Temozolomide CF 5 mg, capsules, hard

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

TEMOZOLOMIDE

Beschikbaar vanaf:

Centrafarm B.V.

ATC-code:

L01AX03

INN (Algemene Internationale Benaming):

TEMOZOLOMIDE

farmaceutische vorm:

Capsule, hard

Samenstelling:

GELATINE (E 441) ; GROENE INKT ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 0-WATER ; NATRIUMZETMEELGLYCOLAAT ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; STEARINEZUUR (E 570) ; TARTRAZINE ALUMINIUMLAK (E 102) ; TITAANDIOXIDE (E 171) ; WIJNSTEENZUUR, (L (+) Vorm) (E 334), GELATINE (E 441) ; GROENE INKT ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 0-WATER ; NATRIUMZETMEELGLYCOLAAT (E468) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; STEARINEZUUR (E 570) ; TARTRAZINE ALUMINIUMLAK (E 102) ; TITAANDIOXIDE (E 171) ; WIJNSTEENZUUR, (L (+) Vorm) (E 334),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Temozolomide

Product samenvatting:

Hulpstoffen: GELATINE (E 441); GROENE INKT; IJZEROXIDE GEEL (E 172); INDIGOKARMIJN ALUMINIUMLAK (E 132); LACTOSE 0-WATER; NATRIUMZETMEELGLYCOLAAT (E468); PROPYLEENGLYCOL (E 1520); SCHELLAK (E 904); SILICIUMDIOXIDE (E 551); STEARINEZUUR (E 570); TARTRAZINE ALUMINIUMLAK (E 102); TITAANDIOXIDE (E 171); WIJNSTEENZUUR, (L (+) Vorm) (E 334);

Autorisatie datum:

2010-07-23

Bijsluiter

2018-06-26/PH
PACKAGE LEAFLET: INFORMATION FOR THE USER
TEMOZOLOMIDE CF 5 MG, CAPSULES, HARD
TEMOZOLOMIDE CF 20 MG, CAPSULES, HARD
TEMOZOLOMIDE CF 100 MG, CAPSULES, HARD
TEMOZOLOMIDE CF 140 MG, CAPSULES, HARD
TEMOZOLOMIDE CF 180 MG, CAPSULES, HARD
TEMOZOLOMIDE CF 250 MG, CAPSULES, HARD
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 [Product Name] is and what it is used for
2. What you need to know before you take [Product Name]
3. How to take [Product Name]
4. Possible side effects
5. How to store [Product Name]
6. Contents of the pack and other information
1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[Product Name] contains a medicine called temozolomide. This medicine
is an antitumour
agent.
[Product Name] is used for the treatment of specific forms of brain
tumours:

in adults with newly-diagnosed glioblastoma multiforme. [Product Name]
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. [Product Name] is
used in these
tumours if they return or get worse after standard treatment.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [PRODUCT NAME]
DO NOT TAKE [PRODUCT NAME]

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

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Temozolomide CF 5 mg, capsules, hard
Temozolomide CF 20 mg, capsules, hard
Temozolomide CF 100 mg, capsules, hard
Temozolomide CF 140 mg, capsules, hard
Temozolomide CF 180 mg, capsules, hard
Temozolomide CF 250 mg, capsules, hard
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 5/20/100/140/180/250 mg temozolomide.
_[Product Name] 5 mg: _
Excipient with known effect
Each hard capsule contains 87 mg anhydrous lactose and 0.21 mg sodium.
_[Product Name] 20 mg: _
Excipient with known effect
Each hard capsule contains 72 mg anhydrous lactose, sunset yellow FCF
(E110) and
0.21 mg sodium.
_[Product Name] 100 mg: _
Excipient with known effect
Each hard capsule contains 84 mg anhydrous lactose and 0.42 mg sodium.
_ _
_[Product Name] 140 mg: _
Excipient with known effect
Each hard capsule contains 117 mg anhydrous lactose and 0.588 mg
sodium.
_[Product Name] 180 mg: _
Excipient with known effect
Each hard capsule contains 150 mg anhydrous lactose and 0.756 mg
sodium.
_[Product Name] 250 mg: _
Excipient with known effect
Each hard capsule contains 209 mg anhydrous lactose and 1.05 mg
sodium.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Hard capsule.
_[Product Name] 5 mg: _
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 with a diameter of
approximately 5.7 mm and
a length of approximately 15.9 mm.
_[Product Name] 20 mg: _
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 with a diameter
of approximately 6.2 mm
and a length of approximately 18.0 mm.
_[Product Name] 100 mg: _
The hard capsules have a white opaque body and cap with two stripes in
pink ink on the cap
and with “T 100 mg” in pink ink on the body with a diameter of
approximately 6.8 mm and a
length of approximately 19.4 mm.
_[Product Name] 140 mg: _
The hard caps