ZYPREXA 7.5 MG

Ország: Izrael

Nyelv: angol

Forrás: Ministry of Health

Aktív összetevők:

OLANZAPINE

Beszerezhető a:

ELI LILLY ISRAEL LTD, ISRAEL

ATC-kód:

N05AH03

Gyógyszerészeti forma:

TABLETS

Összetétel:

OLANZAPINE 7.5 MG

Az alkalmazás módja:

PER OS

Recept típusa:

Required

Gyártó:

LILLY S.A., SPAIN

Terápiás csoport:

OLANZAPINE

Terápiás terület:

OLANZAPINE

Terápiás javallatok:

Acute and maintenance treatment of schizophrenia. Zyprexa is indicated for the management of the manifestations of psychotic disorders. Zyprexa 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 Zyprexa is indicated for the prevention of recurrence in patients with Bipolar Disorder. Combination therapy in Bipolar I Disorder: The combination of Zyprexa with lithium or valproate is indicated for the short-term treatment of acute manic episodes associated with Bipolar I Disorder.

Engedély dátuma:

2012-03-31

Betegtájékoztató

I ZYPRTB A 12
Page 1 of 8
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
This medicine is to be supplied by a doctor’s prescription only
ZYPREXA
5 MG
Tablets
COMPOSITION:
Each tablet contains:
olanzapine 5 mg
ZYPREXA
7.5 MG
Tablets
COMPOSITION:
Each tablet contains:
olanzapine 7.5 mg
ZYPREXA
10 MG
Tablets
COMPOSITION:
Each tablet contains:
olanzapine 10 mg
INACTIVE INGREDIENTS AND ALLERGENS: See section 6 “Additional
information” and “Important information
regarding some of the ingredients of this medicine” in section 2.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains
concise information about this medicine. If you have any further
questions, refer to the doctor or
pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm
them even if it seems to you that their illness is similar.
VITAL INFORMATION ABOUT THIS MEDICINE:
Antipsychotics (like ZYPREXA) can increase the risk of death in
elderly people who are
experiencing confusion, memory loss, and loss of touch with reality
(dementia-related
psychosis). This medicine is not intended for adult patients who
suffer from dementia-related
psychosis.
ZYPREXA is intended for adults over 18 years of age.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Acute and maintenance treatment of schizophrenia.
ZYPREXA is indicated for the management of the manifestations of
psychotic disorders.
ZYPREXA 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 olanazapine
treatment, ZYPREXA is indicated
for the prevention of recurrence in patients with Bipolar Disorder.
Combination therapy in Bipolar I Disorder:
The combination of ZYPREXA with lithium or valproate is indicated for
the short-term treatment of
acute manic episodes associated with Bipolar I Disorder.
THERAPEUTIC GROUP:
Atypical antipsychotic medic

Termékjellemzők

X ZYPRTBVT A 13
Draft2
Page
1
of
24
ZYPREXA
ZYPREXA® VELOTAB®
1
DOSAGE FORMS AND STRENGTHS
ZYPREXA 5 mg, 7.5 mg, and 10 mg tablets
ZYPREXA Velotab 5 mg and 10 mg orodispersible tablets (orally
disintegrating tablets)
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS ARE AT AN INCREASED
RISK OF DEATH. ANALYSES OF SEVENTEEN PLACEBO-CONTROLLED TRIALS (MODAL
DURATION OF 10 WEEKS), LARGELY IN PATIENTS
TAKING ATYPICAL ANTIPSYCHOTIC DRUGS, REVEALED A RISK OF DEATH IN
DRUG-TREATED PATIENTS OF BETWEEN 1.6 TO 1.7
TIMES THE RISK OF DEATH IN PLACEBO-TREATED PATIENTS. OVER THE COURSE
OF A TYPICAL 10-WEEK CONTROLLED TRIAL, THE
RATE OF DEATH IN DRUG-TREATED PATIENTS WAS ABOUT 4.5%, COMPARED TO A
RATE OF ABOUT 2.6% IN THE PLACEBO GROUP.
ALTHOUGH THE CAUSES OF DEATH WERE VARIED, MOST OF THE DEATHS APPEARED
TO BE EITHER CARDIOVASCULAR (E.G., HEART
FAILURE, SUDDEN DEATH) OR INFECTIOUS (E.G., PNEUMONIA) IN NATURE.
OBSERVATIONAL STUDIES SUGGEST THAT, SIMILAR TO
ATYPICAL ANTIPSYCHOTIC DRUGS, TREATMENT WITH CONVENTIONAL
ANTIPSYCHOTIC DRUGS MAY INCREASE MORTALITY. THE
EXTENT TO WHICH THE FINDINGS OF INCREASED MORTALITY IN OBSERVATIONAL
STUDIES MAY BE ATTRIBUTED TO THE
ANTIPSYCHOTIC DRUG AS OPPOSED TO SOME CHARACTERISTIC(S) OF THE
PATIENTS IS NOT CLEAR. ZYPREXA (OLANZAPINE) IS
NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS [SEE WARNINGS AND PRECAUTIONS
(5.1, USE IN SPECIFIC POPULATIONS (8.5)].
2
INDICATIONS AND USAGE
Zyprexa tablets and velotabs: Acute and maintenance treatment of
schizophrenia. Zyprexa is indicated for the
management of the manifestations of psychotic disorders. Zyprexa 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 Zyprexa is indicated for
the prevention of recurrence in patients with
Bipolar Disorder. Combinat