Instructions for use Potenciale film-coated tablets 50 mg blister No. 4
Composition
active ingredient: sildenafil citrate;
1 tablet contains sildenafil citrate equivalent to sildenafil – 50 mg or 100 mg;
excipients: microcrystalline cellulose, croscarmellose sodium, hypromellose, magnesium stearate, colloidal anhydrous silicon dioxide, titanium dioxide (E 171), talc, propylene glycol, polyethylene glycol 6000 (macrogol 6000), indigo carmine (E 132).
Dosage form
Film-coated tablets.
Main physicochemical properties: round, film-coated tablets, blue (for 50 mg dosage) or blue (for 100 mg dosage), with convex upper and lower surfaces. When broken, when viewed under a magnifying glass, a core surrounded by one continuous layer is visible.
Pharmacotherapeutic group
Drugs used for erectile dysfunction. Sildenafil. ATX code G04B E03.
Pharmacological properties
Pharmacodynamics
Mechanism of action: Sildenafil is an oral drug used to treat erectile dysfunction. During sexual arousal, the drug restores impaired erectile function by increasing blood flow to the penis.
The physiological mechanism that causes an erection involves the release of nitric oxide (NO) in the corpora cavernosa during sexual arousal. The released nitric oxide activates the enzyme guanylate cyclase, which stimulates an increase in cyclic guanosine monophosphate (cGMP) levels, which in turn causes relaxation of the smooth muscle of the corpora cavernosa, facilitating blood flow.
Sildenafil is a potent and selective inhibitor of cGMP-specific phosphodiesterase 5 (PDE5) in the corpus cavernosum, where PDE5 is responsible for the breakdown of cGMP. The effects of sildenafil on erection are peripheral in nature. Sildenafil does not have a direct relaxant effect on isolated human corpus cavernosum, but it potently enhances the relaxant effect of NO on this tissue. When the NO/cGMP pathway is activated, as occurs with sexual stimulation, sildenafil's inhibition of PDE5 leads to an increase in cGMP levels in the corpus cavernosum. Thus, sexual arousal is required for sildenafil to produce the desired pharmacological effect.
Pharmacodynamic effects. In vitro studies have shown that sildenafil is selective for PDE5, which is actively involved in the erection process. The effect of sildenafil on PDE5 is more potent than on other known phosphodiesterases. This effect is 10 times more potent than the effect on PDE6, which is involved in photoconversion processes in the retina. When using the maximum recommended doses, the selectivity of sildenafil for PDE5 is 80 times higher than its selectivity for PDE1, 700 times higher than for PDE2, PDE3, PDE4, PDE7, PDE8, PDE9, PDE10 and PDE11. In particular, the selectivity of sildenafil for PDE5 is 4000 times higher than its selectivity for PDE3 - a cGMP-specific isoform of phosphodiesterase, which is involved in the regulation of cardiac contractility.
Pharmacokinetics
Absorption. Sildenafil is rapidly absorbed. Peak plasma concentrations are reached within 30-120 minutes (median 60 minutes) after oral administration in the fasted state. The mean absolute oral bioavailability is 41% (range 25% to 63%). Over the recommended dose range (25 to 100 mg), the AUC and Cmax of sildenafil increase proportionally with dose after oral administration.
When sildenafil is taken with food, the extent of absorption is reduced with a mean delay in Tmax to 60 minutes and a mean decrease in Cmax by 29%.
Distribution. The mean steady-state volume of distribution (Vd) is 105 liters, indicating distribution of the drug into body tissues. After a single oral dose of 100 mg sildenafil, the mean maximum total plasma concentration of sildenafil is approximately 440 ng/ml (the coefficient of variation is 40%). Since the binding of sildenafil and its main N-desmethyl metabolite to plasma proteins reaches 96%, the mean maximum plasma concentration of free sildenafil reaches 18 ng/ml (38 nmol). The degree of binding to plasma proteins does not depend on the total concentrations of sildenafil.
In healthy volunteers who used sildenafil once at a dose of 100 mg, less than 0.0002% (average 188 ng) of the administered dose was detected in the ejaculate after 90 minutes.
Elimination: The total clearance of sildenafil is 41 l/h, resulting in a half-life of 3-5 hours. After both oral and intravenous administration, sildenafil is excreted as metabolites primarily in the feces (approximately 80% of the administered oral dose) and to a lesser extent in the urine (approximately 13% of the administered oral dose).
Pharmacokinetics in special patient groups.
