Eriacta online in Australia

What is Eriacta used for?

Sildenafil is indicated for adult men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual activity.

Sexual stimulation is required for sildenafil to be effective.

Conditions for which this medicine may be prescribed

• Erectile dysfunction

Method of administration and dosage of the drug Eriacta

Dose

Use in adults

The recommended dose is 50 mg taken as needed, approximately one hour before any sexual activity. Depending on the efficacy and tolerance, the dose can be increased to 100 mg or reduced to 25 mg. The maximum recommended dose is 100 mg. The maximum recommended frequency of use is once a day.

If the medicine is taken with food, the action of sildenafil may be delayed compared to taking it on an empty stomach (see section Pharmacokinetic properties).

Special populations

Elderly

No dose adjustment is required in the elderly (≥ 65 years of age).

Renal insufficiency

The dosage recommendations described in the "Use in Adults" section apply to patients with mild to moderate renal impairment (creatinine clearance = 30 to 80 ml / min).

Since sildenafil clearance decreases in patients with severe renal impairment (creatinine clearance minus 30 ml / min), use of a 25 mg dose should be considered. Depending on the efficacy and tolerance, the dose can be gradually increased to 50 mg and up to 100 mg, if necessary.

Liver failure

Since the clearance of sildenafil decreases in patients with hepatic impairment (eg, Cirrhosis), the use of a 25 mg dose should be considered. Depending on the efficacy and tolerance, the dose can be gradually increased to 50 mg and up to 100 mg, if necessary.

Pediatric population

Sildenafil is not indicated for people under the age of 18.

Use in patients taking other medications.

Excluding ritonavir with which the combination is not recommended (see section 4.4), the use of a starting dose of 25 mg should be considered in patients receiving concomitant treatment with CYP3A4 inhibitors (see section Interactions with other medicinal products and other forms of interaction) .

To reduce the risk of postural hypotension in patients receiving alpha-blocker therapy, patients receiving alpha-blocker therapy should be stabilized before starting sildenafil treatment. In addition, consideration should be given to initiating treatment with sildenafil at a dose of 25 mg (see sections 4.4 and 4.4).

Administration form

Oral use.

Possible side effects of Eriacta

• Rhinitis
• Hypersensitivity reaction
• Headache
• Feeling dizzy
• Drowsiness
• Hypoesthesia
• Stroke
• Transient ischemic attack
• Epilepsy crisis
• Recurrent epilepsy attack
• Syncope
• Impaired color vision.
• Chloropsy
• Cyanopsy
• Erythropsy
• Xanthopsie
• Visual disturbance
• Blurry vision
• Lacrimal disorders
• Dry Eye
• Increased tear discharge
• Eye pain
• Photophobia
• Photopsia
• Ocular hyperemia
• Radiance
• Conjunctivitis
• Non-arteritic anterior ischemic optic neuropathy
• Retinal vascular occlusion
• Retinal hemorrhage
• Retinal arteriosclerosis
• Retinal abnormality
• Glaucoma
• Impaired visual field
• Diplopia
• Decreased visual acuity
• Myopia
• Asthenopia
• Eye floats
• Iris disorder
• Mydriasis
• Visual halo
• Eye edema
• Eye swelling
• Eye problems
• Conjunctival hyperemia
• Eye irritation
• Abnormal sensation in the eye.
• Eyelid edema
• Scleral discoloration
• Labyrinthine vertigo
• Tinnitus
• Deafness
• Tachycardia
• Palpitation
• Sudden cardiac death
• Myocardial infarction
• Ventricular arrhythmia
• Atrial fibrillation
• Unstable angina
• Redness
• Hot flushes
• Hypertension
• Hypotension
• Nasal congestion
• Epistaxis
• Sinus congestion
• Feeling of constriction of the pharynx.
• Nasal edema
• Dry nose
• Sickness
• Dyspepsia
• Gastroesophageal reflux
• Vomiting
• Upper abdominal pain
• Dry mouth
• Oral hypoesthesia
• Acne
• Stevens-Johnson syndrome
• Lyell syndrome
• Myalgia
• Pain in the extremities
• Hematuria
• Bleeding from the penis
• Priapism
• Hematospermia
• Increased erection
• Chest pain
• Tired
• Warm feeling
• Irritability
• Incrise of cardiac frecuency

Show more Security profile summary

The safety profile of sildenafil is based on 9,570 patients from 74 double-blind, placebo-controlled clinical trials. The most common side effects reported in clinical trials among sildenafil-treated patients were headache, flushing, dyspepsia, nasal congestion, dizziness, nausea, flushing, visual disturbances, cyanopsy, and blurred vision.

The unwanted effects reported during post-marketing surveillance refer to an estimated period of more than 10 years. The frequencies of these effects cannot be reliably determined as not all undesirable effects are reported to the Marketing Authorization Holder and included in the tolerance database.

Table of adverse reactions.

In the table below, all clinically important undesirable effects, which have appeared in clinical trials with a higher incidence than placebo, are listed by organ system classes and by frequency (very common (≥ 1/10), Common ( ≥ 1/100 and less than 1/10), uncommon (≥1 / 1000 and less than 1/100), rare (≥ 1/10000 and less than 1/1000).

Within each group frequency, adverse reactions should be presented in descending order of severity.

Table 1: Clinically important adverse reactions reported with a higher incidence than placebo in controlled clinical trials and clinically important adverse reactions reported during post-marketing surveillance.

* Only reported during post-marketing surveillance

** Impaired color vision: chloropsia, chromatopsia, cyanopsy, erythropsy and xanthopsia.

*** Tear disorders: dry eyes, tear disorder and increased tear discharge.

Contraindications: when not to use this medicine?

• Sildenafil hypersensitivity
• Contraindication for sexual activity.
• Loss of vision in one eye due to non-arteritic anterior ischemic optic neuropathy
• Severe liver failure
• Hypotension minus 90/50 mmHg
• Stroke history
• History of myocardial infarction
• Retinitis pigmentosa

Hypersensitivity to the active substance or to any of the excipients included in the Composition section.

Given its known effects on the nitric oxide / cyclic guanosine monophosphate (cGMP) pathway (see section Pharmacodynamic properties), sildenafil may potentiate the hypotensive effects of nitrates; Therefore, its concomitant administration with nitric oxide donors (such as amyl nitrite) or with nitrates in any form is contraindicated.

Concomitant administration of PDE5 inhibitors, such as sildenafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated due to the risk of symptomatic hypotension (see section 4.5). other medications and other forms of interactions).

Medicines used to treat erectile dysfunction, including sildenafil, should not be used in men for whom sexual activity is not recommended (for example, patients with severe cardiovascular disorders such as unstable angina or severe heart failure).

Sildenafil is contraindicated in patients who have lost vision in one eye after previous non-arteritic ischemic optic neuropathy (NAION), whether or not this event has been associated with previous exposure to a PDE5 inhibitor (see Warnings and precautions for use).

The safety of sildenafil has not been studied in the following patient subgroups: severe liver failure, hypotension (blood pressure minus 90/50 mmHg), recent history of stroke or myocardial infarction, and inherited retinal degenerative disorders known as retinitis pigmentosa (A minority of these patients have genetic disorders of retinal phosphodiesterases). Its use in these patients, therefore, is contraindicated.

Presentation of this medicine

1, 2, 4, 6, 8, 10, 12, 16, 20, 24 or 28 tablets in ampoules (Aclar / Aluminum).

Not all presentations can be marketed.

Appearance and shape

Tablet.

Sildenafil Sandoz 50 mg tablet is a light blue, round, slightly speckled tablet with a cross marked on one side and the number "50" engraved on the other side.

The tablet can be divided into four equal doses.

Only taking the complete tablet or taking two quarters of tablets simultaneously respects the dose.

