ZAPPA 5

0718E

119948010

PATIENT PACKAGE INSERT IN

ACCORDANCE WITH THE PHARMACISTS’

REGULATIONS (PREPARATIONS) - 1986

The medicine is dispensed with

a doctor’s prescription only.

Zappa 5, 7.5, 10

Zappa ODT 5, 10

Tablets

Orodispersible tablets

Composition:

Each Zappa 5 tablet contains: olanzapine 5 mg

Each Zappa 7.5 tablet contains: olanzapine 7.5 mg

Each Zappa 10 tablet contains: olanzapine 10 mg

Each Zappa ODT 5

orodispersible

tablet contains:

olanzapine 5 mg

Each Zappa ODT 10 orodispersible tablet contains:

olanzapine 10 mg

For the list of inactive ingredients, please see 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.

Essential information about the preparation:

Antipsychotics (like Zappa and Zappa ODT) may increase

the risk of death in elderly patients who suffer from

confusion, memory loss and loss of touch with reality

(dementia associated with psychosis). The preparation is

not intended for treatment of psychosis in elderly patients

who suffer from dementia.

Zappa and Zappa ODT are intended for adults above the

age of 18, due to the lack of information about its efficacy

and safety in children and adolescents below the age of

1.

WHAT IS THE MEDICINE INTENDED fOR?

Zappa and Zappa ODT are antipsychotics to treat

schizophrenia patients and symptoms of psychotic

disorders. In addition, the preparations are intended for the

treatment of bipolar affective disorder.

Therapeutic group: Atypical antipsychotic medicines.

2.

BEfORE USING THE MEDICINE

Do not use the preparation if:

∙ You are sensitive (allergic) to olanzapine or to any of

the additional ingredients of the medicine. Signs of an

allergic reaction include: rash, swallowing or breathing

difficulties, swelling of the lips, face, throat or tongue.

∙ You are at risk of narrow-angle glaucoma-type

(increased intraocular pressure) eye problems.

Special warnings regarding use of this medicine:

∙ Avoid situations in which an excessive increase in body

temperature and dehydration are possible, such as

increased physical activity or frequent stay in hot places.

Be sure to drink fluids to prevent dehydration.

∙ Zappa and Zappa ODT may cause hypotension upon

transition from lying down to sitting up. The symptoms

include: dizziness, rapid or slow heart rate, and even

fainting in some patients. This effect usually occurs at

the beginning of treatment.

∙ Zappa and Zappa ODT can cause sleepiness,

hypotension upon transition from lying down to sitting

up, and motoric and sensory instability which may

cause falls resulting in fractures and other injuries. Use

with caution and consider the risks/benefits in patients

with a medical history or who are taking medicines that

may increase the risk of falls.

∙ Weight gain has been observed in patients taking Zappa

and Zappa ODT. Weight should be monitored regularly.

∙ Monitor blood sugar and lipid levels since Zappa

and Zappa ODT may cause an increase in these

parameters.

∙ In patients with a medical history of low levels of white

blood cells, blood count tests should be regularly

performed during the first months of treatment for follow-

up. Zappa and Zappa ODT may cause a decrease in

the levels of white blood cells. Discontinuation of Zappa

and Zappa ODT treatment should be considered upon

appearance of the first symptom of this condition. Patients

suffering from reduced levels of white blood cells must be

monitored for symptoms indicating infection or fever. If

these occur, immediately discontinue the treatment with

Zappa and Zappa ODT.

∙ Taking Zappa and Zappa ODT is not recommended

for elderly patients suffering from dementia due to

the possibility of severe side effects: falls, sleepiness,

peripheral edema, unusual gait, urinary incontinence,

lethargy, weight gain, weakness, fever, pneumonia, dry

mouth, visual hallucinations, stroke and death.

∙ Patients with schizophrenia and bipolar disorders are

at a greater risk of attempted suicide. Therefore, these

patients must be closely monitored while being treated

with Zappa and Zappa ODT.

Before treatment with Zappa and Zappa ODT, tell the

doctor if:

∙ You suffer, or have suffered in the past, from cardiac

dysfunction.

∙ You suffer, or have suffered in the past, from a stroke or

“mini-stroke” (temporary symptoms of stroke).

∙ You suffer from problems with the liver, gastrointestinal

system (such as bowel obstruction).

∙ You suffer from problems of the blood system, nervous

system, Alzheimer’s, bone marrow, breast cancer.

∙ You experience suicidal thoughts.

∙ You suffer, or have suffered in the past, from enlargement

of the prostate gland.

