ZAPPA 5

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

OLANZAPINE

Available from:

UNIPHARM LTD, ISRAEL

ATC code:

N05AH03

Pharmaceutical form:

FILM COATED TABLETS

Composition:

OLANZAPINE 5 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

UNIPHARM LTD, ISRAEL

Therapeutic area:

OLANZAPINE

Therapeutic indications:

Acute and maintenance treatment of Schizophrenia. Zappa is indicated for the management of the manifestations of psychotic disorders. Zappa is indicated for the short-term treatment of acute manic episodes associated with Bipolar I Disorder. Prevention of recurrence in Bipolar Disorder: In patients whose manic episode has responded to Olanzapine treatment Zappa is indicated for the prevention of reccurence in patients with Bipolar Disorder. Combination therapy in Bipolar I Disorder: The combination of Zappa with lithium or valproate is indicated for the short-term treatment of acute manic episodes associated with Bipolar I Disorder.

Authorization date:

2019-02-20

Patient Information leaflet

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 “Further
Information” and section 2 “Important information about some
of the ingredients of the medicine”.
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.
1. WHAT IS THE MEDICINE INTENDED FOR?
For acute and maintenance treatment of schizophrenia.
ZAPPA and ZAPPA ODT are intended for the treatment of
symptoms of psychotic disorders.
ZAPPA and ZAPPA ODT are intended for the short-term
treatment of severe mania attacks associated with bipolar I
disorder.
Prevention of recurrence of bipolar disorder:
In patients whose mania attack responded to treatment with
olanzapine, ZAPPA and ZAPPA ODT are indicated to prevent
recurrence in patients with bipolar disorder.
Combination treatment of bipolar I disorder:
The combinatio