Letrozole 2.5 mg film-coated tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Letrozole

제공처:

Accord Healthcare Ireland Ltd.

ATC 코드:

L02BG; L02BG04

INN (국제 이름):

Letrozole

복용량:

2.5 milligram(s)

약제 형태:

Film-coated tablet

치료 영역:

Aromatase inhibitors; letrozole

승인 상태:

Marketed

승인 날짜:

2010-01-29

환자 정보 전단

NL/H/1383/001/IB/030 - version 02 - 10/2023
PACKAGE LEAFLET: INFORMATION FOR THE USER
LETROZOLE 2.5 MG 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, pharmacist or
nurse.
- 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, pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Letrozole Tablets is and what it is used for
2. What you need to know before you take Letrozole Tablets
3. How to take Letrozole Tablets
4. Possible side effects
5. How to store Letrozole Tablets
6. Contents of the pack and other information
1. WHAT LETROZOLE TABLETS IS AND WHAT IT IS USED FOR
WHAT LETROZOLE TABLETS IS AND HOW IT WORKS
Letrozole Tablets 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 Tablets 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 TABLETS IS USED FOR
Letrozole Tablets 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 y

제품 특성 요약

Health Products Regulatory Authority
11 October 2023
CRN00DSLQ
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Letrozole 2.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 2.5 mg letrozole.
Excipient(s) with known effect:
Each film-coated tablet contains 61.5 mg of lactose.
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 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
- Adjuvant treatment of postmenopausal women with hormone receptor
positive i nvasive 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 secti