Letrozole Actavis 2.5 mg Film-coated Tablets

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Letrozole

Dostępny od:

Actavis Group PTC ehf

Kod ATC:

L02BG; L02BG04

INN (International Nazwa):

Letrozole

Dawkowanie:

2.5 milligram(s)

Forma farmaceutyczna:

Film-coated tablet

Typ recepty:

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

Dziedzina terapeutyczna:

Aromatase inhibitors; letrozole

Status autoryzacji:

Marketed

Data autoryzacji:

2009-09-25

Ulotka dla pacjenta

V023
October 2017
PACKAGE LEAFLET: INFORMATION FOR THE USER
LETROZOLE ACTAVIS 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 Actavis is and what it is used for
2.
What you need to know before you take Letrozole Actavis
3.
How to take Letrozole Actavis
4.
Possible side effects
5.
How to store Letrozole Actavis
6.
Contents of the pack and other information
1 WHAT LETROZOLE ACTAVIS IS AND WHAT IT IS USED FOR
WHAT LETROZOLE ACTAVIS IS AND HOW IT WORKS
Letrozole Actavis 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 Actavis 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 ACTAVIS IS USED FOR
Letrozole Actavis 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.

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Letrozole Actavis 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 Actavis 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 Actavis 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 Letro