Sildenafil Accord 50 Mg Film-coated Tablets

In clinical trials sildenafil was administered to more than patients aged Search eMC: Healthcare professionals are asked to report any suspected adverse reactions sildenafil Yellow Card Scheme Website: The maximum recommended dosing frequency is once per day. Excipient with known effect: Already a patient? Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: Effect on bleeding Studies with human platelets indicate dosage sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. Dry eye, Lacrimal disorder and Lacrimation increased. Though the mg effects do not last longer than a lower dosage, the higher concentration does have a dosage profound effect. Due to the nitrate component it has the potential to result in aserious interaction with sildenafil. Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. Pharmaceutical particulars 6. These additional blood pressure reductions were of a similar magnitude to those seen when sildenafil was administered alone to healthy volunteers see section 5. Concomitant use with other PDE5 inhibitors or other treatments for erectile dysfunction. In addition, physicians should advise patients what to do in the event of postural hypotensive symptoms. Table 1: If you are using sildenafil for the first time, it is very likely sildenafil you will be prescribed this dosage. The following groups were not well represented or excluded from clinical trials: Sildenafil causes mild and transient decreases in blood pressure which, in the majority of cases, do not translate into clinical effects.

Effect on bleeding Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. There was no effect on sperm motility or morphology after single mg oral doses of sildenafil in healthy volunteers see section 5. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result. 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. Throat tightness, Nasal oedema, Nasal dryness. This means that side effects can be more pronounced as well. The maximum recommended dosing frequency is once per day. Therefore, inhibitors of these isoenzymes may reduce sildenafil clearance and inducers of these isoenzymes may increase sildenafil clearance. SmPC Patient Leaflet. Last updated on eMC: Summary of the safety profile The safety profile of Sildanafil is based on patients in 74 double blind placebo-controlled clinical studies. Do not use this service. The maximum recommended dose is mg. Renal insufficiency: 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. In clinical studies, riociguat has been shown to augment the hypotensive effects of PDE5 inhibitors, sildenafil 50 mg dosage. Studies in vitro have shown that sildenafil is selective for PDE5, which is involved in the erection process. Cases of non-arteritic anterior ischaemic optic neuropathy, a dosage condition, have been reported spontaneously and in an observational study in connection with the intake of sildenafil and other PDE5 inhibitors see section 4. The recommended dose is 50mg taken as needed approximately one hour before sexual activity. 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. Based on efficacy and toleration, the dose may be increased to 50 mg and mg as necessary. Musculoskeletal and connective tissue disorders. Erectile dysfunction is a condition that affects the majority of men at some point during their lives. There was no increase in adverse events with the sildenafil dose.

Chest pain. Marketing authorisation number s 9. If Sildenafil is taken with food, the onset of activity may be delayed compared to the fasted state see Section 5. Assess the tolerability and efficacy of sildenafil initiated at the mg dose in men with ED. Summary of the safety profile The safety profile of Sildenafil is based on patients in 74 double-blind placebo-controlled clinical studies. Its effect is more potent on PDE5 than on other known phosphodiesterases, sildenafil 50 mg dosage. The N-desmethyl metabolite is further metabolised, with a terminal half life of approximately 4 h. Prolonged sildejafil and priapism have been reported with sildenafil in post-marketing experience. Table 1: Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat. Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of sildenafil patients, since there is a degree of cardiac risk associated with sexual activity. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Based on efficacy andtolerability, the dose may be increased step-wise sildensfil 50mg and mg as necessary. 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. Clinical dosage 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 wildenafil. 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

Due to the nitrate component it has the potential to result in aserious interaction with sildenafil. Chest pain, Fatigue, Sildenafil hot. Concomitant use with alpha-blockers Caution is advised when sildenafil is administered to patients taking an alpha-blocker, as the coadministration may sildenfail to symptomatic hypotension in a sildenzfil susceptible individuals see section 4. Healthcare professionals sldenafil asked to report any suspected sildenafil reactions via the Yellow Card Scheme at: SmPC Patient Leaflet. The safety and efficacy of sildenafil was maintained in long-term studies. When sildenafil and doxazosin were administered simultaneously to patients stabilized on doxazosin therapy, there were infrequent reports of patients who experienced symptomatic postural hypotension. Alternative treatments for ED include tablets such as Cialis and Spedrawhich contain different active ingredients but have a similar effect to sildenafil. 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. Further information on clinical trials In clinical trials sildenafil was administered to more than patients aged They will probably encourage you to try it a few more times before you move onto something else. Not all pack sizes may be marketed. Therefore the use sildenagil such combinations is not recommended. The safety of sildenafil has dossge dosage studied in the following sub-groups of patients and its use is therefore contraindicated: This means that side effects can be dosagr pronounced as well. Paediatric population Sildenafil is not indicated for individuals below 18 years of age. Nitric oxide then activates the enzyme guanylate cyclase, which results in increased levels of dosage guanosine monophosphate cGMPproducing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood. The following patient groups were represented: 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 5 vision. Date of revision of the text. There was no increase in adverse events with the higher dose. Its effect is more potent on PDE5 than on other known phosphodiesterases. Marketing authorisation holder 8. This site uses cookies.

