Letrozole Actavis 2.5mg film-coated Tablets

Země: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktivní složka:

LETROZOLE

Dostupné s:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC kód:

L02BG04

INN (Mezinárodní Name):

LETROZOLE 2.5 mg

Léková forma:

FILM-COATED TABLET

Složení:

LETROZOLE 2.5 mg

Druh předpisu:

POM

Terapeutické oblasti:

ENDOCRINE THERAPY

Stav Autorizace:

Withdrawn

Datum autorizace:

2012-05-28

Informace pro uživatele

Page 1 of 6 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

LETROZOLE ACTAVIS 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. Do not pass it on to
others. It may harm them, even if their 
symptoms are the same as yours. 
- 
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please 
tell your doctor or pharmacist. 

WHAT IS IN THIS LEAFLET:  
1. 
What Letrozole Actavis is and what it is used for 
2. 
What you need to know before you take Letrozole Actavis 
3. 
How to take Letrozole Actavis 
4. 
Possible side effects 
5. 
How to store Letrozole Actavis 
6. 
Contents of the pack and other information 

1. 
WHAT LETROZOLE ACTAVIS IS AND WHAT IT IS USED FOR 

WHAT LETROZOLE ACTAVIS IS AND HOW IT WORKS 
Letrozole Actavis 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 Actavis 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 ACTAVIS IS USED FOR 
Letrozole Actavis 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 canc

Charakteristika produktu

Page 1 of 15

1. 
NAME OF THE MEDICINAL PRODUCT 

Letrozole Actavis 2.5 mg film-coated tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each film-coated tablet contains 2.5 mg letrozole. 

Excipient: Each tablet contains 58.4 mg lactose as lactose
monohydrate. 

For a full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 

Film-coated tablet 

Letrozole Actavis 2.5 mg are yellow, round, lenticular, film-coated
tablets.  

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

- 
Adjuvant treatment of postmenopausal women with hormone receptor
positive 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
advanced breast cancer.  
- 
Advanced breast cancer in women with natural or artificially induced
postmenopausal status after 
relapse or disease progression, 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 

_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 Actavis 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