ARIMIDEX TABLET 1 mg

4.1 Therapeutic indications

ARIMIDEX is indicated for adjuvant treatment of postmenopausal women with hormone receptor positive early invasive breast cancer.

Treatment of advanced breast cancer in postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer. Efficacy has not been demonstrated in oestrogen receptor negative patients unless they had a previous positive clinical response to tamoxifen.

4.3 Contraindications

ARIMIDEX is contraindicated in:

• premenopausal women.
• pregnant or lactating women.
• patients with severe renal impairment (creatinine clearance less than 20ml/min).
• patients with moderate or severe hepatic disease.
• patients with known hypersensitivity to anastrozole or to any of the excipients as referenced on the carton.

Oestrogen-containing therapies should not be co-administered with ARIMIDEX as they would negate its pharmacological action.

Concurrent tamoxifen therapy (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration

Adults including elderly:One 1mg tablet to be taken orally once a dayChildren:Not recommended for use in childrenRenal Impairment:No dose change is recommended in patients

with mild or moderate renal impairmentHepatic Impairment:No dose change is recommended in patients

with mild hepatic disease.

For early disease, the recommended duration of treatment should be 5 years.