| 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.
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