ARIMIDEX Film Coated Tablet 1 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
16-04-2024
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Active ingredient:
ANASTRAZOLE
Available from:
B & S Healthcare
Dosage:
1 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2011-06-23
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Arimidex 1mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1 mg anastrozole.
Excipients: each film-coated tablet contains 93 mg lactose monohydrate.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from the United Kingdom_
White, biconvex, 6mm in diameter embossed with a logo on one side and a tablet strength marking on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of early breast cancer in postmenopausal women who are hormone-receptor positive.
Treatment of advanced breast cancer in postmenopausal women.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults includes the elderly:
One 1mg tablet to be taken orally once a day.
Children:
Arimidex is not recommended for use in children due to insufficient data on safety and efficacy (_see sections 4.4 and_
_5.1)._
Renal Impairment: No dose change is recommended.
Hepatic Impairment: No dose change is recommended.
4.3 CONTRAINDICATIONS
Arimidex must not be administered during pregnancy or lactation.
Patients with known hypersensitivity to anastrozole or to any of the excipients referenced in _Section 6.1._
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Arimidex is not recommended for use in children or in premenopausal women as safety and efficacy have not been
established in these groups of patients _(see sections 5.1)._
Arimidex should not be used in boys with growth hormone deficiency in addition to growth hormone treatment. In the
pivotal clinical trial, efficacy was not demonstrated and safety was not established _(see section 5.1)._
IRISH MEDICINES BOARD
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