Suhagra online in Australia

What is Suhagra used for?

Suhagra is indicated in adult men with erectile dysfunction, which is the inability to achieve or maintain an erection of the penis sufficient for satisfactory sexual activity.

Sexual stimulation is required for Suhagra to be effective.

Conditions for which this medicine may be prescribed

• Erectile dysfunction

Method of administration and dosage of the drug Suhagra

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 frequency of use is once a day.

If the medicine is taken with food, the action of Suhagra 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 paragraph "Use in adults" 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

Suhagra is not indicated for people under 18 years of age.

Use in patients taking other medications.

Excluding ritonavir for 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 minimize the possible occurrence of orthostatic 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 Suhagra

• 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
• Visual field impairment
• 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
• Vertigo maze
• 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
• Allergic reaction

See 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 adverse reactions reported in clinical trials among sildenafil-treated patients were headache, redness, dyspepsia, nasal congestion, dizziness, nausea, redness, 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 that have appeared during 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) .Side effects should be presented in descending order of gravity.

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
• Allura AC network 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

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

Given the knowledge of its mode of action in the pathway of nitrogen monoxide / cyclic guanosine monophosphate (cGMP) (see section Pharmacodynamic properties), an enhancement of the hypotensive effects of nitrates by sildenafil has been demonstrated; Therefore, its concomitant administration with nitric oxide donors (such as amyl nitrite) or with nitrates in any form is contraindicated.

Co-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 Interactions with other medicinal products and other forms of interaction)

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).

Suhagra is contraindicated in patients with vision loss in one eye due to anterior non-arteritic ischemic optic neuropathy (NAIAN), whether or not this event has been associated with prior exposure to a PDE5 inhibitor (See Warnings and Precautions section of 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 known inherited degenerative disorders of the retina, such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).

Presentation of this medicine

Inserts (PVC / PVDC / Aluminum).

Boxes of 1, 2, 4, 8 or 12 tablets.

Not all presentations can be marketed.

Appearance and shape

Compressed film.

Blue oval tablet, engraved "50" on one side and with a punctuation line on the other.

The break bar only makes it easier to take the tablet, it doesn't divide it into equal doses.

Suhagra: its other forms

• Suhagra 50 mg film-coated tablet, box of 4
• Suhagra 50 mg film-coated tablet, box of 8
• Suhagra 100 mg film-coated tablet, box of 4
• Suhagra 100 mg film-coated tablet, box of 8
• Suhagra 100 mg film-coated tablet, box of 12

Composition of the drug Suhagra

* per unit dose Active ingredients: Sildenafil Thinners with known effects? : Allura AC red aluminum lacquer Other excipients: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate, opadry II blue: polyvinyl alcohol, talc, macrogol 4000, titanium oxide, indigotine aluminum lacquer, oxide of black iron driving and using machines

Sildenafil may have a minor influence on the ability to drive and use machines.

Since dizziness and vision disorders have been reported in clinical studies with sildenafil, patients should know how they react to Suhagra before driving a vehicle or operating machinery.

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

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

Cardiovascular risk factors.

Before starting treatment for erectile dysfunction, physicians should examine the cardiovascular function of their patients, as any sexual activity carries a cardiac risk. Sildenafil has vasodilatory properties that result in transient and slight decreases in blood pressure (see Pharmacodynamic properties section). Before prescribing sildenafil, doctors should carefully assess the potential risk in patients who may have certain underlying conditions affected by these vasodilatory effects, especially during sexual activity. Patients with increased sensitivity to vasodilators are those who have an obstacle to left ventricular ejection (eg, aortic stenosis, obstructive hypertrophic cardiomyopathy), or the rare syndrome of multiple system atrophy, which manifests as severe insufficiency of the autonomous control of blood pressure.

Suhagra enhances 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. use of sildenafil. Most, but not all, of these patients 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 the use of sildenafil without sexual activity. It is not possible to determine if these events are directly related to these or other factors.

Priapism

Medicines to treat erectile dysfunction, including 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 (REVATIO), 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 Suhagra 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 sildenafil is administered to patients taking an alpha-blocker, as co-administration may cause symptomatic hypotension in a small number of susceptible individuals (see section Interactions with other medicinal products and other forms of interactions). This occurs more frequently within 4 hours of taking sildenafil. In order to minimize the possible occurrence of orthostatic hypotension, patients on alpha-blockers should be hemodynamically stable before starting sildenafil treatment. The initiation of treatment with a dose of 25 mg should be considered (see section 4.2). Additionally, physicians should advise their patients what to do 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

Suhagra is not indicated in women.

