Effex Sildenafil tabs 100mg #15

Effex Sildenafil instruction

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Description

Tablets are round, biconvex, film-coated from pale orange with a pinkish imitation to pale brown with a pinkish imitation of the color; in cross section, the core is from white to almost white.
Pharmacotherapeutic group: Erectile dysfunction treatment agent - PDE5 inhibitor

Pharmacodynamics

Sildenafil is a powerful selective inhibitor of cyclic guanosine monophosphate (cGMP) -specific phosphodiesterase 5th type (PDE5).
The basis of the physiological mechanism of erection is the release of nitric oxide (NO) in the cavernous body during sexual stimulation. This, in turn, leads to an increase in cGMP levels, resulting in relaxation of the smooth muscle tissue of the cavernous body and increased blood flow in the cavernous body.
Sildenafil does not have a direct relaxing effect on the isolated cavernous body, but it enhances the relaxing effect of nitric oxide, causing inhibition of PDE5, which is responsible for the disintegration of cGMP in the cavernous body.
The pharmacological effect is achieved only in the presence of sexual stimulation.
In vitro studies have shown that sildenafil is selective for PDE5. Its activity in relation to other known isoenzymes is much lower: PDE6 - 10 times, PDE1 - more than 80 times, PDE2, PDE4, PDE7-11 - more than 700 times. Sildenafil is 4,000 times more active in relation to PDE5 compared with PDEZ, which is of great importance, since PDEZ is one of the key enzymes regulating myocardial contractility.
A prerequisite for the effectiveness of sildenafil is sexual stimulation.
The use of sildenafil in doses up to 100 mg resulted in a slight short-term decrease in blood pressure. The antihypertensive effect is associated with the vasodilating action of sildenafil, associated with an increase in the level of cGMP in vascular smooth muscle cells.
Some patients after 1 hour after taking the drug in a dose of 100 mg using the Farnsworth-Munsel 100 test revealed a slight and transient violation of the ability to distinguish shades of color (blue / green). Two hours later, color perception was restored. Violation of color vision caused by inhibition of PDE6, which is involved in the process of transmitting light in the retina. Sildenafil does not affect visual acuity, contrast perception, electroretinogram indices, intraocular pressure or pupil diameter.

Pharmacokinetics of Effex Sildenafil

Suction

After ingestion is rapidly absorbed. The maximum plasma concentration is reached within 30-120 minutes (60 minutes on average) when ingested on an empty stomach. Bioavailability varies from 25 to 63%. When taken in combination with fatty foods, the absorption rate decreases: Cmax maximizes by 29%, and the time to reach the maximum concentration (Tmax) increases by 60 minutes, but the degree of absorption does not change significantly (the area under the pharmacokinetic curve concentration - time (AUC) decreases by 11%).

Distribution

The volume of distribution of sildenafil in the equilibrium state is on average 105 liters. The bond with plasma proteins of sildenafil and its main circulating N-demethyl metabolite is approximately 96% and does not depend on the total concentration of the drug. Less than 0.0002% of the dose (188 ng on average) was detected in semen 90 minutes after taking sildenafil.

Metabolism

Sildenafil is metabolized mainly in the liver by the action of the cytochrome P450: CYP3A4 microsomal isoenzymes (primary pathway) and CYP2C9 (secondary pathway). The major circulating metabolite resulting from N-demethylation of sildenafil is further metabolized. The selectivity of this metabolite on PDE is comparable to that of sildenafil, and its activity against PDE5 in vitro is about 50% of the activity of sildenafil. The concentration of the metabolite in the blood plasma is about 40% of the concentration of sildenafil. The N-demethyl metabolite undergoes further metabolism; The final half-life is about 4 hours.

Removal

The total clearance of sildenafil is 41 l / h, and the final half-life is 3-5 hours. After ingestion, sildenafil is excreted as metabolites, mainly by the intestines (approximately 80% of the oral dose) and, to a lesser extent, by the kidneys (approximately 13% of the oral dose).

Pharmacokinetics in Special Patient Groups

Elderly patients

In healthy elderly patients (65 years and older), the clearance of sildenafil is reduced, and the concentration of free sildenafil in plasma is about 40% higher than in young people (18-45 years). Age does not have a clinically significant effect on the incidence of side effects.

