EROPID

Posology Use in adults:

The recommended dose is 50 mg taken with water approximately one hour before sexual activity. . The maximum recommended dosing frequency is once per day. 2). Patients should be advised that they may need to take Sildenafil a number of times on different occasions (a maximum of one 50 mg tablet per day), before they can achieve a penile erection satisfactory for sexual activity.

If after several attempts on different dosing occasions patients are still not able to achieve a penile erection sufficient for satisfactory sexual activity, they should be advised to consult a doctor.

Special populations Use in the elderly:

Dosage adjustments are not required in elderly patients (≥ 65 years old).

Use in patients with impaired renal function:

No dosage adjustments are required for patients with mild to moderate renal impairment. 4 for further information). g. cirrhosis). 4 for further information). 3).

Use in children and adolescents:

Sildenafil is not indicated for individuals below 18 years of age.

Use in patients using other medicines:

Pharmacokinetic analysis of clinical trial data indicated a reduction in sildenafil clearance when co-administered with CYP3A4 inhibitors (such as ritonavir, ketoconazole, itraconazole, erythromycin, cimetidine). 4 for further information).

g. alfuzosin, doxazosin or tamsulosin), patients should be stabilised on alpha blocker therapy prior to initiating sildenafil treatment. 5). Method of administration For oral use.

Summary of the safety profile The safety profile of Sildenafil is based on on > 9,000 patients in > 70 double- blind placebo controlled clinical studies. The most commonly reported adverse reactions in clinical studies among sildenafil treated patients were headache, flushing, dyspepsia, nasal congestion, dizziness, nausea, hot flush, visual disturbance, cyanopsia and vision blurred.

Adverse reactions from post-marketing surveillance has been gathered covering an estimated period >10 years. Because not all adverse reactions are reported to the Marketing Authorisation Holder and included in the safety database, the frequencies of these reactions cannot be reliably determined.

Tabulated list of adverse reactions. In the table below all medically important adverse reactions, which occurred in clinical trials at an incidence greater than placebo are listed by system organ class and frequency (very common (≥ 1/10), common (≥1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥ 1/10,000 to <1/1,000).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Table 1:

Medically important adverse reactions reported at an incidence greater than placebo in controlled clinical studies and medically important adverse reactions reported through post-marketing surveillance. System Organ Class Very common ( ≥1/10) Common (≥ 1/100 and <1/10) Uncommon (≥ 1/1,000 and <1/100) Rare (≥ 1/10,000 and <1/1,000) Infections and infestations Rhinitis Immune system disorders Hypersensitivity Nervous system disorders Headache Dizziness Somnolence, Hypoaesthesia Cerebrovascular accident, Transient ischaemic attack, Seizure,* Seizure recurrence,* Syncope Eye disorders Visual colour distortions**, Visual disturbance, Vision blurred Lacrimation disorders***, Eye pain, Photophobia, Photopsia, Ocular hyperaemia, Visual brightness, Conjunctivitis Non-arteritic anterior ischaemic optic neuropathy (NAION)*, Retinal vascular occlusion*, Retinal haemorrhage, Arteriosclerotic retinopathy, Retinal disorder, Glaucoma, Visual field defect, Diplopia, Visual acuity reduced, Myopia, Asthenopia, Vitreous floaters, Iris disorder, Mydriasis, Halo vision, Eye oedema, Eye swelling, Eye disorder, Conjunctival hyperaemia, Eye irritation, Abnormal sensation in eye, Eyelid oedema, Scleral discoloration Ear and Labyrinth disorders Vertigo, Tinnitus Deafness Cardiac disorders Tachycardia, Palpitations Sudden cardiac death*, Myocardial infarction, Ventricular arrhythmia*, Atrial fibrillation, Unstable angina Vascular disorders Flushing, Hot flush Hypertension, Hypotension Respiratory, thoracic and mediastinal disorders Nasal congestion Epistaxis, Sinus congestion Throat tightness, Nasal oedema, Nasal dryness Gastrointestinal disorders Nausea, Dyspepsia Gastro oesophagael reflux disease, Vomiting, Abdominal pain upper, Dry mouth Hypoaesthesia oral Skin and subcutaneous tissue disorders Rash Stevens-Johnson Syndrome (SJS)*, Toxic Epidermal Necrolysis (TEN)* Musculoskeletal and connective tissue disorders Myalgia, Pain in extremity Renal and urinary disorders Haematuria Reproductive system and breast disorders Penile haemorrhage, Priapism*, Haematospermia, Erection increased General disorders and administration site conditions Chest pain, Fatigue, Feeling hot Irritability Investigations Heart rate increased *Reported during post-marketing surveillance only **Visual colour distortions: Chloropsia, Chromatopsia, Cyanopsia, Erythropsia and Xanthopsia ***Lacrimation disorders: Dry eye, Lacrimal disorder and Lacrimation increased Reporting of side effects If you get any side effects, talk to you doctor, pharmacist or nurse.

g. hypertension, diabetes mellitus, hypercholesterolaemia or cardiovascular disease. As a result, all men with erectile dysfunction should be advised to consult their doctor within 6 months for a clinical review of potential underlying conditions and risk factors associated with erectile dysfunction (ED).

If symptoms of ED have not improved after taking Sildenafil on several consecutive occasions, or if their erectile dysfunction worsens, the patient should be advised to consult their doctor. Cardiovascular risk factors Since there is a degree of cardiac risk associated with sexual activity, the cardiovascular status of men should be considered prior to initiation of therapy.

Agents for the treatment of erectile dysfunction, including sildenafil, are not recommended to be used by those men who with light or moderate physical activity, such as walking briskly for 20 minutes or climbing 2 flights of stairs, feel very breathless or experience chest pain.

g. via coronary artery bypass grafting, stenting, or angioplasty), patients with asymptomatic controlled hypertension, and those with mild valvular disease. These patients may be suitable for treatment but should consult a doctor before resuming sexual activity.

Patients previously diagnosed with the following must be advised to consult with their doctor before resuming sexual activity: uncontrolled hypertension, moderate to severe valvular disease, left ventricular dysfunction, hypertrophic obstructive and other cardiomyopathies, or significant arrhythmias.

1). , 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. 3).

Serious cardiovascular events, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, hypertension and hypotension have been reported post-marketing in temporal association with the use of sildenafil.

1. The film coating of the Sildenafil tablet contains tartrazine, which may cause allergic reactions. Tartrazine has been linked with the exacerbation of asthma, however, the clinical evidence is inconclusive. 1), sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors (such as amyl nitrite) or nitrates in any form is therefore contraindicated.

5). 5). Agents for the treatment of erectile dysfunction, including sildenafil, should not be used by those men for whom sexual activity may be inadvisable and these patients should be referred to their doctor. This includes patients with severe cardiovascular disorders such as a recent (6 months) acute myocardial infarction (AMI) or stroke, unstable angina or severe cardiac failure.

Sildenafil should not be used in patients with severe hepatic impairment, hypotension (blood pressure < 90/50 mmHg) and known hereditary degenerative retinal disorders 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. 4). Sildenafil should not be used in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease).

Sildenafil is not indicated for use by women. The product is not intended for men without erectile dysfunction. This product is not intended for men under 18 years of age.