Eriacta: its other forms

• Eriacta 50 mg, tablet, box of 24
• Eriacta 100 mg, tablet, box of 24
• Eriacta 25 mg, tablet, box of 4
• Eriacta 25 mg tablet, box of 8
• Eriacta 50 mg tablet, box of 4
• Eriacta 50 mg, tablet, box of 8
• Eriacta 100 mg, tablet, box of 4
• Eriacta 100 mg, tablet, box of 8
• Eriacta 100 mg, tablet, box of 12

View all forms of the drugComposition of the drug Eriacta

* per unit dose Active ingredients: Sildenafil Excipients: calcium hydrogen phosphate (anhydrous), microcrystalline cellulose, copovidone, croscarmellose sodium, magnesium stearate, sodium saccharin, indigotine aluminum lake No excipient with known effect? not present in the composition of this medicine

Effects on ability to drive and use machines

The effects on the ability to drive and use machines have not been studied. Since dizziness and vision disturbances have been reported in clinical studies with sildenafil, patients should know how they react to sildenafil before driving or operating machines.

Warnings and precautions for use

• Indications limited to adult men over 18 years
• Obstacle to expulsion of the left ventricle
• Multiple systemic atrophy
• Cardiovascular risk
• Anatomic malformation of the penis.
• Predisposition to priapism.
• Priapism
• Visual abnormality
• Hemorrhagic disorder
• Active gastroduodenal ulcer
• Severe kidney failure (Clcr minus 30 ml / min)
• Mild to moderate liver failure
• Heavy alcohol consumption

Show more A medical history and clinical examination should be performed to diagnose erectile dysfunction and determine its possible underlying cause before considering medication.

Cardiovascular risk factors.

Before starting treatment for erectile dysfunction, the physician should examine the patient's cardiovascular function, as any sexual activity involves cardiac risk. Sildenafil has vasodilatory properties that result in transient and slight decreases in blood pressure (see Pharmacodynamic properties section). Before prescribing sildenafil, the physician should carefully assess the risk in the patient with certain underlying conditions of being affected by these vasodilatory effects, especially during sexual activity. The patients with the highest sensitivity to vasodilators are those who have an obstacle to ejection in the left ventricle (for example, aortic stenosis, obstructive hypertrophic cardiomyopathy) or those with rare multisystemic atrophy syndrome, which manifests as severe autonomic control failure of blood pressure.

Sildenafil potentiates the hypotensive effects of nitrates (see section Contraindications).

Since its commercialization, serious cardiovascular events such as myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension and hypotension have been reported with the use of sildenafil Most, but not all, of these patients they had pre-existing cardiovascular risk factors. Many events have been reported to occur during or shortly after intercourse, and some were reported to occur after using sildenafil without sexual activity. It is not possible to determine if these events are directly related to these or other factors.

Priapism

Medicines used to treat erectile dysfunction, such as sildenafil, should be used with caution in patients with an anatomical deformation of the penis (such as angulation, sclerosis of the corpora cavernosa or Peyronie's disease) or in patients presenting pathologies that may predispose them to priapism ( such as sickle cell anemia, multiple myeloma, or leukemia).

Prolonged erections and priapism have been reported in post-marketing experience in patients receiving sildenafil. If an erection lasts more than 4 hours, the patient should seek medical help immediately. If priapism is not treated right away, it can lead to damage to penile tissue and permanent impotence.

Concomitant use with other PDE5 inhibitors or other treatments for erectile dysfunction

The safety and efficacy of combining sildenafil with other PDE5 inhibitors, other treatments for pulmonary arterial hypertension (PAH) containing sildenafil, or other treatments for erectile dysfunction have not been studied. . Therefore, it is not recommended to use such associations.

Effects on vision.

Visual abnormalities have been reported spontaneously after the use of sildenafil and other PDE5 inhibitors (see section 4.8). Non-arteritic anterior ischemic optic neuropathy, a rare disease, was reported spontaneously in an observational study after the use of sildenafil and other PDE5 inhibitors (see section 4.8). Patients should be advised that, in case of any sudden visual defect, they should stop taking sildenafil and seek immediate medical attention (see section 4.3).

Concomitant use of ritonavir

Concomitant administration of sildenafil and ritonavir is not recommended (see section Interactions with other medicinal products and other forms of interaction).

Concomitant use of alpha blockers

Caution is advised when administering sildenafil to patients taking an alpha-blocker, as concomitant administration may cause symptomatic hypotension in certain susceptible individuals (see section Interactions with other medicinal products and other forms of interaction). ) This occurs most often within 4 hours of taking sildenafil. To reduce the risk of developing orthostatic hypotension, patients receiving alpha-blocker therapy should be hemodynamically stable before starting sildenafil treatment. The initiation of treatment with sildenafil at a dose of 25 mg should be considered (see section 4.2). In addition, the doctor should warn the patient about the action to take in case of symptoms of orthostatic hypotension.

Effect on bleeding

Studies in human blood platelets show that sildenafil enhances the antiplatelet effect of sodium nitroprusside in vitro. There are no data on the safety of sildenafil in patients with bleeding disorders or active peptic ulcer. Therefore, sildenafil should only be administered to these patients after careful evaluation of the risk-benefit balance.

Women

Sildenafil is not indicated for women.

Mechanism of action: how does it work?

Pharmacotherapeutic group: urological: drugs used in erectile dysfunction, ATC code: G04BE03

Mechanism of action

Sildenafil is an oral treatment for erectile dysfunction. Under natural conditions, that is, with sexual stimulation, it restores poor erectile function by increasing blood flow to the penis.

The physiological mechanism responsible for penile erection involves the release of nitric oxide (NO) in the corpora cavernosa during sexual stimulation. Nitric oxide then activates the enzyme guanylate cyclase, leading to an increase in cyclic guanosine monophosphate (cGMP) concentrations by inducing relaxation of the smooth muscles of the corpora cavernosa and promoting blood flow.

Sildenafil is a potent and selective inhibitor of cGMP-specific phosphodiesterase type 5 (PDE5) in the corpora cavernosa; This is where PDE5 is responsible for the degradation of cGMP. Sildenafil has a site of peripheral action on erections. Sildenafil does not have a direct relaxing effect on the tissue of isolated human cavernous bodies, but it significantly improves the relaxing effects of NO on this tissue. When the NO / cGMP pathway is activated, as during sexual stimulation, inhibition of PDE5 by sildenafil leads to increased concentrations of cGMP in the corpora cavernosa. Therefore, sexual stimulation is necessary for sildenafil to produce its beneficial pharmacological effects.

Pharmacodynamic effects

In vitro studies have shown that sildenafil is selective for PDE5, which participates in the erectile process. Its effect is more powerful in PDE5 than in other known phosphodiesterases. There is a 10 times greater selectivity compared to PDE6, involved in the phototransduction process of the retina. At the maximum recommended doses, there is a selectivity of 80 times compared to PDE1 and more than 700 times compared to PDE2, 3, 4, 7, 8, 9, 10 and 11. In particular, sildenafil is more than 4,000 times more. selective for PDE5 than for PDE3, the cAMP-specific phosphodiesterase isoform involved in the control of cardiac contractility.

Clinical efficacy and safety

Two clinical studies were specifically designed to assess when and after how long sildenafil could induce an erection in response to sexual stimulation. In a study of penile plethysmography (RigiScan) in fasting patients taking sildenafil, the mean time to achieve an erection sufficient for intercourse (stiffness 60%) was 25 minutes (range: 12 to 37 minutes) In another study With RigiScan, sildenafil could still induce an erection in response to sexual stimulation 4 to 5 hours after administration.

Sildenafil causes small transient drops in blood pressure that, in most cases, have no clinical effect. The maximum mean decrease in systolic blood pressure when reclined after oral administration of 100 mg sildenafil was 8.4 mmHg. The corresponding change in diastolic blood pressure at bedtime was 5.5 mmHg. These reductions in blood pressure are consistent with the vasodilatory effects of sildenafil, possibly due to the increase in cGMP concentrations in smooth vascular muscles. Single oral sildenafil doses up to 100 mg administered to healthy volunteers have had no clinically relevant effect on the ECG.

