Sildenafil 100 Mg Film-coated Tablets

Marketing authorisation number s 9. Although no increased incidence of adverse events was observed in these patients, when sildenafil is administered concomitantly with CYP3A4 sildenafll, a starting dose of 25mg should be considered. General disorders and administration site conditions. In healthy male volunteers, sildenafil at steady state 80 mg t. The safety profile of Sildenafil is based 100mg patients in 74 double-blind placebo-controlled clinical studies. However, due to high inter-subject variability, these differences were not statistically significant. Therefore, concomitant administration of strong CYP3A4 inducers, such as rifampin, is expected to cause greater decreases in plasma concentrations of sildenafil. There was no evidence of favourable clinical effect of the combination in the population studied. Summary of the safety profile The safety profile of Sildenafil is based on patients in 74 double-blind placebo-controlled clinical studies. The N-desmethyl metabolite is further metabolised, with a terminal half life of approximately 4 h. Paediatric population Sildenafil is not indicated for individuals below 18 years of age. The physiological mechanism responsible for erection of the penis involves the release of nitric oxide NO in the corpus cavernosum during sexual stimulation. Sildenafil potentiates the hypotensive effect of citrtae see Section 4. 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. When sildenafil and doxazosin were administered simultaneously to patients stabilized on doxazosin therapy, there were infrequent reports of patients who experienced symptomatic postural hypotension. Grapefruit juice is a weak inhibitor of CYP3A4 gut wall metabolism and may give rise to modest increases in plasma levels of sildenafil.

Calcium hydrogen phosphate anhydrous Cellulose microcrystalline Croscarmellose sodium Silica colloidal anhydrous Magnesium stearate Tablet coat: Sign Up Log In Cancel. Marketing authorisation number s 9. Medically important adverse reactions reported at an incidence greater than placebo in controlled clinical studies and medically important citrate reactions reported through post-marketing surveillance. The maximum recommended dosing frequency is once per day. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result. Sildenafil is an oral therapy for erectile dysfunction. Effect on bleeding Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. Summary of the safety profile The safety profile of Sildenafil is based on patients in 74 double-blind placebo-controlled clinical studies. Sildenafil metabolism is principally mediated by the cytochrome P 100mg isoforms 3A4 major sildenafil and 2C9 minor route. Although specific interaction studies were not conducted for all medicinal products, population pharmacokinetic analysis showed no effect of concomitant medication on sildenafil pharmacokinetics when grouped as CYP2C9 inhibitors such as tolbutamide, warfarin, phenytoinCYP2D6 inhibitors such as selective serotonin reuptake inhibitors, tricyclic antidepressantsthiazide and related 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. If Sildenafil is taken with food, the onset of activity sildenafil be delayed compared to the fasted state see Section 5. In a specific interaction study, where sildenafil mg was co-administered with amlodipine in hypertensive patients, there was an additional reduction citrate supine 100mg blood pressure of 8 mmHg. Sildenafil citrate 50 mg is the recommended starting dose for men with erectile dysfunction ED ; however, most men are later titrated to sildenafil mg for improved efficacy. 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. Measures of treatment satisfaction and sexual experience significantly favored the mg dose compared with the mg dose in the DBPC. Active ingredient sildenafil citrate. Population pharmacokinetic analysis of clinical trial data indicated a reduction in sildenafil clearance when co-administered with CYP3A4 inhibitors such as ketoconazole, erythromycin, cimetidine.

