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Review
Sildenafil - from POM to P

https://doi.org/10.1136/dtb.2018.10.000024

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    Generic name: Sildenafil

    Brand name: Viagra Connect

    Formulation: 50mg film-coated tablets

    Market authorisation holder: Pfizer Consumer Healthcare Ltd

    Indication: Viagra Connect is indicated in adult men with erectile dysfunction

    Dose: 50mg approximately one hour before sexual activity (maximum 50mg daily)

    Classification: Pharmacy medicine (P)

    Key learning points

    • Sildenafil 50mg tablets (Viagra Connect) are available as a pharmacy medicine for use by men aged ≥18 years who have erectile dysfunction.

    • In fixed-dose studies three times as many men reported that 50mg sildenafil improved their erections compared with placebo (74% vs. 25%).

    • The market authorisation holder (Pfizer Consumer Healthcare Ltd.) has published training materials and a checklist to help pharmacists assess whether a patient is suitable for Viagra Connect.

    • As part of the assessment process, pharmacists are advised to take into consideration a patient’s cardiovascular health, other medical conditions and all medicines that the patient is taking.

    • The market authorisation holder advises that men should make an appointment with their GP within 6 months of first purchasing Viagra Connect.

    • Retail price: £19.99 (4 tablets), £34.99 (8 tablets).

    Background

    Phosphodiesterase-5 (PDE-5) inhibitors (e.g. sildenafil) are a first-line option for the management of erectile dysfunction.1 Sildenafil (25mg, 50mg and 100mg) has been available as a prescription only medicine (POM) since 1998. Following an application from the licence-holder (Pfizer Consumer Healthcare) to reclassify sildenafil as a medicine that can be supplied without prescription from pharmacies under the supervision of a pharmacist, the Medicines and Healthcare products Regulatory Agency (MHRA) has licensed a product containing 50mg sildenafil as a pharmacy medicine (P).2-4

    Efficacy

    As the formulations of the P and POM sildenafil products …

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