Elderly patients: In healthy elderly volunteers (aged 65 years and older), a decrease in sildenafil clearance was observed, which resulted in an increase in plasma concentrations of sildenafil and its active N-demethylated metabolite by approximately 90% compared with the corresponding concentrations in healthy younger volunteers (18-45 years). Due to age-related differences in plasma protein binding, the corresponding increase in plasma concentrations of free sildenafil was approximately 40%.
Renal impairment. In volunteers with mild to moderate renal impairment (creatinine clearance 30-80 ml/min), the pharmacokinetics of sildenafil remained unchanged after a single oral dose of 50 mg. The mean AUC and Cmax of the N-desmethyl metabolite increased by 126% and 73%, respectively, compared with those in age-matched volunteers without renal impairment. However, due to high individual variability, these differences were not statistically significant. In volunteers with severe renal impairment (creatinine clearance below 30 ml/min), sildenafil clearance was reduced, resulting in mean increases in AUC and Cmax of 100% and 88%, respectively, compared with age-matched volunteers without renal impairment. In addition, the AUC and Cmax values of the N-demethylated metabolite were significantly increased by 79% and 200%, respectively.
Hepatic impairment: In volunteers with mild to moderate liver cirrhosis (Child-Pugh class A and B), sildenafil clearance was reduced, resulting in increased AUC (84%) and Cmax (47%) compared to age-matched volunteers without hepatic impairment. The pharmacokinetics of sildenafil in patients with severe hepatic impairment have not been studied.
Indication
The drug is recommended for use in men with erectile dysfunction, which is defined as the inability to achieve or maintain a penile erection necessary for successful sexual intercourse.
Sexual arousal is required for the drug to be effective.
Contraindication
Hypersensitivity to the active substance or to any of the excipients. Concomitant use with nitric oxide donors (such as amyl nitrite) or nitrates in any form is contraindicated, as sildenafil is known to affect the nitric oxide/cyclic guanosine monophosphate (cGMP) metabolic pathways and potentiate the hypotensive effect of nitrates.
The concomitant use of PDE5 inhibitors (including sildenafil) with guanylate cyclase stimulators such as riociguat is contraindicated as it may lead to symptomatic hypotension (see section 4.5).
Conditions in which sexual activity is not recommended (e.g. severe cardiovascular disorders such as unstable angina and severe heart failure). Loss of vision in one eye due to non-arteritic anterior ischemic optic neuropathy, whether or not this pathology is associated with previous use of PDE5 inhibitors. The presence of diseases such as severe liver dysfunction, arterial hypotension (blood pressure below 90/50 mm Hg), recent stroke or myocardial infarction and known hereditary degenerative retinal diseases such as retinitis pigmentosa (a small number of such patients have genetic disorders of retinal phosphodiesterases), since the safety of sildenafil has not been studied in these subgroups of patients.
Interaction with other medicinal products and other types of interactions
Effects of other drugs on sildenafil.
In vitro studies: Sildenafil metabolism is primarily mediated by cytochrome P450 (CYP) isoform 3A4 (major pathway) and isoform 2C9 (minor pathway). Therefore, inhibitors of these isoenzymes may reduce sildenafil clearance, and inducers of these isoenzymes may increase sildenafil clearance.
Co-administration of the HIV protease inhibitor ritonavir, a very potent P450 inhibitor at steady state (500 mg once daily) with sildenafil (single dose of 100 mg), resulted in a 300% (4-fold) increase in sildenafil Cmax and a 1000% (11-fold) increase in sildenafil plasma AUC. After 24 hours, plasma sildenafil levels were still approximately 200 ng/ml compared to approximately 5 ng/ml with sildenafil alone, consistent with the significant effect of ritonavir on a wide range of P450 substrates. Sildenafil does not affect the pharmacokinetics of ritonavir. Based on these pharmacokinetic data, co-administration of sildenafil and ritonavir is not recommended (see section 4.4); In any case, the maximum dose of sildenafil should under no circumstances exceed 25 mg within 48 hours.
Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at a steady-state dose (1200 mg three times daily) with sildenafil (100 mg once daily) resulted in a 140% increase in sildenafil Cmax and a 210% increase in sildenafil systemic exposure (AUC). Sildenafil had no effect on the pharmacokinetics of saquinavir (see section 4.2). More potent CYP3A4 inhibitors such as ketoconazole and itraconazole are expected to have a greater effect.
