Blastomat 140 mg, harde capsules

Country: Netherlands

Language: Dutch

Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Active ingredient:

TEMOZOLOMIDE 140 mg/stuk

Available from:

Alvogen IPCo S.ar.l 5, rue Heienhaff 1736 SENNINGERBERG (LUXEMBURG)

ATC code:

L01AX03

INN (International Name):

TEMOZOLOMIDE 140 mg/stuk

Pharmaceutical form:

Capsule, hard

Composition:

AMMONIA (E 527) ; GELATINE (E 441) ; IJZEROXIDE ZWART (E 172) ; INDIGOKARMIJN (E 132) ; KALIUMHYDROXIDE (E 525) ; LACTOSE 0-WATER ; NATRIUMZETMEELGLYCOLAAT ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; STEARINEZUUR (E 570) ; TITAANDIOXIDE (E 171) ; WIJNSTEENZUUR, (L (+) Vorm) (E 334) ; ZWARTE INKT, AMMONIA (E 527) ; GELATINE (E 441) ; IJZEROXIDE ZWART (E 172) ; INDIGOKARMIJN (E 132) ; KALIUMHYDROXIDE (E 525) ; LACTOSE 0-WATER ; NATRIUMZETMEELGLYCOLAAT (E468) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; STEARINEZUUR (E 570) ; TITAANDIOXIDE (E 171) ; WIJNSTEENZUUR, (L (+) Vorm) (E 334) ; ZWARTE INKT,

Administration route:

Oraal gebruik

Therapeutic area:

Temozolomide

Product summary:

Hulpstoffen: AMMONIA (E 527); GELATINE (E 441); IJZEROXIDE ZWART (E 172); INDIGOKARMIJN (E 132); KALIUMHYDROXIDE (E 525); LACTOSE 0-WATER; NATRIUMZETMEELGLYCOLAAT (E468); PROPYLEENGLYCOL (E 1520); SCHELLAK (E 904); SILICIUMDIOXIDE (E 551); STEARINEZUUR (E 570); TITAANDIOXIDE (E 171); WIJNSTEENZUUR, (L (+) Vorm) (E 334); ZWARTE INKT;

Authorization date:

2012-11-13

Patient Information leaflet

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BLASTOMAT 5 MG, HARDE CAPSULES
BLASTOMAT 20 MG, HARDE CAPSULES
BLASTOMAT 100 MG, HARDE CAPSULES
BLASTOMAT 140 MG, HARDE CAPSULES
BLASTOMAT 180 MG, HARDE CAPSULES
BLASTOMAT 250 MG, HARDE 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 Blastomat is and what it is used for
2.
What you need to know before you take Blastomat
3.
How to take Blastomat
4.
Possible side effects
5.
How to store Blastomat
6.
Contents of the pack and other information
1.
WHAT BLASTOMAT IS AND WHAT IT IS USED FOR
Blastomat contains a medicine called temozolomide. This medicine is an
antitumour agent.
Blastomat is used for the treatment of specific forms of brain
tumours:
-
In adults with newly-diagnosed glioblastoma multiforme. Blastomat 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. Blastomat is used in these
tumours if they return or get
worse after standard treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BLASTOMAT
DO NOT TAKE BLASTOMAT
-
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 (an anticancer
medicine sometimes called
DTIC). Signs of allergic reaction includ

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAAM VAN HET GENEESMIDDEL
Blastomat 5 mg, harde capsules
Blastomat 20 mg, harde capsules
Blastomat 100 mg, harde capsules
Blastomat 140 mg, harde capsules
Blastomat 180 mg, harde capsules
Blastomat 250 mg, harde 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 399.3 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 hard capsules
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 hard capsules
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 hard capsules
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 hard capsules
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 hard capsules
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 hard capsules
The hard gelatin capsules size 0 and white opaque cap /white opaque
body with “250” printed in black
ink on the body.
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4.