Public Assessment Report - mhra.gov.uk

1 Public Assessment Report Decentralised Procedure Viagra Connect 50 mg film-coated tablets (sildenafil citrate). UK/H/6416/001/DC. UK licence no: PL 00165/0392. Pfizer Consumer Healthcare Ltd 1. PAR Viagra Connect 50 mg film-coated tablets UK/H/6416/001/DC. LAY SUMMARY. Viagra Connect 50 mg film-coated tablets (sildenafil). This is a summary of the Public Assessment Report (PAR) for Viagra Connect 50 mg film- coated tablets (PL 00165/0392; UK/H/6416/001/DC). It explains how Viagra Connect 50 mg film-coated tablets were assessed and their authorisation recommended, as well as the conditions of use.

2 It is not intended to provide practical advice on how to use this product. The product will be referred to as Viagra Connect throughout the remainder of this lay summary. For practical information about using Viagra Connect , patients should read the package leaflet or contact their doctor or pharmacist. What is Viagra Connect and what is it used for? Viagra Connect is a hybrid generic medicine'. This means that it is similar to a reference medicine already authorised in the European Union (EU) called Viagra (Pfizer Limited), containing the same active substance, but is authorised under a different legal classification (non-prescription) and has a maximum dose of 50 mg, that is taken once per day.

3 Viagra Connect is a treatment for adult men (aged 18 years and older) with erectile dysfunction (also known as impotence). This is when a man cannot get or keep an erection hard enough for satisfactory sexual activity. How does Viagra Connect work? The active substance in Viagra Connect is sildenafil. It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by relaxing the blood vessels in the penis, allowing blood to flow into the penis when the patient gets sexually excited, causing an erection. Viagra Connect will only help achieve an erection in men who are sexually excited (stimulated).

4 How is Viagra Connect used? The patient should always take this medicine exactly as his/her doctor has advised. The patient should check with his/her doctor or pharmacist if unsure. The instructions for use are: take one tablet, as needed, approximately 1 hour before sexual activity;. swallow the tablet whole with water;. do not take more than one tablet a day. An erection will not occur only by taking Viagra Connect . This medicine will only help get an erection with sexual arousal. The patient and his partner should engage in foreplay just as the patient would if he were not taking a medicine for erectile dysfunction.

5 The amount of time this medicine takes to work varies from person to person, but it normally takes between 30 to 60 minutes to work. If the patient feels that the effect of Viagra Connect is too strong or too weak, he should talk to his pharmacist or doctor. Please read Section 3 of the package leaflet for detailed information on dosing recommendations, the route of administration, and the duration of treatment. 2 . PAR Viagra Connect 50 mg film-coated tablets UK/H/6416/001/DC. This medicine can be obtained without a prescription. What benefits of Viagra Connect have been shown in studies?

6 It was concluded that, in accordance with EU requirements, Viagra Connect has been shown to have the same quality and to be bioequivalent to Viagra, as the tablets are the same formulation. Therefore, the MHRA decided that, as for Viagra; the benefits are greater than the risks and recommended that Viagra Connect can be approved for use. What are the possible side effects of Viagra Connect ? Because Viagra Connect is a generic medicine, its possible side effects are taken as being the same as those of the reference medicine, Viagra. For the full list of all side effects reported with Viagra Connect , see Section 4 of the package leaflet available on the MHRA website.

7 For the full list of restrictions, see the package leaflet. Why is Viagra Connect approved? It was concluded that, in accordance with EU requirements, Viagra Connect has been shown to have comparable quality and is considered bioequivalent to Viagra. Therefore, the MHRA decided that, for Viagra Connect , the benefits are greater than the risks and recommended that it can be approved for use. What measures are being taken to ensure the safe and effective use of Viagra Connect ? A Risk Management Plan (RMP) has been developed to ensure that Viagra Connect is used as safely as possible.

8 Based on this plan, safety information has been included in the SmPC. and the package leaflet for this product, including the appropriate precautions to be followed by healthcare professionals and patients. Known side effects are continuously monitored. Furthermore, new safety signals reported by patients and healthcare professionals will be monitored and reviewed continuously, as well. Other information about Viagra Connect . On 13 September 2017, Poland, Sweden and the UK agreed to grant a Marketing Authorisation for Viagra Connect . Following a subsequent national phase, a Marketing Authorisation was granted on 28/11/2017 in the UK.

9 During the procedure, Viagra Connect was re-classified from a prescription only medicine to a pharmacy medicine; an annex following this Report describes the reclassification in more detail. The full PAR for Viagra Connect follows this summary. For more information about treatment with Viagra Connect , read the package leaflet or contact your doctor or pharmacist. This summary was last updated in January 2018. 3 . PAR Viagra Connect 50 mg film-coated tablets UK/H/6416/001/DC. TABLE OF CONTENTS. I Introduction Page 5. II Quality aspects Page 6. III Non-Clinical aspects Page 7.

10 IV Clinical aspects Page 9. V User consultation Page 25. VI Overall conclusion, benefit/risk Assessment Page 25. and recommendation Table of content of the PAR update for Page 29. MRP and DCP. Annex: Prescription only medicine to Page 30. Pharmacy medicine Reclassification 4 . PAR Viagra Connect 50 mg film-coated tablets UK/H/6416/001/DC. I INTRODUCTION. Based on the review of the data on quality, safety and efficacy, the Reference Member State (RMS) and Concerned Member States (CMSs) considered that the application for Viagra Connect 50 mg film-coated tablets (PL 00165/0392; UK/H/6416/001/DC) could be approved.