Letrozole 2.5 mg Film-coated Tablets

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Letrozole

Boleh didapati daripada:

Accord Healthcare Ireland Ltd.

Kod ATC:

L02BG; L02BG04

INN (Nama Antarabangsa):

Letrozole

Dos:

2.5 milligram(s)

Borang farmaseutikal:

Film-coated tablet

Kawasan terapeutik:

Aromatase inhibitors; letrozole

Status kebenaran:

Marketed

Tarikh kebenaran:

2009-09-25

Risalah maklumat

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 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
tamixofen. Letrozole is also used
to prevent breast tumour spreading to other parts of the body in
patients with adva

Ciri produk

Health Products Regulatory Authority
12 November 2019
CRN0099VK
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 with known effect:
Each tablet contains 58.4 mg lactose as lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Letrozole 2.5 mg are yellow, round, lenticular, film-coated tablets.
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 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 tum our 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