∙ You suffer from epilepsy, diabetes or high blood sugar

levels, high or low blood pressure, high levels of

cholesterol or triglycerides in the blood.

∙ You are sensitive to any food or medicine. Zappa: This

medicine contains lactose and may cause sensitivity in

people sensitive to lactose. Zappa ODT: This medicine

contains mannitol and acesulfame potassium.

If you are taking, or have recently taken, other

medicines, including non-prescription medicines or

nutritional supplements, tell the doctor or pharmacist.

In particular, inform the doctor or pharmacist if you are

taking:

∙ Diazepam: Concomitant administration of Zappa or

Zappa ODT and diazepam may cause hypotension upon

transition from lying down to sitting up (orthostatic).

∙ Medicines affecting the CYP1A2 enzyme, e.g.,

carbamazepine, fluvoxamine, omeprazole and rifampicin –

may affect the levels of olanzapine in the blood.

∙ Medicines containing activated charcoal – may reduce

the absorption of olanzapine.

∙ Medicines affecting the central nervous system such

as sedatives, antidepressants and sleep medications,

anti-epileptic medicines – care should be taken upon

concomitant administration of these medicines and

olanzapine.

∙ Medicines used to reduce blood pressure – olanzapine

may enhance the blood pressure-lowering effect when

administered in combination with these medicines.

∙ Medicines that mimic the action of dopamine (such as a

medicine for the treatment of Parkinson’s – levodopa) -

olanzapine may inhibit the activity of these medicines.

Use of Zappa and Zappa ODT with food and drink:

Zappa and Zappa ODT may be taken with or without

food.

Use of the medicine and alcohol consumption:

Avoid consuming alcohol while using Zappa and Zappa

ODT.

Pregnancy and breastfeeding:

Consult a doctor or pharmacist before using the medicine.

Consult a doctor if you are pregnant or planning to get

pregnant. Neonates may develop withdrawal syndrome if the

mother has taken the medicine during the last trimester (the

last three months) of pregnancy. The withdrawal syndrome

includes the following symptoms: restlessness, tremor,

muscle stiffness/weakness, sleepiness, nervousness,

respiratory and feeding problems. If your child develops one

or more of the above symptoms, contact the doctor.

Do not use the medicine if you are breastfeeding.

Driving and operating machinery:

Use of this medicine may affect judgment capability, thinking

capability and motor skills. Therefore, exercise caution while

driving a vehicle, operating dangerous machinery and

engaging in any activity which requires alertness.

Smoking:

If you smoke – tell the doctor before commencing treatment

with 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.

∙ The dosage and treatment regimen will be determined by

the doctor only.

∙ Do not exceed the recommended dosage.

∙ Zappa 5 and Zappa 10: If necessary, the tablet can be

halved for immediate use. There is no information about

crushing or chewing the tablet. Swallow the medicine with

a little water.

Zappa 7.5: Do not halve the tablet. There is no information

about crushing or chewing the tablet. Swallow the tablet

with a little water.

Zappa ODT: Separate one unit from the tray and carefully

peel off the cover. Do not push the tablet. Take out the

tablet with dry hands and immediately place it whole

into your mouth. The tablet dissolves quickly in saliva;

therefore, it can be easily swallowed with or without a

drink.

∙ There is no information about use of this preparation in a

nasogastric tube.

∙ Use this medicine at regular intervals, as determined by

the attending doctor.

∙ If you accidentally take too high a dose, you may feel

drowsy, experience impaired speech, aggressiveness

or restlessness, rapid heart rate and a reduced level of

consciousness.

If you took an overdose, 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.

∙ If you forgot to take this medicine at the required time,

do not take a double dose. Take the next dose at the

scheduled time and consult the doctor.

∙ Adhere to the treatment regimen recommended by the

doctor.

∙ Even if there is an improvement in your health, do not

stop treatment with the medicine without consulting the

doctor or pharmacist.

∙ If you stop taking the medicine, you may experience:

nausea, vomiting and sweating.

∙ 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.

∙ Tests and follow-up: At the beginning and during

treatment, monitor blood sugar levels, especially

if you have diabetes or borderline sugar levels

(100-126 mg/dL when fasting); blood lipid levels should

also be monitored, especially in patients suffering from

blood lipid level disturbances or risk factors of developing

such disturbances.

∙ Weight gain is a common side effect of treatment with

Zappa and Zappa ODT. Take this into account before

beginning the treatment and routinely monitor weight.

∙ In patients with a history of low white blood cell levels,

monitor white blood cell levels during the first months of

treatment. Discontinuation of treatment with Zappa and

Zappa ODT should be considered upon appearance of

the first significant symptom indicating reduced white

blood cells.

