FEMARA 2.5 Milligram Film Coated Tablet

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

LETROZOLE

Beschikbaar vanaf:

Novartis Pharmaceuticals UK Ltd

ATC-code:

L02BG04

INN (Algemene Internationale Benaming):

LETROZOLE

Dosering:

2.5 Milligram

farmaceutische vorm:

Film Coated Tablet

Prescription-type:

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

Therapeutisch gebied:

Aromatase inhibitors

Autorisatie-status:

Authorised

Autorisatie datum:

1997-01-10

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
FEMARA 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.
WHAT IS IN THIS LEAFLET
1. What Femara is and what it is used for
2. What you need to know before you take Femara
3. How to take Femara
4. Possible side effects
5. How to store Femara
6. Contents of the pack and other information
1. WHAT FEMARA IS AND WHAT IT IS USED FOR
WHAT FEMARA IS AND HOW IT WORKS
Femara 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. Femara 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 FEMARA IS USED FOR
Femara 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.
Femara is also used to prevent breast tumour spreading to other parts
of the body in patients
with advanced breast cancer.
If you have any question

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Femara 2.5 mg film-coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: letrozole.
Each film-coated tablet contains 2.5 mg letrozole.
Each tablet contains 61.5 mg of lactose. For the full list of
excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets
Film-coated tablet, dark yellow, round, slightly biconvex with
bevelled edges. One side bears the imprint “FV”, the
other “CG”.
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
_Adult and elderly patients_
The recommended dose of Femara is 2.5 mg once daily. No dose
adjustment is required for elderly patients.
In patients with advanced or metastatic breast cancer, treatment with
Femara should continue until tumour progression is
evident.
In the adjuvant and extended adjuvant setting, treatment with Femara
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 F