Sildenafil 50 Mg Film-coated Tablets

Maximum observed plasma concentrations are reached within 30 to minutes median 60 minutes of oral dosing in the fasted state. Do not use this service. Grapefruit juice is a weak inhibitor of CYP3A4 gut wall metabolism and may give rise to modest sildenafil in plasma levels of sildenafil. Population pharmacokinetic analysis of clinical trial data indicated a reduction in sildenafil clearance when co-administered with CYP3A4 inhibitors such as ketoconazole, erythromycin, cimetidine. Sildenafil tablets should not be administered to men with rare hereditary problems of galactose intolerance, 5 lactase deficiency or glucose-galactose malabsorption. Torrent mg sildenafil tablets are scored and can be easily broken in 2. Legal Category POM: Effects of other medicinal products on sildenafil In vitro studies: Sildenafil of sildenafil tablst a dose of 25 mg should be considered see section 4. Musculoskeletal and connective tissue disorders. Sildenafil metabolism sildenqfil principally mediated by the cytochrome P CYP isoforms 3A4 major route and 2C9 minor route. Mechanism of action Sildenafil is an oral therapy for erectile dysfunction. ATC Code: However, due to high inter-subject variability, these differences were not statistically significant. Stronger CYP3A4 inhibitors such as ketoconazole and itraconazole would be expected to have greater effects. Two clinical studies were specifically designed to tablet the time window after dosing during which sildenafil could produce an erection in response to sexual stimulation. 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. Population pharmacokinetic analysis of clinical trial data indicated a reduction in sildenafil clearance when co-administered with CYP3A4 inhibitors such as ketoconazole, erythromycin, cimetidine. Method of administration For oral tablet. In three specific drug-drug interaction studies, the alpha-blocker doxazosin 4 mg and 8 mg and sildenafil 25 mg, 50 mg, or mg were administered simultaneously to patients with benign prostatic hyperplasia BPH stabilized on doxazosin therapy. See section 4. Cardiovascular risk factors Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status sildenqfil their patients, since there is a degree of cardiac risk associated with sexual activity. Due to the nitrate component it has the potential to result in aserious interaction with sildenafil.

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. The mean maximum decreases in supine systolic blood pressure following mg oral dosing of sildenafil was 8. Musculoskeletal and connective tissue sildenaril. Clinical particulars 4. Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, sildenafil 50 mg tablet, genotoxicity, carcinogenic potential, and toxicity to reproduction. Company contact details Sildenafil Healthcare Limited. Date of first authorisation: Reporting suspected adverse reactions after authorisation of the medicinal product is important. The major circulating metabolite results from N-demethylation of sildenafil. 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. Across all trials, the proportion of patients reporting improvement on sildenafil were as follows: In clinical studies, riociguat has been shown to augment the hypotensive effects of PDE5 inhibitors. Concomitant use tablet other PDE5 inhibitors or other treatments for erectile dysfunction The safety and efficacy sildenafi, combinations of sildenafil with other PDE5 Inhibitors, or other pulmonary arterial hypertension PAH treatments containing sildenafil REVATIOother treatments for erectile dysfunction have not been studied. Toggle navigation. These decreases in blood pressure are consistent with the vasodilatory effects of sildenafil, probably due to increased cGMP levels in vascular smooth muscle. Mechanism of action Sildenafil is an oral therapy for erectile dysfunction.

Using 100mg sildenafil tablets for a 50mg dose

The physiological mechanism responsible for erection of the penis involves the release of nitric oxide NO in the corpus tableg during sexual stimulation. Toggle navigation. Nicorandil is a hybrid of potassium channel activator and nitrate. Sildenafil at 50 mg or mg significantly improved erection quality, treatment satisfaction, anxiety levels, and the sexual experience compared with placebo during DBPC. Assess the tolerability and efficacy of sildenafil initiated at the mg dose in men with ED. Each 50 mg film-coated tablet contains 3. Across all trials, the proportion of patients reporting sipdenafil on sildenafil were tbalet follows: Sildenafil is rapidly tablet. Therefore sexual stimulation is required in order for sildenafil to produce its intended beneficial pharmacological effects. Nervous system disorders. In cases of overdose, standard supportive measures should be adopted as required. Reduced anxiety. It is recommended that several attempts are made using the recommended starting dose before adjusting. Priaprism Agents tableg the treatment of erectile dysfunction, including sildenafil, sildenafil 50 mg tablet, should be used with caution in patients with anatomical deformation of mt 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. Not all pack sizes may be marketed. Author information: Company contact details Pfizer Limited. 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.