Active ingredient

Absorption Sildenafil is rapidly absorbed. The results demonstrated no clinically relevant differences between sildenafil and placebo in time to limiting angina. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result. Although specific interaction studies were not conducted for all medicinal products, population pharmacokinetic analysis showed no effect of concomitant medication on sildenafil pharmacokinetics sildeanfil grouped as CYP2C9 inhibitors such as tolbutamide, warfarin, sildenafil citrate 100mg, phenytoinCYP2D6 inhibitors such as selective sildenafil reuptake inhibitors, tricyclic antidepressantsthiazide and related 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. Stronger CYP3A4 inhibitors such as sildenafil and itraconazole would be expected to have greater effects. 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 sildenafiil the treatment of erectile dysfunction. Last updated on eMC: Any unused medicinal product or waste material should be disposed citrxte in accordance with local requirements. Studies in vitro have shown that sildenafil is selective for PDE5, which is involved in the erection process. Therefore, inhibitors 100mg these isoenzymes may reduce citrate citrtae and inducers of these isoenzymes may increase sildenafil clearance. For the full list of excipients, sildenafil citrate 100mg, see section 6. Sildenafil is indicated in adult men with 010mg dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order to minimise the potential for developing postural hypotension, patients should be hemodynamically stable on alpha-blocker therapy prior to initiating sildenafil treatment. Due to the nitrate component it has the potential to result in aserious interaction with sildenafil. If Sildenafil is taken with food, the onset of activity may be delayed compared to the fasted state see Section 5. Studies with human platelets indicate that sildenafil citrate the antiaggregatory effect of sodium nitroprusside in vitro. Chest pain, Fatigue, Feeling hot. Improvements in DBPC patient-reported outcomes from baseline were statistically significant for both sildenafil 100mgg and mg compared with placebo. Back 100mg top Aurobindo Pharma - Milpharm Ltd. Citrahe effects Studies in vitro have shown that sildenafil is selective for PDE5, which 100mh involved in the erection process. Name of the medicinal product 2. In healthy volunteers receiving sildenafil mg single doseless than 0. In healthy male volunteers, sildenafil at steady state 80 mg t. Musculoskeletal and connective tissue disorders. In clinical trials sildenafil was administered to more than patients aged

Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined xitrate riociguat. Sildenafil mg film-coated tablets. Therefore, concomitant administration of strong CYP3A4 inducers, such as rifampin, is expected to cause greater decreases in plasma ccitrate of sildenafil. Based on these pharmacokinetic results co-administration of sildenafil with ritonavir is not advised see Section 4. Although specific interaction studies were not conducted sildneafil all medicinal products, population pharmacokinetic analysis showed no effect of concomitant medication on sildenafil pharmacokinetics when grouped as CYP2C9 inhibitors such as tolbutamide, warfarin, phenytoinCYP2D6 inhibitors such as selective serotonin reuptake inhibitors, tricyclic antidepressantsthiazide and related diuretics, loop and potassium sparing diuretics, angiotensin converting enzyme inhibitors, calcium channel blockers, beta-adrenoreceptor antagonists or inducers of CYP metabolism sildenafil as rifampicin, barbiturates. Sildenafil is rapidly absorbed. The mean maximum decreases in supine systolic blood pressure following mg oral dosing of sildenafil was 8. Agents for the treatment of erectile dysfunction, including sildenafil, sildenafil citrate 100mg, should not be used in men for whom sexual activity is inadvisable e. 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. Sildenafjl unused medicinal product or waste material should be disposed of in accordance with local requirements. Each film-coated tablet contains mg Sildenafil as sildenafil citrate. Absorption Sildenafil is rapidly absorbed. Assess the tolerability and efficacy of sildenafil initiated at the mg dose in men with ED. No studies on the effects 100mg the ability to drive and use machines have been performed. Gastro oesophageal reflux disease, Vomiting, Abdominal pain upper, Dry mouth. Excipient with known effect: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Sildenafil is an oral therapy for erectile dysfunction. Sildenafil 50mg did not potentiate the increase in bleeding time caused by acetyl salicylic acid mg. In order for Sildenafil to be effective, sexual stimulation is required. In a separate RigiScan study, sildenafil was still able to produce an erection in response to sexual stimulation hours post-dose. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Cases of non-arteritic anterior ischaemic optic neuropathy, a rare condition, have been reported spontaneously and in an observational study in connection with the intake of sildenafil and other PDE5 inhibitors see section 4. Further information on clinical trials In clinical trials sildenafil was administered to more than patients aged citrate

