CRED NPM

06/11/2024

2. Ability to Correctly Assess Warnings & Contraindications

• Initial centralised switch proposal maintained the same indication as for Rx ie all men >18yrs

• CONTRAINDICATIONS: Use in certain male population is contraindicated eg

severe hepatic impairment, recent stroke/MI, history of retinal disorders/NAION, concomitant use with nitrates/nitrites etc

• The contraindications & need to understand ‘fitness for sex’ made the proposed OTC labelling complex and there were concerns that they would not be well understood

The Organisation for Professionals in Regulatory Affairs

13

3. Need for Medical Advice to Down Titrate from 50mg to 25mg

• Initial centralised switch proposal maintained the same posology as for Rx ie start at 50mg and then down/up titrate to 25mg or 100mg based on tolerability and effect • SPECIAL WARNINGS: Certain special populations are advised to consider 25mg dose: men with hepatic or renal impairment; men taking CYP3A4 inhibitors; men taking alpha blockers • The adjustments in posology needed made the proposed OTC labelling complex and there were concerns that they would not be well understood

The Organisation for Professionals in Regulatory Affairs

14

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