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Sildenafil 50mg to go OTC

MHRA agrees first sildenafil OTC switch

December 8th 2017

Tagged: Clinical Zone news Pharmacy owners' news

By Ailsa Colquhoun

The Medicines and Healthcare products Regulatory Agency (MHRA) has agreed to reclassify Viagra Connect from a prescription only medicine (POM) to a Pharmacy (P) medicine in the UK for the treatment of erectile dysfunction in men aged 18 years and over

Viagra Connect will be available through pharmacy outlets in the following circumstances:

  • For oral use
  • Strength: 50 mg sildenafil citrate
  • For adult men with erectile dysfunction
  • Dose: 50 mg tablet to be taken as needed with water approximately one hour before sexual activity
  • Maximum pack size: 8 tablets

The company has produced pharmacy training and a checklist that pharmacists can choose to use when supplying the medicine. This checklist can be used to determine whether the medicine is suitable for a patient by asking a series of questions around cardiovascular health, other medicines and other conditions. The patient will have the patient information leaflet and packaging to refer to, which contain the key safety messages.

Medicines containing sildenafil will still also be available to obtain on prescription.

The DDA was in favour of this reclassification.

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