Reasons for adding or updating:

• Change to section 6.5 - Nature and contents of container
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 26-Jul-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

The key changes are:

·        Section 6.5 of the SmPC and Section 6 of the PIL were updated with the new pack size(s)

Reasons for adding or updating:

• Change to section 9 - Date of first authorisation/renewal of the authorisation
• Change to section 10 - Date of revision of the text
• Change to section 1 - Name of the medicinal product
• 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 4.6 - Fertility, pregnancy and lactation
• Change to section 4.8 - Undesirable effects - how to report a side effect
• Change to section 5.1 - Pharmacodynamic properties
• Change to section 6.6 - Special precautions for disposal and other handling

Date of revision of text on the SPC: 23-Sep-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Updated to bring the texts in line with the latest EU QRD template and include wording on ADR reporting. 

Reasons for adding or updating:

• Change to section 7 - Marketing authorisation holder
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 18-Dec-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The key changes are:
    Section 7 (Marketing Authorisation Holder), deletion of the Bayer Schering Pharma Trading Style

 

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 note -that  the revision date has not changed 

 

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.
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.

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 ( Undesirable 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

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: 04-Jun-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.2 (Posology) has been significantly updated to provide additional information and guidance, including a section on special populations.

Section 10 (Revision date) this is now 4 June 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 ( Contraindications) - addition of text "must not be used in patients with meningioma of a history of meningioma".

Section 4.4 ( Special warnings) - additional text has been inserted regarding meningiomas.

Section 4.8 ( Undesirable effects) - details regarding occurence of multiple meningiomas have been added.

Section 10 (Revision date) - this is now 9 September 2009.

Reasons for adding or updating:

• Change to section 7 - Marketing Authorisation Holder
• Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
• Change to section 9 - Date of first Authorisation/renewal of the Authorisation
• Change to section 10 date of revision of the text

Date of revision of text on the SPC: 01-May-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



All updates are due to change of ownership, from Schering Healthcare Ltd to Bayer Plc effective from 1 May 2008

Section 7: MAH now Bayer plc
Section 8: Licence number is now PL 00010/0519
Section 9: Date of first authorisation is now 1 May 2008
Section 10: Revision date is now 1 May 2008 

Reasons for adding or updating:

• Correction of spelling/typing errors

Reasons for adding or updating:

• Change to section 1 - trade name
• Change to section 4.3 - Contra-indications
• Change to section 4.4 - Special Warnings and Precautions for Use
• Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
• Change to section 4.7 - Effects on Ability to Drive and Use Machines
• Change to section 4.8 - Undesirable Effects
• Change to section 4.9 - Overdose
• Change to section 5.1 - Pharmacodynamic Properties
• Change to section 5.2 - Pharmacokinetic Properties
• Change to section 5.3 - Preclinical Safety Data
• Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

• Change to section 9 - Date of Renewal of Authorisation

Reasons for adding or updating:

• Transferred from eMC version 1

Reasons for adding or updating:

• No reasons supplied