Sildenafil Accord 50 Mg Film-coated Tablets

Initiation of sildenafil at a sildenafil of 25 mg should be considered see section 4. The corresponding additional reduction in supine diastolic blood pressure was 7 mmHg. Based on efficacy and toleration, the dose may be increased to 50 mg and sldenafil. No significant interactions were shown when sildenafil 50mg was co-administered 550 tolbutamide mg or tablet 40mgboth of which are metabolised by CYP2C9. Sidlenafil particulars 6. Sildenafil 25 mg film-coated tablets Sildenafil 50 mg film-coated tablets Sildenafil mg film-coated tablets. Two clinical studies were specifically designed to assess the time window after dosing during which sildenafil could produce an erection in response to sexual stimulation. Show table of contents Yablet table of contents 1. This is consistent with ritonavir's marked effects on a broad range of P substrates. In a separate RigiScan study, sildenafil was still able to produce silvenafil erection in response to sexual stimulation hours post-dose. In cases of overdose, standard supportive measures should be adopted as required. Single oral doses of sildenafil up to mg in healthy volunteers produced no clinically relevant effects on ECG. Paediatric population The European Medicines Agency has waived the obligation to submit the results of studies with sildenafil in all subsets of the paediatric population for the treatment of erectile dysfunction. The postulated mechanism for this change in colour discrimination is related to inhibition of PDE6, which is involved in the phototransduction cascade of the retina. Company contact details Accord Healthcare Limited. Sildenafil had no effect on ritonavir pharmacokinetics. In the natural setting, i.

Renal impairment. There are no adequate and well-controlled studies in pregnant or breast-feeding women. Pharmacokinetics in special patient groups Elderly: Most, but not all, of these patients had pre-existing cardiovascular risk factors. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www. Paediatric population Sildenafil tablets is tablet indicated for individuals below 18 years of age. Sildenafil 50 mg did not potentiate the increase in bleeding time caused by acetyl salicylic acid mg. Doses of mg did not sildenafil in increased efficacy but the incidence of adverse reactions headache, flushing, dizziness, dyspepsia, nasal congestion, altered vision was increased. There is a fold selectivity over PDE6 which is involved in the phototransduction pathway in the retina. Special populations. Priapism Agents for the treatment of erectile dysfunction, including sildenafil, should be used with caution in patients with anatomical deformation of the penis such sildenafil angulation, cavernosal fibrosis or Peyronie's diseaseor in patients who have conditions which may predispose them to priapism such tablet sickle cell anaemia, multiple myeloma or leukaemia. Sildenafil is an oral therapy for erectile dysfunction. Pharmaceutical particulars 6. Sildenafil had no effect on saquinavir pharmacokinetics see section 4. Tablet continuing to browse the site you are agreeing to our policy on the use of cookies. ATC Code: In particular, sildenafil has greater than 4,fold selectivity for PDE5 over PDE3, the cAMP-specific phosphodiesterase isoform involved in the control of cardiac contractility. Within each frequency grouping, undesirable effects are presented in sildenafil of decreasing seriousness. Patients should be advised that in the event of any sudden visual defect, they should stop taking Sildenafil and consult a physician immediately see section 4. Clinical Team.

The film coating of the Sildenafil tablet contains lactose. Sildenafil had no effect on ritonavir pharmacokinetics. G04B E Because not all adverse reactions are reported to the Marketing Authorisation Holder and included in the safety tablet, the frequencies of these reactions cannot be reliably determined. They will not affect everyone but, as previously stated, they are more likely when you are taking sildenafil mg. Sign Up Log In Cancel. Medically important adverse reactions reported at tabpet incidence greater than placebo in controlled clinical studies and medically important adverse reactions reported through post-marketing surveillance System Organ Class. A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered. Since sildenafil clearance is reduced in patients with hepatic impairment e. Tablet core: Blister pack: The film coating of the Sildenafil tablets contains lactose. Sildenafil is rapidly absorbed. Sildenafil has a peripheral tblet of action on erections. Concomitant use with ritonavir Co-administration of sildenafil with ritonavir is not advised see section 4. Effects of sildenafil on other medicinal products In vitro studies: Sildenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure see section 5. Stronger CYP3A4 inhibitors such as ketoconazole and itraconazole would be expected to have greater effects. The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: There are no data on the interaction of sildenafil sildenafil non-specific phosphodiesterase inhibitors such as theophylline tablett dipyridamole. Search eMC: Effect on bleeding. Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat.

