The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail

Panadeine Extra Strength Tablets Paracetamol 500 mg Codeine Phosphate hemihydrate 12.8 mg

GlaxoSmithKline Consumer Healthcare (Ireland) LimitedPA0678/026/003

Main Information

Trade NamePanadeine Extra Strength Tablets Paracetamol 500 mg Codeine Phosphate hemihydrate 12.8 mg
Active SubstancesParacetamol
Codeine phosphate hemihydrate
Dosage FormFilm-coated tablet
Licence HolderGlaxoSmithKline Consumer Healthcare (Ireland) Limited
Licence NumberPA0678/026/003

Group Information

ATC CodeN02AJ06 codeine and paracetamol


License statusAuthorised
Licence Issued28/06/2012
Legal statusProduct not subject to medical prescription
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceRetail sale through pharmacies only in blister packs containing not more than 24 unit dosage forms. Not more than two such packs should be supplied in the course of any one retail transaction unless a valid prescription exists. Packs containing more than 24 unit dosage forms are prescription only.
Marketing StatusNot marketed


Summary of Product CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportPDF Version
« Back