Femara 2.5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Letrozole

Available from:

Novartis Ireland Limited

ATC code:

L02BG; L02BG04

INN (International Name):

Letrozole

Dosage:

2.5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

Aromatase inhibitors; letrozole

Authorization status:

Marketed

Authorization date:

1997-01-10

Patient Information leaflet

1
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 advanced br

Summary of Product characteristics

Health Products Regulatory Authority
24 February 2021
CRN009W9N
Page 1 of 14
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.
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