Temozolomide Sun

Krajina: Európska únia

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktívna zložka:

temozolomide

Dostupné z:

Sun Pharmaceutical Industries Europe B.V.

ATC kód:

L01AX03

INN (Medzinárodný Name):

temozolomide

Terapeutické skupiny:

Antineoplastic agents

Terapeutické oblasti:

Glioma; Glioblastoma

Terapeutické indikácie:

Temozolomide Sun 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.

Prehľad produktov:

Revision: 19

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2011-07-13

Príbalový leták

48
B. PACKAGE LEAFLET
49
PACKAGE LEAFLET: INFORMATION FOR THE USER
TEMOZOLOMIDE SUN 5 MG HARD CAPSULES
TEMOZOLOMIDE SUN 20 MG HARD CAPSULES
TEMOZOLOMIDE SUN 100 MG HARD CAPSULES
TEMOZOLOMIDE SUN 140 MG HARD CAPSULES
TEMOZOLOMIDE SUN 180 MG HARD CAPSULES
TEMOZOLOMIDE SUN 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 SUN is and what it is used for
2.
What you need to know before you take Temozolomide SUN
3.
How to take Temozolomide SUN
4.
Possible side effects
5.
How to store Temozolomide SUN
6.
Contents of the pack and other information
1.
WHAT TEMOZOLOMIDE SUN IS AND WHAT IT IS USED FOR
Temozolomide SUN contains a medicine called temozolomide. This
medicine is an antitumour agent.
Temozolomide SUN is used for the treatment of specific forms of brain
tumours:
-
in adults with newly-diagnosed glioblastoma multiforme. Temozolomide
SUN is at 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 SUN is used in
these tumours if they
return or get worse after standard treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEMOZOLOMIDE SUN
DO NOT TAKE TEMOZOLOMIDE SUN
-
if you are allergic to temozolomide or any of the other ingredients of
this medicine (listed in
section 6).
-
if you have had an allergic reaction to dacarbazine (

Súhrn charakteristických

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Temozolomide SUN 5 mg hard capsules
Temozolomide SUN 20 mg hard capsules
Temozolomide SUN 100 mg hard capsules
Temozolomide SUN 140 mg hard capsules
Temozolomide SUN 180 mg hard capsules
Temozolomide SUN 250 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
5 mg hard capsules
Each hard capsule contains 5 mg temozolomide.
Excipient with known effect
Each hard capsule contains 30.97 mg of lactose.
20 mg hard capsules
Each hard capsule contains 20 mg temozolomide.
Excipient with known effect
Each hard capsule contains 18.16 mg of lactose.
100 mg hard capsules
Each hard capsule contains 100 mg temozolomide.
Excipient with known effect
Each hard capsule contains 90.801 mg of lactose.
140 mg hard capsules
Each hard capsule contains 140 mg temozolomide.
Excipient with known effect
Each hard capsule contains 127.121 mg of lactose.
180 mg hard capsules
Each hard capsule contains 180 mg temozolomide.
Excipient with known effect
Each hard capsule contains 163.441 mg of lactose.
250 mg hard capsules
Each hard capsule contains 250 mg temozolomide.
Excipient with known effect
Each hard capsule contains 227.001 mg of lactose.
For the full list of excipients, see section 6.1.
3
3.
PHARMACEUTICAL FORM
5 mg hard capsule (capsule)
Hard gelatin capsules, with white opaque cap and body, imprinted in
green ink. The cap is imprinted
with ‘890’. The body is imprinted with ‘5 mg’ and two stripes.
20 mg hard capsule (capsule)
Hard gelatin capsules, with white opaque cap and body, imprinted in
yellow ink. The cap is imprinted
with ‘891’. The body is imprinted with ’20 mg’ and two
stripes.
100 mg hard capsule (capsule)
Hard gelatin capsules, with white opaque cap and body, imprinted in
pink ink. Thw cap is imprinted
with ‘892’. The body is imprinted with ‘100 mg’ and two
stripes.
140 mg hard capsule (capsule)
Hard gelatin capsules, with white opaque cap and body, imprinted in
blue ink. The cap is imprinted
with ‘929’. The b