketoconazole) or viral infections (such as protease inhibitors, used to

treat HIV).

atropine, a medicine which may be used in some eye drops or cough

and cold preparations.

adrenaline, a medicine used in emergency situations.

Oral contraceptives.

.!. Use of the medicine and food:

Tell

doctor

frequently

consume

beverages

that

contain

caffeine (coffee, tea, cola). A sudden change in caffeine drinking habits

can change the effect of Lozapine.

.!. Use of the medicine and alcohol consumption:

Do not drink wine or alcoholic beverages during the course of treatment

with the medicine.

Lozapine may enhance the effects of alcohol.

.!. Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, consult the doctor or pharmacist

before using medicines.

Before using Lozapine, tell the doctor if you are pregnant or you think that

you might be pregnant. The doctor will discuss with you the benefits and

possible risks of using the medicine during pregnancy. Tell your doctor

immediately if you become pregnant during treatment with the medicine.

The following symptoms may occur in newborn babies of mothers who

have used Lozapine in the last trimester of pregnancy: tremor, muscle

stiffness and/or weakness, sleepiness, restlessness, agitation, breathing

problems and difficulty in feeding. In some cases, these symptoms resolve

spontaneously,

other

cases,

babies

require

treatment

Intensive Care Unit or hospitalization.

If your baby develops these symptoms, contact a doctor.

Do not breastfeed during the course of treatment with the medicine.

Clozapine, the active ingredient of Lozapine, may pass into breast milk

and affect your baby.

Women of childbearing age, contraceptive methods:

Some women taking certain antipsychotic medications have irregular

periods or no periods at all. Your periods might return when the treatment

with other antipsychotic medicine is changed to Lozapine. In these

circumstances, you must use an effective contraceptive.

.!. Driving and using machinery:

Using this medicine might cause drowsiness, especially at the beginning

of treatment. Therefore, refrain from driving or operating machines until

you get used to the medicine and the drowsiness disappears. In any case,

take care while driving a car, operating machines and performing any

activity requiring alertness.

.!. Smoking:

Tell the doctor if you smoke. A sudden change in smoking habits can

change the effect of Lozapine.

Elderly (60 years of age and above):

Your

doctor

may adjust the treatment for you if you are 60 years old or

older.

Children and adolescents:

Treatment of children below the age of 16 is not recommended due to lack

of data.

.!.

Important

information

about

some

of

the

ingredients

in

this

medicine:

The preparation contains lactose. If you have been told by a doctor that

you have intolerance to some sugars, inform the doctor before using this

medicine.

3.

HOW SHOULD YOU USE THE MEDICINE?

Always use according to the doctor’s instructions. Check with the

doctor or pharmacist if you are uncertain.

To minimize the risk of low blood pressure, seizures, and sleepiness,

the doctor will increase your dosage gradually.

It is important that you do not change your dosage or stop taking the

medicine without consulting the doctor. Continue taking the tablets

according to the doctor's instructions.

If you are 60 years of age or older, your doctor may start you on a

lower dosage and increase it more gradually because you are at

higher risk of developing undesirable side effects (see section 2

“Special warnings regarding use of the medicine”).

The dosage and manner of treatment will be determined by the

doctor only. The usual dosage is generally:

The usual starting dosage 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.

If tolerated well, your doctor will then gradually increase the dosage in

intervals of 25-50 mg over the next 2-3 weeks until a dose of 300 mg per

day is reached. After that, if necessary, the daily dosage may be increased

in intervals of 50-100 mg at half-weekly intervals, or preferably, at weekly

intervals.

The effective dosage is usually between 200 mg and 450 mg, divided into

several doses a day. Some people might need a higher dosage. A daily

dosage of up to 900 mg is allowed. Increased side effects (particularly

seizures) are possible at daily dosages over 450 mg. Always take the

lowest effective dosage for you.

Most people take part of their dosage in the morning and part in the

evening. The doctor will instruct you exactly how to divide your daily dose.

If your daily dosage is only 200 mg, you can take this as a single dose in

the evening.

Taking Lozapine at the same time every day will help you remember when

you have to take the medicine.

Once you have been taking Lozapine with successful results for some

time, the doctor may try to lower the dosage. You will need to take

Lozapine for at least 6 months.

