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.
Section 4.2: Removal of indication for use in children under 6 years of age. Addition of maximum daily dose information Addition of extra warnings:
Use only when simple measures have failed to provide adequate relief.
Use for more than 5 consecutive days is not recommended Section 4.3 CI in children under 6. Section 4.4 Children 2 to 6 years: Not more than 3 doses should be given in any 24 hours.
changed to:
Children 6 to 12 years: Not more than 3 doses should be given in any 24 hours.
Consult a pharmacist or other healthcare professional before use in children under 6 years. changed to:
Consult a pharmacist or other healthcare professional before use in children under 12 years.