Section 4.8

Include myocardial infarction, update the footnotes, correct the frequency descriptor for cardiac failure from uncommon to common.

Section 10

Date of revision of text: 6^th January 2011

Casodex  50mg SPC changes

Section 4.3
First and second paragraphs updated, now reads as
"

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 of this product."




Section 4.8
Table updated,

Table 1       Frequency of Adverse Reactions

1.     Hepatic changes are rarely severe and were frequently transient, resolving or improving with continued therapy or following cessation of therapy.

2.     Hepatic failure has occurred rarely in patients treated with Casodex, but a causal relationship has not been established with certainty. Periodic liver function testing should be considered (see also section 4.4).

3.     May be reduced by concomitant castration.

4.     Observed in a pharmaco-epidemiology study of LHRH agonists and anti-androgens used in the treatment of prostate cancer. The risk appears to be increased when Casodex 50 mg was used in combination with LHRH agonists but no increase in risk was evident when Casodex 150 mg was used as a monotherapy to treat prostate cancer.

Final paragraph in previous version now deleted.

Section 10
15th July 2010

Section 4.3

Additional wording in 3^rd paragraph, “(see section 4.5)”.

Section 4.4

Insertion of new 1^st paragraph, “Initiation of treatment should be under the direct supervision of a specialist”.

Insertion of new 5^th paragraph, “A reduction in glucose tolerance has been observed in males receiving LHRH agonists.  This may manifest as diabetes or loss of glycaemic control in those with pre-existing diabetes.  Consideration should therefore be given to monitoring blood glucose in patients receiving Casodex in combination with LHRH agonists”.

Section 4.5

Additional wording in 3^rd paragraph after the word, contraindicated, “(see section 4.3)”.

Section 4.8

Additional 1^st paragraph before Table 1, “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 (cannot be estimated from the available data)”.

Table 1 and references amended.

Last paragraph amended, “In addition, cardiac failure was reported in clinical trials (as a possible adverse drug reaction in the opinion of investigating clinicians, with a frequency of > 1%) during treatment with Casodex plus an LHRH analogue.  There is no evidence of a causal relationship with drug treatment”.

Section 10

Revised date, “26^th February 2009”

Section 4.4

Change of text to 3rd paragraph - Includes a reference to hepatic failure

‘Severe hepatic changes and hepatic failure have been observed …….’

And additional paragraph at the end of section 4.4 has a warning regarding lactose

‘Each tablet of Casodex contains 61 mg of lactose monohydrate.  Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.’

Section 4.5

BAN to rINN change  ‘cyclosporin’ to ‘ciclosporin’

Section 4.8

Change of text in 2^nd paragraph after the Table references’ from ‘rarely’ to ‘uncommonly’

Thrombocytopenia has been reported uncommonly.

Section 5.2

Additional text – last paragraph

In a clinical study the mean concentration of R‑bicalutamide in semen of men receiving Casodex 150 mg was 4.9 microgram/ml.  The amount of bicalutamide potentially delivered to a female partner during intercourse is low and by extrapolation possibly equates to approximately 0.3 microgram/kg.  This is below that required to induce changes in offspring of laboratory animals.

Section 6.1

Update 2 names to correct Ph Eur names:

Povidone

Sodium Starch Glycolate

E number added to Titanium Dioxide

Titanium Dioxide (E171).

Section 10