Letrozole 2.5mg film-coated tablets

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Letrozole

Tilgængelig fra:

Fresenius Kabi Deutschland GmbH

ATC-kode:

L02BG; L02BG04

INN (International Name):

Letrozole

Dosering:

2.5 milligram(s)

Lægemiddelform:

Film-coated tablet

Terapeutisk område:

Aromatase inhibitors; letrozole

Autorisation status:

Not marketed

Autorisation dato:

2011-07-22

Indlægsseddel

Ver 002, July 2019 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 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

Produktets egenskaber

Health Products Regulatory Authority
05 February 2020
CRN00976Z
Page 1 of 14
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 al