Letrozole Fair-Med Healthcare 2.5mg film coated Tablets

Kraj: Malta

Język: angielski

Źródło: Medicines Authority

Składnik aktywny:

LETROZOLE

Dostępny od:

FAIR-MED HEALTHCARE GmbH Planckstr. 13, 22765 Hamburg, Germany

Kod ATC:

L02BG04

INN (International Nazwa):

LETROZOLE 2.5 mg

Forma farmaceutyczna:

FILM-COATED TABLET

Skład:

LETROZOLE 2.5 mg

Typ recepty:

POM

Dziedzina terapeutyczna:

ENDOCRINE THERAPY

Status autoryzacji:

Withdrawn

Data autoryzacji:

2012-07-26

Ulotka dla pacjenta

Page 1 of 6 
PACKAGE LEAFLET: INFORMATION FOR THE USER 
_ _
LETROZOLE FAIR-MED HEALTHCARE 2.5MG FILM COATED TABLETS 
Letrozole 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE. 
- 
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. 
_ _
IN THIS LEAFLET: 
1. 
What Letrozole Fair-Med Healthcare is and what it is used for 
2. 
Before you take Letrozole Fair-Med Healthcare 
3. 
How to take Letrozole Fair-Med Healthcare 
4. 
Possible side effects 
5. 
How to store Letrozole Fair-Med Healthcare 
6. 
Further information 

1. 
WHAT LETROZOLE FAIR-MED HEALTHCARE IS AND WHAT IT IS USED FOR 

WHAT LETROZOLE FAIR-MED HEALTHCARE IS 

Letrozole Fair-Med Healthcare contains an active substance called
letrozole. It belongs to a group 
of medicines called aromatase inhibitors. It is a hormonal
(“endocrine”) breast cancer treatment.  

WHAT LETROZOLE FAIR-MED HEALTHCARE IS USED FOR 
Letrozole Fair-Med Healthcare is used to prevent breast cancer
happening again. It can be used   
  as a first treatment after breast surgery or following five
years of treatment with tamoxifen. 
Letrozole Fair-Med Healthcare is also used to prevent breast tumours
spreading to other 
parts of the body in patients with advanced breast cancer. 

Letrozole Fair-Med Healthcare should only be used for: 
–  oestrogen receptor-positive breast cancer and  
–  only in women after menopause i.e cessation of periods. 

HOW LETROZOLE FAIR-MED HEALTHCARE WORKS 

Growth of breast cancer is frequently stimulated by oestrogens, which
are female sex hormones.  
Letrozole Fair-Med Healthcare r

Charakterystyka produktu

 
Page 1 of 15 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Letrozole Fair-Med Healthcare 2.5 mg film coated tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Letrozole 

Each film-coated tablet contains: 2.5 mg letrozole.   
Excipients: Sunset yellow FCF (E110).  For a full list
of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 

Film coated tablet 
Yellow, round, biconvex, film-coated, tablets. Debossed "2.5" on one
side, plain on reverse. 

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 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. 
Efficacy has not been demonstrated in patients with hormone receptor
negative breast cancer 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Adult and elderly patients 
The recommended dose of Letrozole Fair-Med Healthcare is 2.5
mg once daily. No dose adjustment 
is required for elderly patients. In the adjuvant setting, it is
recommended to treat for 5 years or until 
tumour relapse occurs.. In the adjuvant setting, clinical experience
is available for 2 years (median 
duration of treatment was 25 months). In the extended adjuvant
setting, clinical experience is 
available for 4 years (median duration of treatment). In patients with
advanced or metastatic 
disease, treatment with Letrozole Fair-Med Healthcare should
continue until tumour progression is 
evident.  

Children 
Not  applicable. 

Patients with