When sildenafil (100 mg once daily) was administered with erythromycin, a moderate CYP3A4 inhibitor, at steady state (500 mg twice daily for 5 days), a 182% increase in sildenafil systemic exposure (AUC) was observed. In healthy male volunteers, there was no effect of azithromycin (500 mg daily for 3 days) on the AUC, Cmax, Tmax, elimination rate constant, and subsequent half-life of sildenafil or its major circulating metabolite. Cimetidine (a cytochrome P450 inhibitor and non-specific CYP3A4 inhibitor) at a dose of 800 mg when co-administered with sildenafil at a dose of 50 mg in healthy volunteers resulted in a 56% increase in plasma concentrations of sildenafil.
Grapefruit juice is a weak inhibitor of CYP3A4 in the intestinal wall and may cause a modest increase in plasma levels of sildenafil.
Single administration of antacids (magnesium hydroxide/aluminum hydroxide) did not affect the bioavailability of sildenafil.
Although specific drug interaction studies have not been performed with all drugs, population pharmacokinetic analysis suggests that sildenafil pharmacokinetics were not altered by concomitant use of drugs belonging to the CYP2C9 inhibitor group (tolbutamide, warfarin, phenytoin), CYP2D6 inhibitor group (such as selective serotonin reuptake inhibitors, tricyclic antidepressants), thiazide and thiazide-like diuretics, loop and potassium-sparing diuretics, angiotensin-converting enzyme inhibitors, calcium antagonists, beta-adrenoceptor antagonists, or inducers of CYP450 metabolism (such as rifampicin, barbiturates).
In a study in healthy male volunteers, co-administration of the endothelin antagonist bosentan (a moderate inducer of CYP3A4, CYP2C9 and possibly CYP2C19) at steady state with sildenafil at steady state resulted in a decrease in sildenafil AUC and Cmax. Therefore, co-administration of potent CYP3A4 inducers such as rifampin may result in a more pronounced decrease in sildenafil plasma concentrations.
Nicorandil is a hybrid of a calcium channel activator and a nitrate. The nitrate component makes it possible for it to have a serious interaction with sildenafil.
Effect of sildenafil on other drugs.
In vitro studies: Sildenafil is a weak inhibitor of cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50 > 150 μM). Since peak plasma concentrations of sildenafil are approximately 1 μM, the effect of the drug on the clearance of substrates of these isoenzymes is unlikely.
There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors such as theophylline and dipyridamole.
In vivo studies: Since sildenafil is known to have an effect on nitric oxide/cyclic guanosine monophosphate (cGMP) metabolism, it has been shown to potentiate the hypotensive effect of nitrates, and its concomitant use with nitric oxide donors or nitrates in any form is contraindicated (see section 4.3).
Riociguat. Preclinical studies have demonstrated an additive systemic blood pressure lowering effect when PDE5 inhibitors are co-administered with riociguat. Clinical studies have demonstrated that riociguat potentiates the hypotensive effect of PDE5 inhibitors. No beneficial clinical effect was observed in patients enrolled in the study when PDE5 inhibitors were co-administered with riociguat.
Concomitant use of sildenafil and alpha-blockers may lead to symptomatic hypotension in some susceptible patients. This reaction has most often occurred within 4 hours of sildenafil administration (see sections 4.2 and 4.4). Symptomatic orthostatic hypotension has occasionally been reported in patients stabilised on doxazosin when sildenafil is administered concomitantly. These reports have included dizziness and fainting, but without syncope.
No significant interactions were observed with the concomitant use of sildenafil (50 mg) and tolbutamide (250 mg) or warfarin (40 mg), which are metabolized by CYP2C9.
Sildenafil (50 mg) did not prolong bleeding time induced by acetylsalicylic acid (150 mg).
Sildenafil (50 mg) did not potentiate the hypotensive effect of alcohol in healthy volunteers at mean maximum blood ethanol levels of 80 mg/dL.
In patients taking sildenafil, no differences in the side effect profile were observed compared to placebo when using such classes of antihypertensive drugs as diuretics, beta-adrenergic blockers, ACE inhibitors, angiotensin II antagonists, antihypertensive drugs (vasodilators and centrally acting), adrenergic neurone blockers, calcium channel blockers and alpha-adrenergic blockers.
Sildenafil at a dose of 100 mg did not affect the pharmacokinetics of the HIV protease inhibitors, saquinavir and ritonavir, which are CYP3A4 substrates.
In healthy male volunteers, the use of sildenafil at steady state resulted in an increase in the AUC and Cmax of bosentan.