Do not exceed the recommended dose.

Do not chew. Swallow the medicine with water.

Tests and follow-up

Before beginning use of the medicine, the doctor will check your medical

history and refer you to blood tests to ensure that your white blood cell

count is normal. This is very important because your body needs white

blood cells to fight infections. You can start treatment only if the blood

count is normal.

Be sure to have regular blood tests before you start treatment, during

treatment and after you stop treatment with the medicine (for at least 4

weeks). The doctor will give you instructions about this. It is important to

perform all the blood tests as recommended by the doctor.

The medicine may cause a severe decline in white blood cell count

(agranulocytosis) - Regular blood tests are the only way for the doctor to

know if you are at risk of developing agranulocytosis.

The doctor will also perform a physical examination prior to beginning

treatment. The doctor may also perform an ECG to check your heart, but

only if this test is essential, or if you have specific concerns.

If you have liver problems, you should regularly perform liver function tests

for as long as you are taking the medicine.

If you have high levels of blood sugar (diabetes), the doctor may regularly

test your blood sugar levels.

Lozapine may cause alterations in blood lipids. Lozapine may cause

weight gain. The doctor will monitor your weight and blood lipid levels.

If you accidentally took a higher dosage

or if a child has accidentally

swallowed the medicine, refer immediately to a doctor or proceed to a

hospital emergency room, and bring the package of the medicine with you.

Symptoms

overdose

are:

sleepiness,

tiredness,

lack

energy,

unconsciousness, coma, confusion, hallucinations, agitation, incoherent

speech, stiff limbs, trembling hands, seizures (fits), increased production of

saliva, dilation of the black part of the eye, blurred vision, low blood

pressure,

collapse,

fast

irregular

heartbeat,

difficulty

breathing

shallow breathing.

If you forgot to take this medicine

at the scheduled time, take a dose as

soon as you remember. If the next scheduled dose is close (there are less

than 4 hours before the next dose), skip the forgotten dose and take the

next dose at the scheduled time. Never take a double dose to compensate

for a forgotten dose. If you have not taken Lozapine for more than 48

hours, do not resume treatment with the medicine and contact the

doctor

as soon as possible.

Be sure to adhere to the treatment regimen as recommended by the

doctor.

Even if there is an improvement in your health, do not stop treatment with

the medicine without consulting the doctor.

If you stop taking the medicine

Do not stop taking the medicine without consulting the doctor because you

experience

withdrawal

symptoms.

These

symptoms

include

excessive sweating, headache, nausea, vomiting, and diarrhea.

If you

experience any of these signs, refer to the doctor immediately. If you

do not receive immediate treatment, these signs may be followed by

more serious side effects.

Your original symptoms may return. If you need to stop treatment, the

doctor

will gradually reduce the dosage for one to two weeks. The doctor

will advise you how to decrease your daily dosage.

If you need to stop treatment immediately, you will have to be checked by

your doctor.

If the doctor decides that you must restart Lozapine treatment and the last

dose was taken more than two days earlier, start at a dosage of 12.5 mg.

Do not take medicines in the dark! Check the label and the dose each

time you take the medicine. Wear glasses if you need them.

If you have further questions regarding use of the medicine, consult the

doctor or pharmacist.

4.

SIDE EFFECTS:

As with any medicine, use of Lozapine may cause side effects in some

users. Do not be alarmed by the list of side effects. You may not suffer

from any of them.

Refer to the attending doctor immediately before taking the next

dose:

With the first signs of cold, fever, flu-like symptoms, throat-ache, or

other signs of infection. You will have to have blood tests urgently to

check whether these symptoms are related to the medicine.

If you experience a sudden and quick rise in body temperature,

muscle rigidity which can lead to loss of consciousness (neuroleptic

malignant syndrome), because you may be suffering from a serious

side effect that requires immediate treatment.

If you experience severe chest pain, pressure or crushing pain in the

chest (chest pain may radiate to left arm, jaw, neck, and upper

abdomen),

shortness

breath,

sweating,

weakness,

dizziness,

nausea,

vomiting,

palpitations

(symptoms

heart

attack).

Proceed to an emergency room immediately.

