LOZAPINE 100 MG

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

CLOZAPINE

Tilgængelig fra:

TARO INTERNATIONAL LTD, ISRAEL

ATC-kode:

N05AH02

Lægemiddelform:

TABLETS

Sammensætning:

CLOZAPINE 100 MG

Indgivelsesvej:

PER OS

Recept type:

Required

Fremstillet af:

GENTHON B.V.

Terapeutisk gruppe:

CLOZAPINE

Terapeutisk område:

CLOZAPINE

Terapeutiske indikationer:

Treatment of schizophrenic patients only in cases who are nonresponsive to conventional therapy.

Autorisation dato:

2015-04-27

Indlægsseddel

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
INSTRUCTIONS FOR ISSUING THIS PREPARATION:
DURING THE FIRST 18 WEEKS:
PERFORM A BLOOD TEST ONCE A WEEK DURING THE FIRST 18 WEEKS.
THE LOCAL PHARMACY WILL DISPENSE THE MEDICINE FOR ONE WEEK OF
TREATMENT ONLY, ACCORDING TO A DOCTOR’S PRESCRIPTION, PROVIDED THAT
IT
CARRIES A STAMP AS FOLLOWS:
“WHITE BLOOD CELL TEST HAS BEEN CONDUCTED AND RESULTS ARE NORMAL”.
STARTING FROM WEEK 19 OF TREATMENT:
A BLOOD TEST MUST BE CONDUCTED AT LEAST ONCE A MONTH.
THE LOCAL PHARMACY WILL DISPENSE THE MEDICINE FOR ONE MONTH OF
TREATMENT ONLY, ACCORDING TO A DOCTOR’S PRESCRIPTION, PROVIDED THAT
IT
CARRIES A STAMP AS FOLLOWS:
“WHITE BLOOD CELL TEST HAS BEEN CONDUCTED AND RESULTS ARE NORMAL”.
LOZAPINE 25 MG TABLETS LOZAPINE 100 MG TABLETS
Active ingredient and quantity:
Active ingredient and quantity:
Each tablet contains:
Each tablet contains:
Clozapine 25 mg
Clozapine 100 mg
For a list of inactive ingredients, please refer to 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.
This medicine is not intended for infants and children below the age
of 16,
as there is not enough information on its use in this age group.
Prior to starting treatment with Lozapine, you must perform a blood
test to
ensure that you may take the medicine.
•
Since the medicine may cause a decrease in the number of white
blood cells, a white blood cell count and a differential blood count
must be performed prior to beginning treatment. The treatment may
be started only if the blood count is found to be normal.
•
A WHITE BLOOD CELL COUNT SHOULD BE PERFORMED EVERY WEEK FOR