Letrozole Galenicum 2.5mg, film coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LETROZOLE

Available from:

Galenicum Health, S.L.U Calle Sant Gabriel, 50 Esplugues de Llobregat 08950 Barcelona, Spain

ATC code:

L02BG04

INN (International Name):

LETROZOLE 2.5 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

LETROZOLE 2.5 mg

Prescription type:

POM

Therapeutic area:

ENDOCRINE THERAPY

Authorization status:

Withdrawn

Authorization date:

2013-07-25

Patient Information leaflet

Page 1 of 6 
PACKAGE LEAFLET: INFORMATION FOR THE USER 
LETROZOLE GALENICUM 2,5MG FILM-COATED TABLETS 
(letrozole) 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS 
IMPORTANT INFORMATION FOR YOU. 

‐  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 only. Do not pass
it on to others. It may harm them, 
even if their symptoms are the same as yours.  
‐  If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side 
effects not listed in this leaflet.  

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

1 WHAT LETROZOLE GALENICUM IS AND WHAT IT IS USED FOR  

WHAT LETROZOLE GALENICUM IS AND HOW IT WORKS 
Letrozole Galenicum 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 càncer is frequently stimulated by oestrogens which
are female sex hormones. 
Letrozole Galenicum reduces the amount of oestrogen y blocking an
enzyme (“aromatase”) 
involved in the production of oestrogens and therefore may block
the growth of breast càncer 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 GALENICUM IS USED FOR  
Letrozole Galenicum is used to preventbreast 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 immedi

Summary of Product characteristics

Page 1 of 16 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. NAME OF THE MEDICINAL PRODUCT  

Letrozole Galenicum 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.  

Yellow, circular, 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  

ADULT AND ELDERLY PATIENTS  

Posology 
_Adult and elderly patients _
The recommended dose of Letrozole Galenicum 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 Galenicum should 
continue until tumour progression is evident. 

In the adjuvant and extended setting, treatment with Letrozole
Galenicum should continue for 5 years or 
until tumour r