If you have rapid and irregular heartbeat, even at rest, palpitations,

breathing problems, chest pain, or unexplained tiredness. The doctor

will examine your heart and, if necessary, will refer you immediately

to a cardiologist.

If you experience a sensation of pressure, heaviness, crushing pain,

burning or constriction in the chest (signs of inadequate blood and

oxygen flow to the heart muscle). The doctor will examine your heart.

If you are nauseous, if you vomit and/or lose your appetite. The

doctor will examine your liver.

If you have severe constipation. The doctor will treat it to prevent

further complications.

If you have signs of respiratory tract infection or pneumonia, such as

fever, cough, difficulty breathing, wheezing.

If you have signs of blood clots in the veins, especially in the legs

(symptoms include swelling, pain, and redness in the leg), which may

travel through the blood vessels to the lungs and cause chest pain

and difficulty breathing.

If you experience excessive sweating, headache, nausea, vomiting

and diarrhea (symptoms of cholinergic syndrome).

If you experience a severe decline in quantity of urine (signs of kidney

failure).

If you experience seizures.

If you are a man and you suffer from a painful and prolonged

erection. This effect is called priapism. If you experience an erection

lasting for more than 4 hours, you may require immediate medical

treatment to avoid complications.

Additional side effects:

Occurring frequently:

Drowsiness, dizziness, fast heartbeat, constipation, increased production

of saliva, low levels of white blood cells (leukopenia), high level of white

blood cells (leukocytosis), high levels of a specific type of white blood cell

(eosinophilia),

weight

gain,

blurred

vision,

headache,

tremor,

rigidity,

restlessness,

seizures,

convulsions,

spasms,

abnormal

movements,

inability to initiate movement, inability to remain motionless, high blood

pressure,

faint

dizziness

after

changing

position,

sudden

loss

consciousness,

nausea,

vomiting,

loss

appetite,

mouth,

minor

abnormalities

liver

function

tests,

loss

of bladder

control, difficulty

passing

urine,

tiredness,

fever,

increased

sweating,

raised

body

temperature, speech disorders (e.g. slurred speech), changes in ECG.

Occurring infrequently:

Lack

white

blood

cells

(agranulocytosis),

neuroleptic

malignant

syndrome (a disorder characterized by high fever, impaired consciousness

and muscle stiffness), speech disorders (e.g., stuttering), blood pressure

fluctuations, lack of orientation.

Occurring rarely:

Low levels of red blood cells (anemia), restlessness, agitation, confusion,

hallucinations, circulatory collapse, irregular heartbeat, inflammation of the

heart muscle (myocarditis) or of the membrane surrounding the heart

muscle (pericarditis), fluid build up around the heart (pericardial effusion),

difficulty in swallowing (for instance, food going down the wrong way),

respiratory tract infection and pneumonia, high levels of sugar in the blood:

excessive thirst, dry mouth and excessive urination may be signs of high

levels of sugar in the blood (diabetes mellitus) – if you experience any of

them, inform the doctor as soon as possible since Lozapine may cause or

exacerbate diabetes, blood clots in the lungs (thromboembolism),

inflammation of the liver (hepatitis), liver disease causing yellowing of the

skin and eyes/dark urine/itching/nausea and/or loss of appetite,

inflammation of the pancreas leading to severe upper abdominal pain,

raised levels of enzymes in the blood called creatinine phosphokinase,

significant drop in blood pressure.

Occurring very rarely:

Increase in the number of blood platelets, with possible clotting in the

blood vessels, decrease in the number of blood platelets (which may be

manifested by bleeding or spontaneous bruising), uncontrollable

movements of mouth/tongue and limbs, involuntary purposeless

movements such as twitching, lip smacking, rapid eye blinking, obsessive

thoughts

compulsive

repetitive

behavior

(symptoms

obsessive

compulsive

disorder),

skin

reactions,

swelling

front

(enlargement of the saliva glands), difficulty breathing, complications due

to uncontrolled blood sugar levels (such as coma or ketoacidosis), very

high levels of triglycerides or cholesterol in the blood, disorder of the heart

muscle

(cardiomyopathy),

arrested

heartbeat

(cardiac

arrest),

severe

constipation

with

abdominal

pain

abdominal

cramps

caused

obstruction of the bowel (paralytic ileus), swollen abdomen, abdominal

pain, severe liver damage (fulminant hepatic necrosis, appearing suddenly

and developing very fast), inflammation of the kidneys, persistent painful

erection (priapism), sudden unexplained death.

