Temozolomide Sandoz

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

temozolomide

Available from:

Sandoz GmbH

ATC code:

L01AX03

INN (International Name):

temozolomide

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Glioma; Glioblastoma

Therapeutic indications:

For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.For the treatment of children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

Product summary:

Revision: 17

Authorization status:

Withdrawn

Authorization date:

2010-03-15

Patient Information leaflet

132
B. PACKAGE LEAFLET
Medicinal product no longer authorised
133
PACKAGE LEAFLET: INFORMATION FOR THE USER
TEMOZOLOMIDE SANDOZ 5 MG HARD CAPSULES
TEMOZOLOMIDE SANDOZ 20 MG HARD CAPSULES
TEMOZOLOMIDE SANDOZ 100 MG HARD CAPSULES
TEMOZOLOMIDE SANDOZ 140 MG HARD CAPSULES
TEMOZOLOMIDE SANDOZ 180 MG HARD CAPSULES
TEMOZOLOMIDE SANDOZ 250 MG HARD CAPSULES
temozolomide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Temozolomide Sandoz is and what it is used for
2.
What you need to know before you take Temozolomide Sandoz
3.
How to take Temozolomide Sandoz
4.
Possible side effects
5.
How to store Temozolomide Sandoz
6.
Contents of the pack and other information
1.
WHAT TEMOZOLOMIDE SANDOZ IS AND WHAT IT IS USED FOR
Temozolomide Sandoz contains a medicine called temozolomide. This
medicine is an antitumour
agent.
Temozolomide Sandoz is used for the treatment of specific forms of
brain tumours:
•
in adults with newly-diagnosed glioblastoma multiforme. Temozolomide
Sandoz is first used
together with radiotherapy (concomitant phase of treatment) and after
that alone (monotherapy
phase of treatment).
•
in children 3 years and older and adult patients with malignant glioma
, such as glioblastoma
multiforme or anaplastic astrocytoma. Temozolomide Sandoz is used in
these tumours if they
return or get worse after standard treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEMOZOLOMIDE SANDOZ
_ _
DO NOT TAKE TEMOZOLOMIDE SANDOZ
•
if you are allergic to temozolomide or any of the other ingredi

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Temozolomide Sandoz 5 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 5 mg of temozolomide.
Excipient with known effect:
Each hard capsule contains 168 mg of anhydrous lactose.
For the full list of excipients, see section 6.1.
_ _
3.
PHARMACEUTICAL FORM
Hard capsule (capsule).
_ _
The hard capsules have a white coloured body, a green coloured cap,
and are imprinted with black
ink. The cap is imprinted with “TMZ”. The body is imprinted with
“5”.
_ _
Each capsule is approximately 15.8 mm in length.
_ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Temozolomide Sandoz is indicated for the treatment of:
-
adult patients with newly-diagnosed glioblastoma multiforme
concomitantly with radiotherapy
(RT) and subsequently as monotherapy treatment,
-
children from the age of three years, adolescents and adult patients
with malignant glioma, such
as glioblastoma multiforme or anaplastic astrocytoma, showing
recurrence or progression after
standard therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Temozolomide Sandoz should only be prescribed by physicians
experienced in the oncological
treatment of brain tumours.
Anti-emetic therapy may be administered (see section 4.4).
Posology
_ _
_Adult patients with newly-diagnosed glioblastoma multiforme _
Temozolomide Sandoz is administered in combination with focal
radiotherapy (concomitant phase)
followed by up to 6 cycles of temozolomide (TMZ) monotherapy
(monotherapy phase).
_ _
_Concomitant phase _
TMZ is administered orally at a dose of 75 mg/m
2
daily for 42 days concomitant with focal
radiotherapy (60 Gy administered in 30 fractions). No dose reductions
are recommended, but delay or
discontinuation of TMZ administration should be decided weekly
according to haematological and
non-haematological toxicity criteria. TMZ administration can be
continued throughout the 42 day
concomitant period (up to 49 days)