MHRA reclassifies Cialis Together tablets to a Pharmacy medicine
Following advice from the Commission on Human Medicines, the Medicines and Healthcare products Regulatory Agency (MHRA) has reclassified Cialis Together so that it can now be made available for purchase over the counter, without a prescription.
Cialis Together (containing 10mg tadalafil citrate) will be available to purchase from pharmacies, if marketed. This means that in the future, it could be available to buy without a prescription for use by men over 18 who have erectile dysfunction.
This decision was made following a reassuring assessment of the safety of Cialis Together and advice from the Commission on Human Medicines.
Products for the treatment of erectile dysfunction have been available to purchase in pharmacies since 2018 when Viagra Connect (sildenafil 50 mg tablets) was first reclassified with Pharmacy legal status.
If marketed, Cialis Together will be sold from pharmacies following a discussion with the pharmacist. Pharmacists will be able to determine whether treatment is appropriate for the patient and can give advice on erectile dysfunction, usage of the medicine, potential side effects, and if further consultation with a general practitioner is required.
Cialis Together will not be sold to those with severe cardiovascular disorders; at high cardiovascular risk; severe kidney or severe liver failure; or taking certain interacting medicines. Use of Cialis Together in these groups of men must continue to be under the supervision of a doctor.
Erectile dysfunction medicines are a popular target for criminals selling unlicensed and counterfeit medicines. Every year, the MHRA and UK Border Force seize millions of pounds worth of unlicensed and counterfeit erectile dysfunction medicines.
Dr Laura Squire, MHRA’s Chief Officer for Healthcare, Quality and Access said:
“This decision is good news for men’s health. Men who suffer from erectile dysfunction will be able to obtain this treatment safely and conveniently from their local pharmacy without a prescription, which not only gives them greater control over their choices but increases awareness of erectile dysfunction.
“Erectile dysfunction can be a debilitating condition, so it’s important men feel they have fast access to quality and legitimate care.
“We will continue to listen to and engage with patients to improve access to a wide range of medicinal products when it is safe to do so.”
Notes to Editors
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The Commission on Human Medicines (CHM) advises ministers on the safety, efficacy and quality of medicinal products.
- Following advice from the Commission on Human Medicines, the MHRA has decided to make Cialis Together (containing tadalafil 10 mg) available from pharmacies without a prescription for adult men with erectile dysfunction. This was the first application for a tadalafil product to be available as a pharmacy medicine.
- Cialis Together will be available through pharmacies without a prescription with a maximum dose of one tablet each day, and a maximum pack size of 8 tablets. Other medicines containing tadalafil will still be available to obtain on prescription.
- Products for the treatment of erectile dysfunction have been available to purchase in pharmacies since 2018 when Viagra Connect (sildenafil 50 mg tablets) was first reclassified with Pharmacy legal status. This application for Cialis Together with a Pharmacy legal status is also used to treat erectile dysfunction in similar patient groups and has similar safety profile.
- Pharmacists, who are trained healthcare professionals, will have access to training materials and a checklist that will enable them to advise men on whether these tablets are appropriate and safe for them to use and give the information they need, so they can make informed choices. Health advice about erectile dysfunction and tadalafil is available on the NHS website.