Skip to content
SPC Logo

Setofilm 4 mg Orodispersible Films

Last Updated on eMC 24-Jan-2017 View document  | Norgine Limited Contact details

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 24-Jan-2017 and displayed until Current

Reasons for adding or updating:

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.9 - Overdose

Date of revision of text on the SPC: 08-Jan-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.5 Interactions with other medicines:

 

Apomorphine has been moved at the beginning of the section

 

Section 4.9 Overdose – Below has been included.

 

Paediatric population

Peadiatric cases consistent with serotonin syndrome have been reported after inadvertent oral overdoses of ondansetron (exceeded estimated ingestion of 4 mg/kg) in infants and children aged 12 months to 2 years

Updated on 06-Jan-2016 and displayed until 24-Jan-2017

Reasons for adding or updating:

  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 16-Oct-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Date of revsion:

October 2015

Updated on 14-Feb-2014 and displayed until 06-Jan-2016

Reasons for adding or updating:

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Date of revision of text on the SPC: 01-Jan-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:





In Section 4.5 - Text updated with antifungal agents to indicate Ketoconazole.

Updated on 09-Jul-2013 and displayed until 14-Feb-2014

Reasons for adding or updating:

  • New SPC for new product

Legal Category:POM

Black Triangle (CHM): NO

Company contact details

Norgine Limited

Company image
Address

Norgine House, Widewater Place, Moorhall Road, Harefield, Middlesex, UB9 6NS

Fax

+44 (0)1895 825 865

Medical Information e-mail
Telephone

+44 (0)1895 826 600

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?

Active ingredients

ondansetron

Legal categories

POM - Prescription Only Medicine

This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Continue