In a study of the hemodynamic effects of a single oral dose of sildenafil 100 mg in 14 patients with severe coronary artery disease (stenosis plus 70% of at least one coronary artery), mean systolic and diastolic blood pressure decreased by 7% and 6% respectively of the initial value. The average pulmonary systolic pressure decreased by 9%. No effect of sildenafil on cardiac output or any reduction in blood flow in the stenosed coronary arteries has been demonstrated.

A double-blind, placebo-controlled trial evaluated 144 patients with erectile dysfunction and chronic stable angina pectoris who were taking exertional anti-angina pectoris (except nitrates) therapy regularly. No clinically significant difference between sildenafil and placebo. at the time since the onset of an angina attack.

Mild and transient differences in color differentiation (blue and green) have been detected in some subjects using the Farnsworth-Munsell 100 color test that assesses color difference one hour after administration of a 100 mg dose. ; two hours after administration, no further effects were noted. The advanced mechanism of this change in color distinction is related to PDE6 inhibition, which plays a role in the retina phototransduction cascade. Sildenafil has no effect on visual acuity or contrast sensitivity. In a placebo-controlled study in a small number of patients with a documented form of early macular degeneration (n = 9), sildenafil (single dose, 100 mg) showed no significant change in visual testing (visual acuity, Amsler, color distinction simulating traffic lights, Humphrey's perimeter and photostress).

There was no effect on sperm motility or morphology after oral administration of a single 100 mg dose of sildenafil in healthy volunteers (see section Fertility, pregnancy and lactation).

Other information on clinical trials

In clinical studies, sildenafil has been administered to more than 8,000 patients between the ages of 19 and 87.

The following groups of patients were represented: elderly (19.9%), patients with hypertension (30.9%), diabetes mellitus (20.3%), ischemic heart disease (5.8%), hyperlipidemia (19.8%), spinal cord injury (0.6 %), depression (5.2%), transurethral resection of the prostate (3.7%), radical prostatectomy (3.3%). In contrast, the following groups were poorly represented or excluded from clinical studies: patients who underwent pelvic surgery or radiation therapy, patients with severe kidney or liver failure, and patients with certain cardiovascular conditions (see section Contraindications).

In fixed-dose studies, the proportion of patients reporting improvement in their erections through treatment was 62% (25 mg), 74% (50 mg), and 82% (100 mg) compared to 25% in patients receiving placebo In clinical studies, the rate of discontinuation of treatment due to sildenafil was low and similar to placebo. Combining all studies, the proportion of sildenafil patients reporting improvement was (per population) 84% (psychogenic erectile dysfunction), 77% (mixed erectile dysfunction), 68% (organic erectile dysfunction), 67% (elderly), 59 % (diabetes mellitus), 69% (ischemic heart disease), 68% (hypertensive), 61% (transurethral resection of the prostate), 43% (radical prostatectomy), 83% (spinal cord injury) and 75% (depression ). The safety and efficacy of sildenafil were maintained in long-term studies.

Pediatric population

The Australian Medicines Agency has canceled the obligation to present the results of pediatric studies with sildenafil for the treatment of erectile dysfunction. For information on use in the pediatric population, see the Dosage and method of administration section.

Interactions: do not take this medicine with ..

Effects of other medicinal products on sildenafil

In vitro studies

Sildenafil is metabolized mainly by isoenzymes 3A4 (main route) and 2C9 (secondary route) of cytochrome P450 (CYP). Therefore, inhibitors of these isoenzymes can decrease sildenafil clearance and inducers of these isoenzymes can increase sildenafil clearance.

In vivo studies

Population pharmacokinetic analysis of clinical trial data has shown a decreased clearance of sildenafil when co-administered with CYP3A4 inhibitors (such as ketoconazole, erythromycin, cimetidine). Although the incidence of side effects has not been increased in these patients, when co-administered with sildenafil and CYP3A4 inhibitors, a starting dose of 25 mg should be considered.

