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Bayer plc
Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
Telephone: +44 (0)1635 563 000
Fax: +44 (0)1635 563 393
WWW: http://www.bayer.co.uk

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?
Summary of Product Characteristics last updated on the eMC: 11/11/2010
SPC Levonelle One Step

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 11/11/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   22-Mar-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The change is the addition of Boots as an own label distributor.

Updated on 01/12/2009 and displayed until 11/11/2010
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02-Nov-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


There are several minor editorial changes, but the main changes are:-

 

3. Pharmaceutical Form

A description of the impression mark 'G00' has been added.

 

4.4 Special Warnings and precautions for use

A statement that Levonelle is not recommended for patients who are at risk of ectopic pregnancy has been added.

The statement on patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption has been amended to state that they should not take Levonelle.

 

4.7 Undesirable Effects

The MedRA table has been amended to current SOC labels and 'Headache' has been moved from common to very common.

Post marketing events have been added.

 

5.1 Pharmacodynamic properties

The previous statement on the 1998 Lancet study has been removed.

 

5.2 Pharmacokinetic properties

The previous reference to a pharmacokinetic study in 15 healthy women has been removed.

 

5.3 Preclinical safety data.

A statement on preclinical data from conventional studies on chronic toxicity, mutagenicity and carcinogenicity has been added.

 

6.4 Special precautions for storage

The statement on storing in the original packaging has been expanded to explain that this is in order to protect the product from light.
Updated on 11/12/2007 and displayed until 01/12/2009
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   11/2007
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.3 (Shelf-life) has been updated to 4 years. 
Section 10 (Date of revision) has been updated to 18.11.2007. 
Updated on 21/10/2004 and displayed until 11/12/2007
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  levonorgestrel