Last Updated on eMC 28-06-2018 View medicine  | Aspire Pharma Ltd 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 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Date of revision of text on the SPC:25-06-2018

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.2 Elderly has been updated.

Section 4.4 Suicidality & Pathological gambling and other impulse control disorders have been updated.

Section 4.5 Ketaconazole and other CYP3A4 inhibitorsCarbamazepine and other CYP3A4 inducers Valproate and lithium have been updated.

Section 4.6 Pregnancy, Breast-feeding & Fertility have been updated.

Section 4.7 Effects on ability to drive and use machines has been updated.

Section 4.8 Tabulated list of adverse reactionsOther findings & Pathological gambling and other impulse control disorders have been updated.

Section 5.1 Lipid parameters has been updated.

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC