Femara 2.5 mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LETROZOLE

Available from:

Novartis Ireland Limited Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4,, Ireland

ATC code:

L02BG04

INN (International Name):

LETROZOLE 2.5 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

LETROZOLE 2.5 mg

Prescription type:

POM

Therapeutic area:

ENDOCRINE THERAPY

Authorization status:

Authorised

Authorization date:

2005-11-24

Patient Information leaflet

Page 1 of 7
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 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 or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
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

Summary of Product characteristics

Page 1 of 17
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.
Excipient with known effect: each tablet contains 61.5 mg of lactose
(monohydrate)
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.
Page 2 of 17
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) cou