Following the below approval to change the local representative in IT, we have now been advised to update the PIL revision date in line with Italy (10/2020) – please note all other content remains the same.

The new PIL code is CP0062-6 superseding CP0062-5.

Reasons for adding or updating:

• Change to section 6.3 - Shelf life
• Change to section 10 - Date of revision of the text

Date of revision of text on the SmPC:01-09-2019

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Shelf life now changed from 18 months to 24 months:

6.3 Shelf life

24 months

 In-use shelf life: 30 days

Date of revision of text changed to  

09/2018

Admin error on last entry identified

The national reporting adverse event reporting information was missing from bottom of section 4.8.

This was changed from

Reporting of suspected adverse reactions

 Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

This was changed to

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:

United Kingdom: Yellow Card Scheme at www.mhra.gov.uk/yellowcard  

Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie

No other changes have been made