ENDOXAN 50 mg TABLETS

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Baxter Healthcare South Africa (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS CYCLOPHOSPHAMIDE 50,0 mg

Authorization status:

Registered

Authorization date:

2006-11-09

Patient Information leaflet

APPLICANT/HCR:
Baxter Healthcare South Africa (Pty) Ltd
PRODUCT NAME:
Endoxan 50 mg Tablets
Each tablet contains cyclophosphamide monohydrate equivalent to 50 mg
anhydrous
cyclophosphamide.
Endoxan_Tab_PIL_v04_20220921
Page 1 of 18
Approved: 14 October 2022
PATIENT INFORMATION LEAFLET_ _
SCHEDULING STATUS: S4
ENDOXAN 50 MG TABLETS
CYCLOPHOSPHAMIDE MONOHYDRATE
ENDOXAN tablets contain 24,6 mg lactose monohydrate in the tablet core
and 51,11 mg sucrose
in the tablet coating.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING ENDOXAN
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, please ask your doctor, pharmacist,
nurse or other health
care provider.
•
ENDOXAN 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.
IMPORTANT THINGS TO KNOW ABOUT ENDOXAN
Your doctor has prescribed ENDOXAN because you have cancer that can be
treated. ENDOXAN
is a medicine that kills cancer cells but, as a result, also attacks
normal cells. It can therefore have
a number of side effects. Your doctor will not give you ENDOXAN unless
he or she thinks that your
cancer is more of a risk to you than any possible side effects. Your
doctor will check you regularly
and treat any side effects where possible. ENDOXAN:
•
will reduce your blood cell count, which may make you feel tired and
be more likely to get
infections.
APPLICANT/HCR:
Baxter Healthcare South Africa (Pty) Ltd
PRODUCT NAME:
Endoxan 50 mg Tablets
Each tablet contains cyclophosphamide monohydrate equivalent to 50 mg
anhydrous
cyclophosphamide.
Endoxan_Tab_PIL_v04_20220921
Page 2 of 18
Approved: 14 October 2022
•
can affect your kidneys and bladder. You may be given another medicine
called Mesna to
help prevent any damage. If you notice blood in your urine, tell your
doctor immediately.
•
like most anti-cancer or chemotherapy medicines, you may lose your
hair (anything from
thinning to total loss), although it should s

Summary of Product characteristics

APPLICANT/HCR:
Baxter Healthcare South Africa (Pty) Ltd
PRODUCT NAME:
Endoxan 50 mg Tablets
Each tablet contains cyclophosphamide monohydrate equivalent to 50 mg
anhydrous
cyclophosphamide.
Endoxan_Tab_PI_v04_20220921
PAGE 1 OF 34
Approved: 14 October 2022
PROFESSIONAL INFORMATION
SCHEDULING STATUS: S4
1. NAME OF THE MEDICINE
ENDOXAN 50 mg TABLETS
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
tablet
contains
cyclophosphamide
monohydrate
equivalent
to
50
mg
anhydrous
cyclophosphamide.
_Excipients with known effect _
ENDOXAN tablets contain 24,6 mg lactose monohydrate in the tablet core
and 51,11 mg
sucrose in the tablet coating.
3. PHARMACEUTICAL FORM
Tablets.
White round biconvex sugar-coated tablets with a white core.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MALIGNANT DISEASES:
Oral ENDOXAN is used in combination chemotherapy regimens or as
monotherapy in the
following indications:
•
Chronic lymphocytic leukaemia
•
Non-Hodgkin’s lymphomas, plasmacytoma
•
Neuroblastoma
APPLICANT/HCR:
Baxter Healthcare South Africa (Pty) Ltd
PRODUCT NAME:
Endoxan 50 mg Tablets
Each tablet contains cyclophosphamide monohydrate equivalent to 50 mg
anhydrous
cyclophosphamide.
Endoxan_Tab_PI_v04_20220921
PAGE 2 OF 34
Approved: 14 October 2022
•
Primary and metastatic breast cancer
•
Severe active forms of lupus nephritis, Wegener’s granulomatosis
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ENDOXAN should only be prescribed by medical practitioners experienced
with this medicine.
The dosage must be adapted to each patient individually.
Duration of therapy and intervals will depend on the indication, the
applied combination
chemotherapy schedule, the patient’s general state of health, the
laboratory parameters and
the recovery of the blood cell counts.
Unless otherwise prescribed the following dosages are recommended:
For continuous therapy 1 - 4 tablets (50 – 200 mg) daily; if
necessary, more tablets may be
taken.
The dose recommendations given mainly apply to the treatment with
cyclophosphamide a