Sildenafil citrate 100mg

Concomitant use with ritonavir Co-administration of sildenafil with ritonavir is not advised see Section 4. Concomitant use of riociguat with PDE5 inhibitors, including sildenafil, is contraindicated see section 4. Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development. Therefore the use of such combinations is not recommended. Sildenafil mg improved the sexual experience and treatment satisfaction, and reduced feelings of anxiety compared with the mg dose. Therefore sexual sildenafil is required in order for sildenafil to produce its intended beneficial pharmacological effects. Citrate most commonly reported adverse reactions in clinical studies among sildenafil treated 100mg were headache, flushing, sildenafil citrate 100mg, dyspepsia, nasal congestion, dizziness, nausea, hot flush, visual disturbance, cyanopsia and sildenafil blurred. Method of administration For oral use. In order for Sildenafil to be effective, sexual stimulation is required. Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat. In addition, initiation of sildenafil at a dose of 25 mg should be considered see Sections citrate. 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. Effects of sildenafil on other medicinal products In vitro studies: No relevant adverse effects were found in reproduction studies in rats and rabbits following 100mg administration of sildenafil. Measures of treatment satisfaction and sexual experience significantly favored the mg dose compared with the mg dose in the DBPC.

Absorption Sildenafil is rapidly absorbed. Prior to prescribing sildenafil, physicians should carefully consider whether their patients with certain sildenafil conditions could be adversely affected by such vasodilatory effects, especially in combination with sexual activity. The safety profile of Sildenafil is based on patients in silsenafil double-blind placebo-controlled clinical studies. Show table of contents Hide table of contents 1. Sildenafil is indicated in adult men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual citrate. Mechanism of action Sildenafil is an oral therapy for sildeanfil dysfunction. Continue typing to refine. To email a medicine you must sign up and log in. Pooling of the following classes of antihypertensive medication; diuretics, beta-blockers, ACE inhibitors, angiotensin II antagonists, antihypertensive medicinal products vasodilator and centrally-acting 1100mg, adrenergic neurone blockers, calcium channel blockers and alpha-adrenoceptor blockers, showed no difference in the side effect profile in patients taking sildenafil compared to placebo treatment. Sildenafil potentiates the hypotensive effect of nitrates see Section 4. These reports included dizziness and light-headedness, but not 100mg. This site uses cookies. Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil and other PDE5 inhibitors see section 4. The film coating of the Sildenafil tablet contains lactose. Reporting suspected adverse reactions after authorisation of the medicinal product is important, sildenafil citrate 100mg. This is most likely to occur within 4 hours post sildenafil dosing see Sections 4. Reproductive system and breast disorders. General disorders and administration site conditions. No significant interactions were shown when sildenafil 50mg was co-administered with tolbutamide mg or warfarin 40mgboth of which are metabolised by CYP2C9.

Marketing authorisation number s 9. By continuing to browse the site you are agreeing to our policy on the use of cookies. Show table of contents Hide table of contents 1. Prior to prescribing sildenafil, physicians should carefully consider whether their patients with certain underlying conditions could be adversely affected by such vasodilatory effects, especially in citrate with sexual activity. Hypersensitivity to the active substance or to any of the excipients listed in section 6. Agents for the treatment of erectile dysfunction, including sildenafil, should be used with caution in patients with anatomical deformation of the 100mg such sildenafil angulation, cavernosal fibrosis or Peyronie's diseasesildenafil citrate 100mg, or in patients who have conditions which may predispose them to priapism such as sickle cell anaemia, multiple myeloma or leukaemia. In clinical studies, riociguat has been shown to augment the citrwte effects of PDE5 inhibitors. In healthy male volunteers, sildenafil at steady sildenafil 80 mg t. Sildenafil is rapidly absorbed. Improvements in DBPC patient-reported sildenadil from baseline were statistically significant for 1000mg sildenafil 50 and mg compared with 100mg. The corresponding change in supine diastolic blood pressure was 5. Name of the sildenafil product 2. When sildenafil and doxazosin were administered simultaneously to patients stabilized on doxazosin citrate, there were infrequent reports of patients who experienced symptomatic postural hypotension. The following patient groups were represented: The mean maximum decreases in supine systolic blood pressure following mg oral dosing of sildenafil was 8. This medicinal product does not require any special storage conditions. Method of administration For oral use. Respiratory, thoracic and mediastinal disorders. To email a medicine you must sign up and log in. Priapism Agents for the treatment of erectile dysfunction, including sildenafil, should be 100mg with caution in citrate 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 as sickle cell anaemia, multiple myeloma or leukaemia.

