FEMARA

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

LETROZOLE

Available from:

NOVARTIS ISRAEL LTD

ATC code:

L02BG04

Pharmaceutical form:

FILM COATED TABLETS

Composition:

LETROZOLE 2.5 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

NOVARTIS PHARMA STEIN AG, SWITZERLAND

Therapeutic group:

LETROZOLE

Therapeutic area:

LETROZOLE

Therapeutic indications:

Femara (letrozole tablets) is indicated for first-line treatment in postmenopausal women with hormone receptor positive or in whome hormone receptor status cannot be determined locally advanced or metastatic breast cancer. Femara is also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy. Extended adjuvant treatment of early breast cancer in post menopausal women who have received prior standard adjuvant tamoxifen therapy. Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer.

Authorization date:

2023-03-31

Patient Information leaflet

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Summary of Product characteristics

Page 1 of 15
FEM API OCT20 V1
REF UK SMPC APR 2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Femara
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 monohydrate.
This medicine contains less than 1 mmol sodium (23 mg) per tablet,
that is to say essentially ‘sodium-
free’.
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 early breast cancer.
•
Extended adjuvant treatment of early breast cancer in postmenopausal
women who have received
prior standard adjuvant tamoxifen therapy.
•
First-line treatment in postmenopausal women with hormone receptor
positive, or in whom the
hormone receptor status cannot be determined, locally advanced or
metastatic breast cancer.
•
Treatment
of
advanced
breast
cancer
in
postmenopausal
women
with
disease
progression
following anti-oestrogen therapy.
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.
Page 2 of 15
FEM API OCT20 V1
REF UK SMPC APR 2020
In the adjuvant and extended adjuvant setting, treatment with Femara
should continue for 5 years or
until tumour relapse occurs, whichever is first.
_Paediatric population _
Femara is not recommended for use in children and adolescents. The
safety and efficacy of Femara in
children and adolescents aged up to 17 years have not been
established. Limited data are available and
no recommendation on a posology can be made.
_Renal