If you have further questions regarding use of the medicine,

consult the doctor or pharmacist.

4.

SIDE EffECTS

As with any medicine, use of Zappa and Zappa ODT 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.

Zappa and Zappa ODT may cause severe side effects:

Increased risk of death in elderly patients who are

experiencing confusion, memory loss and loss of touch

with reality (psychosis associated with dementia). Zappa

and Zappa ODT are not intended for use in elderly

patients with dementia.

Increase in blood sugar levels (hyperglycemia) may

occur in patients suffering from diabetes as well as in

patients who are not suffering from diabetes. Increase

in blood sugar levels may cause:

∙ ketoacidosis - increased level of acid in the blood due

to build-up of ketones

∙ coma

∙ death

Your doctor must perform blood tests for your blood

sugar levels before starting and during treatment with

Zappa and Zappa ODT. Patients who are not suffering

from diabetes may experience an increase in blood

sugar levels when discontinuing Zappa and Zappa

ODT treatment.

Patients suffering from diabetes and some patients who

did not suffer from diabetes when they started Zappa

and Zappa ODT treatment, may need a medicine to

reduce their blood sugar levels when discontinuing

Zappa and Zappa ODT treatment.

If you suffer from diabetes, your doctor will instruct you

how often to have blood tests for blood sugar levels.

Refer to a doctor if you experience symptoms of high

blood sugar levels:

∙ increased thirst

∙ increased frequency of urination

∙ increased sensation of hunger

∙ weakness and tiredness

∙ nausea

∙ confusion or fruity breath odor

Increase in blood lipid and cholesterol levels may

occur in patients who are being treated with Zappa and

Zappa ODT. Your doctor must perform blood tests for

blood cholesterol and lipid levels at the beginning of and

during treatment even if you are not experiencing any

symptoms.

Weight gain is very common in patients who are being

treated with Zappa and Zappa ODT. Some patients

experience extreme weight gain, therefore, your doctor

must weigh you during the course of treatment with

Zappa and Zappa ODT. Consult the doctor about

watching your weight, such as a healthy diet and

physical activity.

Increased frequency of stroke or “mini-stroke” -

transient ischemic attack (TIA) in elderly people with

psychosis associated with dementia (elderly people

who are suffering from loss of touch with reality due

to confusion and memory loss). Zappa and Zappa

ODT are not approved for use in these patients.

Neuroleptic malignant syndrome - a rare but very

serious condition which may occur in patients who

are taking antipsychotic medicines, including Zappa

and Zappa ODT. Neuroleptic malignant syndrome may

cause death and requires hospitalization. Refer to the

doctor immediately if you experience:

∙ high fever

∙ increased sweating

∙ stiff muscles

∙ confusion

∙ changes in your breathing, heartbeat and blood

pressure

Drug reaction with eosinophilia and systemic

symptoms (DRESS). This effect may include: rash, fever,

swollen glands and involve other internal organs such as:

liver, kidneys, lungs and heart. This effect can sometimes

be lethal; therefore, tell the doctor immediately if you

experience any of these signs.

Tardive dyskinesia – a condition that causes involuntary

movements, mainly of the face or tongue. This effect may

continue even after you stop treatment with Zappa and

Zappa ODT. This effect may also start after you stop

treatment with Zappa and Zappa ODT. Tell the doctor

if you are having involuntary body movements.

Drop in blood pressure when changing position,

including symptoms such as dizziness, fast or slow

heartbeat, or fainting.

10. Difficulty swallowing which may cause food or

beverages to reach the lungs.

11. Seizures - tell your doctor if you experience seizures

during the course of treatment with Zappa and Zappa

ODT.

12. Problems regulating body temperature - you may

suffer from an increase in body temperature, for

example, when you exercise or when you are in a

very hot place. It is important to drink water to prevent

dehydration. Refer to the doctor immediately if you

become very ill and have symptoms of dehydration:

∙ excessive sweating or lack of sweat

∙ dry mouth

∙ fever

∙ increased thirst, urine retention

Additional side effects:

Side effects occurring very frequently:

Weakness, dry mouth, constipation, indigestion, sleepiness,

dizziness, injury from an accident, sleep disorders,

parkinsonism.