Concomitant administration of 100 mg single dose of sildenafil with protease inhibitor ritonavir, a very potent inhibitor of cytochrome P 450, at steady state (500 mg twice daily), increased by 300% (4-fold) of C max of sildenafil and a 1000% (11-fold) increase in plasma AUC of sildenafil. After 24 hours, plasma sildenafil concentrations were still approximately 200 ng / mL, compared to approximately 5 ng / mL when sildenafil was administered alone. This is consistent with the marked effects of ritonavir on a large number of P 450 cytochrome substrates. Sildenafil has no effect on ritonavir pharmacokinetics. In view of these pharmacokinetic results, concomitant administration of sildenafil and ritonavir is not recommended (see section 4.4), and in no case should the maximum sildenafil dose exceed 25 mg in 48 hours.

Co-administration of 100 mg sildenafil as a single dose with saquinavir protease inhibitor, a CYP3A4 inhibitor, at steady state (1200 mg three times daily), produced a 140% increase in sildenafil C max and an increase 210% in the AUC of sildenafil. Sildenafil has no effect on the pharmacokinetics of saquinavir (see section 4.2). We can expect to see more marked effects with potent CYP3A4 inhibitors such as ketoconazole and itraconazole.

A 182% increase in systemic exposure to sildenafil (AUC) was observed when taking a single 100 mg dose of sildenafil with erythromycin (moderate CYP3A4 inhibitor) balance (500 mg twice daily for 5 days). In healthy male volunteers, no effect of azithromycin (500 mg daily for 3 days) was observed on AUC, on C max, on let max, on the constant elimination rate or half-life of sildenafil or its major circulating metabolite. Co-administration of sildenafil (50 mg) and cimetidine (800 mg), a cytochrome P450 inhibitor, and a non-specific CYP3A4 inhibitor, resulted in a 56% increase in plasma sildenafil concentrations in healthy volunteers.

Grapefruit juice is a weak inhibitor of CYP3A4-mediated metabolism in the intestinal wall and may slightly increase plasma concentrations of sildenafil. Antacids (magnesium hydroxide / aluminum hydroxide) in single doses have no effect on the bioavailability of sildenafil.

Although specific interaction studies have not been performed for all medicinal products, population pharmacokinetic analysis has shown that co-administration of substances from the CYP2C9 group of inhibitors (such as tolbutamide, warfarin, phenytoin) or CYP2D6 (as specific inhibitors of serotonin reuptake, tricyclic antidepressants), thiazides and related diuretics, loop diuretics and potassium conservers, converting enzyme inhibitors Angiotensin, calcium channel blockers, beta-adrenergic receptor blockers or metabolism inducers CYP 450 mediated (such as rifampicin and barbiturates) had no effect on the pharmacokinetics of sildenafil. In a study in healthy male volunteers, concomitant administration of endothelin antagonists bosentan (a moderate inducer of CYP3A4, CYP2C9 and possibly CYP2C19) at steady state (125 mg twice daily) and sildenafil at steady state (80 mg three times a day) resulted in a decrease of 62.6% and 55.4% respectively in AUC and maxCar for sildenafil. Therefore, co-administration of potent CYP3A4 inducers, such as rifampicin, is expected to lead to further decreases in plasma concentrations of sildenafil.

Nicorandil is a hybrid compound of potassium channel activator and nitro derivative. Due to the nitro derived component, it can cause severe interaction with sildenafil.

Effects of sildenafil on other medications.

In vitro studies

Sildenafil is a weak inhibitor of isoenzymes 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50 plus 150 µM) of cytochrome P 450. The maximum plasma concentration of sildenafil is approximately 1 µM after administration at recommended doses. , en Sildenafil is unlikely to affect the removal of substrates for these isoenzymes.

There are no data available on the interaction between sildenafil and nonspecific phosphodiesterase inhibitors, such as theophylline or dipyridamole.

In vivo studies

Given its known effects on the nitric oxide / cyclic guanosine monophosphate (cGMP) pathway (see section Pharmacodynamic properties), sildenafil may potentiate the hypotensive effects of nitrates: its concomitant administration with donors of nitrogen monoxide (such as amyl nitrite ) or with nitrates in any form, therefore it is contraindicated (see section Contraindications).