Sildenafil 50 mg dosage

Sign Up Log In Cancel. In cases of overdose, standard supportive measures should be adopted as required. Sildenafil causes mild and transient decreases in blood pressure which, in the majority of cases, do not translate into clinical effects. Sildenafil 50 mg film-coated tablets. 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, dosage sildenafil is administered concomitantly with CYP3A4 inhibitors, a starting dose of 25mg should be considered. Therefore sexual stimulation is required in order for sildenafil to produce its intended beneficial pharmacological effects. 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. Sildenafil is a popular erectile dysfunction ED tablet, taken by men who find it hard to get an erection on their own. Bear in mind that sildenafil, and all other ED tablets, will only work if you become sexually aroused; it is not, in itself, an 'aphrodisiac'. Gastro oesophageal reflux disease, Vomiting, Abdominal pain upper, Dry mouth. Effects of sildenafil on other medicinal products In vitro studies: There was no effect on sperm motility or morphology after single mg oral doses of sildenafil in healthy volunteers see section 4. Name of the medicinal product 2. 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. Pharmaceutical form 4. It may be that your doctor initially prescribes you sildenafil mg, however it is more common to sildenafil on the 50mg dosage and work up to mg if you have no success. In the natural setting, i. The film coating of the Sildenafil tablet contains lactose. Posology Use in adults The recommended dose is 50mg taken as needed approximately one hour before sexual activity. Posology Use in adults:

Paediatric population The European Medicines Agency 5 sildenafil the sildenafjl to submit sildenfail results of studies with Sildenafil in all subsets of the paediatric population for the treatment of erectile dysfunction. Method of administration For oral use. The higher dose can therefore have a positive psychological effect, helping men and their partners to feel more confident about having sex. The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: Due to the nitrate component dosate has the potential to have serious interaction with sildenafil. Cellulose microcrystalline Calcium hydrogen phosphate anhydrous Croscarmellose sodium Hypromellose 5 cp E Magnesium stearate Film coat: Within each frequency grouping, undesirable effects are presented in order of dosage seriousness. Studies in vitro have shown that sildenafil is selective for PDE5, which is involved in the erection process. The film coating of the Sildenafil tablet contains lactose. Based on efficacy and toleration, the dose may be increased to 50 mg and mg. Concomitant use with ritonavir Dosage of sildenafil with ritonavir is not advised see Section 4. Reproductive system and breast disorders. The mg tablets from Dr. Therefore sexual stimulation is required in order for sildenafil to produce its intended beneficial pharmacological effects. Alternative treatments for ED include tablets sikdenafil as Cialis and Spedrawhich contain different active ingredients but have a similar effect to sildenafil. This information is intended for use by health professionals. In order for Sildenafil ddosage be effective, sexual stimulation is required. The corresponding additional reduction in supine diastolic blood pressure was 7 mmHg. In addition, physicians should advise patients what to do in the event of postural hypotensive symptoms. Name of the medicinal product 2. Grapefruit juice is sildenafil weak inhibitor of CYP3A4 gut wall metabolism and may give rise to modest increases in plasma levels of sildenafil. The following groups were not well represented or excluded from clinical trials: Show table of contents Hide table of contents 1. Blue, almond shaped, biconvex, film dosxge tablets, debossed with '50' on one side and plain on other side.

Sildenafil (Viagra): Drug to Treat Erectile Dysfunction or Impotence in Men

For the full list of excipients, see section 6. In some cases, if the root of your impotence is psychological, counselling may be helpful. In addition, physicians should advise patients what to do in the event of postural hypotensive symptoms. Priapism 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 eosage to priapism such as sickle cell anaemia, multiple myeloma or leukaemia. Initiation of sildenafil at a dose of 25 mg dosate be considered see section 4. Sign Up Log In Cancel. The maximum recommended dose is mg. In the event of an erection that persists for longer than 4 hours, the patient should seek immediate medical assistance. Musculoskeletal dosage connective tissue disorders. Method of administration For oral use. No relevant adverse effects were found in reproduction studies in rats and rabbits following oral administration of sildenafil. Musculoskeletal and connective tissue disorders. 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. Gastro oesophageal reflux disease, Vomiting, Abdominal pain upper, Dry mouth. Serious cardiovascular events, including myocardial dosaage, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, hypertension and hypotension have been reported post-marketing in sildenafil association with the use of Sildenafil tablets Most, but not all, of these patients had pre-existing cardiovascular risk factors. By continuing to browse the site you are agreeing to our policy on the use of cookies. 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.

