Name of the medicinal product Sildenafil mg film-coated tablets 2. Qualitative and quantitative composition Each film-coated tablet contains mg Sildenafil as sildenafil citrate, co sildenafil 100mg.
Excipient with known effect: Each 50 mg film-coated tablet contains 7. For the full list of excipients, co sildenafil 100mg, see section 6.
Pharmaceutical form Film-coated tablet White to off-white, round In order for Sildenafil 100mg be effective, sexual stimulation is required, co sildenafil 100mg. Based on efficacy and tolerability, the dose may be increased to mg or decreased to 25mg.
The maximum recommended dose is mg, co sildenafil 100mg. The maximum recommended dosing frequency is once per day. If Sildenafil is taken with food, the onset of activity may be delayed compared to the fasted state see Section 5. Based on efficacy and tolerability, the dose may be increased step-wise to 50mg and mg as sildenafil. Hepatic impairment Since sildenafil clearance is reduced in sildenafil with hepatic impairment e. Paediatric population Sildenafil is not indicated for individuals below 18 years of age.
Use in patients taking other aldara 5 cheap products With the exception of ritonavir for which co-administration with sildenafil is not advised see Section 4. In order to minimise the potential of developing postural hypotension in patients receiving 100mg treatment, patients should be stabilised on alpha-blocker therapy prior to initiating sildenafil treatment.
In addition, initiation of sildenafil at a dose of 25 mg should be considered see Sections 4. Method of administration 4. The co-administration of PDE5 inhibitors, including sildenafil, co sildenafil 100mg, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension sildenafil section 4. Agents for the treatment of erectile dysfunction, including sildenafil, should not be used in men for whom sexual activity sildenafil inadvisable e.
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 100mg or not with previous PDE5 inhibitor exposure see section 4. The safety of sildenafil has not been studied in the following sub-groups of patients and its sildenafil is therefore contraindicated: 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 100mg cardiac risk associated with sexual activity.
Sildenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure see Section 5. 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 100mg with sexual activity, co sildenafil 100mg.
Patients with increased susceptibility to vasodilators include those with left ventricular outflow obstruction e. Sildenafil potentiates the hypotensive effect of nitrates see Section 4.
Serious cardiovascular events, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, co sildenafil 100mg, transient ischaemic sildenafil, hypertension and hypotension have been reported post-marketing in temporal association with the use of Sildenafil. Most, but not all, of these patients had pre-existing cardiovascular risk factors.
Many events were reported to occur during or shortly after sexual intercourse and a few were reported to occur shortly after the 100mg of Sildenafil without sexual activity. It is not possible to determine whether sildenafil events are sildenafil directly to these factors or to other factors.
Prolonged erections and priapism have been reported with sildenafil in post-marketing experience. In the event of an erection that persists for longer than 4 hours, the patient should seek immediate medical assistance, co sildenafil 100mg.
If priapism is not treated immediately, co sildenafil 100mg, penile tissue damage and permanent loss of potency 100mg result. Concomitant use with other PDE5 inhibitors or other treatments for erectile dysfunction The 100mg and efficacy of combinations of sildenafil with other PDE5 inhibitors, or other pulmonary arterial hypertension PAH treatments containing sildenafil REVATIOco sildenafil 100mg, or other treatments for erectile dysfunction have not been studied.
Therefore the use of such combinations is not recommended. Effects on vision Cases of visual defects have been reported spontaneously in connection with the intake of 100mg and other PDE5 inhibitors see section 4. Cases of non-arteritic anterior ischaemic optic neuropathy, co sildenafil 100mg, 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 should be advised that in the event of any sudden 100mg defect, they should stop taking sildenafil and consult a physician immediately see section 4. Concomitant use with ritonavir Co-administration of sildenafil with ritonavir is not advised see Section 4. Concomitant use with alpha-blockers Caution is advised when sildenafil is administered to patients taking an sildenafil, as the coadministration may lead to symptomatic hypotension in a few susceptible individuals see Section sildenafil.
This is most likely to occur within 4 hours post sildenafil dosing. In order to minimise the potential buy imodium capsules developing postural hypotension, patients should be hemodynamically stable on alpha-blocker therapy prior to initiating sildenafil treatment. Initiation of sildenafil at a dose of 25 mg should be considered see Section 4.
In addition, physicians should advise patients what to do in the event of postural hypotensive symptoms. Effect on bleeding Studies with 100mg platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. There is no safety information on the administration of sildenafil to patients with bleeding disorders or active peptic ulceration. Therefore sildenafil should be administered to these patients only after careful benefit-risk assessment.
The film coating of the Sildenafil tablet contains sildenafil. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this 100mg.
Sildenafil is not indicated for use by women. Sildenafil metabolism is principally mediated by the cytochrome P CYP isoforms 3A4 major route and 2C9 minor route.
Therefore, co sildenafil 100mg, inhibitors of these isoenzymes may reduce sildenafil clearance and inducers of these isoenzymes may increase sildenafil clearance. Population pharmacokinetic analysis of clinical trial data indicated a reduction in sildenafil clearance when co-administered with CYP3A4 inhibitors such as ketoconazole, erythromycin, cimetidine, co sildenafil 100mg.
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 had no effect on ritonavir pharmacokinetics. Based on these pharmacokinetic sildenafil co-administration of sildenafil with ritonavir is not advised see Section 4.
Sildenafil had no effect on saquinavir pharmacokinetics see Section 4. Stronger CYP3A4 inhibitors such as ketoconazole and itraconazole would be expected to have greater effects.
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, co sildenafil 100mg, or subsequent half-life of sildenafil or its principal circulating metabolite. Grapefruit juice is a weak inhibitor of CYP3A4 gut wall metabolism and may give rise to modest increases in plasma levels of celebrex buy in canada. 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, sildenafil and potassium sparing diuretics, angiotensin converting sildenafil inhibitors, calcium channel blockers, beta-adrenoreceptor antagonists or inducers of CYP metabolism such as rifampicin, barbiturates.
In a study of healthy male volunteers, co-administration of the endothelin antagonist, bosentan, an inducer of CYP3A4 [moderate], co sildenafil 100mg, 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 Therefore, concomitant administration of strong CYP3A4 100mg, such as rifampin, is expected to cause greater decreases in plasma concentrations of sildenafil.
Nicorandil is a hybrid of potassium channel 100mg and nitrate. Due to the nitrate component it has the potential to result in aserious interaction with sildenafil, co sildenafil 100mg.
Effects sildenafil sildenafil on other medicinal products In vitro studies: There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole. Preclinical studies showed additive systemic blood sildenafil lowering effect when PDE5 inhibitors were combined with riociguat. In clinical studies, riociguat has been shown to augment the hypotensive effects of PDE5 inhibitors. There was no evidence of favourable sildenafil effect of the combination sildenafil cefaclor 500 pharma population studied, co sildenafil 100mg.
Concomitant use of riociguat with PDE5 inhibitors, including sildenafil, is contraindicated see section 4. Concomitant administration of sildenafil to patients taking alpha-blocker therapy may lead to symptomatic hypotension in a few susceptible individuals. This is most likely to occur within 4 hours post sildenafil dosing see Sections 4. 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 avapro tab 300mg on doxazosin therapy.
When sildenafil and doxazosin were administered simultaneously to patients stabilized on doxazosin therapy, there were infrequent reports of patients 100mg experienced symptomatic postural hypotension. These reports included dizziness and light-headedness, co sildenafil 100mg, but not syncope. No significant interactions were shown when 100mg 50mg was co-administered with tolbutamide mg or warfarin 40mgboth of which are metabolised by CYP2C9, co sildenafil 100mg.
Sildenafil 50mg did not potentiate the increase in bleeding time caused by acetyl salicylic acid mg. Pooling of the following classes of antihypertensive medication; diuretics, co sildenafil 100mg, beta-blockers, ACE inhibitors, angiotensin II antagonists, antihypertensive medicinal products vasodilator and centrally-actingadrenergic 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.
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. The 100mg additional reduction in supine diastolic blood pressure was 7 mmHg. These additional blood pressure reductions were of a similar magnitude to those seen when sildenafil was administered alone to healthy volunteers see Section 5.
Sildenafil mg did not sildenafil the sildenafil state pharmacokinetics of the HIV protease inhibitors, saquinavir and ritonavir, both of which are CYP3A4 substrates. In healthy male volunteers, sildenafil at steady state 80 mg 100mg. There are no adequate and well-controlled studies in pregnant or breastfeeding women. No relevant adverse effects were found in reproduction studies in rats and rabbits following oral administration of sildenafil.
There was no effect on sperm motility 100mg morphology after single mg oral doses of sildenafil in healthy volunteers see section 5, co sildenafil 100mg. As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they react to Sildenafil, co sildenafil 100mg, before driving or operating machinery.
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, co sildenafil 100mg. Because not all adverse reactions are reported to the Marketing Authorisation Holder and included in the safety database, the frequencies of these reactions cannot be reliably determined.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness, co sildenafil 100mg. Medically important adverse reactions reported at an incidence greater than placebo in controlled clinical studies and medically important adverse 100mg reported through post-marketing surveillance System Organ Class.
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