Letrozole Synthon 2.5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Letrozole

Available from:

Synthon BV

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:

Not marketed

Authorization date:

2008-12-12

Patient Information leaflet

M1.3.1_03.LOO.tab.001.10.IE.1179.01
PACKAGE LEAFLET: INFORMATION FOR THE USER
LETROZOLE SYNTHON 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 Letrozole Synthon 2.5 mg, film-coated tablets is and what it is
used for
2.
What you need to know before you take Letrozole Synthon 2.5 mg,
film-coated tablets
3.
How to take Letrozole Synthon 2.5 mg, film-coated tablets
4.
Possible side effects
5.
How to store Letrozole Synthon 2.5 mg, film-coated tablets
6.
Contents of the pack and other information
1.
WHAT LETROZOLE SYNTHON 2.5 MG, FILM-COATED TABLETS IS AND WHAT IT IS
USED FOR
WHAT LETROZOLE SYNTHON 2.5 MG, FILM-COATED TABLETS IS AND HOW IT WORKS
Letrozole Synthon 2.5 mg, film-coated tablets 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. Letrozole 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 LETROZOLE SYNTHON 2.5 MG, FILM-COATED TABLETS IS USED FOR
Letrozole 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

Summary of Product characteristics

Health Products Regulatory Authority
22 April 2021
CRN00C2RG
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Letrozole Synthon 2.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg letrozole.
Excipient: each tablet contains 61.5 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Yellow film-coated round biconvex tablets, debossed with L9OO on one
side and 2.5 on the other side.
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 early 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-invasive 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
_Adults and elderly patients_
The recommended dose of letrozole is 2.5 mg once daily. No dose
adjustment is required for elderly patients.
In patients with advanced or metastatic breast cancer, treatment with
letrozole should continue until tumour progression if
evident.
In the adjuvant and extended adjuvant setting, treatment with
letrozole 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