Occurring at unknown frequency:

Blood clots in the veins, excessive sweating, headache, nausea, vomiting

and diarrhea (symptoms of cholinergic syndrome), strong chest pain,

shortness of breath (symptoms of heart attack), pressure or heaviness in

the chest (signs of insufficient oxygen and blood flow to the heart muscle),

severely decreased urine output (sign of kidney failure), hepatic disorders

including fatty liver disease, death of liver cells, liver injury / toxicity,

hepatic disorders including replacement of normal liver tissue by scar

tissue, which leads to loss of liver function, including those life threatening

cases such as liver failure (which may lead to death), liver injury (injury of

liver cells, bile duct in the liver or both) and liver transplantation, allergic

reaction (swelling mainly of the face, mouth, throat and tongue, which may

cause pain or itching), rash, red- purple spots, fever or itching due to

inflammation of blood vessels, colitis leading to diarrhea, abdominal pain,

fever, skin discoloration; butterfly rash on the face, joint pain, muscle pain,

fever and tiredness (lupus erythematosus); a sudden and uncontrollable

increase

blood

pressure

(pseudo

pheochromocytoma);

intense,

permanent and involuntary muscle contraction, and involuntary muscle

contractions which may lead to twisted movements of the body or body

parts (pleurothotonus); in men – an ejaculation disorder associated with

entry of semen into the urinary bladder instead of being discharged via the

penis (a dry orgasm or retrograde ejaculation), changes in brain waves (in

electroencephalogram/EEG test), diarrhea, stomach discomfort after a

meal, heartburn, muscle weakness, muscle spasms, muscle pain, runny

nose, bedwetting at night.

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 you suffer from any side effect, consult the doctor or the pharmacist.

This also includes side effects not mentioned in the leaflet.

Reporting side effects:

You can report side effects to the Ministry of Health (MoH) by following the

link ‘Reporting Side Effects of Medication’ on the MoH home page

(www.health.gov.il) which links to an online form for reporting side effects,

or by clicking the link:

https://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=

AdversEffectMedic@ moh.gov.il

5.

HOW SHOULD THE MEDICINE BE STORED?

Avoid poisoning! This medicine, and any other medicine, should be

kept in a safe place out of the reach and sight of children and/or

infants in order to avoid poisoning. Do not induce vomiting unless

explicitly instructed to do so by the doctor!

Do not use the medicine after the expiry date (exp. date) appearing

on the package. The expiry date refers to the last day of that month.

Store in a cool and dry place, below 25°C.

Close tightly and prevent penetration of air and moisture.

Do not discard medicines in the wastewater or in the waste bin. Ask

your pharmacist how to dispose of medicines that are no longer in

use. These measures will help to protect the environment.

6.

FURTHER INFORMATION:

In addition to the active ingredient, the medicine also contains:

Lactose monohydrate, pregelatinized starch, povidone, maize starch, talc,

colloidal anhydrous silica, magnesium stearate.

Each Lozapine 25 mg tablet contains: 48 mg lactose.

Each Lozapine 100 mg tablet contains: 192 mg lactose.

What does the medicine look like and what are the contents of the

package:

Lozapine 25 mg: round, yellow, odorless tablets, with a dividing line on

both sides and “CPN 25” engraved on one side.

Lozapine 100 mg: round, yellow, odorless tablets, with a dividing line on

both sides and “CPN 100” engraved on one side.

Each carton package contains blisters with 50 tablets.

License holder and address:

Taro International Ltd., 14 Hakitor St.,

Haifa Bay 2624761.

Manufacturer and address:

Genthon BV, Nijmegen, the Netherlands.

Registration number of the medicine in the National Drug Registry of

the Ministry of Health:

Lozapine 25 mg tablets: 116 44 29643

Lozapine 100 mg tablets: 116 45 29644

This leaflet was checked and approved by the Ministry of Health in April

2016.