When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
4.4 Special warnings and precautions for use
Now includes the following red text:
For external use only.
Keep out of reach of children.
Do not spray on face.
Use in a ventilated area.
Avoid inhalation.
Guard against slipping.
Discontinue use if the condition is made worse.
Do not apply to broken skin.
Patients being dispensed or treated with large quantities (> 100g) of any paraffin based product should be advised to regularly change clothing or bedding impregnated with the product and keep away from naked flames as there is a fire hazard.