Letrozole 2.5mg Film Coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LETROZOLE

Available from:

Accord Healthcare Limited

ATC code:

L02BG04

INN (International Name):

LETROZOLE

Pharmaceutical form:

FILM-COATED TABLET

Composition:

LETROZOLE 2.5 mg

Prescription type:

POM

Therapeutic area:

ENDOCRINE THERAPY

Authorization status:

Authorised

Authorization date:

2008-10-10

Patient Information leaflet

Page 1 of 6
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 are 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 ARE AND WHAT IT IS USED FOR
WHAT LETROZOLE TABLETS ARE 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 ARE 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
tamixofe

Summary of Product characteristics

Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Letrozole 2.5mg film-coated Tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg letrozole.
Excipient(s) with known effect:
Each tablet contains 61.500 mg of lactose monohydrate.
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).
Page 2 of 17
In the neoadjuvant