Last Updated on eMC 03-03-2015 View medicine  | Leo Laboratories 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 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC:13-02-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.4: update to effects of calcium metabolism, local adverse reactions and unevaluated use paragraphs$0Section 4.6: update to wording in pregnancy section$0$0Section 4.8: additional general statement about frequency of adverse reactions$0

Reasons for adding or updating:

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:21-10-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

- In Section 7 the address of the Marketing Authorisation Holder is changed
- In Section 10 the revision date is updated

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life

Date of revision of text on the SPC:01-08-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

6.3 Shelf life:  Addition of in-use shelf-life:
Unopened container:  2 years
After first opening of container:  6 months

Reasons for adding or updating:

  • Improved Electronic Presentation

Date of revision of text on the SPC:01-10-2010

Legal Category:POM

Black Triangle (CHM): NO

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical Safety Data

Date of revision of text on the SPC:01-10-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Updates in line with the company core safety information.

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-10-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 4.8, undesirable effects have been updated to include frequency details.
Other sections have been updated with the aim of achieving consistency across the product range.

Reasons for adding or updating:

  • 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 5.3 - Preclinical Safety Data

Date of revision of text on the SPC:01-02-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.4: Addition of warning re exposure to sunlight.
Section 4.5: Amendment to wording.
Section 5.3: Information from new studies added.

Reasons for adding or updating:

  • Change to section 6. 5 - Nature and Contents of Container

Reasons for adding or updating:

  • Change to section 6.1 - List of Excipients
  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • Change to section 6. 5 - Nature and Contents of Container

Reasons for adding or updating:

  • Transferred from eMC version 1

Reasons for adding or updating:

  • No reasons supplied

Reasons for adding or updating:

  • No reasons supplied

Reasons for adding or updating:

  • No reasons supplied