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SILDENAFIL is a brand name for Sildenafil. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Sildenafil orodispersible film is indicated in adult men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Sildenafil orodispersible film to be effective, sexual stimulation is required.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Use in adults The recommended dose is one 50 mg film taken approximately one hour before sexual activity. The maximum recommended dosing frequency is once per day. 2). Patients may need to take Sildenafil orodispersible film a number of times on different occasions (a maximum of one 50 mg film 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 are advised to consult a doctor. Special populations Elderly patients Dosage adjustments are not required in elderly patients (≥ 65 years old).
Patients with renal impairment No dosage adjustments are required for patients with mild to moderate renal impairment. 4 for further information). g. cirrhosis). 4 for further information). 3). Paediatric population Sildenafil orodispersible film is not indicated for individuals below 18 years of age.
Use in patients taking other medicinal products 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, tamsulosin), patients should be stabilised on alpha-blocker therapy prior to initiating Sildenafil treatment. 5). Method of administration Sildenafil orodispersible films are for oral use and are taken without water.
If desired Sildenafil orodispersible film may also be used with water. The orodispersible film should be placed in the mouth, on the tongue, and allowed to dissolve before swallowing. It should be taken immediately upon removal from the sachet.
Summary of the safety profile The safety profile of Sildenafil orodispersible film is based on 9570 patients in 74 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. Infections and infestations Uncommon Rhinitis Immune system disorders Uncommon Hypersensitivity Nervous system disorders Very common Headache Common Dizziness Uncommon Somnolence, Hypoaesthesia Rare Cerebrovascular accident, Transient ischaemic attack, Seizure*, Seizure recurrence*, Syncope Eye disorders Common Visual disturbance, Visual colour distortion**, Visual blurred Uncommon Conjunctivitis, Visual brightness, Ocular hyperaemia, Photophobia, Photopsia, Eye pain, Lacrimation disorders*** Rare 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 Uncommon Vertigo, Tinnitus Rare Deafness Cardiac disorders Uncommon Palpitations, Tachycardia Rare Sudden cardiac death*, Myocardial infarction, Ventricular arrhythmia*, Atrial fibrillation, Unstable angina Vascular disorders Common Flushing.
g. hypertension, diabetes mellitus, hypercholesterolaemia or cardiovascular disease. As a result, all men with erectile dysfunction are 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 orodispersible film on several consecutive occasions, or if their erectile dysfunction worsens, the patient is 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 are 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. 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 consult 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 orodispersible film should not be used in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease).
Sildenafil orodispersible film 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Hot flush Uncommon Hypertension, Hypotension Respiratory, thoracic and mediastinal disorders Common Nasal congestion Uncommon Epistaxis, Sinus congestion Rare Throat tightness, Nasal oedema, Nasal dryness Gastrointestinal disorders Common Nausea, Dyspepsia Uncommon Gastro oesophageal reflux disease, Abdominal pain upper, Vomiting, Dry mouth Rare Hypoaesthesia oral Skin, subcutaneous and soft tissue disorders Uncommon Rash Rare Stevens-Johnson Syndrome (SJS)*, Toxic Epidermal Necrolysis (TEN)* Musculoskeletal and connective tissue disorders Uncommon Myalgia, Pain in extremity Renal and urinary disorders Uncommon Haematuria Reproductive system and breast disorders Rare Haematospermia, Penile haemorrhage, Priapism*, Erection increased General disorders and administration site conditions Uncommon Chest pain, Fatigue, Feeling hot Rare Irritability Investigations Uncommon 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 suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
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Most, but not all, of these patients had pre-existing cardiovascular risk factors. Many events were reported to occur during or shortly after sexual intercourse and a few were reported to occur shortly after the use of Sildenafil without sexual activity.
It is not possible to determine whether these events are related directly to these factors or to other factors. Priapism Patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia), should consult a doctor before using agents for the treatment of erectile dysfunction, including sildenafil.
Prolonged erections and priapism have been reported with Sildenafil in post-marketing experience. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.
Concomitant use with other PDE5 inhibitors or other treatments for erectile dysfunction The safety and efficacy of combinations of Sildenafil with other PDE5 Inhibitors, or other pulmonary arterial hypertension (PAH) treatments containing Sildenafil (REVATIO), or other treatments for erectile dysfunction have not been studied.
Therefore, the use of such combinations is not recommended. 8). 8). 3). Concomitant use with CYP3A4 inhibitors Pharmacokinetic analysis of clinical trial data indicated a reduction in sildenafil clearance when co-administered with CYP3A4 inhibitors (such as ketoconazole, itraconazole, erythromycin, cimetidine).
5). This is most likely to occur within 4 hours post Sildenafil dosing. In order to minimise the potential for developing postural hypotension, patients should be hemodynamically stable on alpha-blocker therapy prior to initiating Sildenafil treatment.
Thus, patients taking alpha blockers are advised to consult their doctor before taking Sildenafil orodispersible film as a 25 mg dose may be more suitable for them. Treatment should be stopped if symptoms of postural hypotension occur, and patients should seek advice from their doctor on what to do.
Effect on bleeding Studies with human platelets indicate that Sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. There is no safety information on the administration of Sildenafil to […]