Temozolomide Lotus 180 mg, capsules, hard

Pays: Pays-Bas

Langue: néerlandais

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

Ingrédients actifs:

TEMOZOLOMIDE 180 mg/stuk

Disponible depuis:

Lotus Support Services S.R.L. 47 Theodor Pallady Boulevard, 2nd Office, Entrance B, 1st Floor, 3rd District 032 258 BOEKARES

Code ATC:

L01AX03

DCI (Dénomination commune internationale):

TEMOZOLOMIDE 180 mg/stuk

forme pharmaceutique:

Capsule, hard

Composition:

AMMONIA (E 527) ; GELATINE (E 441) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; 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 ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; 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,

Mode d'administration:

Oraal gebruik

Domaine thérapeutique:

Temozolomide

Descriptif du produit:

Hulpstoffen: AMMONIA (E 527); GELATINE (E 441); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); 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;

Date de l'autorisation:

1900-01-01

Notice patient

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

Résumé des caractéristiques du produit

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Temozolomide Lotus 20 mg, capsules, hard
Temozolomide Lotus 100 mg, capsules, hard
Temozolomide Lotus 140 mg, capsules, hard
Temozolomide Lotus 180 mg, capsules, hard
Temozolomide Lotus 250 mg, capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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 20 mg hard capsule contains 182.2 mg of anhydrous lactose.
Each 100 mg hard capsule contains 85.7 mg of anhydrous lactose.
Each 140 mg hard capsule contains 119.98 mg of anhydrous lactose.
Each 180 mg hard capsule contains 154.26 mg of anhydrous lactose.
Each 250 mg hard capsule contains 214.25 mg of anhydrous lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
_ _
Temozolomide 20 mg Capsule is rich yellow opaque/ white opaque, No. 2
capsules, imprinted with
“LP” in black ink on the rich yellow opaque cap and “605” in
black ink on the white opaque body of
the capsules, and filled with white to off-white powder.
Temozolomide 100 mg Capsule is pink opaque/ white opaque, No. 2
capsules, imprinted with “LP” in
black ink on the rich pink opaque cap and “606” in black ink on
the white opaque body of the capsules,
and filled with white to pink powder.
_ _
Temozolomide 140 mg Capsule is powder blue opaque/ white opaque, No. 1
capsules, imprinted with
“LP” in black ink on the powder blue opaque cap and “607” in
black ink on the white opaque body of
the capsules, and filled with white to pink powder.
Temozolomide 180 mg Capsule is Swedish orange opaque/ white opaque,
No. 0 capsules, imprinted
with “LP” in black ink on the Swedish orange opaque cap and
“608” in black ink on the white opaque
body of the capsules, and filled with white to pink powder.
Temozolomide 250