Side effects occurring frequently:

Fever, tremor, back ache, chest pain, limb pains, joint pains,

increased heart rate, hypertension, vomiting, physical

restlessness, increased appetite, behavioral changes,

increased triglyceride levels in the blood, weight gain,

hypotension upon transition from lying down to sitting

up, bleeding under the skin manifesting as patches on the

skin, peripheral edema, abnormal gait, stiff muscles, speech

impediment, runny nose, cough, lazy eye, inflammation of

the pharynx, drowsiness, urinary incontinence, urinary tract

infection, increased prolactin levels, increased blood levels

of alkaline phosphatase, discharge of milk from the breasts,

enlarged breasts in men.

Side effects occurring infrequently:

Chills, facial edema, sensitivity to light, attempted suicide,

stroke, vasodilatation, nausea, vomiting, tongue edema,

reduced white blood cell levels, reduced platelet levels,

high blood levels of bilirubin, low blood levels of proteins,

coordination problems, impaired speech, reduced libido,

lack of sensitivity, nose bleeding, hair loss, dry eyes,

changes in visual focus (accommodation), impotence,

changes in the menstrual cycle, urine retention, urinary

frequency and urgency, large urine volume, breast pain,

dystonia (spasm of the neck muscles, difficulty swallowing,

difficulty breathing, tongue protrusion), abdominal distension

and death due to diabetes.

Side effects occurring rarely:

Chills, fever, hangover effect, blocked intestine, fatty liver,

osteoporosis, coma, pulmonary edema, dilated pupils,

sudden death.

Side effects of unknown frequency:

Allergic reaction [such as: anaphylactic reaction, swelling of

the face or throat (angioedema), itch, rash], diabetes-related

coma, ketoacidosis, jaundice, pancreatitis and hepatitis, liver

injury, restless legs syndrome, neutropenia (reduced number

of a certain type of white blood cells), painful and prolonged

erection (priapism), painful muscle injury (rhabdomyolysis),

venous thrombosis, stuttering.

If a side effect occurs, if one of the side effects worsens, or

if you suffer from a side effect not mentioned in this leaflet,

consult with the doctor.

Side effects can be reported to the Ministry of Health by

clicking on the link “Report Side Effects of Drug Treatment”

found on the Ministry of Health homepage (www.health.gov.il)

that directs you to the online form for reporting side effects,

or by reporting to “Unipharm Ltd”.

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 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)

that appears on the package. The expiry date refers to

the last day of that month.

∙ Store the medicine at a temperature that does not exceed

25°C and in a place protected from light.

6.

fURTHER INfORMATION

In addition to the active ingredient, the medicine also

contains:

Zappa:

Lactose monohydrate, Microcrystalline cellulose,

Hydroxypropyl cellulose, Crospovidone, Magnesium

stearate, Opadry white Y-1-7000, Opadry yellow OY-

6478.

Zappa ODT:

Ludiflash [D-Mannitol, Crospovidone, Poly (vinyl acetate),

Povidone], Crospovidone, Sodium stearyl fumarate, Grape

flavour, Acesulfame potassium.

Zappa 5 tablets contain: 116.45 mg lactose monohydrate

per tablet.

Zappa 7.5 tablets contain: 174.68 mg lactose monohydrate

per tablet.

Zappa 10 tablets contain: 232.9 mg lactose monohydrate

per tablet.

What the medicine looks like and the content of the

package:

Zappa:

Zappa is packaged in a tray (blister), provided in a carton

box.

Zappa 5 and Zappa 10 are round, biconvex, yellow tablets

with a score line on one side.

Zappa 7.5 are round, biconvex, yellow tablets.

Zappa ODT:

Zappa ODT is packaged in a tray (blister), provided in a

carton box.

Zappa ODT are round, biconvex, light yellow tablets.

Zappa ODT are orodispersible tablets, intended for

swallowing.

For Zappa 5 and Zappa 10, there are pack sizes with 5, 7,

10, 14, 15, 28, 30 and 56 tablets.

For Zappa 7.5, Zappa ODT 5 and Zappa ODT 10, there are

pack sizes with 5, 7, 10, 14, 15, 28, 30, 56 and 60 tablets.

Not all package sizes may be marketed.

Registration Holder: Unipharm Ltd., P.O.B. 21429, Tel

Aviv 6121301.

Manufacturer and address: Trima Ltd., Kibbutz

Maabarot.

This leaflet was checked and approved by the Ministry

of Health in July 2013 and was updated in July 2018 in

accordance with the Ministry of Health guidelines.

Registration numbers of the medicine in the National Drug

Registry of the Ministry of Health:

Zappa 5: 146 70 33248 00 Zappa 7.5: 146 71 33250 00

Zappa 10: 146 72 33251 00 Zappa ODT 5: 150 20 33645 00

Zappa ODT 10: 150 21 33756 00