Temozolomide 20mg capsules

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Temozolomide

Tilgjengelig fra:

Sun Pharmaceutical Industries Europe B.V.

ATC-kode:

L01AX03

INN (International Name):

Temozolomide

Dosering :

20mg

Legemiddelform:

Capsule

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 08010500; GTIN: 8718309123222

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
TEMOZOLOMIDE SUN 20 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 SUN is and what it is used for
2.
What you need to know before you take Temozolomide SUN
3.
How to take Temozolomide SUN
4.
Possible side effects
5.
How to store Temozolomide SUN
6.
Contents of the pack and other information
1.
WHAT TEMOZOLOMIDE SUN IS AND WHAT IT IS USED FOR
Temozolomide SUN contains a medicine called temozolomide. This
medicine is an antitumour agent.
Temozolomide SUN is used for the treatment of specific forms of brain
tumours:
-
in adults with newly-diagnosed glioblastoma multiforme. Temozolomide
SUN is at 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 SUN is used in
these tumours if they
return or get worse after standard treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEMOZOLOMIDE SUN
DO NOT TAKE TEMOZOLOMIDE SUN
-
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 include itchiness, breathlessness or
wheezing, or swelling of
the face, lips, tongue or throat.
-
if the numbers of certain kinds of blood

Preparatomtale

OBJECT 1
TEMOZOLOMIDE 20 MG HARD CAPSULES
Summary of Product Characteristics Updated 21-Jun-2018 | Ranbaxy (UK)
Limited a Sun Pharmaceutical
Company
1. Name of the medicinal product
Temozolomide SUN 20 mg hard capsules
2. Qualitative and quantitative composition
Each hard capsule contains 20 mg temozolomide.
Excipient with known effect
Each hard capsule contains 18.16 mg of lactose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard capsule (capsule).
Hard gelatin capsule, with white opaque cap and body, imprinted in
yellow ink. The cap is imprinted with
'891'. The body is imprinted with '20 mg' and two stripes.
4. Clinical particulars
4.1 Therapeutic indications
Temozolomide SUN is indicated for the treatment of:
- adult patients with newly-diagnosed glioblastoma multiforme
concomitantly with radiotherapy (RT) and
subsequently as monotherapy treatment.
- children from the age of three years, adolescents and adult patients
with malignant glioma, such as
glioblastoma multiforme or anaplastic astrocytoma, showing recurrence
or progression after standard
therapy.
4.2 Posology and method of administration
Temozolomide SUN should only be prescribed by physicians experienced
in the oncological treatment of
brain tumours.
Anti-emetic therapy may be administered (see section 4.4).
Posology
_Adult patients with newly-diagnosed glioblastoma multiforme_
Temozolomide SUN is administered in combination with focal
radiotherapy (concomitant phase)
followed by up to 6 cycles of temozolomide (TMZ) monotherapy
(monotherapy phase).
_Concomitant phase_
TMZ is administered orally at a dose of 75 mg/m
2
daily for 42 days concomitant with focal radiotherapy
(60 Gy administered in 30 fractions). No dose reductions are
recommended, but delay or discontinuation
of TMZ administration should be decided weekly according to
haematological and non-haematological
toxicity criteria. TMZ administration can be continued throughout the
42 day concomitant period (up to
49 days) if all of the following conditions are met:
-