Mechanism of action: how does it work?

Pharmacotherapeutic group: urological; medicines used in erectile dysfunction, ATC code: G04B E03.

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. Nitrogen oxide then activates the enzyme guanylate cyclase, leading to an increase in cyclic guanosine monophosphate (cGMP) concentrations, which induces relaxation of the smooth muscles of the corpora cavernosa and promotes 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 evaluate 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 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 certain subjects using the Farnsworth-Munsell 100 test, which evaluates the 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 of 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 waived the obligation to report the results of studies with sildenafil in all subgroups of the pediatric population for the treatment of erectile dysfunction (see section 4.2). for information on pediatric use).

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.

Co-administration of 100 mg single-dose sildenafil with ritonavir antiprotease, a very potent steady state cytochrome P 450 inhibitor (500 mg twice daily), produced a 300% (4-fold) increase in C max. sildenafil and a 1000% (11-fold) increase in sildenafil AUC. After 24 hours, the plasma concentrations of sildenafil were still approximately 200 ng / ml, while they were approximately 5 ng / ml when sildenafil alone was administered. 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 any case, the maximum dose of sildenafil should not exceed 25 mg in 48 hours

Concomitant administration of 100 mg sildenafil once daily with saquinavir antiprotease, a CYP3A4 inhibitor, at steady state (1200 mg three times daily) resulted in a 140% increase in C max of sildenafil and an increase in 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 reuptake of serotonin, tricyclic antidepressants), thiazides and related diuretics, loop diuretics and potassium preservatives, conversion enzyme inhibitors Angiotensin, calcium channel blockers, beta-adrenergic receptor blockers or inducers of CYP 450-mediated metabolisms (such as rifampicin and barbiturates) had no effect on the pharmacokinetics of sildenafil. In a study in healthy male volunteers, concomitant administration of the endothelin antagonist, 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 62.6% and 55.4% decrease in AUC and C max of sildenafil respectively. 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 of potassium channel activator and nitro derivative. Due to the nitro derived component, it can cause severe interaction with sildenafil.

Sildenafil effects on other medicines.

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. Suhagra is unlikely to affect the removal of substrates for these isoenzymes.

No interaction data are available between sildenafil and nonspecific phosphodiesterase inhibitors, such as theophylline or dipyridamole.

In vivo studies

Given the knowledge of its mode of action at the level of the nitric oxide / cGMP pathway (see section Pharmacodynamic properties), an enhancement of the hypotensive effects of nitrate derivatives by sildenafil has been demonstrated; therefore, its concomitant administration with nitric oxide donors or nitro derivatives in any form is contraindicated (see section Contraindications).

Riociguat

Preclinical studies have shown an increase in the systemic hypotensive effect when PDE5 inhibitors were combined with riociguat. In clinical studies, riociguat has been shown to increase the hypotensive effects of PDE5 inhibitors. No benefit of association has been demonstrated in the study population. Concomitant use of riociguat with PDE5 inhibitors, such as sildenafil, is contraindicated (see section 4.3).

Concomitant administration of sildenafil to patients taking alpha-blocker therapy may cause symptomatic hypotension in a small number of 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 blood pressure from 7/7 mmHg, 9/5 mmHg, and 8/4 mmHg and additional mean reductions in blood pressure at a standing position of 6/6 mmHg, 11/4 mmHg and 4/5 mmHg were observed, 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 in patients taking sildenafil in combination with one of the following classes of antihypertensives: diuretics, beta-blockers, ACE inhibitors, angiotensin II inhibitors, vasodilators, action antihypertensives. central, 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 5.1).

Sildenafil (100 mg) does not affect the steady-state pharmacokinetics of saquinavir and ritonavir, two CYP3A4 antiprotease substrates.

In healthy male volunteers, sildenafil at steady state (80 mg three times a day) produced 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 do not provide greater efficacy, but increased the incidence of adverse effects (headache, redness of the face, dizziness, dyspepsia, nasal congestion, blurred vision).

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.

Suhagra: pregnancy, lactation and fertility

Suhagra is not indicated in 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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