LETROZOLE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LETROZOLE

Available from:

Accord Healthcare Limited

ATC code:

L02BG04

INN (International Name):

LETROZOLE

Dosage:

2.5 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

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

Therapeutic area:

letrozole

Authorization status:

Marketed

Authorization date:

2009-03-20

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LETROZOLE 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, 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, pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Letrozole Tablets is and what it is used for
2. What you need to know before you take Letrozole Tablets
3. How to take Letrozole Tablets
4. Possible side effects
5. How to store Letrozole Tablets
6. Contents of the pack and other information
1. WHAT LETROZOLE TABLETS IS AND WHAT IT IS USED FOR
WHAT LETROZOLE TABLETS IS AND HOW IT WORKS
Letrozole 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 Tablets 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 TABLETS IS USED FOR
Letrozole Tablets 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. Letrozole
Tab

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Letrozole 2.5 mg film-coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: letrozole.
Each film coated tablet contains 2.5 mg letrozole.
Excipient(s) with known effect:
Each tablet contains 61.5 mg of lactose.
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Yellow, round, biconvex, film-coated tablets plain on both sides.
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 Letrozole Tablets 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 Tablets should continue until tumour
progression is evident.
In the adjuvant and extended adjuvant setting, treatment with
Letrozole Tablets 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 5.1).
In the neoadjuvant setting, treatment with Letrozol