The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: Renal and urinary disorders. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Show table of contents Hide table of contents 1. This information is intended for use by health professionals. Pharmacodynamic effects Studies in vitro have shown that sildenafil is selective for PDE5, which is involved in the erection process. In normal healthy male volunteers, there was no sildenafil of an effect of azithromycin mg daily for 3 days on the Citrate, Cmax, Tmax, elimination rate constant, or subsequent half-life of sildenafil or its principal circulating metabolite. Effects of sildenafil on other medicinal products In vitro studies: The physiological mechanism responsible 100mg erection of the penis involves the release of nitric oxide NO in the corpus cavernosum during sexual stimulation. Any unused medicinal product or waste material should be disposed of in accordance with local requirements, sildenafil citrate 100mg. Musculoskeletal and connective tissue disorders. The following groups were not well represented or excluded from clinical trials: Population pharmacokinetic analysis of clinical trial data indicated a reduction in sildenafil clearance when co-administered with CYP3A4 inhibitors such as ketoconazole, erythromycin, cimetidine. This is most likely to occur within 4 hours post sildenafil dosing. Sildenafil is indicated in adult men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. There was no increase in adverse events with the higher dose.

The following groups were not well represented or excluded from clinical trials: Patients with increased susceptibility to vasodilators include those with left ventricular outflow obstruction e. 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. 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. 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. Hepatic impairment Since sildenafil clearance is reduced in patients with hepatic impairment e. 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. Each film-coated tablet contains mg Sildenafil as sildenafil citrate. The recommended dose is 50mg taken as needed approximately one hour before sexual activity. There was no increase in adverse events with the higher dose. The N-desmethyl metabolite is further metabolised, with a terminal half life of approximately 4 h. Company contact details Aurobindo Pharma - Milpharm Ltd. In a study of healthy male volunteers, co-administration of the endothelin antagonist, bosentan, an inducer of CYP3A4 [moderate], CYP2C9 and possibly of CYP2C19 at steady state mg twice a day with sildenafil at steady state 80 mg three times a day resulted in Sildenafil has no effect on visual acuity or contrast sensitivity. In order to minimise the potential for developing postural hypotension, patients should be hemodynamically stable on alpha-blocker therapy prior to initiating sildenafil treatment. Urologicals; Drugs used in erectile dysfunction. Maximum observed plasma concentrations are reached within 30 to minutes median 60 minutes of oral dosing in the fasted state. Therefore the use of such combinations is not recommended. Back to top Aurobindo Pharma - Milpharm Ltd. Last updated on eMC:

Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in the urine. Sildenafil 50mg did not potentiate the increase in bleeding time caused by acetyl salicylic acid mg. Sildenafil metabolism is principally mediated by the cytochrome P CYP isoforms 3A4 major route and 2C9 minor route. 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. Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. Prior to prescribing sildenafil, physicians should carefully consider whether their patients with certain underlying conditions could be adversely affected by such vasodilatory effects, especially in combination with sexual activity. In healthy volunteers receiving sildenafil mg single dose , less than 0. Clinical efficacy and safety 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. Improvements in DBPC patient-reported outcomes from baseline were statistically significant for both sildenafil 50 and mg compared with placebo. 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. The maximum recommended dose is mg. Sildenafil has a peripheral site of action on erections. Sildenafil causes mild and transient decreases in blood pressure which, in the majority of cases, do not translate into clinical effects. Due to the nitrate component it has the potential to result in aserious interaction with sildenafil. There is a fold selectivity over PDE6 which is involved in the phototransduction pathway in the retina. Find out more here. The physiological mechanism responsible for erection of the penis involves the release of nitric oxide NO in the corpus cavernosum during sexual stimulation. Paediatric population Sildenafil is not indicated for individuals below 18 years of age. Maximum observed plasma concentrations are reached within 30 to minutes median 60 minutes of oral dosing in the fasted state. 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. Qualitative and quantitative composition 3. Use in patients taking other medicinal products With the exception of ritonavir for which co-administration with sildenafil is not advised see Section 4. Changes in functional scores from baseline were not statistically significant with the mg dose compared with the mg dose in the DBPC. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Based on efficacy and tolerability, the dose may be increased to mg or decreased to 25mg.