Riociguat: Preclinical studies have shown an additive effect in lowering systemic blood pressure when PDE5 inhibitors are combined with riociguat. In clinical studies, the hypotensive effect of PDE5 inhibitors was increased with riociguat. In the study population, there is no evidence of a beneficial clinical effect of this association. Co-administration of riociguat with PDE5 inhibitors, including sildenafil, is contraindicated (see section 4.3).

Concomitant administration of sildenafil to patients taking alpha-blocker therapy may cause symptomatic hypotension in some susceptible individuals. This occurs most frequently within 4 hours after taking sildenafil (see sections 4.2 and 4.4 and Warnings and precautions for use). In three specific drug interaction studies, alpha-blockers doxazosin (4 mg and 8 mg) and sildenafil (25 mg, 50 mg or 100 mg) were administered simultaneously in patients with benign prostatic hyperplasia (BPH) stabilized under doxazosin treatment. In the populations of these studies, additional mean reductions in standing blood pressure of 7/7 mmHg, 9/5 mmHg, and 8/4 mmHg and additional mean reductions in standing blood pressure of 6/6 mmHg, 11 were observed. / 4 mmHg and 4/5 mmHg, respectively. When sildenafil and doxazosin were co-administered to patients stabilized with doxazosin therapy, rare reports of patients with symptomatic orthostatic hypotension were observed. These reports included dizziness and intoxicating sensations, but not fainting.

No significant interaction was observed when co-administered with sildenafil (50 mg) and tolbutamide (250 mg) or warfarin (40 mg), two substances metabolized by CYP2C9.

Sildenafil (50 mg) does not potentiate the lengthening of bleeding time induced by acetylsalicylic acid (150 mg).

Sildenafil (50 mg) does not potentiate the hypotensive effect of alcohol in healthy volunteers with an average maximum blood alcohol concentration of 80 mg / dl.

Compared to placebo, there was no difference in the safety profile of patients taking sildenafil in combination with one of the following classes of antihypertensive drugs: diuretics, beta-blockers, ACE inhibitors, angiotensin II inhibitors, vasodilators, antihypertensive drugs. central action, adrenergic antagonists, calcium channel blockers and alpha blockers. In a specific interaction study where sildenafil (100 mg) was administered with amlodipine in hypertensive patients, a further decrease in systolic blood pressure of 8 mmHg was observed while lying down. The corresponding decrease in diastolic blood pressure was 7 mmHg while lying down. These additional reductions in blood pressure were similar to those observed when sildenafil was administered only to healthy volunteers (see section 5.2).

Sildenafil (100 mg) does not affect the steady-state pharmacokinetics of saquinavir and ritonavir, two HIV protease inhibitors that are substrates for CYP3A4.

In healthy male volunteers, steady state sildenafil (80 mg three times a day) resulted in a 49.8% increase in AUC for bosentan and a 42% increase in C max bosentan (125 mg twice a day). .

Incompatibilities

Aimlessly.

How to react in case of overdose?

In studies in volunteers receiving single doses of up to 800 mg, the side effects were the same as for lower doses, but their incidence and severity increased. The 200 mg doses did not show greater efficacy, but the incidence of adverse effects (headache, hot flashes, dizziness, dyspepsia, nasal congestion, vision problems) increased.

In the event of an overdose, the usual symptomatic treatment measures should be implemented as necessary. Kidney dialysis should not accelerate the elimination of sildenafil, which is strongly bound to plasma proteins and is not excreted in the urine.

Eriacta: pregnancy, lactation and fertility

Sildenafil is not indicated for women.

There have been no adequate and adequately controlled studies in pregnant or lactating women.

In reproductive studies in rats and rabbits, no relevant side effects were observed after oral administration of sildenafil.

There was no effect on sperm motility or morphology after oral administration of a single 100 mg dose of sildenafil in healthy volunteers (see Pharmacodynamic properties section).

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