Although specific interaction studies were not conducted for all medicinal products, population pharmacokinetic analysis showed no effect of concomitant treatment on sildenafil pharmacokinetics when grouped as CYP2C9 inhibitors such as tolbutamide, warfarin, phenytoin , CYP2D6 inhibitors such as selective serotonin reuptake inhibitors, tricyclic antidepressants , thiazide 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. Fox are scored for easy division, allowing you to take half for a 50mg dose, or a full tablet should your doctor later recommend mg. Sildenafil 50 mg did not potentiate the increase in bleeding time caused by acetyl salicylic acid mg. Date of revision of the text. Due to the nitrate component it has the potential to have serious interaction with sildenafil. This site uses cookies. The physiological mechanism responsible for erection of the penis involves the release of nitric oxide NO in the corpus cavernosum during sexual stimulation. In order for Sildenafil tablets to be effective, sexual stimulation is required. Effects of sildenafil on other medicinal products In vitro studies: In healthy male volunteers, sildenafil at steady state 80 mg t. 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 , other treatments for erectile dysfunction have not been studied. 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. Company contact details Aurobindo Pharma - Milpharm Ltd. Tablet core: 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. The film coating of the Sildenafil tablets contains lactose. Protein binding is independent of total drug concentrations.

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Back to top Aurobindo Pharma - Milpharm Ltd. A number of factors go into the success of an ED medication, and they are not guaranteed to work every time. Side effects are more likely at higher doses. To email a medicine you must sign up and log in. Not all pack sizes may be marketed. However, due to high inter-subject variability, these differences were not statistically significant. If your doctor believes treatment is appropriate, they can prescribe a tablet such as s ildenafil , which — as we have seen — comes in three different dosages, the two most popular being sildenafil 50mg and sildenafil mg. See section 4. Generic sildenafil citrate comes in preparations of 25mg, 50mg and mg. After oral dosing of sildenafil AUC and C max increase in proportion with dose over the recommended dose range mg. Active ingredient sildenafil citrate. As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they react to Sildenafil tablets, before driving or operating machinery. 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. Sildenafil showed no effect on cardiac output, and did not impair blood flow through the stenosed coronary arteries. Sildenafil tablets is not indicated for use by women. If you have a medical emergency, call or NHS Sildenafil had no effect on saquinavir pharmacokinetics see section 4. Pharmacological properties 5. 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 The safety and efficacy of sildenafil was maintained in long-term studies. The maximum recommended dosing frequency is once per day. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 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.

This uncertainty can lead to a great deal of anxiety for couples who have already had to deal with the frustration of erectile dysfunction — not knowing if they should again get their hopes up for a successful sexual encounter only to be disappointed. Active ingredient sildenafil citrate. Patients with increased susceptibility to vasodilators include those with left ventricular outflow obstruction e. 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. 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. The effects of sildenafil mg do not last longer than the 50mg dosage, but they tend to be stronger. There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole. Pooling of the following classes of antihypertensive medication; diuretics, beta-blockers, ACE inhibitors, angiotensin II antagonists, antihypertensive medicinal products vasodilator and centrally-acting , 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. 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 blurred vision. The corresponding additional reduction in supine diastolic blood pressure was 7 mmHg. Most, but not all, of these patients had pre-existing cardiovascular risk factors. The following groups were not well represented or excluded from clinical trials: Sign Up Log In Cancel. The physiological mechanism responsible for erection of the penis involves the release of nitric oxide NO in the corpus cavernosum during sexual stimulation. 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 Method of administration For oral use. Urologicals; Drugs used in erectile dysfunction. Although no increased incidence of adverse events was observed in these patients, when sildenafil is administered concomitantly with CYP3A4 inhibitors, a starting dose of 25 mg should be considered. If 50mg is very effective the dose can be reduced to 25mg. At maximum recommended doses, there is an fold selectivity over PDE1, and over fold over PDE 2, 3, 4, 7, 8, 9, 10 and Across all trials, the proportion of patients reporting improvement on sildenafil were as follows: 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. Pharmaceutical particulars 6. Changes in functional scores from baseline were not statistically significant with the mg dose compared with the mg dose in the DBPC. Sildenafil is an oral therapy for erectile dysfunction. 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. Hypersensitivity to the active substance or to any of the excipients listed in section 6.

Maximum observed plasma concentrations are reached within 30 to minutes median 60 minutes of oral dosing in the fasted state. Find out more here. In clinical trials sildenafil was administered to more than patients aged Sildenafil is not indicated for use by women. In healthy volunteers receiving sildenafil mg single dose , less than 0. Show table of contents Hide table of contents 1. Reproductive system and breast disorders. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website: In addition, physicians should advise patients what to do in the event of postural hypotensive symptoms. G04B E 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. 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. Protein binding is independent of total drug concentrations. Women Sildenafil Tablets are not indicated for use by women. Therefore the use of such combinations is not recommended. Method of administration For oral use. Most, but not all, of these patients had pre-existing cardiovascular risk factors. At this dose you and your doctor can monitor your physical reaction to the medicine and address any side effects early on. White to off-white, round 9. Why choose LloydsPharmacy? The effects of sildenafil mg do not last longer than the 50mg dosage, but they tend to be stronger.