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SIMARAX is a brand name for Sildenafil. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Simarax 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 Simarax 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 tablet 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 Simarax 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.
For the POM product only:
Based on efficacy and tolerability, the dose may be increased to 100 mg or decreased to 25 mg. The maximum recommended dose is 100 mg. Special populations Elderly Dosage adjustments are not required in elderly patients (≥ 65 years old).
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 Simarax 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 or tamsulosin), patients should be stabilised on alpha-blocker therapy prior to initiating sildenafil treatment. 5). Method of administration For oral use.
The safety profile of Sildenafil Tablets is based 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.
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 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) 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 suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
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 Simarax 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. 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). Simarax should not be used in patients with anatomical deformation of thepenis (such as angulation, cavernosal fibrosis or Peyronie's disease).
Simarax 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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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 occasionally 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 treatments for erectile dysfunction The safety and efficacy of combinations of sildenafil with 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 for further information). 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 should be advised to consult their doctor before taking Simarax as a 25 mg tablet 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 patients with bleeding disorders or active peptic ulceration.
Therefore the use of sildenafil is not recommended in those patients with history of bleeding disorders or active peptic […]