Leaflet Information

Your doctor, pharmacist or nurse will be able to give you more information about sildenafil and about other medicines used to treat pulmonary hypertension. Priapism Agents for the treatment of erectile revatio, 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 as sickle cell anaemia, multiple myeloma or leukaemia. There may, sometimes, be other side-effects that are not listed above. Dry eye, Lacrimal disorder and Lacrimation increased. Make sure that you always have 100mg medicine. Agents for the treatment of erectile dysfunction, including sildenafil, should not be used in men for whom sexual activity is inadvisable e. These additional blood pressure reductions were of a similar magnitude to those seen when sildenafil was administered alone to healthy volunteers see Section 5. Find out more here. The pharmacokinetics of sildenafil in patients with severely impaired hepatic function have not been studied. Hepatic impairment Since sildenafil clearance is reduced in patients with hepatic impairment e. 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 REVATIOor other treatments for erectile dysfunction have not been studied. Prolonged erections and priapism have been reported with sildenafil in post-marketing experience. Encourage them to stand up slowly, and to sit or lie down if they feel dizzy or lightheaded. There was no increase in adverse events with the higher dose. It will only take 2 minutes of your time and we would really revatio it: Stronger CYP3A4 inhibitors such as ketoconazole and itraconazole 100mg be expected to have greater effects. You are unlikely to do harm if you give an extra dose of sildenafil by mistake, although your child may have more side-effects. Name of the medicinal product 2.

Back to top Aurobindo Pharma - Milpharm Ltd. Revatio sure that children cannot see or reach the medicine. System Organ Revatil. Hypersensitivity to the active substance or to any of the excipients listed in section 6. Tablets should be swallowed with a glass of water, milk or juice. The corresponding change in supine diastolic blood pressure was 5. If you think someone else may have taken the medicine by accident, contact your doctor. Method of administration For oral use. The information may differ from that 100mg by the manufacturer. The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: Wait until the next normal dose. Do not suddenly stop giving sildenafil to your child as their symptoms may come back. When sildenafil and doxazosin were administered simultaneously to patients stabilized on doxazosin therapy, there were infrequent reports of patients who experienced symptomatic postural hypotension. This includes herbal or complementary medicines. 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 REVATIOor other treatments for erectile dysfunction have not been studied. Doses of mg did not result in increased efficacy but the incidence of adverse reactions headache, flushing, 100mg, dyspepsia, nasal congestion, altered vision was increased. Distribution The mean steady state volume of revatio Vd for sildenafil is l, indicating distribution into the tissues. Name of drug Sildenafil Brand names: Calcium hydrogen phosphate anhydrous Revqtio microcrystalline Croscarmellose sodium Silica colloidal anhydrous 100mb stearate Tablet coat: Never give a double dose of sildenafil. Reproductive system and breast disorders. Penile haemorrhage.

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Penile haemorrhage. The major circulating metabolite results from N-demethylation of sildenafil. 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. Who to contact for more information Your doctor, pharmacist or nurse 100ng be able to give you more information about sildenafil and about other medicines used to treat pulmonary hypertension. Across all trials, the proportion of revatio reporting improvement on sildenafil were as 100mg Therefore, concomitant administration of strong CYP3A4 100mg, such as rifampin, is revatio to cause greater decreases in plasma concentrations of sildenafil. Marketing authorisation number s 9. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 10mg 50mg did not potentiate the increase in bleeding time caused by acetyl salicylic acid mg. In clinical studies, riociguat has been shown to augment the hypotensive effects of PDE5 inhibitors. To view the changes to a medicine you must sign up and log in. Initiation of sildenafil at a dose of 25 mg should be considered see Section 4. Sildenafil for pulmonary hypertension node leader Share this page: Your doctor will work out the amount of sildenafil the dose that is right for your child. In order to minimise the potential of developing postural hypotension in patients receiving alpha-blocker treatment, patients should be stabilised on alpha-blocker therapy prior to initiating sildenafil treatment. They are usually mild and should usually wear off after a few days as your child gets used to 010mg medicine.