Application features
Before starting therapy, the patient's medical history should be collected and a physical examination should be performed to diagnose erectile dysfunction and determine its possible causes.
Cardiovascular risk factors. Since sexual activity carries a certain cardiac risk, the physician should assess the patient's cardiovascular status before initiating any treatment for erectile dysfunction. Sildenafil has a vasodilating effect, manifested by a mild and transient decrease in blood pressure (see section "Pharmacodynamics"). Before prescribing sildenafil, the physician should carefully consider whether this effect may adversely affect patients with certain underlying diseases, especially in combination with sexual activity. Patients with increased sensitivity to vasodilators include patients with obstruction of the outflow tract of the left ventricle (e.g. aortic stenosis, hypertrophic obstructive cardiomyopathy) or patients with the rare syndrome of multiple system atrophy, one of the manifestations of which is severe dysregulation of blood pressure by the autonomic nervous system.
Sildenafil potentiates the hypotensive effect of nitrates (see section "Contraindications").
Serious cardiovascular adverse reactions, including myocardial infarction, unstable angina, SCD (sudden cardiac death), ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, and hypotension, have been reported in postmarketing experience in association with sildenafil use. Most, but not all, patients had cardiovascular risk factors. Many of these adverse reactions occurred during or shortly after sexual intercourse, and only a few occurred shortly after drug use without sexual activity. Therefore, it is not possible to determine whether the development of these adverse reactions is directly related to the risk factors or whether their development is due to other factors.
Priapism: Erectile dysfunction drugs, including sildenafil, should be prescribed with caution in patients with anatomical deformities of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease) or in patients with conditions predisposing to priapism (such as sickle cell anemia, multiple myeloma, or leukemia).
Cases of prolonged erection and priapism have been reported in the post-marketing setting. If an erection lasts more than 4 hours, patients should seek immediate medical attention. If not treated promptly, priapism can lead to penile tissue damage and permanent loss of potency.
Effects on vision: Spontaneous reports of visual defects have been associated with the use of sildenafil and other PDE5 inhibitors (see section 4.8). Cases of non-arteritic anterior ischemic optic neuropathy, a rare condition, have been reported spontaneously and in an observational study in association with the use of sildenafil and other PDE5 inhibitors (see section 4.8). Patients should be advised that in the event of sudden visual impairment, the drug should be discontinued and a physician should be consulted immediately (see section 4.8).
Concomitant use with ritonavir: Concomitant use of sildenafil and ritonavir is not recommended (see section 4.5).
Concomitant use with α-adrenergic blockers. Sildenafil should be used with caution in patients taking α-adrenergic blockers, as the combination may lead to symptomatic hypotension in some susceptible patients. Symptomatic hypotension usually occurs within 4 hours of sildenafil administration. To minimise the potential for postural hypotension in patients taking α-adrenergic blockers, patients should be stabilised on α-adrenergic blockers before starting sildenafil. A starting dose of 25 mg should also be considered (see section 4.2). Patients should also be advised what to do if they experience symptoms of postural hypotension.
Effects on bleeding. Studies in human platelets have shown that sildenafil potentiates the antiaggregatory effects of sodium nitroprusside in vitro. There is no information on the safety of sildenafil in patients with coagulation disorders or acute peptic ulcer. Therefore, sildenafil should only be used in these patients after careful consideration of the benefit-risk ratio.
After administration of a dose of 100 mg to healthy volunteers, no effect on sperm morphology or motility was observed (see section "Pharmacodynamics").
Hearing loss: Physicians should advise patients to discontinue use of PDE5 inhibitors, including Potenciale, and seek immediate medical attention if they experience sudden hearing loss or decrease.
These events, which may also be accompanied by tinnitus and dizziness, have been reported in temporal association with the use of PDE5 inhibitors, including sildenafil. It is not possible to determine whether these events are directly related to the use of PDE5 inhibitors or to other factors.
Concomitant use with antihypertensive drugs. Sildenafil has a systemic vasodilator effect and may further reduce blood pressure in patients taking antihypertensive drugs. In a separate drug interaction study, concomitant administration of amlodipine (5 mg or 10 mg) and oral sildenafil (100 mg) resulted in a mean additional reduction in systolic blood pressure of 8 mm Hg and diastolic blood pressure of 7 mm Hg.
Sexually transmitted diseases. Use of the drug does not protect against sexually transmitted diseases. Patients should be instructed on the necessary precautions to protect against sexually transmitted diseases, including human immunodeficiency virus.
