CLOZAPINE 25 OETHMAAN TABLET

Land: Sydafrika

Sprog: engelsk

Kilde: South African Health Products Regulatory Authority (SAHPRA)

Tilgængelig fra:

Oethmaan Biosims (Pty) Ltd

Dosering:

See ingredients

Lægemiddelform:

TABLET

Sammensætning:

EACH TABLET CONTAINS CLOZAPINE 25,0 mg

Autorisation status:

Registered

Autorisation dato:

2007-01-11

Indlægsseddel

APPLICANT: Oethmaan Biosims (Pty) Ltd
DATE OF SAHPRA APPROVAL
02 August 2022
PRODUCT:
CLOZAPINE 25 mg OETHMAAN
CLOZAPINE 50 mg OETHMAAN
CLOZAPINE 100 mg OETHMAAN
DOSAGE FORM AND STRENGTH:
Each tablet contains: 25 mg/50 mg/100 mg
clozapine
Initial:
02/08/2022
P
age 1 of 24
PATIENT INFORMATION LEAFLET - CLEAN
INFORMATION LEAFLET
SCHEDULING STATUS:
S5
CLOZAPINE 25 OETHMAAN, TABLET
CLOZAPINE 50 OETHMAAN, TABLET
CLOZAPINE 100 OETHMAAN, TABLET
CLOZAPINE
CONTAINS SUGAR (LACTOSE MONOHYDRATE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN CLOZAPINE
OETHMAAN.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other healthcare
provider.
APPLICANT: Oethmaan Biosims (Pty) Ltd
DATE OF SAHPRA APPROVAL
02 August 2022
PRODUCT:
CLOZAPINE 25 mg OETHMAAN
CLOZAPINE 50 mg OETHMAAN
CLOZAPINE 100 mg OETHMAAN
DOSAGE FORM AND STRENGTH:
Each tablet contains: 25 mg/50 mg/100 mg
clozapine
Initial:
02/08/2022
P
age 2 of 24
•
CLOZAPINE OETHMAAN has been prescribed for you personally and you
should not share
your medicine with other people. It may harm them, even if their
symptoms are the same as
yours.
WHAT IS IN THIS LEAFLET
1. What CLOZAPINE OETHMAAN is and what it is used for
2. What you need to know before you take CLOZAPINE OETHMAAN
3. How to take CLOZAPINE OETHMAAN
4. Possible side effects
5. How to store CLOZAPINE OETHMAAN
6. Contents of the pack and other information
1.
WHAT CLOZAPINE OETHMAAN IS AND WHAT IT IS USED FOR
CLOZAPINE OETHMAAN contains a medicine called clozapine which belongs
to a group of
medicines called antipsychotics (medicines that are used to treat
specific mental disorders such
as psychosis). CLOZAPINE OETHMAAN is used:
•
To treat the symptoms of severe schizophrenia (a mental disorder), in
people who have not
responded to other medications.
•
To help reduce the risk of suicidal behaviour in people with
schizophrenia or similar
disorders.
APPLICANT: Oethmaan Biosims (Pty) Ltd
DATE OF SAHPRA APPROVAL
02 August 2022
PRODU

Produktets egenskaber

APPLICANT: Oethmaan Biosims (Pty) Ltd
DATE OF SAHPRA APPROVAL:
02 August 2022
PRODUCT:
CLOZAPINE 25 mg OETHMAAN
CLOZAPINE 50 mg OETHMAAN
CLOZAPINE 100 mg OETHMAAN
DOSAGE FORM AND STRENGTH:
Each tablet contains: 25 mg/50 mg/100 mg
clozapine
Initial:
02/08//2022
Page 1 of 32
PROFESSIONAL INFORMATION – CLEAN COPY
SCHEDULING STATUS:
1. NAME OF THE MEDICINE:
CLOZAPINE 25 OETHMAAN, Tablets
CLOZAPINE 50 OETHMAAN, Tablets
CLOZAPINE 100 OETHMAAN, Tablets
WARNING
BECAUSE
OF
THE
SIGNIFICANT
RISK
THAT
CLOZAPINE
OETHMAAN
CAN
CAUSE
FATAL
AGRANULOCYTOSIS, ITS USE SHOULD BE LIMITED TO SEVERELY ILL
SCHIZOPHRENIC PATIENTS WHO
ARE NON-RESPONSIVE TO, OR INTOLERANT OF CLASSIC NEUROLEPTIC MEDICINAL
TREATMENT.
PRESCRIBERS
SHOULD
COMPLY
FULLY
WITH
THE
REQUIRED
SAFETY
MEASURES.
AT
EACH
CONSULTATION A PATIENT RECEIVING CLOZAPINE OETHMAAN SHOULD BE REMINDED
TO
CONTACT THE TREATING PHYSICIAN IMMEDIATELY IF ANY KIND OF INFECTION
BEGINS TO DEVELOP.
PARTICULAR ATTENTION SHOULD BE PAID TO “FLU-LIKE” COMPLAINTS SUCH
AS FEVER OR SORE
THROAT AND TO OTHER EVIDENCE OF INFECTION, WHICH MAY BE INDICATIVE OF
NEUTROPENIA.
PATIENTS WHO ARE BEING TREATED WITH CLOZAPINE OETHMAAN MUST HAVE
INITIALLY
NORMAL LEUCOCYTE FINDINGS (BASELINE WHITE BLOOD CELL COUNT ≥ 3
500/MM
3 AND NORMAL
DIFFERENTIAL BLOOD COUNT) BEFORE INITIATION OF TREATMENT. REGULAR
WHITE BLOOD CELL
(WBC)
COUNTS
AND
IF
POSSIBLE,
ABSOLUTE
NEUTROPHIL
COUNTS
(ANC)
SHOULD
BE
PERFORMED (WEEKLY DURING THE FIRST 18 WEEKS AND AT LEAST EVERY TWO
WEEKS THEREAFTER
S5
APPLICANT: Oethmaan Biosims (Pty) Ltd
DATE OF SAHPRA APPROVAL:
02 August 2022
PRODUCT:
CLOZAPINE 25 mg OETHMAAN
CLOZAPINE 50 mg OETHMAAN
CLOZAPINE 100 mg OETHMAAN
DOSAGE FORM AND STRENGTH:
Each tablet contains: 25 mg/50 mg/100 mg
clozapine
Initial:
02/08//2022
Page 2 of 32
THROUGHOUT TREATMENT AND FOR ONE MONTH AFTER DISCONTINUATION OF
TREATMENT).
ORTHOSTATIC HYPOTENSION, WITH OR WITHOUT SYNCOPE, CAN OCCUR WITH
CLOZAPINE
OETHMAAN TREATMENT. COLLAPSE CAN BE PROFOUND AND MAY BE ACCOMPANIED BY
CARDIAC AND/OR RESPIRATORY ARREST. SUCH EVEN