LETROZOLE

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

LETROZOLE

Mevcut itibaren:

Fresenius Kabi Oncology Plc

ATC kodu:

L02BG04

INN (International Adı):

LETROZOLE

Doz:

2.5 Milligram

Farmasötik formu:

Film Coated Tablet

Reçete türü:

Product subject to prescription which may not be renewed (A)

Terapötik alanı:

letrozole

Yetkilendirme durumu:

Not Marketed

Yetkilendirme tarihi:

2011-07-22

Bilgilendirme broşürü

(Travesh)
D:\Europe\Letrozole\Ireland
+UK
(IRL+GBR)\16
Oct
2015\Letrozol
PIL
-
IRL+GBR.indd
DIMENSION: 200 X 280 MM
Black
LETROZOLE PACK INSERT - IRELAND/UK
VER. 03
TIMES NEW ROMAN 8 PTS.
16 OCTOBER 2015 12:00 PM
PACKAGE LEAFLET: INFORMATION FOR THE USER
LETROZOLE 2.5 MG FILM-COATED TABLETS
LETROZOLE
The name of this medicine is Letrozole 2.5 mg Film-coated tablets,
called
Letrozole tablets in the rest of the leaflet.
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 or pharmacist.
•
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 side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Letrozole is and what it is used for
2. What you need to know before you take Letrozole
3. How to take Letrozole
4. Possible side effects
5. How to store Letrozole
6. Contents of the pack and other information
1.
WHAT LETROZOLE IS AND WHAT IT IS USED FOR
WHAT LETROZOLE IS AND HOW IT WORKS
Letrozole contains an active substance called letrozole. It belongs to
a group of
medicines called aromatase inhibitors. It is a hormonal (or
“endocrine”) breast
cancer treatment. Growth of breast cancer is frequently stimulated by
oestrogens
which are female sex hormones. Letrozole reduces the amount of
oestrogen by
blocking an enzyme (“aromatase”) involved in the production of
oestrogens and
therefore may block the growth of breast cancer that needs oestrogens
to grow.
As a consequence tumour cells slow or stop growing and/or spreading to
other
parts of the body.
WHAT LETROZOLE IS USED FOR
This medicine is used to treat breast cancer in women who have gone
through
menopause i.e cessation of periods.
It is used to prevent cancer from hap

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Letrozole 2.5mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg letrozole.
_Excipients_
Each film-coated tablet contains 79.20 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Yellow, circular, biconvex film-coated tablets, debossed with
‘DB03’ on one side and plain on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adjuvant treatment of postmenopausal women with hormone receptor
positive invasive early breast cancer.
Extended adjuvant treatment of hormone-dependent invasive early breast
cancer in postmenopausal women who
have received prior standard adjuvant tamoxifen therapy for 5 years.
First-line treatment in postmenopausal women with hormone-dependent
advanced breast cancer.
Advanced breast cancer after relapse or disease progression, in women
with natural or artificially induced
postmenopausal endocrine status, who have previously been treated with
anti-oestrogens.
Neo-adjuvant treatment of postmenopausal women with hormone receptor
positive, HER-2 negative breast
cancer where chemotherapy is not suitable and immediate surgery not
indicated.
Efficacy has not been demonstrated in patients with hormone receptor-
negative breast cancer.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
_Adult and elderly patients_
The recommended dose of Letrozole is 2.5 mg once daily. No dose
adjustment is required for elderly patients.
In patients with advanced or metastatic breast cancer, treatment with
letrozole should continue until tumour progression
is evident.
In the adjuvant
and extended adjuvant
setting,
treatment
with letrozole should continue for 5 years or until
tumour
relapse occurs, whichever is first.
In the adjuvant setting a sequential treatment schedule (letrozole 2
years followed by tamoxifen 3 years) could also be
considered (see sections 4.4 and 5.1).
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