Ability to influence reaction speed when driving vehicles or other mechanisms
Studies of the effect of the drug on the ability to drive vehicles and work with other mechanisms have not been conducted.
Since dizziness and visual disturbances have been reported in clinical studies with sildenafil, patients should be aware of their individual reaction to the drug before driving or operating machinery.
Use during pregnancy or breastfeeding
The drug is not intended for use by women.
Method of administration and doses
The drug should be administered orally.
Adults. The recommended dose of the drug is 50 mg, to be used if necessary approximately 1 hour before sexual activity. Depending on the effectiveness and tolerability of the drug, the dose can be increased to 100 mg or reduced to 25 mg*. The maximum recommended dose is 100 mg. The frequency of use of the maximum recommended dose of the drug is 1 time per day. When the drug is used with food, the effect of the drug may occur later than when it is used on an empty stomach.
Elderly patients: No dose adjustment is required for elderly patients (≥ 65 years).
Patients with renal impairment. For patients with mild to moderate renal impairment (creatinine clearance 30-80 ml/min), the recommended dose is the same as that given above in the Adults section.
Patients with hepatic impairment. Since sildenafil clearance is reduced in patients with hepatic impairment (e.g. cirrhosis), the recommended dose is 25 mg*. Depending on efficacy and tolerability, the dose may be increased to 50 mg and 100 mg.
Patients taking other medicinal products: If patients are taking CYP3A4 inhibitors concomitantly (see section 4.5), a starting dose of 25 mg* should be considered (except for ritonavir, the concomitant use of which with sildenafil is not recommended, see section 4.4).
To minimise the potential for postural hypotension in patients taking α-adrenergic blockers, their condition should be stabilised with α-adrenergic blockers before starting sildenafil. A starting dose of 25 mg* should also be considered (see sections 4.4 and 4.5).
* When prescribing sildenafil at a dose of 25 mg, use the drug in the appropriate dosage or dosage form.
Children
The drug is not indicated for use in persons under 18 years of age.
Overdose
In clinical trials with volunteers, when using a single dose of sildenafil up to 800 mg, adverse reactions were similar to those observed with sildenafil at lower doses, but occurred more frequently and were more severe. The use of sildenafil at a dose of 200 mg did not lead to increased efficacy, but caused an increase in the number of cases of adverse reactions (headache, hot flashes, dizziness, dyspepsia, nasal congestion, visual disturbances).
In the event of overdose, standard supportive measures should be employed as necessary. Hemodialysis is unlikely to enhance sildenafil clearance due to the high degree of plasma protein binding and the lack of urinary elimination of sildenafil.
Adverse reactions
Infectious and invasive diseases: rhinitis.
Immune system disorders: hypersensitivity.
Nervous system: headache, dizziness, drowsiness, hypoesthesia, stroke, transient ischemic attack, seizures*, recurrent seizures*, syncope, ataxia, neuralgia, neuropathy, paresthesia, tremor, vertigo, depression, insomnia, abnormal dreams, decreased reflexes.
On the part of the organs of vision: color perception disorders**, visual disorders, blurred vision, lacrimation disorders***, eye pain, photophobia, photopsia, ocular hyperemia, visual brightness, conjunctivitis, non-arteritic anterior ischemic optic neuropathy*, retinal vascular occlusion*, retinal hemorrhage, arteriosclerotic retinopathy, retinal disorders, glaucoma, visual field defects, diplopia, decreased visual acuity, myopia, asthenopia, floating vitreous opacities, iris disorders, mydriasis, halos in the field of vision, eye edema, eye swelling, eye disorders, conjunctival hyperemia, eye irritation, abnormal eye sensations, eyelid edema, sclera discoloration.
From the side of the organs of hearing and vestibular apparatus: dizziness, tinnitus, deafness.
Cardiovascular system: tachycardia, palpitations, SCD (sudden cardiac death)*, myocardial infarction, ventricular arrhythmia*, atrial fibrillation, unstable angina, hot flashes, hot flushes, hypertension, hypotension, angina, AV block, migraine, postural hypotension, myocardial ischemia, cerebral thrombosis, sudden cardiac arrest, ECG abnormalities, cardiomyopathy.
From the respiratory system, chest and mediastinal organs: nasal congestion, epistaxis, sinus congestion, feeling of tightness in the throat, swelling of the nasal mucosa, dry nose, bronchial asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, increased salivation, increased cough.
