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CASODEX Film-coated tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Casodex 150 mg film-coated tablets.

Qualitative and quantitative composition

Each tablet contains 150 mg bicalutamide (INN). For the full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablet (tablet). White.

Therapeutic indications

Casodex 150 mg is indicated either alone or as adjuvant to radical prostatectomy or radiotherapy in patients with locally advanced prostate cancer at high risk for disease progression (see section 5.1). ...

Posology and method of administration

Posology Adult males including the elderly: The dosage is one 150 mg tablet to be taken orally once a day. Casodex 150 mg should be taken continuously for at least 2 years or until disease progression. ...

Contraindications

Casodex 150 mg is contraindicated in females and children (see section 4.6). Casodex 150 mg must not be given to any patient who has shown a hypersensitivity reaction to the active substance or to any ...

Special warnings and precautions for use

Initiation of treatment should be under the direct supervision of a specialist. Bicalutamide is extensively metabolised in the liver. Data suggest that its elimination may be slower in subjects with severe ...

Interaction with other medicinal products and other forms of interaction

In vitro studies have shown that R-bicalutamide is an inhibitor of CYP 3A4, with lesser inhibitory effects on CYP 2C9, 2C19 and 2D6 activity. Although clinical studies using antipyrine as a marker of cytochrome ...

Fertility, pregnancy and lactation

Pregnancy Bicalutamide is contraindicated in females and must not be given to pregnant women. Breast-feeding Bicalutamide is contraindicated during breast-feeding. Fertility Reversible impairment of male ...

Effects on ability to drive and use machines

Casodex is unlikely to impair the ability of patients to drive or operate machinery. However, it should be noted that occasionally somnolence may occur. Any affected patients should exercise caution. ...

Undesirable effects

In this section, undesirable effects are defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to ≤1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000); not known ...

Overdose

There is no human experience of overdosage. There is no specific antidote; treatment should be symptomatic. Dialysis may not be helpful, since bicalutamide is highly protein bound and is not recovered ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antiandrogen ATC code: L02BB03 Mechanism of action Bicalutamide is a non-steroidal antiandrogen, devoid of other endocrine activity. It binds to the wild type or normal androgen ...

Pharmacokinetic properties

Absorption Bicalutamide is well absorbed following oral administration. There is no evidence of any clinically relevant effect of food on bioavailability. Distribution Bicalutamide is highly protein bound ...

Preclinical safety data

Bicalutamide is a potent antiandrogen and a mixed function oxidase enzyme inducer in animals. Target organ changes, including tumour induction (Leydig cells, thyroid, liver) in animals, are related to ...

List of excipients

Tablet Core: Lactose monohydrate Magnesium stearate Povidone Carboxymethyl amidon sodium Film-coating material: Hypromellose Macrogol 300 Titanium dioxide

Incompatibilities

Not applicable.

Shelf life

Shelf life: 4 years.

Special precautions for storage

Do not store above 30°C.

Nature and contents of container

PVC/Aluminium foil blister pack comprising strips of 5, 10 and 14 tablets to give pack sizes of 10, 20, 30, 40, 50, 80, 90, 100, 200 or 14, 28, 56, 84, 140 and 280 tablets. Not all pack sizes may be marketed. ...

Special precautions for disposal and other handling

No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

AstraZeneca UK Ltd., 600 Capability Green, Luton, LU1 3LU, UK

Marketing authorization number(s)

PL 17901/0006

Date of first authorization / renewal of the authorization

Date of first authorisation: 18<sup>th</sup> June 2000 Date of latest renewal: 16<sup>th</sup> June 2004

Date of revision of the text

12<sup>th</sup> February 2018

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