Last Updated on eMC 10-05-2017 View medicine  | Chiesi 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.

Reasons for adding or updating:

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:01-03-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



A Type IB Variation was submitted to update the Summary of Product Characteristics to be in line with the outcome of the EU Paediatrics work-sharing procedure for Tramadol - IE/W/0016/pdWS/001 published in January 2017.

The changes concern the section 5.1 and 5.2 of the SmPC, in which information regarding paediatric population has been added.

 

The following text in red has been added/update in the SPC.

 

5.1     Pharmacodynamic properties

 

Paediatric population

Effects of enteral and parenteral administration of tramadol have been investigated in clinical trials involving more than 2000 paediatric patients ranging in age from neonate to 17 years of age. The indications for pain treatment studied in those trials included pain after surgery (mainly abdominal), after surgical tooth extractions, due to fractures, burns and traumas as well as other painful conditions likely to require analgesic treatment for at least 7 days.

At single doses of up to 2 mg/kg or multiple doses of up to 8 mg/kg per day (to a maximum of 400 mg per day) efficacy of tramadol was found to be superior to placebo, and superior or equal to paracetamol, nalbuphine, pethidine or low dose morphine. The conducted trials confirmed the efficacy of tramadol. The safety profile of tramadol was similar in adult and paediatric patients older than 1 year (see section 4.2).

 

5.2      Pharmacokinetic properties

  Paediatric population

The pharmacokinetics of tramadol and O-desmethyltramadol after single-dose and multiple-dose oral administration to subjects aged 1 year to 16 years were found to be generally similar to those in adults when adjusting for dose by body weight, but with a higher between-subject variability in children aged 8 years and below.

In children below 1 year of age, the pharmacokinetics of tramadol and O-desmethyltramadol have been investigated, but have not been fully characterized. Information from studies including this age group indicates that the formation rate of O-desmethyltramadol via CYP2D6 increases continuously in neonates, and adult levels of CYP2D6 activity are assumed to be reached at about 1 year of age. In addition, immature glucuronidation systems and immature renal function may result in slow elimination and accumulation of O-desmethyltramadol in children under 1 year of age.

 

10.         DATE OF REVISION OF THE TEXT

                   March 2017

 

Reasons for adding or updating:

  • New individual SPC (was previously included in joint SPC)

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Marketing Authorisation Holder - Chiesi Limited, Cheadle Royal Business Park, Highfield, Cheadle SK8 3GY UK Changed to Chiesi Limited 333 Styal Road, Manchester M22 5LG UK

Date of revision of the Text – February 2014 changed to July 2015