Renal dysfunction

With mild (creatinine clearance (CK) 50-80 ml / min) and moderate (CK 30-49 ml / min) degree of renal failure, the pharmacokinetics of sildenafil after a single dose of 50 mg are not changed. In severe renal failure (CC <30 ml / min), the clearance of sildenafil is reduced, which leads to an approximately twofold increase in the area under the pharmacokinetic concentration-time curve AUC (100%) and Сmax (88%) compared with those in normal kidney function patients of the same age group.

Liver function disorders

In patients with cirrhosis of the liver (stages A and B according to Child-Pugh classification), the clearance of sildenafil decreases, leading to an increase in AUC (84%) and Cmax (47%) compared with those in normal liver function in patients of the same age group . The pharmacokinetics of sildenafil in patients with severe hepatic impairment (Child-Pugh stage C) has not been studied.

Indications

Treatment of erectile dysfunction, characterized by the inability to achieve or maintain an erection of the penis, sufficient for satisfactory sexual intercourse.
Effex Sildenafil is effective only with sexual stimulation.

Contraindications

Hypersensitivity to sildenafil or to any other component of the drug.
Use in patients who constantly or intermittently donate nitric oxide, organic nitrates or nitrites in any form, as Effex Sildenafil enhances the hypotensive effect of nitrates (see the section "Interaction with other drugs").
The safety and efficacy of Effex Sildenafil when used together with other means of treating erectile dysfunction has not been studied, therefore, the use of such combinations is not recommended (see the section "Special Instructions").
Combined use with ritonavir.
Liver dysfunction.
Chronic renal failure severe.
Severe heart failure, unstable angina, suffered a stroke or myocardial infarction, life-threatening arrhythmias, arterial hypertension (BP> 170/100 mm Hg) or hypotension (BP <90/50 mm Hg) during the last 6 months ( see section "Special instructions").
According to the registered indication Effex Sildenafil is not intended for use in children under 18 years of age.
According to the registered indication Effex Sildenafil is not intended for use in women.

Carefully

Anatomical deformity of the penis (angulation, cavernous fibrosis or Peyronie's disease) (see section "Special Instructions").
Diseases predisposing to the development of priapism (sickle cell anemia, multiple myeloma, leukemia, thrombocythemia) (see section "Special instructions").
Diseases accompanied by bleeding.
Exacerbation of gastric ulcer and 12 duodenal ulcer.
Hereditary retinitis pigmentosa (see section "Special instructions").

Pregnancy and lactation

According to the registered indication of the drug is not intended for use in women.

Dosage and administration

Inside
The recommended dose for most adult patients is 50 mg of sildenafil approximately 1 hour before sexual activity.
Given the efficacy and tolerability of the dose can be increased to 100 mg. The maximum recommended dose is 100 mg. The maximum recommended frequency of use is 1 time per day.

Elderly patients

Dosage adjustment of Effex Sildenafil is not required.

Renal dysfunction

For patients with mild or moderate severity of renal failure (CC 30-80 ml / min) dose adjustment is not required.

Combined use with other medicines

To minimize the risk of postural hypotension in patients taking α-blockers, sildenafil should be started only after stabilization of hemodynamics is achieved in these patients. It should also consider the feasibility of reducing the initial dose of sildenafil (see the section "Interaction with other drugs" and "Special instructions").

