Temozolomide Hetero 100 mg hard capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TEMOZOLOMIDE

Available from:

Hetero Europe S.L. Viladecans Business Park - Edificio Brasil Catalunya 83-85 08840 Viladecans, Spain

ATC code:

L01AX03

INN (International Name):

TEMOZOLOMIDE 100 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

TEMOZOLOMIDE 100 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2016-11-17

Patient Information leaflet

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
TEMOZOLOMIDE HETERO 5 MG HARD CAPSULES
TEMOZOLOMIDE HETERO 20 MG HARD CAPSULES
TEMOZOLOMIDE HETERO 100 MG HARD CAPSULES
TEMOZOLOMIDE HETERO 140 MG HARD CAPSULES
TEMOZOLOMIDE HETERO 180 MG HARD CAPSULES
TEMOZOLOMIDE HETERO 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 Hetero is and what it is used for
2.
What you need to know before you take Temozolomide Hetero
3.
How to take Temozolomide Hetero
4.
Possible side effects
5.
How to store Temozolomide Hetero
6.
Contents of the pack and other information
1.
WHAT TEMOZOLOMIDE HETERO IS AND WHAT IT IS USED FOR
Temozolomide Hetero contains a medicine called temozolomide. This
medicine is an antitumour
agent.
Temozolomide Hetero is used for the treatment of specific forms of
brain tumours:
-
in adults with newly-diagnosed glioblastoma multiforme. Temozolomide
Hetero 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 Hetero is used in
these tumours if they
return or get worse after standard treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEMOZOLOMIDE HETERO
DO NOT TAKE TEMOZOLOMIDE HETERO:
-
if you are allergic to temozolomide or any of the other ingredients of
this medicine (listed in
section 6).
-
if you have had a

Summary of Product characteristics

Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Temozolomide Hetero 5 mg hard capsules
Temozolomide Hetero 20 mg hard capsules
Temozolomide Hetero 100 mg hard capsules
Temozolomide Hetero 140 mg hard capsules
Temozolomide Hetero 180 mg hard capsules
Temozolomide Hetero 250 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 5 mg temozolomide.
Each hard capsule contains 20 mg temozolomide.
Each hard capsule contains 100 mg temozolomide.
Each hard capsule contains 140 mg temozolomide.
Each hard capsule contains 180 mg temozolomide.
Each hard capsule contains 250 mg temozolomide.
Excipient with known effect:
Each 5 mg hard capsule contains 93 mg of anhydrous lactose.
Each 20 mg hard capsule contains 16 mg of anhydrous lactose.
Each 100 mg hard capsule contains 82 mg of anhydrous lactose.
Each 140 mg hard capsule contains 115 mg of anhydrous lactose.
Each 180 mg hard capsule contains 148 mg of anhydrous lactose.
Each 250 mg hard capsule contains 206 mg of anhydrous lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
_Temozolomide Hetero_ _5 mg_: opaque, green cap & white body, size '3'
hard gelatin capsules imprinted
with '13' on cap and 'H' on body, filled with off white to pale pink
granular powder.
_Temozolomide Hetero_ _20 mg_: Opaque , yellow cap & white body, size
'4' hard gelatin capsules
imprinted with '14' on cap and 'H' on body, filled with off white to
pale pink granular powder.
_Temozolomide Hetero_ _100 mg_: Opaque, pink cap & white body, size
'1' hard gelatin capsules
imprinted with '15' on cap and 'H' on body, filled with off white to
pale pink granular powder.
_Temozolomide Hetero_ _140 mg_: Opaque, blue cap & white body, size
'0' hard gelatin capsules
imprinted with '16' on cap and 'H' on body, filled with off white to
pale pink granular powder.
_Temozolomide Hetero_ _180 mg_: Opaque, orange cap & white body, size
'0' hard gelatin capsules
imprinted with '17' on cap and 'H' on body, filled