LETROVITAE FILM-COATED TABLETS 2.5MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Letrozole

Available from:

UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED

ATC code:

L02BG04

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Letrozole 2.50mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

SAG Manufacturing S.L.U.

Authorization status:

ACTIVE

Authorization date:

2020-11-10

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Letrovitae 2.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg letrozole.
Each tablet contains 45 mg of lactose monohydrate (see section 4.4)
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Film-coated tablets
Yellow, circular, biconvex film-coated tablets plain on both sides.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Letrozole is not indicated in hormone receptor negative disease.
Letrozole is indicated in:

Adjuvant treatment of postmenopausal women with hormone receptor
positive invasive early breast cancer.

Extended
adjuvant
treatment
of
invasive
early
breast
cancer
in
postmenopausal
women
who
have
received
prior
standard
adjuvant
tamoxifen therapy for five years.

First-line treatment in postmenopausal women with hormone-dependent
advanced breast cancer.

Treatment of advanced breast cancer after relapse or progression of
the
disease in women with natural or artificially induced postmenopausal
endocrine state, who have been previously treated with anti-estrogens.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Adult
The recommended dose of letrozole is 2.5 mg once daily. In the
adjuvant and
extended adjuvant setting, treatment with Letrovitae should continue
for 5 years
or until disease relapse/recurrence, whichever comes first.
In patients with advanced or metastatic breast cancer, treatment with
letrozole
should continue until the progression of the tumor is evident.
Special populations
Paediatric population
The use of Letrovitae in children and adolescents is not recommended.
The safety
and efficacy of Letrovitae in children and adolescents up to 17 years
of age have
not been established. Limited data are available and a dosage
recommendation
can not be made.
Geriatric patients (65 years of age or older)
No dose adjustment is required for elderly patients.
Renal impairment
No dose adjustment of Letrovitae is required f