Temozolomide 5mg capsules

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Temozolomide

Dostupné z:

Actavis UK Ltd

ATC kód:

L01AX03

INN (Medzinárodný Name):

Temozolomide

Dávkovanie:

5mg

Forma lieku:

Capsule

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 08010500; GTIN: 5012617025104

Príbalový leták

Temozolomide 5mg, 20mg, 100mg, 140mg, 180mg and 250mg Capsules PIL -
UK/EIRE
item no: AAAH7917
print proof no: 2
origination date: 20.03.15
originated by: S.Anson
revision date: 08.04.15
revised by: S.Anson
dimensions: 180 x 600
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
2.
3.
4.
5.
6.
1.
2.
3.
date sent: 20.03.15
supplier: EirGen
technically app. date: 23.03.15
min pt size: 9
TECHNICAL APPROVAL
TEMOZOLOMIDE 5MG, 20MG, 100MG,
140MG, 180MG AND 250MG CAPSULES, HARD
_Continued over page_
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 IS AND WHAT IT IS
USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TEMOZOLOMIDE
3
HOW TO TAKE TEMOZOLOMIDE
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE TEMOZOLOMIDE
6
CONTENTS OF THE PACK AND OTHER
INFORMATION
1
WHAT TEMOZOLOMIDE IS AND WHAT IT IS
USED FOR
Temozolomide capsules contain 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

Súhrn charakteristických

OBJECT 1
TEMOZOLOMIDE ACTAVIS 5MG CAPSULES, HARD
Summary of Product Characteristics Updated 03-Mar-2016 | Accord-UK Ltd
1. Name of the medicinal product
Temozolomide Actavis 5mg Capsules, hard
2. Qualitative and quantitative composition
Each 5 mg hard capsule contains 5 mg temozolomide.
Excipient(s) with known effect:
Each hard capsule contains 399.3 mg of anhydrous lactose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard capsule.
The 5 mg hard capsule are size 0 (21.7 mm in length), have an opaque
white body, an opaque green cap.
The body is imprinted with "5" in black ink.
4. Clinical particulars
4.1 Therapeutic indications
Temozolomide 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 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 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:
- absolute neutrophil count (ANC) ≥ 1.5 x 10
9