Side effects

The most frequent side effects were headache and hot flashes.
Usually, the side effects of Effex Sildenafil are mild or moderate and are transient.
In studies using a fixed dose, it has been shown that the incidence of some adverse events increases with increasing dose.
On the part of the immune system: rarely - hypersensitivity reactions (including skin rash), allergic reactions.
On the part of the organ of vision: often - blurred vision, blurred vision, cyanopsy; infrequently - eye pain, photophobia, photopsia, chromatopsia, eye redness / scleral injections, change in brightness of light perception, mydriasis, conjunctivitis, hemorrhage in the eye tissue, cataract, disruption of the lacrimal apparatus; rarely - swelling of the eyelids and surrounding tissues, feeling of dryness in the eyes, presence of rainbow circles in the field of view around the light source, increased eye fatigue, seeing objects in yellow (xantopsia), seeing objects in red (erythropsy), conjunctival hyperemia, irritation of the mucous membrane eye shell, discomfort in the eyes; unknown frequency - nonarteritis anterior ischemic neuropathy of the optic nerve (NPINZ), retinal vein occlusion, visual field defect, diplopia *, temporary loss of vision or reduced visual acuity, increased intraocular pressure, retinal edema, vascular retinal disease, vitreous detachment / vitreous traction.
On the part of the organ of hearing: infrequently - a sudden decline or loss of hearing, noise in the ears, pain in the ears.
Since the cardiovascular system: often - "tides"; infrequently - tachycardia, feeling of heartbeat, lowering blood pressure, increasing heart rate, unstable angina, atrioventricular block, myocardial ischemia, cerebral thrombosis, cardiac arrest, heart failure, abnormalities in electrocardiogram readings, cardiomyopathy; rarely - atrial fibrillation.
From the side of blood and lymphatic system: infrequently - anemia, leukopenia.
Metabolism and nutrition: infrequently - feeling of thirst, edema, gout, uncompensated diabetes mellitus, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemia, hypernatremia.
On the part of the respiratory system: often - nasal congestion; infrequently - nasal bleeding, rhinitis, asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, an increase in the volume of discharge of sputum, increased cough; rarely - a feeling of tightness in the throat, dryness of the mucous membrane of the nasal cavity, swelling of the nasal mucosa.
On the part of the gastrointestinal tract: often - nausea, dyspepsia; rarely gastroesophageal reflux disease, vomiting, abdominal pain, dryness of the oral mucosa, glossitis, gingivitis, colitis, dysphagia, gastritis, gastroenteritis, esophagitis, stomatitis, abnormal liver function tests, rectal bleeding; rarely - hypostezia of the oral mucosa.
From the musculoskeletal system: often - back pain; infrequently - myalgia, pain in the limbs, arthritis, arthrosis, tendon rupture, tenosynovitis, bone pain, myasthenia, synovitis.
On the part of the genitourinary system: infrequently - cystitis, nocturia, breast enlargement, urinary incontinence, hematuria, impaired ejaculation, swelling of the genitals, anorgasmia, hematospermia, damage to the tissues of the penis; rarely, prolonged erections and / or priapism.
From the central and peripheral nervous system: very often - headache; often - dizziness; infrequently - drowsiness, migraine, ataxia, hypertonia, neuralgia, neuropathy, paresthesia, tremor, vertigo, symptoms of depression, insomnia, unusual dreams, increased reflexes, kinesthesia; seldom - spasms *, repeated spasms *, syncope.
On the part of the skin and subcutaneous tissues: infrequently - skin rash, urticaria, herpes simplex, pruritus, sweating, ulceration of the skin, contact dermatitis, exfoliative dermatitis; frequency is unknown - Stevens-Johnson syndrome, toxic epidermal necrolysis.
Other: infrequently - fever, swelling of the face, photosensitivity reaction, shock, asthenia, fatigue, pain of different localization, chills, accidental falls, pain in the chest, accidental injuries; rarely irritability.
* Side effects identified during post-marketing studies.

Cardiovascular complications

The post-marketing use of sildenafil for the treatment of erectile dysfunction reported adverse events such as severe cardiovascular complications (including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, hemorrhagic stroke, transient ischemic attack, and I have an unacceptable template, transient ischemic attack, I can apply a pattern, transient ischemic attack, I can apply a card, I have an unpleasant heart attack, I have a heart attack, transient ischemic attack, transient ischemic stroke, I can apply a pattern, transient ischemic attack, I can apply a pattern, transient ischemic attack, I can use a card, I have an unpatched card, I have an unpleasant heart attack, I have a heart attack, I have a heart failure, I have a heart attack, I have a heart attack, I have a sudden heart attack ), which had a temporary connection with the use of sildenafil, most of these patients, but not all of them, had risk factors for cardiovascular complications. Many of these adverse events were observed shortly after sexual activity, and some of them were observed after taking sildenafil without subsequent sexual activity. It is not possible to establish the existence of a direct connection between the observed adverse events and the specified or other factors.

Visual impairment

In rare cases, during post-registration use of all PDE5 inhibitors, including sildenafil, non-arteritis anterior ischemic arthral nerve neuropathy (NPINZN) was reported - a rare disease and cause of loss or loss of vision. Most of these patients had risk factors, in particular a decrease in the ratio of excavation diameters and optic nerve head ("stagnant disc"), over 50 years of age, diabetes, hypertension, coronary heart disease, hyperlipidemia and smoking. In an observational study, it was assessed whether the recent use of drugs of the class of PDE5 inhibitors is related to the acute onset of NPINSN.
The results indicate an approximately 2-fold increase in the risk of NPINZN within 5 elimination half-lives after the use of a PDE5 inhibitor. According to published literature data, the annual incidence of NPINSN is 2.5-11.8 cases per 100,000 men aged> 50 years in the general population.
Patients should be advised to discontinue sildenafil therapy in the event of a sudden loss of vision and immediately consult a physician. Persons who have already had a case of an NPINZN have an increased risk of a recurrence of NPINZN. Therefore, the physician should discuss this risk with such patients and discuss with them the potential chance of adverse effects of PDE5 inhibitors. PDE5 inhibitors, including sildenafil, in these patients should be used with caution and only in situations where the expected benefit outweighs the risk.

