ZAPPA 5

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

OLANZAPINE

Tilgængelig fra:

UNIPHARM LTD, ISRAEL

ATC-kode:

N05AH03

Lægemiddelform:

FILM COATED TABLETS

Sammensætning:

OLANZAPINE 5 MG

Indgivelsesvej:

PER OS

Recept type:

Required

Fremstillet af:

TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL

Terapeutisk gruppe:

OLANZAPINE

Terapeutisk område:

OLANZAPINE

Terapeutiske indikationer:

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.

Autorisation dato:

2016-09-30

Indlægsseddel

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
18.
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,