Who can use Sidena? Only adult men aged 18 years or older who have erectile dysfunction (ED) can use the product. The active ingredient in Sidena, sildenafil, is a part of the class of medicines known as Phosphodiesterase 5 Inhibitors (PDE5i) that are recommended as a first line treatment for ED by The European Association of Urology Guidelines. Sidena is licenced for packs of 2, 4 and 8 tablets (not all sizes may be marketed). There are a number of contraindications or special warnings which mean that in certain circumstances the product cannot be used by men with ED, see below. Who must not use Sidena? Men aged under 18 years, as it not indicated for this age group. These men should be directed to their GP for follow up if they believe they have an issue relating to erectile function Women, as it is only indicated for men aged 18 years and over. For a woman interested in the product for their male partner, it is important to ask them to encourage their partner to visit the pharmacy or their doctor for additional advice Men who do not have ED. It is important that you establish that the man has a problem getting or keeping an erection which is satisfactory for sexual performance. Sidena will not enhance men’s erections or sexual performance and it will not help problems such as premature ejaculation. Men in the latter group should be directed to their GP for further advice Men allergic to sildenafil or any other ingredient in the medicine. Men with the following health problems must not use Sidena: Men with hypotension (<90/50 mm Hg) must not use Sidena. This is because the safety of sildenafil has not been studied in these sub-groups of patients, and its use is, therefore, contraindicated Men with previously diagnosed mild, moderate or severe hepatic impairment (e.g. liver cirrhosis), should be advised to talk with their GP about a suitable starting dose or alternative options for the treatment of ED. Men should be asked the questions included in the Pharmacy Consultation Guide (see Section 3) relating to those diagnosed with liver disease or liver problems. If they are under the care of a doctor for liver problems, they will be aware of this and answer ‘yes’. As such, this means that you must not supply the product and refer them to their GP Men with previously diagnosed severe renal impairment. In most cases, patients with severe renal impairment will have some signs or symptoms of the underlying issues and will be under the care of a GP or renal specialist. A question is included in the Pharmacy Consultation Guide which asks the man whether he is suffering from severe kidney problems. If the answer to this is ‘yes’, then they should be advised to talk with their doctor about alternative options for the treatment of ED Sidena must not be used in patients with anatomical deformation of the penis Men with the following cardiovascular (CV) issues must not use Sidena: Men who get very breathless or experience chest pains with light or moderate physical activity, such as walking briskly for 20 minutes or climbing 2 flights of stairs should be referred to their GP17 Men who have been advised against sexual activity because of a CV problem. This group of men are potentially at higher risk due to the burden of over activity on their heart and as such should be referred back to their GP Men with recent history (in the last 6 months) of stroke or myocardial infarction are also contraindicated from using Sidena and will need to follow up with their GP Patients with increased susceptibility to vasodilators include those with left ventricular outflow obstruction (e.g. aortic stenosis), or those with the rare syndrome of multiple system atrophy manifesting as severely impaired autonomic control of blood pressure. Men with these conditions must not use the product without consulting a doctor Patients previously diagnosed with the following must be advised to consult with their GP before resuming sexual activity: uncontrolled hypertension hypotension unstable angina moderate to severe valvular disease left ventricular dysfunction hypertrophic obstructive and other cardiomyopathies significant arrhythmias severe cardiac failure Note: Some low-risk cardiovascular patients may be suitable for Sidena, as long as their doctor has advised they can resume sexual activity: those with asymptomatic controlled hypertension, mild valvular disease or who have had successful coronary artery bypass grafting, stenting or angioplasty. Men taking certain other medicines must not use Sidena Men taking nitrates (e.g. isosorbide mononitrate/dinitrate and glyceryl trinitrate), nitric oxide donors (e.g. nicorandil) or ‘poppers’ (e.g. amyl nitrate). Consistent with its known effects on the NO cGMP pathway, sildenafil has been shown to potentiate the hypotensive effects of nitrates, and it is contraindicated for use with nitric oxide donors, nitrates, amyl nitrite (known as the recreational drug ‘poppers’), sodium nitroprusside and nicorandil. These men should be directed to their GP for further advice. The co-administration of sildenafil with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension. Again, these men will need to talk with a doctor for further advice Men taking ritonavir, a potent CYP3A4 inhibitor used in the treatment of HIV, are contraindicated due to the potential for increased blood levels of sildenafil in these patients. They should consult with their doctor for further guidance Men already being treated with another PDE5i or a higher or lower dose of sildenafil should not use Sidena. Men taking 50 mg of sildenafil can use the product providing they meet the criteria for pharmacy supply and do not exceed 50 mg as a daily dose Men taking CYP3A4 inhibitors or alpha-blockers (see Table 2 for examples). These patients should be advised to speak with their GP about a lower suitable starting dose which is available on prescription