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SPC, UK: Casodex 50 mg Film-coated Tablets (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
AstraZeneca UK Limited
Διεύθυνση :
Horizon Place, 600 Capability Green, Luton, Bedfordshire, LU1 3LU
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Δωρεάν εγγραφή

Name of the medicinal product

Casodex 50 mg Film-coated Tablets.

Qualitative and quantitative composition

Each tablet contains 50 mg bicalutamide (INN).

Pharmaceutical form

White film-coated tablet.

Therapeutic indications

Treatment of advanced prostate cancer in combination with LHRH analogue therapy or surgical castration.

Posology and method of administration

Adult males including the elderly: one tablet (50 mg) once a day. Treatment with Casodex should be started at least 3 days before commencing treatment with an LHRH analogue, or at the same time as surgical ...

Contraindications

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

Special warnings and precautions for use

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

Interaction with other medicinal products and other forms of interaction

There is no evidence of any pharmacodynamic or pharmacokinetic interactions between Casodex and LHRH analogues. In vitro studies have shown that R-bicalutamide is an inhibitor of CYP 3A4, with lesser inhibitory ...

Pregnancy and lactation

Casodex is contraindicated in females and must not be given to pregnant women or nursing mothers.

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 Casodex is highly protein bound and is not recovered unchanged ...

Pharmacodynamic properties

Casodex is a non-steroidal antiandrogen, devoid of other endocrine activity. It binds to androgen receptors without activating gene expression, and thus inhibits the androgen stimulus. Regression of prostatic ...

Pharmacokinetic properties

Casodex is well absorbed following oral administration. There is no evidence of any clinically relevant effect of food on bioavailability. The (S)-enantiomer is rapidly cleared relative to the (R)-enantiomer, ...

Preclinical safety data

Casodex is a potent antiandrogen and a mixed function oxidase enzyme inducer in animals. Target organ changes, including tumour induction, in animals, are related to these activities. None of the findings ...

List of excipients

Casodex includes the following excipients: Lactose Monohydrate Magnesium Stearate Hypromellose Macrogol 300 Povidone Sodium Starch Glycolate Titanium Dioxide (E171)

Incompatibilities

None known.

Shelf life

5 years.

Special precautions for storage

Do not store above 30°C.

Nature and contents of container

PVC blister/aluminium foil packs.

Special precautions for disposal and other handling

No special precautions required.

Marketing authorization holder

AstraZeneca UK Limited 600 Capability Green Luton LU1 3LU UK

Marketing authorization number(s)

17901/0005

Date of first authorization / renewal of the authorization

18th June 2000/19th January 2006

Date of revision of the text

9th May 2012