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Bayer plc
Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
Telephone: +44 (0)1635 563 000
Fax: +44 (0)1635 563 393
WWW: http://www.bayer.co.uk

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 04/02/2011
SPC Cyprostat 50mg

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 04/02/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   26-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 ( Special warnings) - Update to hepatotoxicity information based on published data and post-marketing surveillance.

Section 4.8 (Undesirable effects) -

In November 2010 the MHRA Signal Managment Team recommended that we include a revised warning in the SmPC section 4.8 Undesirable Effects:

"Direct hepatic toxicity including jaundice, hepatitis and hepatic failure, including cases with fatal outcome, has been reported in patients treated with 200

 

 

100-300mg Androcur. Most reported cases are in men with advanced carcinoma of the prostate. Toxicity is dose related and develops, usually, several months after treatment has begun."

Please not that the revision date has not changed

 
Updated on 01/02/2011 and displayed until 04/02/2011
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   26-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3 (Contraindications) - additional information has been included for previous or exsisting liver tumours, Dublin-Johnson Syndrome and Rotor syndrome. Also inclusion of Malignant tumours except for carcinoma of the prostate.
Section 5.3 ( Pre-clinical safety data) - thsi has been updated to incorporate changes to section 4.3
Section 10 (Revision date) thsi is now 26 January 2011.
Updated on 19/08/2010 and displayed until 01/02/2011
Reasons for adding or 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
Date of revision of text on the SPC:   11-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 (special warnings)

This has been updated to provide additional information on the warnings surrounding:

1) Shortness of breath: where it is clarified that this may occur under high dosed treatment with Androcur / Cyprostat.

2) Adrenocortical function: it is proposed to make minor changes to the existing paragraph to improve understanding and align the information provided on this topic in section 5.3 for Androcur and Cyprostat.

3) Diabetes mellitus: it is proposed to include some additional supervisory recommendations and move a sentence from section 4.5 to 4.4 as it is a warning and not an interaction.

Section 4.8 (Undesirabe effects)

 

Updated in line with the SmPC Guideline that requests a summary of the safety profile at the beginning of section 4.8 and information on the most serious/frequent occurring ADRs.

The frequencies of the following ADRs are also updated in line with the available data: Hepatic toxicity, shortness of breath, benign and malignant tumours, anaemia and osteoporosis. Where the frequencies are also proposed in section 4.4, they are consequentially updated as part of this variation.

Additionally it is proposed to include two additional side effects in the SmPC of Cyprostat. Currently section 4.8 of the SmPC for Cyprostat 50mg and 100mg contains a statement about 'inhibition of sexual drive and potency'. However, it is felt that the further description of the specific ADRs 'decreased libido' and 'erectile dysfunction' are also required.

Sectrion 10 _ Revision date is now 11 August 2010
Updated on 12/05/2010 and displayed until 19/08/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   05-May-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 ( Posology & method of administration) - this has been updated to include additional information on dosage regimen and special populations.

Section 10 (Revision date) - this is now 5 May 2010
Updated on 15/09/2009 and displayed until 12/05/2010
Reasons for adding or 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
Date of revision of text on the SPC:   09-Sep-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3 (Contra indications) - text " must not be used in patients with meningioma or a history of meningioma" has been added.

Section 4.4 ( Special warnings) - additional text has been added regarding occurence of (multiple) menengiomas.

Section 4.8 (Undesirable effects) - information of occurencr of meningiomas has been inserted.

Section 10 (Revision date) - this is now 9 September 2009
Updated on 09/02/2009 and displayed until 15/09/2009
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change of product licence name
Date of revision of text on the SPC:   27-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Product Licence name has been amended by removal of Generics UK product name (Cyproterone Acetate 50mg) - as Generics UK no longer market their own-label supply.

Revision date is now 27 January 2009. 
Updated on 21/11/2008 and displayed until 09/02/2009
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   07-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.1 (list of excipients) - name of excipient "aerosil (E551)" has been corrected to "colloidal anhydrous silica".
Section 10 (Revision date) is now 07.10.2008
Updated on 09/05/2008 and displayed until 21/11/2008
Reasons for adding or updating:
  • New individual SPC (was previously included in combined SPC)
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  cyproterone acetate