Temozolomide Clonmel 20 mg hard capsules

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Temozolomide

Prieinama:

Clonmel Healthcare Ltd

ATC kodas:

L01AX; L01AX03

INN (Tarptautinis Pavadinimas):

Temozolomide

Dozė:

20 milligram(s)

Vaisto forma:

Capsule, hard

Recepto tipas:

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

Gydymo sritis:

Other alkylating agents; temozolomide

Autorizacija statusas:

Marketed

Leidimo data:

2010-05-21

Pakuotės lapelis

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
TEMOZOLOMIDE CLONMEL 5MG HARD CAPSULES
TEMOZOLOMIDE CLONMEL 20MG HARD CAPSULES
TEMOZOLOMIDE CLONMEL 100MG HARD CAPSULES
TEMOZOLOMIDE CLONMEL 140MG HARD CAPSULES
TEMOZOLOMIDE CLONMEL 180MG HARD CAPSULES
TEMOZOLOMIDE CLONMEL 250MG 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 Clonmel is and what it is used for
2.
What you need to know before you take Temozolomide Clonmel
3.
How to take Temozolomide Clonmel
4.
Possible side effects
5.
How to store Temozolomide Clonmel
6.
Contents of the pack and other information
1.
WHAT TEMOZOLOMIDE CLONMEL IS AND WHAT IT IS USED FOR
Temozolomide Clonmel contains a medicine called temozolomide. This
medicine is an antitumour
agent.
Temozolomide Clonmel is used for the treatment of specific forms of
brain tumours:
-
in adults with newly-diagnosed glioblastoma multiforme. Temozolomide
Clonmel 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 Clonmel is used in
these tumours if they
return or get worse after standard treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEMOZOLOMIDE CLONMEL
DO NOT TAKE TEMOZOLOMIDE CLONMEL
-
if you are allergic to temozolomide or any of the other ingredients of
this medicine (listed in
section 6).
-
if you

Prekės savybės

Health Products Regulatory Authority
06 April 2023
CRN00DHTG
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Temozolomide Clonmel 20 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 20 mg temozolomide.
Excipient with known effect
Each hard capsule contains 72 mg lactose, sunset yellow FCF (E110) and
0.21 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule.
The hard capsules have a white opaque body and cap with two stripes in
orange ink on the cap and with “T 20 mg” in orange
ink on the body with a diameter of approximately 6.2 mm and a length
of approximately 18.0 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Temozolomide Clonmel 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 Clonmel 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 Clonmel 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/m² 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 continue