Sildenafil Oral Suspension Abbreviated Prescribing Information

Abbreviated Prescribing Information: Sildenafil 10 mg/ml Oral suspension. Summary of Product Characteristics before prescribing. Presentation: White to off white oral suspension. Each ml of the oral suspension contains 10 mg of sildenafil (as citrate). Therapeutic Indications: Treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Treatment of paediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension. Posology and Method of Administration: Sildenafil Oral suspension is for oral use only. For adults, the recommended dose is 20 mg (2 ml of Oral suspension) three times a day (taken 6 to 8 hours apart) taken with or without food. Paediatric population (1 year to 17 years): For children and adolescents aged 1 year to 17 years old, the recommended dose is either 10 mg (1 ml of Oral suspension) three times a day for children and adolescents weighing 20 kg or under, or 20 mg (2 ml of Oral suspension) three times a day for children and adolescents weighing over 20 kg, taken with or without food. Higher doses should not be used in children. The safety and efficacy of Sildenafil in children below 1 year of age has not been established. Outside authorised indications, sildenafil should not be used in neonates with persistent pulmonary hypertension of the newborn as risks outweigh the benefits Elderly (≥ 65 years): Dose adjustments are not required in elderly patients. Renal impairment and Hepatic impairment: Initial dose adjustments are not required in patients with renal impairment, including severe renal impairment (creatinine clearance < 30 ml/min) and hepatic impairment (Child-Pugh class A and B); however, a dose adjustment to 20 mg twice daily should be considered if therapy is not well-tolerated. Contra-indications: Hypersensitivity to the active substance or to any of the excipients listed. Co-administration with nitric oxide donors (such as amyl nitrite) or nitrates in any form, guanylate cyclase stimulators, such as riociguat, and combination with the most potent of the CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir), Patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), Severe hepatic impairment (Child-Pugh class C), Recent history of stroke or myocardial infarction, and Severe hypotension (blood pressure < 90/50 mmHg) at initiation. Special Warnings and Precautions for use: The efficacy of Sildenafil has not been established in patients with severe pulmonary arterial hypertension (functional class IV). Sildenafil is not recommended to treat patient with Retinitis pigmentosa and should not be used in patients with pulmonary hypertension secondary to sickle cell anaemia. Caution should be exercised in patients with hypotension, fuid depletion, severe left ventricular outflow obstruction or autonomic dysfunction, bleeding disorders or active peptic ulceration, anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie’s disease), and or in patients who have conditions which may predispose them to priapism, concomitant administration with alpha-blocker, Vitamin K antagonist, vasodilators (mainly prostacyclin) and the possibility of associated veno-occlusive disease, and or PDE5 inhibitor products, including Viagra. The efficacy of sildenafil in patients already on bosentan therapy has not been conclusively demonstrated. Serious cardiovascular events reported in post-marketing experience with sildenafil for male erectile dysfunction. Any warning from the MC, CHM CSM or MHRA. No. Black Triangle notice: Not applicable. Legal Category: Prescription only medicine. The reported adverse reactions: Very common: Headache, Flushing, Diarrhoea, Dyspepsia, and Pain in extremity. Common: Cellulitis, Influenza, Bronchitis, Sinusitis, Rhinitis, Gastroenteritis, Anaemia, Fluid retention, Insomnia, Anxiety, Migraine, Tremor, Paraesthesia, Burning sensation,  Hypoaesthesia, Retinal haemorrhage,  Visual impairment, Vision blurred, Photophobia, Chromatopsia, Cyanopsia, Eye irritation, Ocular hyperaemia, Vertigo, Epistaxis, Cough, Nasal congestion, Gastritis, Gastrooesophageal reflux disease, Haemorrhoids, Abdominal distension, Dry mouth, Alopecia, Erythema, Night sweats, Myalgia, Back pain, and Pyrexia. Uncommon: Visual acuity  reduced,  Diplopia,  Abnormal  sensation  in  eye,  Haematuria,  Penile  haemorrhage, Haematospermia, and Gynaecomastia. Not known: Non-arteritic anterior ischaemic optic neuropathy (NAION), Retinal vascular occlusion, Visual field defect, Sudden hearing loss, Hypotension, Rash, Priapism, and Erection increased. Pack Size and NHS Price: 122ml – £186.75. Marketing Authorisation  Number:  PL  00427/0258  Marketing  Authorisation  Holder:  Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [July-2024]