This is most likely to occur within 4 hours post sildenafil dosing see sections 4. Sildenafil mg should be taken in exactly the same way as the smaller dosage tablet: These additional blood pressure reductions were of a similar magnitude to those seen when sildenafil was administered alone to healthy volunteers see section 5. This is most likely to occur within 4 hours post sildenafil dosing. Caution sildenafi, 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. They will probably encourage you to try it a few more times before you move onto something else. No relevant adverse effects were found in reproduction studies in rats and rabbits following oral administration of sildenafil. 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 tanlet. Chest pain, Fatigue, Feeling hot. Women Sildenafil Tablets are not indicated for use by women. Two clinical studies were specifically designed to assess the time window after dosing jg which sildenafil could produce an erection in response to sexual stimulation. 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 tblet and other PDE5 inhibitors see section 4. Search eMC: Marketing authorisation holder 8. Hypromellose Lactose monohydrate Triacetin Tablet dioxide E 6. 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 sildenavil. Sildenafil is rapidly absorbed. Clinical particulars 4. Paediatric population The European Medicines Agency has waived the obligation to mh the results of studies with Sildenafil in all subsets of the paediatric population for the treatment of erectile dysfunction.

Sildenafil 50 mg tablet

Search eMC: Effect on bleeding. There is no safety information on the administration of sildenafil to patients with bleeding disorders tablet active peptic ulceration. Name of the medicinal product 2. The physiological mechanism responsible for erection of the penis involves the release of nitric oxide NO in the corpus cavernosum during sexual stimulation. The mean maximum decreases in supine systolic blood pressure following mg oral dosing of sildenafil was 8. After oral dosing of sildenafil AUC and C max increase in proportion with dose over the recommended dose range mg. Date sildenafil revision of the text. There are no adequate and well-controlled studies in pregnant or breastfeeding women. Pharmacokinetics in special patient groups Elderly: The mean steady state volume of distribution V d for sildenafil is l, indicating distribution into the tissues. Name of the medicinal product 2. The recommended dose is 50 mg taken as needed approximately one hour before sexual activity. Effects of other medicinal products on sildenafil In vitro studies: Active ingredient sildenafil citrate. After oral dosing of sildenafil AUC and C max increase in proportion with dose over the recommended dose range mg. 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 In healthy volunteers receiving sildenafil mg single doseless than 0. Gastro oesophageal reflux disease, Vomiting, Abdominal pain upper, Dry mouth.

The film coating of the Sildenafil tablet contains lactose. Date of revision of the text. They will probably encourage you to try it a few more sildenagil before you move onto something else. Bear in mind silenafil sildenafil, sildsnafil all other ED tablets, will only work if you become sexually aroused; it is not, in itself, an 'aphrodisiac'. Mechanism of action Sildenafil is an oral sildenafil for erectile dysfunction. Silednafil had no effect sildenafil ritonavir pharmacokinetics. Concomitant administration of sildenafil to patients taking alpha-blocker therapy may lead to symptomatic hypotension sildenafil a few susceptible individuals. Effects on vision. Table 1: 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 mean maximum decreases in supine systolic blood pressure following mg oral dosing of sildenafil was 8. Paediatric population Sildenafil is not indicated for individuals below 18 years tanlet age. Therefore the use of such combinations is not recommended. This site uses cookies. Effects of sildenafil on other medicinal products In vitro studies: A double-blind, placebo-controlled exercise stress trial evaluated patients with erectile dysfunction and chronic stable angina who regularly tablet anti-anginal medicinal products except nitrates. To view atblet changes to a medicine you must sign up and log in. Based on efficacy and tolerability, the dose may be increased to mg or decreased to 25mg. Method of administration For oral use. There was no effect on sperm motility or morphology after single mg oral doses of sidenafil in healthy volunteers see section 5. The mean steady state volume of distribution V d for sildenafil is l, indicating distribution into tablet tissues. Tablet core: To view the changes to a medicine you must sign up and tablet in.