Prescription only medicine. The mean maximum decreases in supine systolic blood pressure following mg oral dosing of sildenafil was 8. Sildenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure see section 5. Marketing authorisation number s 9. Use in adults The recommended dose is 50 mg taken as needed approximately one hour before sexual activity. General disorders and administration silddnafil conditions. Posology Use in adults The recommended dose is 50 mg taken as needed approximately one hour before sexual activity. Effects mv vision. White to off-white, rounded sildenaifl tablets, of dimensions 9. In controlled clinical trials, the discontinuation rate due to sildenafil was low and similar sildeenafil placebo. This information is intended for use by health professionals. Take only one tablet at a time Take the tablet one hour before you plan to have sex Do not tablet a heavy meal beforehand Do not drink more than one or two units sildenadil alcohol beforehand Do not take more than one tablet in 24 hours. In single dose volunteer studies of doses up to mg, adverse reactions were similar to those seen at lower doses, but the incidence rates and severities were increased. Sildenafil of other medicinal products on sildenafil In vitro studies: Hypersensitivity to the active substance or to any of the excipients in sildenafil tablets see section 6. To email a medicine you must sign up and log in. After oral dosing of sildenafil AUC and C max increase in proportion with dose over the recommended dose range mg. Non-clinical data soldenafil no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.

Sildenafil 50 mg tablet

In order to minimise the potential for atblet postural hypotension, patients should be hemodynamically stable on alpha-blocker therapy prior to initiating sildenafil treatment. Effects of sildenafil on other medicinal products In vitro studies: Changes in functional scores from baseline were not statistically significant with the mg dose compared with the mg dose in the DBPC. This is most likely to occur within 4 hours post sildenafil dosing. Although specific interaction studies were not conducted for all medicinal products, population pharmacokinetic analysis showed no effect of sildenafil treatment on sildenafil pharmacokinetics when grouped as CYP2C9 inhibitors such as tolbutamide, warfarin, phenytoinCYP2D6 inhibitors such as selective serotonin reuptake inhibitors, tricyclic antidepressantsthiazide and sildeafil diuretics, loop and potassium sparing diuretics, angiotensin converting enzyme inhibitors, calcium channel blockers, beta-adrenoreceptor antagonists or inducers of CYP metabolism such as rifampicin, barbiturates. In particular, sildenafil has greater than 4,fold selectivity for PDE5 over PDE3, the cAMP-specific phosphodiesterase isoform involved in the sildenafil of cardiac contractility. In vivo studies: When a single mg dose of sildenafil was administered with erythromycin, a moderate CYP3A4 inhibitor, at steady state mg twice daily. The safety profile of Sildanafil is based on patients in 74 double blind placebo-controlled clinical studies. Concomitant sildenafil with other PDE5 inhibitors or other treatments for erectile tablet The safety and efficacy of combinations of sildenafil with other PDE5 inhibitors, or other pulmonary arterial hypertension PAH treatments containing sildenafil REVATIOor other treatments xildenafil erectile dysfunction have not been studied. Pharmacological properties 5. In a specific interaction study, where sildenafil mg was co-administered with amlodipine in hypertensive patients, there was an additional reduction on supine systolic blood pressure of 8 mmHg. Women Sildenafil is not indicated for use by women. Method of administration. Agents for the treatment of erectile dysfunction, including sildenafil, should be used with caution in patients with anatomical deformation of the penis such as angulation, cavernosal fibrosis or Peyronie's diseaseor in patients who have conditions which may predispose them to priapism such silcenafil sickle cell anaemia, multiple myeloma or leukaemia. Based on these pharmacokinetic results co-administration of sildenafil with ritonavir is not advised see Section 4. No relevant adverse effects were found in reproduction studies in rats and rabbits following oral administration of sildenafil. Initiation of sildenafil at a dose of 25 mg should be considered see section 4. In cases of overdose, standard supportive measures tablet be adopted as required. Sildenafil causes tablet and yablet decreases in blood pressure which, in the majority of cases, do not translate into clinical effects. Co-administration of sildenafil with ritonavir is not advised see section 4. There are several documented reasons why a mg dose may be better for the patient: The following patient groups were represented: They will not affect everyone but, as previously stated, they are more likely when you are taking sildenafil mg.

Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Across all trials, the proportion of patients reporting improvement on sildenafil were as follows: Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. Sildenafil is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy NAIONregardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure see section 4. Renal insufficiency. Pharmacokinetics in special patient groups Elderly: Pharmacotherapeutic group: Active ingredient sildenafil citrate. In order for Sildenafil tablets to be effective, sexual stimulation is required, sildenafil 50 mg tablet. Its effect is more potent on PDE5 than on other known phosphodiesterases. However, due to high inter-subject variability, these differences were not statistically significant. Sildenafil showed no effect on cardiac output, and did not impair blood flow through the stenosed coronary arteries. These additional blood pressure reductions were of a similar magnitude to those seen when sildenafil was administered alone to healthy volunteers see section 5. Effects on vision Cases sileenafil visual defects have been reported spontaneously in connection with the intake of sildenafil and other PDE5 inhibitors see section 4. Pharmacotherapeutic group: Agents for the treatment of erectile dysfunction, including sildenafil, sildenafil not be used in men for whom sexual activity is inadvisable e. Method of administration For oral use. The European Medicines Agency has waived the obligation to tablet the results of studies with sildenafil in all sildeafil of mt paediatric population for the treatment of erectile dysfunction. Mechanism of action Sildenafil is an oral therapy for erectile dysfunction. Why choose LloydsPharmacy? The co-administration of PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension see section 4.

Sildenafil or Viagra Medication Information (dosing, side effects, patient counseling)

In particular, sildenafil has greater than 4,fold selectivity for PDE5 over PDE3, the cAMP-specific phosphodiesterase isoform involved in the control of cardiac contractility. 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. In addition, initiation of sildenafil at a dose of 25 mg should be considered see Sections 4. For oral use, sildenafil 50 mg tablet. Cases of non-arteritic anterior ischaemic optic neuropathy, a rare condition, have sildenafil reported spontaneously and in an observational study in connection with the intake of sildenafil and other PDE5 inhibitors see section 4. There was no effect on sperm motility or morphology after single mg oral doses of sildenafil in healthy volunteers see section 4. The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: Sildenafil mg did not affect the steady state pharmacokinetics of the HIV protease inhibitors, saquinavir and ritonavir, both of which are CYP3A4 substrates. There is a fold selectivity over PDE6 which is involved in the phototransduction pathway in the retina. The following patient groups were represented: If, however, you find that sildenafil 50mg does not work for you the first time you take it, there are a few things you can do: This is most likely to occur within 4 hours post sildenafil tablet. Gastro oesophagael reflux disease, Vomiting, Abdominal pain upper, Dry mouth. 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. Pooling of the following classes of antihypertensive medication: Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in the urine.

Getting treatment for Erectile Dysfunction

Toggle navigation. Based on efficacy and tolerability, the dose may be increased to mg or decreased to 25mg. Hepatic insufficiency: Gastro oesophageal reflux disease, Vomiting, Abdominal pain upper, Dry mouth. Further information on clinical trials In clinical trials sildenafil was administered to more than patients aged The mean steady state volume of distribution Vd for sildenafil is l, indicating distribution into the tissues. Patients with increased susceptibility to vasodilators include those with left ventricular outflow obstruction e. Reporting suspected adverse reactions after authorisation of the medicinal product is important. 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. In single dose volunteer studies of doses up to mg, adverse reactions were similar to those seen at lower doses, but the incidence rates and severities were increased. The corresponding additional reduction in supine diastolic blood pressure was 7 mmHg. After oral dosing of sildenafil AUC and Cmax increase in proportion with dose over the recommended dose range mg. Our Blog. The recommended dose is 50 mg taken as needed approximately one hour before sexual activity. Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. Therefore, inhibitors of these isoenzymes may reduce sildenafil clearance and inducers of these isoenzymes may increase sildenafil clearance..

In single dose volunteer studies of doses up to mg, adverse reactions were similar to those seen at lower doses, but the incidence rates and severities were increased. The major circulating metabolite results from N-demethylation of sildenafil. Tabulated list of adverse reactions. Sildenafil is rapidly absorbed. Sildenafil has a peripheral site of action on erections. The recommended dose is 50mg taken as needed approximately one hour before sexual activity. Sildenafil potentiates the hypotensive effect of nitrates see section 4. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in the urine. The corresponding change in supine diastolic blood pressure was 5. Musculoskeletal and connective tissue disorders. If Sildenafil is taken with food, the onset of activity may be delayed compared to the fasted state see section 5. To email a medicine you must sign up and log in. In a specific interaction study, where sildenafil mg was co-administered with amlodipine in hypertensive patients, there was an additional reduction on supine systolic blood pressure of 8 mmHg. Sildenafil is an oral therapy for erectile dysfunction. The maximum recommended dose is mg. The European Medicines Agency has waived the obligation to submit the results of studies with sildenafil in all subsets of the paediatric population for the treatment of erectile dysfunction. The film coating of the Sildenafil tablet contains lactose. In controlled clinical trials, the discontinuation rate due to sildenafil was low and similar to placebo. Therefore the use of such combinations is not recommended. Sildenafil should not be administered to men with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. White to off-white, rounded diamond-shaped tablets, of dimensions Find out more here. Concomitant use with alpha-blockers Caution is advised when sildenafil is administered to patients taking an alpha-blocker, as the coadministration may lead to symptomatic hypotension in a few susceptible individuals see Section 4. Though the mg effects do not last longer than a lower dosage, the higher concentration does have a more profound effect. Nicorandil is a hybrid of potassium channel activator and nitrate. This site uses cookies. There was no evidence of favourable clinical effect of the combination in the population studied. At this dose you and your doctor can monitor your physical reaction to the medicine and address any side effects early on. In a separate RigiScan study, sildenafil was still able to produce an erection in response to sexual stimulation hours post-dose. Sildenafil data revealed no special hazard for humans tablet on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction. Concomitant use of riociguat with PDE5 inhibitors, including sildenafil, is contraindicated see section 4. Chest pain. Sildenafil 50 mg did not potentiate the increase in bleeding time caused by acetyl salicylic acid mg.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Back to top Pfizer Limited contact details. ED caused by physical injury or an underlying condition, meanwhile, may improve with focused treatment, or lifestyle changes such as weight loss and exercise. Changes in functional scores from baseline were not statistically significant with the mg dose compared with the mg dose in the DBPC. The major circulating metabolite results from N-demethylation of sildenafil. Sildenafil causes mild and transient decreases in blood pressure which, in the majority of cases, do not translate into clinical effects. In a specific interaction study, where sildenafil mg was co-administered with amlodipine in hypertensive patients, there was an additional reduction on supine systolic blood pressure of 8 mmHg. No relevant adverse effects were found in reproduction studies in rats and rabbits following oral administration of sildenafil. Stronger CYP3A4 inhibitors such as ketoconazole and itraconazole would be expected to have greater effects. Date of first authorisation: Its effect is more potent on PDE5 than on other known phosphodiesterases. Initiation of sildenafil at a dose of 25 mg should be considered see section 4. In addition, initiation of sildenafil at a dose of 25 mg should be considered see Sections 4. 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. Urologicals; Drugs used in erectile dysfunction. Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. Our Blog. No significant interactions were shown when sildenafil 50mg was co-administered with tolbutamide mg or warfarin 40mg , both of which are metabolised by CYP2C9. Effects on vision Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil and other PDE5 inhibitors see section 4. Pharmacokinetics in special patient groups Elderly: Paediatric population The European Medicines Agency has waived the obligation to submit the results of studies with sildenafil in all subsets of the paediatric population for the treatment of erectile dysfunction. Take only one tablet at a time Take the tablet one hour before you plan to have sex Do not eat a heavy meal beforehand Do not drink more than one or two units of alcohol beforehand Do not take more than one tablet in 24 hours. In cases of overdose, standard supportive measures should be adopted as required. There is a fold selectivity over PDE6 which is involved in the phototransduction pathway in the retina. G04B E Gastro oesophagael reflux disease, Vomiting, Abdominal pain upper, Dry mouth. Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil and other PDE5 inhibitors see section 4.