Feremazol 2.5 mg film-coated tablets

Држава: Малта

Језик: Енглески

Извор: Medicines Authority

Доступно од:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

АТЦ код:

L02BG04

INN (Међународно име):

LETROZOLE 2.5 mg

Фармацеутски облик:

FILM-COATED TABLET

Састав:

LETROZOLE 2.5 mg

Тип рецептора:

POM

Терапеутска област:

ENDOCRINE THERAPY

Статус ауторизације:

Authorised

Датум одобрења:

2023-09-29

Информативни летак

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FEREMAZOL 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 Feremazol is and what it is used for
2.
What you need to know before you take Feremazol
3.
How to take Feremazol
4.
Possible side effects
5.
How to store Feremazol
6.
Contents of the pack and other information
1.
WHAT FEREMAZOL IS AND WHAT IT IS USED FOR
WHAT FEREMAZOL IS AND HOW IT WORKS
Feremazol contains the active substance letrozole. It belongs to a
group of medicines
called aromatase inhibitors. It is a hormonal (or “endocrine”)
treatment for breast
cancer. The growth of breast cancer is often stimulated by oestrogens
(female sex
hormones). Feremazol reduces the amount of oestrogen by blocking an
enzyme
involved in the production of oestrogen (“aromatase”) and can thus
block the growth
of breast cancer, which needs oestrogen for its growth. As a result,
tumour cells stop
growing or grow more slowly and/or the spread of tumour cells to other
areas of the
body is prevented or slowed down.
WHAT FEREMAZOL IS USED FOR
Feremazol is used to treat breast cancer in women who have gone
through menopause
(after monthly periods have ceased).
Feremazol is used to prevent breast cancer from returning. It can be
used either as a
primary treatment before breast surgery if immediate surgery is not
appropriate, or as
primary treatment after breast surgery or after five years of
treatment with a medicine
called tamoxifen. Feremazol is also used to pre

Карактеристике производа

Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Feremazol 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 65,00 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Dark yellow, round, film coated tablets, debossed with Remedica’s
logo on one side and plain
on the other side, and with a diameter of 6.1 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Adjuvant treatment of postmenopausal women with hormone
receptor-positive primary
breast cancer.
•
Extended
adjuvant
treatment
of
hormone-dependent
primary
breast
cancer
in
postmenopausal women, after previous standard adjuvant therapy with
tamoxifen over
5 years.
•
First-line treatment of hormone-dependent advanced breast cancer in
postmenopausal
women.
•
Treatment of advanced breast cancer, following relapse or disease
progression in women
with postmenopausal status (physiologically or artificially induced),
who have previously
been treated with antioestrogens.
•
Neoadjuvant treatment of postmenopausal women with hormone
receptor-positive,
HER-2-negative breast cancer, for whom chemotherapy is not an option
and immediate
surgical intervention is not indicated.
Efficacy has not been demonstrated in patients with hormone
receptor-negative breast cancer.
Page 2 of 19
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and elderly patients _
The recommended dosage of Feremazol is 1 film-coated tablet once
daily. In elderly patients,
no dose adjustment is required.
In the treatment of advanced or metastatic breast cancer, treatment
with Feremazol should be
performed until tumour progression is established.
In adjuvant and extended adjuvant therapy, treatment with Feremazol
should be continued for
5 years or until tumour relapse, whichever event occurs first.
In adjuvant therapy, sequential treatment (2 years let