Anastrozole - Teva 1 mg

   ANASTROZOLE TEVA 1MG/TAB [28 TABS]

by TEVA Pharma B.V.  Computerweg 10 3542 DR Utrecht NL

1. NAME OF THE MEDICINAL PRODUCT: Anastrozole-Teva 1 mg film-coated tablets.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains 1 mg anastrozole. Excipients

Each tablet contains 87 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 to off-white, round film-coated tablets. "93" on one side and "A10" on the other side.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Anastrozole-Teva is indicated for:

- hormone receptor positive progressive breast cancer in postmenopausal women;

- therapy in postmenopausal women with hormone receptor positive early invasive breast cancer;

- therapy for postmenopausal women with hormone receptor positive early invasive breast cancer who have received adjuvant tamoxifen therapy for 2 to 3 years.

4.2 Posology and method of administration

Dosage

The recommended dose of anastrozole in 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 therapy is 5 years.

Special patient groups

Pediatric 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 adjustment is recommended for patients with mild to moderate renal impairment. In patients with severe renal impairment, anastrozole should be administered with caution (see sections 4.4 and 5.2).

Hepatic impairment

No dose adjustment is recommended for patients with mild liver disease. Caution should be exercised in patients with moderate to severe hepatic impairment (see section 4.4).

Method of administration

Anastrozol-Teva film-coated tablets should be taken orally.

4.3 Contraindications

Anastrozole-Teva is contraindicated in the following cases:

- pregnant women and nursing women;

- in patients with known hypersensitivity to anastrozole or to any of the excipients listed in section 6.1.