Israel - English - Ministry of Health
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
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
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
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.
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
∙ 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
∙ You suffer, or have suffered in the past, from cardiac
∙ 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
∙ 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
∙ 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
Use of the medicine and alcohol consumption:
Avoid consuming alcohol while using Zappa and Zappa
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.
If you smoke – tell the doctor before commencing treatment
with this medicine.
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
∙ There is no information about use of this preparation in a
∙ 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
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
∙ 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
∙ 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
If you have further questions regarding use of the medicine,
consult the doctor or pharmacist.
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
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
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
∙ 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
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
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
∙ changes in your breathing, heartbeat and blood
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
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
∙ 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,
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,
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”.
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
∙ 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.
In addition to the active ingredient, the medicine also
Lactose monohydrate, Microcrystalline cellulose,
Hydroxypropyl cellulose, Crospovidone, Magnesium
stearate, Opadry white Y-1-7000, Opadry yellow OY-
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
Zappa 7.5 tablets contain: 174.68 mg lactose monohydrate
Zappa 10 tablets contain: 232.9 mg lactose monohydrate
What the medicine looks like and the content of the
Zappa is packaged in a tray (blister), provided in a carton
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 is packaged in a tray (blister), provided in a
Zappa ODT are round, biconvex, light yellow tablets.
Zappa ODT are orodispersible tablets, intended for
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
Manufacturer and address: Trima Ltd., Kibbutz
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