ANASTROZOLE 1 Milligram Film Coated Tablet
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
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(SPC)
20-04-2024
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Virkt innihaldsefni:
ANASTROZOLE
Fáanlegur frá:
Ranbaxy Ireland Limited
INN (Alþjóðlegt nafn):
ANASTROZOLE
Skammtar:
1 Milligram
Lyfjaform:
Film Coated Tablet
Gerð lyfseðils:
Product subject to prescription which may not be renewed (A)
Leyfisstaða:
Withdrawn
Leyfisdagur:
2012-10-09
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anastrozole 1 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1 mg anastrozole.
Excipient(s): Each tablet contains 65 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 film-coated tablet with a diameter of 6.6 mm approximately
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Anastrozole Tablets are indicated for the:
Treatment of hormone receptor-positive advanced breast cancer in postmenopausal women.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Anastrozole for adults including the elderly is one 1 mg tablet once a day.
_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 patients with moderate to
severe hepatic impairment (see section 4.4).
Method of administration
Anastrozole should be taken orally.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 26/07/2012_
_CRN 2103768_
_page number: 1_
4.3 CONTRAINDICATIONS
Anastrozole 1mg Tablets are contraindicated in :
Pregnant or breast-feeding women
Patients with known hypersensitivity to anastrozole or to any of the excipients as referenced in section 6.1
4.4 SPEC
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