Letrozole 2.5mg tablets

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Letrozole

Предлага се от:

DE Pharmaceuticals

АТС код:

L02BG04

INN (Международно Name):

Letrozole

дозиране:

2.5mg

Лекарствена форма:

Oral tablet

Начин на приложение:

Oral

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 08030401

Листовка

(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

Данни за продукта

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.
Excipient(s)
with
known
effect:
Each
tablet
contains
61.500
mg
of
lactose
monohydrate.
For the full list of excipients, see Section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet
Yellow, round, biconvex, film coated tablets plain on both sides.
4.1
THERAPEUTIC INDICATIONS
•
Adjuvant treatment of postmenopausal women with hormone receptor
positive invasive early breast cancer.
•
Extended
adjuvant
treatment
of
hormone-dependent
invasive
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
Tablets
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
Tablets should continue until tumour progression is evident.
In the adjuvant and extended adjuvant setting, treatment with
Letrozole Tablets 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).
In the neoadjuvant setting, treatment with Letrozole tablet could be
co