Gastrointestinal: nausea, dyspepsia, gastroesophageal reflux disease, vomiting, upper abdominal pain, dry mouth, oral hypoesthesia, glossitis, colitis, dysphagia, gastritis, gastroenteritis, esophagitis, stomatitis, abnormal liver function tests, rectal bleeding, gingivitis.
Skin and subcutaneous tissue disorders: rash, Stevens-Johnson syndrome*, toxic epidermal necrolysis*, urticaria, herpes, pruritus, sweating, skin ulceration, contact dermatitis, exfoliative dermatitis.
Musculoskeletal and connective tissue disorders: myalgia, pain in extremities, arthritis, arthrosis, tendon rupture, tenosynovitis, bone pain, myasthenia gravis, synovitis.
Renal and urinary disorders: hematuria, cystitis, nocturia, increased urinary frequency, urinary incontinence.
Genital and mammary disorders: penile bleeding, priapism*, hematospermia, prolonged erection, breast enlargement, ejaculation disorder, genital swelling, anorgasmia.
Blood and lymphatic system disorders: anemia, leukopenia.
General disorders and administration site conditions: chest pain, fatigue, feeling hot, irritation, facial swelling, photosensitivity reactions, shock, asthenia, pain, sudden fall, abdominal pain, accidental injury.
Specific sensations: sudden decrease or loss of hearing, earache, hemorrhage in the eye, cataract, dry eyes.
Examination: increased heart rate.
*Reported only during post-marketing surveillance.
** Color perception disorders: chloropsia, chromatopsia, cyanopsia, erythropsia, xanthopsia.
*** Lacrimation disorders: dry eyes, lacrimation disorders and lacrimation increased.
Post-market application experience.
Cardiovascular and cerebrovascular events. Serious cardiovascular, cerebrovascular and vascular events, including cerebrovascular haemorrhage, subarachnoid and intracerebral haemorrhage, and pulmonary haemorrhage, have been reported in temporal association with the use of the drug. Most, but not all, patients had pre-existing cardiovascular risk factors. Many of these events have been reported to occur during or shortly after sexual activity, and a few have occurred immediately after use of the drug without sexual activity. Others have occurred in the hours or days following use of the drug and sexual activity. It is not possible to determine whether these events are directly related to the use of the drug, to sexual activity, to pre-existing risk factors, or to a combination of these factors, or to other factors.
Blood and lymphatic system: Vaso-occlusive crisis. In a small, prematurely terminated study of Revatio (sildenafil) in patients with pulmonary arterial hypertension secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were reported more frequently with sildenafil than with placebo. The clinical significance of this information for patients taking Potenciale for the treatment of erectile dysfunction is unknown.
Nervous system: anxiety, transient global amnesia.
Specific feelings.
Hearing. Cases of sudden hearing loss or hearing impairment have been reported in association with sildenafil use. In some cases, underlying medical conditions and other factors have been reported to play a role in the development of hearing adverse reactions. In many cases, follow-up information is not available. It is not possible to determine whether these events are directly related to sildenafil use, to underlying risk factors for hearing loss, to a combination of these factors, or to other factors.
Organs of vision: Temporary loss of vision, redness of the eyes, burning in the eyes, increased intraocular pressure, retinal edema, retinal vascular disease or bleeding, vitreous detachment.
Cases of non-arteritic anterior ischemic optic neuropathy, which has caused visual impairment, including permanent vision loss, have been reported in association with the use of PDE5 inhibitors, including Potenciale. Many, but not all, of the patients had underlying anatomical or vascular risk factors for non-arteritic anterior ischemic optic neuropathy, including but not necessarily limited to the following: low optic disc diameter ratio (congestive optic disc), age over 50 years, hypertension, coronary artery disease, hyperlipidemia, and smoking. It is not possible to determine whether these events are directly related to the use of PDE5 inhibitors, to the underlying anatomical or vascular risk factors, to a combination of all of these factors, or to other factors.
Reporting of suspected adverse reactions. Reporting of suspected adverse reactions after the registration of a medicinal product is important. This allows for continuous monitoring of the benefit-risk balance associated with the use of this medicinal product. Physicians should report any suspected adverse reactions in accordance with legal requirements.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 30 °C.
Keep out of reach of children.
Packaging
2 tablets in a blister; 1 or 2 blisters in a cardboard pack;
1 tablet in a blister; 1 or 2 or 4 blisters in a cardboard pack.
Vacation category
According to the recipe.
Producer
Technolog PJSC.
Location of the manufacturer and its business address
20300, Ukraine, Cherkasy region, Uman city, Stara Prorizna Street, building 8.
