Temozolomide FAIR-MED 140 mg hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Temozolomide

Available from:

Fairmed Healthcare GmbH

ATC code:

L01AX; L01AX03

INN (International Name):

Temozolomide

Dosage:

140 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other alkylating agents; temozolomide

Authorization status:

Not marketed

Authorization date:

2013-06-28

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
TEMOZOLOMIDE FAIR-MED 5 MG HARD CAPSULES
TEMOZOLOMIDE FAIR-MED 20 MG HARD CAPSULES
TEMOZOLOMIDE FAIR-MED 100 MG HARD CAPSULES
TEMOZOLOMIDE FAIR-MED 140 MG HARD CAPSULES
TEMOZOLOMIDE FAIR-MED 180 MG HARD CAPSULES
TEMOZOLOMIDE FAIR-MED 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 FAIR-MED is and what it is used for
2.
What you need to know before you use Temozolomide FAIR-MED
3.
How to use Temozolomide FAIR-MED
4.
Possible side effects
5.
How to store Temozolomide FAIR-MED
6.
Contents of the pack and other information
1.
WHAT TEMOZOLOMIDE FAIR-MED IS AND WHAT IT IS USED FOR
Temozolomide FAIR-MED contains a medicine called temozolomide. This
medicine is an
antitumour agent.
Temozolomide FAIR-MED is used for the treatment of specific forms of
brain tumours:
-
in adults with newly-diagnosed glioblastoma multiforme. Temozolomide
FAIR-MED
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
FAIR-MED is
used in these tumours if they return or get worse after standard
treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TEMOZOLOMIDE FAIR-MED
DO NOT USE TEMOZOLOMIDE FAIR-MED
-
if you are allergic to temozolomide or any of the other ingredients of
this medicine
(listed in sect

Summary of Product characteristics

Health Products Regulatory Authority
17 May 2022
CRN00CK4J
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Temozolomide FAIR-MED 140 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 140 mg temozolomide.
Excipient with known effect:
Each 140 mg hard capsule contains 86.4 mg of anhydrous lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
The hard gelatin capsules are size 0 and have a blue opaque cap /white
opaque body with 140 printed in black ink on the body.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Temozolomide FAIR-MED hard capsules 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 FAIR-MED hard capsules 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 FAIR-MED hard capsules 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) if all of the following
conditions are met:
- absolut