Casodex 50mg Tablets
- Name:
Casodex 50mg Tablets
- Company:
AstraZeneca Pharmaceuticals (Ireland) DAC
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
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AstraZeneca Pharmaceuticals (Ireland) DAC
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When a pharmaceutical company changes any document, 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.
Updated on 25 April 2019 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 23 January 2019 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 23 January 2019 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 7 – Marketing Authorisation Holder details updated
Section 8 – Marketing Authorisation numbers updated
Section 10 – date of revision updated
Updated on 5 June 2018 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4 - Update with information on the potentiation of coumarin anticoagulant effects which have been reported in patients receiving concomitant Casodex therapy
Section 4.5- Interaction information amended with warfarin and other coumarin anticoagulants when co-administered with Casodex
Section 4.6 - Editorial updates to align with QRD template
Section 4.6 - Update to the fertility section relating to adequate contraception
Section 4.8 - Update with information on the interaction of coumarin anticoagulants with Casodex
Section 5.3 - Update to preclinical safety data in animal studies
Section 10- Change to the date of revision
Updated on 5 June 2018 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 1 December 2016 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 1 December 2016 SmPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.1 LHRH has been unabridged.
Section 4.2 Editorial changes to reflect the QRD template (older to elderly and others)
Section 4.4 Statement on sperm morphology changes & contraception has been added
Section 10 Updated revision date
Updated on 30 November 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 30 November 2016 PIL
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Updated on 28 May 2015 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 8 - MA number
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 2 updated in line with QRD
Section 4.2 updated in line with QRD
Section 4.3 updated in line with QRD
Section 4.4 addition of inforamtion on androgen deprivation therapy may prolong the QT interval
Section 4.5 addition of information on concomitant use of Casdoex with medicinal products knoen to prolong the QT internal or able to induce Torsade de pointes
Section 4.6 updated in line with QRD
Section 4.8 addition of QT prolongation as a ‘not known’ frequency adverse event
Section 4.8 amendment of adverse event reporting details (IMB to HPRA details change)
Section 5.1 updated in line with QRD
Section 5.2 updated in line with QRD
Section 6.6 updated in line with QRD
Section 8 updated in line with QRD
Section 9 updated in line with QRD
Section 10 updated date of revision
Updated on 26 May 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
- Change to date of revision
- Change to improve clarity and readability
- Addition of information on reporting a side effect.
Updated on 27 June 2014 SmPC
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Section 4.8 Add photosensitivity reaction as a rare adverse reaction in the table
- Section 4.8 Add the Reporting of suspected adverse reactions paragraph, email address etc...
- Section 10 New date of revision
Updated on 24 June 2014 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change to improve clarity and readability
- Addition of information on reporting a side effect.
Updated on 30 May 2014 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 4 October 2012 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update to the SPC in line with the PSUR WS procedure
Section 4.8
Changes to table footnotes.
Updated on 13 September 2011 PIL
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 18 April 2011 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.8
Include myocardial infarction, correct the frequency descriptor for cardiac failure from uncommon to common.
Section 10
Date of revision of text: 11th April 2011
Updated on 14 April 2011 PIL
Reasons for updating
- Change to side-effects
Updated on 30 July 2010 PIL
Reasons for updating
- Change of contraindications
- Change to side-effects
- Change to date of revision
Updated on 29 July 2010 SmPC
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.8 - Undesirable effects
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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 |
Common |
Decreased libido |
|
Nervous system disorders |
Very common |
Dizziness |
|
|
Common |
Somnolence |
|
Cardiac disorders |
Uncommon |
Cardiac failure4 |
|
Vascular disorders |
Very common |
Hot flush |
|
Respiratory, thoracic and mediastinal disorders |
Uncommon |
Interstitial lung disease. Fatal outcomes have been reported. |
|
Gastrointestinal disorders |
Very common |
Abdominal pain |
|
|
Common |
Dyspepsia |
|
Hepato-biliary disorders |
Common |
Hepatotoxicity, jaundice, hypertransaminasaemia1 |
|
|
Rare |
Hepatic failure2. Fatal outcomes have been reported. |
|
Skin and subcutaneous tissue disorders |
Common |
Alopecia |
|
Renal and urinary disorders |
Very common |
Haematuria |
|
Reproductive system and breast disorders |
Very common |
Gynaecomastia and breast tenderness3 |
|
|
Common |
Erectile dysfunction |
|
General disorders and administration site conditions |
Very common |
Asthenia |
|
|
Common |
Chest pain |
|
Investigations |
Common |
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”
Updated on 13 July 2010 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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.
Updated on 11 February 2010 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Changes to SPC, Casodex 50mg
Section 4.4
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.”
Section 4.8
Changes to table: Changed made in bold text.
|
System Organ Class |
Frequency |
Event |
|
Blood and lymphatic system disorders |
Very common |
Anaemia |
|
Immune system disorders |
Uncommon |
Hypersensitivity reactions (including angioneurotic oedema and urticaria) |
|
Metabolism and nutrition disorders |
Common |
Anorexia |
|
Psychiatric disorders |
Common |
Decreased libido |
|
Nervous system disorders |
Very common |
Dizziness |
|
|
Common |
Somnolence |
|
Vascular disorders |
Very common |
Hot flush |
|
Respiratory, thoracic and mediastinal disorders |
Uncommon |
Interstitial lung disease. Fatal outcomes have been reported. |
|
Gastrointestinal disorders |
Very common |
Abdominal pain |
|
|
Common |
Dyspepsia |
|
Hepato-biliary disorders |
Common |
Hepatic changes (including elevated levels of transaminases, jaundice)/hepato-biliary disorders1 |
|
|
Rare |
Hepatic failure2. Fatal outcomes have been reported. |
|
Skin and subcutaneous tissue disorders |
Common |
Alopecia |
|
Renal and urinary disorders |
Very common |
Haematuria |
|
Reproductive system and breast disorders |
Very common |
Gynaecomastia and breast tenderness3 |
|
|
Common |
Impotence |
|
General disorders and administration site conditions |
Very common |
Asthenia |
|
|
Common |
Chest pain |
|
Investigations |
Common |
Weight gain |
Section 10
25th January 2010
Updated on 8 February 2010 PIL
Reasons for updating
- Change to side-effects
Updated on 15 September 2009 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to information about driving or using machinery
- Change to date of revision
- Change to appearance of the medicine
Updated on 12 August 2009 SmPC
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.7 - Effects on ability to drive and use machines
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.3 Contraindications
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
Updated on 20 February 2007 PIL
Reasons for updating
- Change to side-effects
Updated on 7 February 2007 SmPC
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Section 4.3 Removal of text-Each tablet of casodex contains 61mg of lactose.....
- Section 4.4-Addition of the word hepatic failure in the 4th paragraph of section 4.4
- Section 4.4-Addition of the text-each tablet of casodex contains...
- Section 4.8-Addition of text under the subtitle rare-Hepato-billiary disorders-Heaptic failure
- Section 5.2-Removal of the letter S, in the word micrograms.
- Section 5.2-Addition of the text-In a clinical study, the mean concentration of...
- Section 10-change in the date of the revision of the text-to reflect the updated approval date
Updated on 17 October 2006 PIL
Reasons for updating
- Change of active ingredient
- Change of inactive ingredient
- Change to warnings or special precautions for use
Updated on 2 October 2006 SmPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.3 - Contraindications
- Change to section 4.8 - Undesirable effects
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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”
Updated on 26 July 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 6 July 2004 SmPC
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 23 May 2003 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)