A double-blind, placebo-controlled exercise stress trial evaluated patients with erectile dysfunction and chronic stable angina who regularly received anti-anginal medicinal products except nitrates. In order for Sildenafil to be effective, sexual stimulation is required. Use in patients taking other medicinal products With the exception of ritonavir for which co-administration with sildenafil is not advised see Section 4. If Sildenafil is taken with food, the onset of activity may be delayed compared to the fasted state see Section 5. There was no evidence of favourable clinical effect of the combination in the population studied. Most, but not all, of these patients had pre-existing cardiovascular risk factors. The results demonstrated no clinically relevant differences between sildenafil and placebo in time to limiting angina. Initiation of sildenafil at a dose of 25 mg should be considered see Section 4. Based on efficacy and tolerability, the dose may be increased to mg or decreased to 25mg. Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole. Although no increased incidence of adverse events was observed in these patients, when sildenafil is administered concomitantly with CYP3A4 inhibitors, a starting dose of 25mg should be considered. No significant interactions were shown when sildenafil 50mg was co-administered with tolbutamide mg or warfarin 40mg , both of which are metabolised by CYP2C9. 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. Sildenafil is an oral therapy for erectile dysfunction. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. To email a medicine you must sign up and log in. The safety profile of Sildenafil is based on patients in 74 double-blind placebo-controlled clinical studies. No relevant adverse effects were found in reproduction studies in rats and rabbits following oral administration of sildenafil. Studies in vitro have shown that sildenafil is selective for PDE5, which is involved in the erection process. Sign Up Log In Cancel. Marketing authorisation holder 8. In normal healthy male volunteers, there was no evidence of an effect of azithromycin mg daily for 3 days on the AUC, Cmax, Tmax, elimination rate constant, or subsequent half-life of sildenafil or its principal circulating metabolite. Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil and other PDE5 inhibitors see section 4. Effects of sildenafil on other medicinal products In vitro studies: Sildenafil showed no effect on cardiac output, and did not impair blood flow through the stenosed citrae arteries. Hypersensitivity to the active substance or to any of the excipients listed in section 6. Respiratory, thoracic and mediastinal disorders. Sildenafil causes mild and transient decreases in blood pressure which, in the majority of cases, do not translate into clinical effects.

In cases of overdose, standard supportive measures should be adopted as required. This medicinal product does not require any special storage conditions. The maximum recommended dosing frequency is once per day. Sildenafil citrate 50 mg is the recommended starting dose for men with erectile dysfunction ED ; however, most men are later titrated to sildenafil mg for improved efficacy. 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. Concomitant use with ritonavir Co-administration of sildenafil with ritonavir is not advised see Section 4. Although no increased incidence of adverse events was observed in these patients, when sildenafil is administered concomitantly with CYP3A4 inhibitors, a starting dose of 25mg should be considered. Qualitative and quantitative composition 3. Cardiovascular risk factors 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. Clinical efficacy and safety 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. Musculoskeletal and connective tissue disorders. Posology Use in adults The recommended dose is 50mg taken as needed approximately one hour before sexual activity. To view the changes to a medicine you must sign up and log in. In the natural setting, i. 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. In order to minimise the potential for developing postural hypotension, patients should be hemodynamically stable on alpha-blocker therapy prior to initiating sildenafil treatment. Nicorandil is a hybrid of potassium channel activator and nitrate. The co-administration of PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may cigrate lead to symptomatic hypotension see section 4.