We need to ensure that this medicine is suitable for the person it is intended for so by adding this product to the cart you are agreeing to a pharmacist contacting the intended person regarding the purchase to this product, also you are acknowledging that you are over 18 years old and aware that the medicine should be used in accordance with the recommendations for use contained in the product packaging.
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
(such as angulation, cavernosal fibrosis or Peyronie’s disease) or in patients with sickle cell anaemia, multiple myeloma or leukaemia. There is an increased risk of priapism with these patients and they should be directed to their GP for further advice
• Sildenafil is contraindicated in patients who have loss of vision in 1 eye because of non- arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection with previous PDE5i exposure or not
• Men who have an inherited eye disease such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases). This is because the safety of sildenafil has not been studied in these sub-groups of patients, and its use is therefore contraindicated
• Men who have any bleeding issues (e.g. haemophilia) or suffer from stomach ulcers must not use Sidena and should be directed to see their GP
• Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose- galactose malabsorption must not take Sidena, because of the lactose contained within the tablet
• Men who have cardiovascular issues, see section below
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
Table 2: Examples of CYP3A4 inhibitors and alpha-blockers
Drug class & Drug Name
Antibiotics:
Erythromycin, clarithromycin, rifampicin
Antifungals:
Itraconazole, ketoconazole
Calcium channel blockers:
Diltiazem, verapamil
H2-antagonists:
Cimetidine
HIV-protease inhibitors:
Amprenavir, fosamprenavir, atazanavir, darunavir, indinavir, lopinavir, ritonavir, saquinavir, tipranavir
Alpha blockers:
Phenoxybenzamine, phentolamine, tolazoline, trazodone, alfuzosin, doxazosin, tamsulosin, prazosin, terazosin
