ANASTROZOL 1 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ANASTROZOLE

Available from:

Welding GmbH & Co. KG

ATC code:

L02BG03

INN (International Name):

ANASTROZOLE

Dosage:

1 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Aromatase inhibitors

Authorization status:

Authorised

Authorization date:

2010-08-06

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anastrozol Welding 1 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1 mg anastrozole.
Excipients: Each film-coated tablet contains 81.5 mg lactose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Anastrozol Welding are white to off-white, round film-coated tablets with “AN1” on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of hormone receptor-positive advanced breast cancer in postmenopausal women.
Adjuvant treatment of hormone receptor-positive early invasive breast cancer in postmenopausal woman.
Adjuvant treatment of hormone receptor-positive early invasive breast cancer in postmenopausal women who have
received 2 to 3 years of adjuvant tamoxifen.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Anastrozol Welding for adults including the elderly is one 1 mg tablet once a day.
For postmenopausal women with hormone receptor-positive early invasive breast cancer, the recommended duration of
adjuvant endocrine treatment is 5 years.
_Special populations_
_Pediatric population_
Anastrozol Welding 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 Anastrozol Welding 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).
IRISH MEDICINES BOARD
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