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 - Ketoconazole and other CYP2D6 inhibitors, Carbamazepine 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 reactions, Other 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