ANASTROZOLE DOCPHARMA 1 Milligram Film Coated Tablet
Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Charakterystyka produktu
(SPC)
20-04-2024
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Składnik aktywny:
ANASTRAZOLE
Dostępny od:
Docpharma BVBA
INN (International Nazwa):
ANASTRAZOLE
Dawkowanie:
1 Milligram
Forma farmaceutyczna:
Film Coated Tablet
Typ recepty:
Product subject to prescription which may not be renewed (A)
Status autoryzacji:
Withdrawn
Data autoryzacji:
2012-11-27
Charakterystyka produktu
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anastrozole Docpharma 1 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1 mg anastrozole as active substance.
Excipients: Each tablet contains 95 mg of lactose monohydrate (see section 4.4).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, round, biconvex, film-coated tablets. Debossed with ‘1’ on one side and plain on the reverse side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Anastrozole is indicated for the :
Treatment of hormone receptor-positive advanced breast cancer in postmenopausal women.
Adjuvant treatment of postmenopausal women with hormone receptor positive early invasive breast cancer.
Adjuvant treatment of early breast cancer in hormone receptor positive postmenopausal women who have
received 2 to 3 years of adjuvant tamoxifen.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration :
Posology :
Adults including the elderly:
The recommended dose of anastrozole 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
Paediatric population:
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 patient with moderate
to severe hepatic impairme
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