Temozolomide Teva

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

temozolomide

Available from:

Teva B.V. 

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: 21

Authorization status:

Authorised

Authorization date:

2010-01-28

Patient Information leaflet

47
B. PACKAGE LEAFLET
48
PACKAGE LEAFLET: INFORMATION FOR THE USER
TEMOZOLOMIDE TEVA 5 MG HARD CAPSULES
TEMOZOLOMIDE TEVA 20 MG HARD CAPSULES
TEMOZOLOMIDE TEVA 100 MG HARD CAPSULES
TEMOZOLOMIDE TEVA 140 MG HARD CAPSULES
TEMOZOLOMIDE TEVA 180 MG HARD CAPSULES
TEMOZOLOMIDE TEVA 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 Teva is and what it is used for
2.
What you need to know before you take Temozolomide Teva
3.
How to take Temozolomide Teva
4.
Possible side effects
5.
How to store Temozolomide Teva
6.
Contents of the pack and other information
1.
WHAT TEMOZOLOMIDE TEVA IS AND WHAT IT IS USED FOR
Temozolomide Teva contains a medicine called temozolomide. This
medicine is an antitumour agent.
Temozolomide Teva is used for the treatment of specific forms of brain
tumours:
-
in adults with newly-diagnosed glioblastoma multiforme. Temozolomide
Teva 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 Teva is used in
these tumours if they
return or get worse after standard treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEMOZOLOMIDE TEVA
DO NOT TAKE TEMOZOLOMIDE TEVA
-
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

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Temozolomide Teva 5 mg hard capsules
Temozolomide Teva 20 mg hard capsules
Temozolomide Teva 100 mg hard capsules
Temozolomide Teva 140 mg hard capsules
Temozolomide Teva 180 mg hard capsules
Temozolomide Teva 250 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Temozolomide Teva 5 mg hard capsules
Each hard capsule contains 5 mg temozolomide.
_Excipient with known effect _
Each hard capsule contains 87 mg of lactose.
Temozolomide Teva 20 mg hard capsules
Each hard capsule contains 20 mg temozolomide.
_Excipients with known effect _
Each hard capsule contains 72 mg of lactose and sunset yellow FCF
(E110).
Temozolomide Teva 100 mg hard capsules
Each hard capsule contains 100 mg temozolomide.
_Excipient with known effect _
Each hard capsule contains 84 mg of lactose.
Temozolomide Teva 140 mg hard capsules
Each hard capsule contains 140 mg temozolomide.
_Excipient with known effect _
Each hard capsule contains 117 mg of lactose.
Temozolomide Teva 180 mg hard capsules
Each hard capsule contains 180 mg temozolomide.
_Excipient with known effect _
Each hard capsule contains 150 mg of lactose.
Temozolomide Teva 250 mg hard capsules
Each hard capsule contains 250 mg temozolomide.
_Excipient with known effect _
Each hard capsule contains 209 mg of lactose.
For the full list of excipients, see section 6.1.
3
3.
PHARMACEUTICAL FORM
Hard capsule.
Temozolomide Teva 5 mg hard capsules
The hard capsules have a white opaque body and cap with two stripes in
green ink on the cap and with
“T 5 mg” in green ink on the body. Each capsule is approximately
16 mm in length.
Temozolomide Teva 20 mg hard capsules
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. Each capsule is
approximately 18 mm in length.
Temozolomide Teva 100 mg hard capsules
The hard capsules have a white opaque body and cap with two stripes in
pink ink on the cap and with
“T 100