Exemestane Fair-Med Healthcare 25mg film-coated Tablets

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Ingredient activ:

EXEMESTANE

Disponibil de la:

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

Codul ATC:

L02BG06

INN (nume internaţional):

EXEMESTANE 25 mg

Forma farmaceutică:

FILM-COATED TABLET

Compoziție:

EXEMESTANE 25 mg

Tip de prescriptie medicala:

POM

Zonă Terapeutică:

ENDOCRINE THERAPY

Statutul autorizaţiei:

Withdrawn

Data de autorizare:

2012-10-23

Prospect

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PACKAGE LEAFLET: INFORMATION FOR THE USER 

EXEMESTANE FAIR-MED HEALTHCARE 25 MG FILM-COATED TABLETS 
Exemestane 

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 Exemestane Fair-Med Healthcare is and what it is used for 
2.  Before you take Exemestane Fair-Med Healthcare  
3.  How to take Exemestane Fair-Med Healthcare  
4.  Possible side effects 
5.  How to store Exemestane Fair-Med Healthcare  
6.  Further information 

1. 
WHAT EXEMESTANE IS AND WHAT IT IS USED FOR 

Your medicine is called Exemestane Fair-Med Healthcare. Exemestane Fair-Med Healthcare 
belongs 
to a group of medicines known as aromatase inhibitors.
These drugs interfere with a substance called 
aromatase, which is needed to make the female sex
hormone, oestrogen, especially in postmenopausal 
women. Reducing oestrogen levels in the body is a way of
treating hormone-dependent breast cancer. 

Exemestane Fair-Med Healthcare is used to treat
hormone-dependent early breast cancer in 
postmenopausal women after they have completed 2-3 years
of treatment with the medicine tamoxifen. 
It is also used to treat
hormone-dependent advanced breast cancer
in postmenopausal women when a 
different hormonal drug treatment has not worked well enough.  

2. 
BEFORE YOU TAKE EXEMESTANE FAIR-MED HEALTHCARE  

DO NOT TAKE EXEMESTANE FAIR-MED HEALTHCAR

Caracteristicilor produsului

 
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SUMMARY OF PORDUCT CHARACTERISTICS 
1. 
NAME OF THE MEDICINAL PRODUCT 

Exemestane Fair-Med Healthcare 25 mg film-coated tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Exemestane 

Each film coated tablet contains 25 mg exemestane.  

For full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 

Film-coated tablet.  
White to off-white, round compound cup film coated tablet, with
“25” on one side and plain on the 
reverse. 

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Exemestane Fair-Med Healthcare is indicated for the adjuvant
treatment of postmenopausal women 
with oestrogen receptor positive invasive early breast
cancer, following 2 – 3 years of initial 
adjuvant tamoxifen therapy.  

Exemestane Fair-Med Healthcare is indicated for the treatment of
advanced breast cancer in women 
with natural or induced postmenopausal status whose disease has
progressed following anti-
oestrogen therapy. Efficacy has not been demonstrated in patients
with oestrogen receptor negative 
status.  

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Adult and elderly patients 
The recommended dose of Exemestane is one film-coated tablet (25mg)
to be taken orally once a 
day, after a meal.  

In patients with early breast cancer, treatment with
Exemestane should continue until completion of 
five years of combined sequential adjuvant hormonal therapy
(tamoxifen followed by Exemestane), 
or earlier if tumour relapse occurs.  
In patients with advanced breast cancer, treatment with Exemestane
should continue until tumour 
progression is evident.  
No dose adjustments are required for patients with hepatic or renal
insufficiency (see section 5.2).  

Children and adolescents 
Not recommended for use in children and adolescents 

4.3 CONTRAINDICATIONS 

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Exemestane is contraindicated in: 
-  
premenopausal women. 
-  
women who are pregnant or breastfeeding 
-  
pat