Femara

Страна: Мальта

Язык: английский

Источник: Medicines Authority

Активный ингредиент:

letrozole 2.5 mg

Доступна с:

Novartis Pharmaceuticals UK Limited

код АТС:

L02BG04

ИНН (Международная Имя):

letrozole

Фармацевтическая форма:

tablet

Статус Авторизация:

Authorised

Дата Авторизация:

2005-11-24

тонкая брошюра

FEMARA
®

(LETROZOLE) 
2.5 mg Film-coated Tablets 
PATIENT LEAFLET 
Novartis   Page 
2 

FEMARA 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING this
medicine 
Keep this leaflet. You may need to read it again. 
If you have further questions, please 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 you notice any side effects not listed in this leaflet, 
please tell your doctor or pharmacist. 

IN THIS LEAFLET 
1 What 
Femara
®
 is and what it is used for 
2 
Before you take Femara 
3 
How to use Femara 
4 Possible 
side 
effects 
5 
How to store Femara 
6 Further 
information 

1 
WHAT FEMARA IS AND WHAT IT IS USED FOR 
WHAT FEMARA IS 
Femara contains a medicine called letrozole. It belongs to a
group of medicines called 
aromatase inhibitors. It is a hormonal (or “endocrine”)
breast cancer treatment. 
WHAT FEMARA IS USED FOR 
Femara is used to: 
•  prevent breast cancer. It can be used as a first
treatment after breast surgery or following a 
treatment with tamoxifen.  
•  prevent breast tumour spreading to other parts of the
body in patients with advanced breast 
cancer.  
•  treat localized breast cancer before breast surgery. 
Femara should only be used for: 
-  oestrogen receptor-positive breast cancer and  
-  only in women after menopause ie. Cessation of periods. 
Novartis   Page 
3 

FEMARA 

HOW FEMARA WORKS 
Growth of breast cancer is frequently stimulated
by oestrogens, which are female sex 
hormones. Femara reduces the amount of oestrogen by blocking an
enzyme (“aromatase”) 
involved in the production of oestrogens. As a
consequence tumour cells slow or stop the 
progression and/or spreading to other parts of the

Характеристики продукта

Page 1 of 15 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
TRADE NAME OF THE MEDICINAL PRODUCT 

Femara
®
 2.5mg, film coated tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Active substance: 4, 4'-[(1H-1, 2,
4-triazol-1-yl)-methylene]bis-benzonitrile (INN/USAN= 
letrozole). 

Each film-coated tablet contains 2.5 mg letrozole. 

For a full list of excipients, see section 6.1 List of excipients 

3. PHARMACEUTICAL 
FORM 

Film-coated tablets. 

Coated tablet, dark yellow, round, slightly biconvex with
bevelled edges. One side bears the 
imprint “FV”, the other “CG”. 

4. CLINICAL 
PARTICULARS 

4.1. THERAPEUTIC 
INDICATIONS 

•  Adjuvant treatment of postmenopausal women with hormone
receptor positive invasive 
early breast cancer. 

•  Extended adjuvant treatment of early breast
cancer in postmenopausal women who have 
received prior standard adjuvant tamoxifen therapy. 

•  First-line treatment in postmenopausal women with advanced breast
cancer. 

•  Advanced breast cancer in women with natural or
artificially induced postmenopausal 
status, who have previously been treated with antioestrogens. 

•  Pre-operative therapy in postmenopausal women
with localised hormone receptor positive 
breast cancer, to allow subsequent breast-conserving surgery in
women not originally 
considered candidates for breast-conserving surgery. Subsequent
treatment after surgery 
should be in accordance with standard of care. 
Page 2 of 15 

4.2. 
POSOLOGY AND METHOD OF ADMINISTRATION 

ADULT AND ELDERLY PATIENTS 

The recommended dose of Femara is 2.5 mg once daily.  

In the adjuvant setting, it is recommended to treat for 5 years
or until tumour relapse occurs.  

In the extended adjuvant setting, following standard adjuvant
tamoxifen therapy, treatment with 
Femara should continue for 3 years or until tumo