Letrozole 2.5mg tablets

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Letrozole

Предлага се от:

Dexcel-Pharma Ltd

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; GTIN: 5033847001362 5033847001287

Листовка

PAGE 1 OF 7
PACKAGE LEAFLET
PAGE 2 OF 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LETROZOLE 2.5 MG FILM-COATED TABLETS
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 any 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 Tablets contain 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
Letrozole is used to treat breast cancer in women who have gone
through menopause i.e cessation of
periods.
It is used to help prevent the cancer from happening again. It can be
used as first treatment before
breast cancer surgery in case immediate surgery is not suitable or it
can be used as first treatment after
breast cancer surgery or following five years treatment with
tamoxifen. Letrozole is also used to
prevent breast tumour spreadin

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Letrozole 2.5 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5mg letrozole.
Excipient
with
known
effect:
each
tablet
contains
61.5mg
lactose
monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow film-coated round biconvex tablets, debossed with L9OO on one
side
and 2.5 on the 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 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 2.5mg 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).
In the neoadjuvant setting, treatment with letrozole cou