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SPC, UK: Arimidex 1mg Film-Coated Tablet (2011)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
AstraZeneca UK Limited
Διεύθυνση :
Horizon Place, 600 Capability Green, Luton, Bedfordshire, LU1 3LU
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Name of the medicinal product

Arimidex 1 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 1 mg anastrozole. Excipients: Each film-coated tablet contains 93 mg of lactose monohydrate (see section 4.4). For a full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablet. White, round, biconvex tablet with logo on one side and strength on the other.

Therapeutic indications

Arimidex is indicated for the: Treatment of hormone receptor-positive advanced breast cancer in postmenopausal women. Adjuvant treatment of hormone receptor-positive early invasive breast cancer in postmenopausal ...

Posology and method of administration

Posology The recommended dose of Arimidex for 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 ...

Contraindications

Arimidex is 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.

Special warnings and precautions for use

General Arimidex should not be used in premenopausal women. The menopause should be defined biochemically (luteinizing-hormone [LH], follicle stimulating hormone [FSH], and/or estradiol levels) in any ...

Interaction with other medicinal products and other forms of interaction

Anastrozole inhibits CYPs 1A2, 2C8/9 and 3A4 in vitro. Clinical studies with antipyrine and warfarin showed that anastrozole at a 1 mg dose did not significantly inhibit the metabolism of antipyrine and ...

Fertility, pregnancy and lactation

Pregnancy There are no data from the use of Arimidex in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Arimidex is contraindicated during pregnancy (see section ...

Effects on ability to drive and use machines

Arimidex has no or negligible influence on the ability to drive and use machines. However, asthenia and somnolence have been reported with the use of Arimidex and caution should be observed when driving ...

Undesirable effects

The following table presents adverse reactions from clinical trials, post-marketing studies or spontaneous reports. Unless specified, the frequency categories were calculated from the number of adverse ...

Overdose

There is limited clinical experience of accidental overdose. In animal studies, anastrozole demonstrated low acute toxicity. Clinical trials have been conducted with various dosages of Arimidex, up to ...

Pharmacodynamic properties

Pharmacotherapeutic group: Enzyme inhibitors ATC code: L02BG03 Mechanism of action and pharmacodynamic effects Arimidex is a potent and highly selective non-steroidal aromatase inhibitor. In postmenopausal ...

Pharmacokinetic properties

Absorption of anastrozole is rapid and maximum plasma concentrations typically occur within two hours of dosing (under fasted conditions). Food slightly decreases the rate but not the extent of absorption. ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction for the ...

List of excipients

Lactose monohydrate Povidone Sodium starch glycollate Magnesium stearate Hypromellose Macrogol 300 Titanium dioxide

Incompatibilities

Not applicable.

Shelf life

5 years.

Special precautions for storage

Do not store above 30°C.

Nature and contents of container

PVC blister/aluminium foil packs of 20, 28, 30, 84, 98, 100 and 300 tablets contained in a carton. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

AstraZeneca UK Limited 600 Capability Green Luton LU1 3LU UK

Marketing authorization number(s)

PL 17901/0002

Date of first authorization / renewal of the authorization

Date of first authorisation: 18 June 2000 Date of latest renewal: 15 February 2010

Date of revision of the text

19th May 2011