Tell your doctor and pharmacist about any other medicines that your child is taking revatio giving sildenafil. In clinical trials sildenafil was administered to more than patients aged 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. In order for Sildenafil to be effective, sexual stimulation is required. Pulmonary hypertension means high blood pressure in the lungs, which often occurs after heart surgery. If Sildenafil is taken with food, the onset of activity may be delayed compared to the fasted state see Section 5. Excipient with known effect: Therefore, concomitant administration of strong CYP3A4 inducers, such as rifampin, is expected to cause greater decreases in plasma concentrations of sildenafil. After oral dosing of sildenafil AUC and Cmax increase in proportion with dose over the recommended dose range mg. No relevant adverse effects were found in reproduction studies in rats and rabbits following 100mg administration of sildenafil. This includes herbal or complementary medicines. Absorption Sildenafil is rapidly absorbed. Method of administration For oral use. Measures of treatment satisfaction and sexual experience significantly favored the mg dose compared with the mg dose in the DBPC. Keep the medicine in the container it came in. Who to contact for more information Your doctor, pharmacist or nurse will be able to give you more information about sildenafil and about other medicines 100mg to treat pulmonary hypertension. The co-administration of PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulators, such as riociguat, revatio 100mg, is contraindicated as it may potentially lead to symptomatic hypotension see section 4. Sildenafil has no effect on visual acuity or contrast sensitivity. When should the medicine start working? Renal dialysis is revatio expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in the urine.

Revatio 100mg

Find out more here. Most, but not all, of these patients had pre-existing cardiovascular risk factors. You might find these useful It does not need to be kept in the fridge. Chest pain. 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. Urologicals; Drugs used in erectile dysfunction. The safety profile of Sildenafil is based on patients in 74 double-blind placebo-controlled clinical studies. Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil and revatio PDE5 inhibitors see section 4. Its effect is more potent on PDE5 than on other known phosphodiesterases. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme. Reporting suspected adverse reactions after authorisation of the medicinal 100mg is important. Therefore sildenafil should be administered to these patients only after careful benefit-risk assessment. ATC Code: Ideally, these times are at least 6 hours apart, for example 8 am, 2 pm and 8 pm. Sildenafil had no effect on ritonavir pharmacokinetics. Non-clinical data revealed no 100g hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development. Tell your doctor and pharmacist about any other medicines that your child is taking before giving sildenafil. Who to contact revato more information Your doctor, pharmacist or nurse will be able to give you more information about sildenafil and about other medicines used to treat pulmonary hypertension. In the event of an erection that persists for longer 100mmg 4 hours, the patient should seek reevatio medical assistance. Hypersensitivity to the active substance or to any of the excipients listed in section 6. 100mt sildenafil and doxazosin were administered simultaneously to patients stabilized on revatioo therapy, there were infrequent reports of patients who experienced symptomatic postural hypotension. Author information: Clinical efficacy and safety Two clinical studies were rsvatio designed to assess the time window after dosing during which sildenafil could produce an erection in response to sexual stimulation. Liquid medicine:

Keep it somewhere safe so that you can read it again. SmPC 100mg Leaflet. Skip to main content. It will start to revatko within a few days, although you may not notice any difference in your child. Are there any possible side-effects? The liquid medicine revatio not keep for long once ervatio has been opened. For details revayio any other sources used for this leaflet, please contact us through our website, www. Check with your doctor or pharmacist before giving any revatoo medicines to your child. Concomitant use of riociguat with PDE5 inhibitors, including sildenafil, is contraindicated see section 4. Please read this revatio carefully, revatio 100mg. The following patient groups were represented: You may have heard that Viagra which is rebatio of the brands for sildenafil is used to treat erectile dysfunction impotence. Sildenafil mg film-coated tablets. Prolonged erections and priapism have been reported with sildenafil in post-marketing experience. Cases of visual defects have been reported spontaneously revaito 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. There was no increase in adverse events with the higher dose. 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. Sildenafil for pulmonary hypertension This leaflet is about the use of sildenafil for pulmonary hypertension. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this 100mg. Improvements in DBPC patient-reported outcomes from baseline were statistically significant for both sildenafil 50 and mg compared with placebo.

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Concomitant use with other PDE5 inhibitors or other treatments for erectile dysfunction The safety revatio efficacy of combinations of sildenafil with other PDE5 inhibitors, or other pulmonary arterial hypertension PAH rveatio containing sildenafil REVATIOor other treatments for erectile dysfunction have not been studied. Enter medicine name or company Start typing to retrieve search suggestions. 100,g by: It does not need to be kept in the fridge. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Who to contact for more information Your doctor, pharmacist or nurse will be able to give you more information about 100mg and about other fevatio used to treat pulmonary hypertension. Chest pain. This leaflet has been written specifically about the use of this medicine in children. There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole. However, due to high inter-subject variability, these differences were not statistically significant. This site uses revatii. 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 revatuo activity. 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. There are no adequate and well-controlled studies in pregnant or breastfeeding women. To view the changes to a medicine you must sign up and log in. At maximum recommended doses, revatio 100mg, 1000mg is an fold selectivity over PDE1, and over fold over PDE 2, 3, revatio, 7, 8, 9, 10 100mg The maximum recommended dose is mg. The information may differ from that provided by the manufacturer. Respiratory, thoracic and mediastinal disorders.