The pharmacokinetics of sildenafil in patients with severely impaired hepatic function have not been studied. The results demonstrated no clinically relevant differences between sildenafil and placebo in time to limiting angina. When sildenafil and doxazosin were administered simultaneously to patients stabilized on doxazosin therapy, there were infrequent reports of patients who experienced symptomatic postural hypotension. The safety profile of Sildenafil is based on patients in 74 double-blind placebo-controlled clinical studies. 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. Patients with increased susceptibility to vasodilators include those with left ventricular outflow obstruction e. The following groups were not well represented or excluded from clinical trials: Satisfaction with treatment. Initiation of sildenafil at a dose of 25 mg should be considered see section 4. Legal Category POM: In addition, physicians should advise patients what to do in the event of postural hypotensive symptoms. 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. 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. In a separate RigiScan study, sildenafil was still able to produce an erection in response to sexual stimulation hours post-dose. Sildenafil mg did not affect the steady state pharmacokinetics of the HIV protease inhibitors, saquinavir and ritonavir, both of which are CYP3A4 substrates. Concomitant use with ritonavir Co-administration of sildenafil with ritonavir is not advised see Section 4. Concomitant administration of sildenafil to patients taking alpha-blocker therapy may lead to symptomatic hypotension in a few susceptible individuals. SmPC Patient Leaflet. Find out more here. Lactose monohydrate 1 mg per 25 mg tablet 2 mg per 50 mg tablet 4 mg per mg tablet. 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. Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. Sildenafil had no effect on ritonavir pharmacokinetics. In vivo studies: As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they react to Sildenafil, before taglet or operating machinery. When sildenafil and doxazosin were administered simultaneously to patients stabilized on doxazosin therapy, there were infrequent reports of patients who experienced symptomatic postural hypotension. Several factors can affect the efficacy of sildenafil sildenfil, including sexual stimulation, and what you eat and drink at the time. Nitric oxide then activates the enzyme guanylate cyclase, which results in increased sildenafil of cyclic guanosine sildenafil cGMPproducing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood. In single dose tablet 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 Accord is also available as 25 mg tablets. Sildenafil mg did not affect the steady state pharmacokinetics of the HIV protease inhibitors, saquinavir and sildenafli, both tablet which are CYP3A4 substrates. At this dose you and your doctor can monitor your physical reaction to the medicine and address any side effects early on. Based on sildebafil and toleration, the dose may be increased to mg or decreased to 25 mg. Therefore, inhibitors of these isoenzymes may reduce sildenafil clearance and inducers of these isoenzymes may increase sildenafil clearance.

Sildenafil metabolism is principally mediated by the cytochrome P CYP isoforms 3A4 major route and 2C9 minor route. Qualitative and quantitative composition 3. Customer Services: Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. To view the changes to a medicine you must sign up and log in. Sildenafil Pfizer may have a minor influence on the ability to drive and use machines. Marketing authorisation number s 9. Further information on clinical trials In clinical trials sildenafil was administered to more than patients aged In three specific drug-drug interaction studies, the alpha-blocker doxazosin 4 mg and 8 mg and sildenafil 25 mg, 50 mg, or mg were administered simultaneously to patients with benign prostatic hyperplasia BPH stabilized on doxazosin therapy. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Erectile dysfunction is a condition that affects the majority of men at some point during their lives. 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. It is associated with ageing and is more common in older men, but it can also be a symptom of an underlying condition such as depression, heart disease or diabetes. Concomitant use with alpha-blockers Caution is advised when sildenafil is administered to patients taking an alpha-blocker, as the co-administration may lead to symptomatic hypotension in a few susceptible individuals see section 4. 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. Alternative treatments for ED include tablets such as Cialis and Spedra , which contain different active ingredients but have a similar effect to sildenafil. Method of administration For oral use. Studies in vitro have shown that sildenafil is selective for PDE5, which is involved in the erection process. No relevant adverse effects were found in reproduction studies in rats and rabbits following oral administration of sildenafil. 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. In healthy volunteers receiving sildenafil mg single doseless than 0. In healthy volunteers receiving sildenafil mg single doseless than 0. Prescription only medicine. Qualitative and quantitative composition 3. There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole.