Letrozole 2.5 mg film-coated tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Letrozole

제공처:

Clonmel Healthcare Ltd

ATC 코드:

L02BG; L02BG04

INN (국제 이름):

Letrozole

복용량:

2.5 milligram(s)

약제 형태:

Film-coated tablet

처방전 유형:

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

치료 영역:

Aromatase inhibitors; letrozole

승인 상태:

Marketed

승인 날짜:

2010-08-06

환자 정보 전단

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
LETROZOLE 2.5MG FILM-COATED TABLETS
Letrozole
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 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
Letrozole 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 following five years treatment with tamoxifen. Letrozole is
also used to prevent breast tumour
spreading to other parts of the body in patients

제품 특성 요약

Health Products Regulatory Authority
04 December 2019
CRN009C2P
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 with known effect
Each film-coated tablet contains 62.0 mg of lactose monohydrate and up
to 0.40 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Yellow, round, biconvex.
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
_Adults and elderly_
The recommended dose of Letrozole is 2.5 mg once daily. No dose
adjustment is required for older people.
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 neo-adjuva