EMA’s safety committee, PRAC, has concluded its review of medicines containing pholcodine, which are used in adults and children to treat non-productive (dry) cough and, in combination with other active substances, for the treatment of symptoms of cold and flu, and has recommended the revocation of the EU marketing authorisations for these medicines.
Healthcare professionals should no longer prescribe or dispense pholcodine-containing medicines and should consider appropriate treatment alternatives.
Products on the IPU Product File which contain pholcodine are:
- Pholcodex 5mg/5ml Oral Solution 150ml. This has already been withdrawn by Pinewood;
- Day Nurse Caps x 20. We are awaiting a response from GSK on this.
