When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
SPC changes – Casodex 50mg IR
Section 4.3
Text updated in first and second paragraphs, now reads,
“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
Text updated in table, now reads,
“Table 1 Frequency of Adverse Reactions
System Organ Class
Frequency
Event
Blood and lymphatic system disorders
Very common
Anaemia
Immune system disorders
Uncommon
Hypersensitivity, angioedema and urticaria
Metabolism and nutrition disorders
Common
Decreased appetite
Psychiatric disorders
Decreased libido Depression
Nervous system disorders
Dizziness
Somnolence
Cardiac disorders
Cardiac failure4
Vascular disorders
Hot flush
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease. Fatal outcomes have been reported.
Gastrointestinal disorders
Abdominal pain Constipation Nausea
Dyspepsia Flatulence
Hepato-biliary disorders
Hepatotoxicity, jaundice, hypertransaminasaemia1
Rare
Hepatic failure2. Fatal outcomes have been reported.
Skin and subcutaneous tissue disorders
Alopecia Hirsuitism/hair re-growth Dry skin Pruritis Rash
Renal and urinary disorders
Haematuria
Reproductive system and breast disorders
Gynaecomastia and breast tenderness3
Erectile dysfunction
General disorders and administration site conditions
Asthenia Oedema
Chest pain
Investigations
Weight increased
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 has been deleted. Section 9 Now reads as, “Date of first authorisation: 21 April 2000 Date of last renewal: 21 April 2010” Section 10 Date of revision of text, ”13 July 2010”
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 has been deleted. Section 9 Now reads as, “Date of first authorisation: 21 April 2000 Date of last renewal: 21 April 2010” Section 10 Date of revision of text, ”13 July 2010”
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 has been deleted. Section 9 Now reads as, “Date of first authorisation: 21 April 2000 Date of last renewal: 21 April 2010” Section 10 Date of revision of text, ”13 July 2010”
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 has been deleted. Section 9 Now reads as, “Date of first authorisation: 21 April 2000 Date of last renewal: 21 April 2010” Section 10 Date of revision of text, ”13 July 2010”
Final paragraph in previous version has been deleted.
Section 9 Now reads as, “Date of first authorisation: 21 April 2000
Date of last renewal: 21 April 2010”
Section 10
Date of revision of text,
”13 July 2010”
SPC Changes – Casodex 50mg
Section 2 Text changes, now reads, “Each film-coated tablet contains 50 mg of bicalutamide. Excipients: 61 mg lactose monohydrate per tablet. For a full list of excipients, see section 6.1.” Section 4.2 Fourth paragraph, the word ‘special’ has been deleted before the word precautions in the final sentence. Section 9 Date of last renewal is now 21 April 2010. Section 10 Date of revision of text is now, 25 June 2010.
Section 2
Text changes, now reads,
“Each film-coated tablet contains 50 mg of bicalutamide.
Excipients: 61 mg lactose monohydrate per tablet.
For a full list of excipients, see section 6.1.”
Section 4.2
Fourth paragraph, the word ‘special’ has been deleted before the word precautions in the final sentence.
Section 9
Date of last renewal is now 21 April 2010.
Date of revision of text is now, 25 June 2010.
Changes to SPC, Casodex 50mg
New Text to 4th paragraph:
“Severe hepatic changes and hepatic failure have been observed rarely with Casodex, and fatal outcomes have been reported (see section 4.8 ). Casodex therapy should be discontinued if changes are severe.”
Changes to table: Changed made in bold text.
Hypersensitivity reactions (including angioneurotic oedema and urticaria)
Anorexia
Hepatic changes (including elevated levels of transaminases, jaundice)/hepato-biliary disorders1
Impotence
Asthenia Chest pain Oedema
Weight gain
25th January 2010
Additional last paragraph
“Co-administration of terfenadine, astemizole or cisapride with Casodex is contraindicated (see section 4.5).”
Section 4.4 Special warnings and precautions for use Major amendments to text, inclusions and deletions.
Section 4.5 Interaction with other medicinal products and other forms of interaction Major amendments to text, inclusions and deletions.
Section 4.7 Additional wording at end of first paragraph, ”However, it should be noted that occasionally somnolence may occur. Any affected patients should exercise caution.”
Section 4.8 including Table 1 Major amendments to section.
Section 10 10th March 2009
Section 1: Addition of: 50 mg Film-coated Tablets to name of medicinal product
Section 2: Addition of: “For excipients, see 6.1.”
Section 4.3: Addition of paragraph on galactose intolerance
Section 4.8: Deletion of the following sentence: "Casodex in general, has been well tolerated with few withdrawals due to adverse events".
Addition of: "Casodex 50 mg is only used in combination with surgical or medical castration. The reported adverse drug profile of Casodex 50 mg therefore includes effects that may also be seen with castration therapy alone. The most common reactions reported reflect the pharmacological activity; with the majority (53%) of patients reporting hot flushes and lower proportions (approximately 10%) reporting gynaecomastia or breast tenderness".
Deletion of footnote: "May be reduced by concomitant castration". From Frequency of Adverse Reactions table
Section 6.1: Addition of 'Monohydrate' after 'Lactose'.
Addition of (E171) after Titanium Dioxide
Section 6.2: Deletion of “None known” and changed to “Not applicable.”
Section 6.6: Change from “no precautions required” to “no requirements”