Anastrozole tablet 1mg, film-cated tablet

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ANASTROZOLE

Available from:

Arrow Generics Limited Whiddon Valley Barnstaple, North Devon, EX32 8NS, United Kingdom

ATC code:

L02BG03

INN (International Name):

ANASTROZOLE 1 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ANASTROZOLE 1 mg

Prescription type:

POM

Therapeutic area:

ENDOCRINE THERAPY

Authorization status:

Withdrawn

Authorization date:

2010-09-16

Patient Information leaflet

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Summary of Product characteristics

Page 1 of 12 
SUMMARY OF PRODUCT CHARACTERISTICS 
ANASTROZOLE 1 MG FILM-COATED TABLETS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Anastrozole 1 mg film-coated Tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each film-coated tablet contains 1 mg anastrozole. 

Excipient(s): Each tablet contains 65 mg of Lactose monohydrate 
For a full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 
Film-coated tablet.  
White, round film-coated tablet.  

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Anastrozole 1 mg film-coated tablets is indicated for the: 

  Treatment of hormone receptor-positive advanced breast cancer
in postmenopausal 
women. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Posology 

The recommended dose of Anastrozole for adults including the
elderly is one 1 mg tablet 
once a day. 

_Special populations _
_ _
_Paediatric population _
Anastrozole is not recommended for use in children and adolescents
due to insufficient data 
on safety and efficacy (see sections 4.4 and 5.1). 
_ _
_Renal impairment _
No dose change is recommended in patients with mild or moderate renal
impairment. In 
patients with severe renal impairment, administration of Anastrozole
should be performed 
with caution (see section 4.4 and 5.2). 
_ _
_Hepatic impairment _
No dose change is recommended in patients with mild hepatic disease.
Caution is advised in 
patients with moderate to severe hepatic impairment (see section
4.4). 

Page 2 of 12 
Method of administration 

Anastrozole should be taken orally. 

4.3 CONTRAINDICATIONS 

Anastrozole is contraindicated in: 
-  
pregnant or breast-feeding women. 
-  
patients with hypersensitivity to anastrozole or to any of the
excipients as referenced 
in section 6.1.  

4.4 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE 

General 

Anastrozole should not be used in premenopausal women. The
menopause should be de