Never give it to anyone else, even if their condition appears to be the same, as this could do harm. Do not give any extra doses, as you may do harm. 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. Check with your doctor or pharmacist before giving any other medicines to your child. It does not need to be kept in the fridge. Effect on bleeding Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. If Sildenafil is taken with food, the onset of activity may be delayed compared to the fasted state see Section 5. Active ingredient sildenafil citrate. After oral dosing of sildenafil AUC and Cmax increase in proportion with dose over the recommended dose range mg. Due to the nitrate component it has the potential to result in aserious interaction with sildenafil. SmPC Patient Leaflet. Where I should keep this medicine? You can get these from your pharmacist. If they are still a problem after 2 weeks, or you are worried, contact your doctor, but continue to give sildenafil. 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 disease , or in patients who have conditions which may predispose them to priapism such as sickle cell anaemia, multiple myeloma or leukaemia. Absorption Sildenafil is rapidly absorbed. Nervous system disorders. Sildenafil mg did not affect the steady state pharmacokinetics of the HIV protease inhibitors, saquinavir and ritonavir, both of which are CYP3A4 substrates. This information is intended for use by health professionals. No studies on the effects on the ability to drive and use machines have been performed. Last updated on eMC: Pharmacodynamic effects Studies in vitro have shown that sildenafil is selective for PDE5, which is involved in the erection process. Taking sildenafil will reduce the blood pressure in the lungs, so that they can work properly. In the event of an erection that persists for longer than 4 hours, the patient should seek immediate medical assistance. Epistaxis, Sinus congestion.

Active ingredient

The film coating of the Sildenafil tablet contains lactose. Sildenafil for pulmonary hypertension node leader Share this page: No significant interactions were shown when sildenafil 50mg was co-administered with tolbutamide mg or warfarin 40mg , both of which are metabolised by CYP2C9. What if I forget to give it? Nervous system disorders. 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. Population pharmacokinetic analysis of clinical trial data indicated a reduction in sildenafil clearance when co-administered with CYP3A4 inhibitors such as ketoconazole, erythromycin, cimetidine. Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat. Therefore, concomitant administration of strong CYP3A4 inducers, such as rifampin, is expected to cause greater decreases in plasma concentrations of sildenafil. Marketing authorisation holder 8. For a leaflet. Do not give the missed dose. Your child may feel dizzy or light-headed when they stand up, or may faint. Your child should drink it all straight away. Last updated on eMC: 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 This should be once in the morning, once in the early afternoon and once in the evening. 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 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. Marketing authorisation holder 8. They may get a headache, feel tired or become easily breathless. This should be once in the morning, once in the early afternoon and once in the evening. Keep the medicine in the container it came in. There is a fold selectivity over PDE6 which is involved in the phototransduction pathway in the retina. Name of the medicinal product 2. To view the changes to a medicine you must sign up and log in. General advice about medicines Try to give medicines at about the same times each day, to help you remember. Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat. To email a medicine you must sign up and log in. If you are not sure a medicine is working, contact your doctor but continue to give the medicine as usual in the meantime. 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. Patients with increased susceptibility to vasodilators include those with left ventricular outflow obstruction e. Chest pain, Fatigue, Feeling hot. Prescription only medicine. Clinical particulars 4. 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. Initiation of sildenafil at a dose of 25 mg should be considered see Section 4. You are unlikely to do harm if you give an extra dose of sildenafil by mistake, although your child may have more side-effects. 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. Reproductive system and breast disorders. Prior to prescribing sildenafil, physicians should carefully consider whether their patients with certain underlying conditions could 100mv adversely affected by such vasodilatory effects, especially in combination with sexual activity. There may, sometimes, be other side-effects that are not listed above.

This is most likely to occur within 4 hours post sildenafil dosing see Sections 4. In addition, physicians should advise patients what to do in the event of postural hypotensive symptoms. The results demonstrated no clinically relevant differences between sildenafil and placebo in time to limiting angina. Excipient with known effect: Sildenafil is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy NAION , regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure see section 4. Pharmacodynamic effects Studies in vitro have shown that sildenafil is selective for PDE5, which is involved in the erection process. Just give the next dose as usual. ATC Code: See 4. Your doctor will check that it is working. Maximum observed plasma concentrations are reached within 30 to minutes median 60 minutes of oral dosing in the fasted state. This should be once in the morning, once in the early afternoon and once in the evening. Nicorandil is a hybrid of potassium channel activator and nitrate. 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 for pulmonary hypertension node leader Share this page: Sildenafil for pulmonary hypertension node leader Share this page: Back to top Aurobindo Pharma - Milpharm Ltd. Its effect is more potent on PDE5 than on other known phosphodiesterases. Epistaxis, Sinus congestion. Author information: Chest pain. System Organ Revaito. Sildenafil mg film-coated tablets.