Temozolomide FAIR-MED 250mg hard capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TEMOZOLOMIDE

Available from:

FAIR-MED HEALTHCARE GmbH Planckstr. 13, 22765 Hamburg, Germany

ATC code:

L01AX03

INN (International Name):

TEMOZOLOMIDE 250 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

TEMOZOLOMIDE 250 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2013-02-21

Patient Information leaflet

Page 1 of 10
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 (lis

Summary of Product characteristics

Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
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
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 399.3mg mg of anhydrous lactose.
Each 20 mg hard capsule contains 384.3 mg of anhydrous lactose.
Each 100 mg hard capsule contains 61.7 mg of anhydrous lactose.
Each 140 mg hard capsule contains 86.4 mg of anhydrous lactose.
Each 180 mg hard capsule contains 111.1 mg of anhydrous lactose.
Each 250 mg hard capsule contains 154.3 mg of anhydrous lactose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
5 mg: The hard gelatin capsules are size 0 and have a green opaque
cap/white opaque body
with 5 printed in black ink on the body.
20 mg: The hard gelatin capsules are size 0 and have an orange opaque
cap /white opaque
body with 20 printed in black ink on the body.
100 mg: The hard gelatin capsules are size 0 and have a purple opaque
cap /white opaque
body with 100 printed in black ink on the body
140 mg: 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
180 mg: The hard gelatin capsules are size 0 and have a chocolate
brown opaque cap /white
opaque body with 180 printed in black ink on the body
250 mg: The hard gelatin capsules size 0 and white opaque cap /white
opaque body with 250
printed in black ink on the body
Page 2 of 21
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Temozolomide FA