Overdose

When using Effex Sildenafil at doses higher than recommended, adverse effects were similar to those noted above, but were usually more common.
Symptomatic treatment. Hemodialysis does not accelerate the excretion of the drug, since sildenafil is firmly bound to plasma proteins and is not excreted by the kidneys.

Interaction

Effect of Other Drugs on Sildenafil Pharmacokinetics
The metabolism of sildenafil occurs mainly under the action of cytochrome isoenzymes CYP3A4 (main route) and CYP2C9, therefore inhibitors of these isoenzymes can reduce the clearance of sildenafil, and inductors, respectively, increase the clearance of sildenafil.
A decrease in the clearance of sildenafil with simultaneous use of cytochrome CYP3A4 isoenzyme inhibitors (ketoconazole, erythromycin, cimetidine) was noted.
Cimetidine (800 mg), a non-specific inhibitor of the cytochrome CYP3A4 isoenzyme, when taken together with sildenafil (50 mg) causes an increase in plasma concentration of sildenafil by 56%.
A single dose of 100 mg of sildenafil together with erythromycin (500 mg / day, 2 times a day for 5 days), a moderate inhibitor of the cytochrome CYP3A4 isoenzyme, while achieving a constant concentration of erythromycin in the blood, leads to an increase in AUC of sildenafil by 182%.
When coadministration of sildenafil (once 100 mg) and saquinavir (1200 mg / day 3 times a day), HIV protease inhibitor and cytochrome CYP3A4 isoenzyme, while achieving a constant concentration of saquinavir in blood, Cmax of sildenafil increased by 140%, and AUC increased by 210%. Sildenafil has no effect on the pharmacokinetics of saquinavir.
More potent inhibitors of cytochrome CYP3A4 isoenzyme, such as ketoconazole and itraconazole, can also cause stronger changes in the pharmacokinetics of sildenafil.
The simultaneous use of sildenafil (once 100 mg) and ritonavir (500 mg 2 times a day), an HIV protease inhibitor and a strong inhibitor of cytochrome P450, while achieving a constant concentration of ritonavir in the blood leads to an increase in Cmax of sildenafil by 300% (4 times ), a AUC at 1000% (11 times). After 24 hours, the concentration of sildenafil in the blood plasma is about 200 ng / ml (after a single use of one sildenafil - 5 ng / ml).
If sildenafil is used in recommended doses for patients who are simultaneously receiving strong inhibitors of the cytochrome CYP3A4 isoenzyme, then C max of free sildenafil does not exceed 200 nM, and the drug is well tolerated.
A single antacid (magnesium hydroxide / aluminum hydroxide) does not affect the bioavailability of sildenafil.
In studies involving healthy volunteers with the simultaneous use of an antagonist of endothelin receptors, bosentan (inducer of CYP3A4 isoenzyme (moderate), CYP2C9 and, possibly, CYP2C19) in equilibrium concentration (125 mg two times in knots) and sildenafil in equilibrium concentration (80 mg three times per day) there was a decrease in AUC and Cmax of sildenafil by 62.6% and 52.4%, respectively. Sildenafil increased AUC and Cmax of bosentan by 49.8% and 42%, respectively. It is assumed that the simultaneous use of sildenafil with powerful inducers of CYP3A4 isoenzyme, such as rifampicin, can lead to a large decrease in the concentration of sildenafil in the blood plasma.
Inhibitors of the isoenzyme cytochrome CYP2C9 (tolbutamide, warfarin), cytochrome isoenzyme CYP2D6 (selective serotonin reuptake inhibitors, tricyclic antidepressants), thiazide and thiazide diuretics, ACE inhibitors and calcium antagonists do not affect the pharmacokinetics of sildenafil.
Azithromycin (500 mg / day for 3 days) has no effect on AUC, Cmax, Tmax, the rate constant of elimination and T1 / 2 of sildenafil or its main circulating metabolite.

Effect of sildenafil on other drugs

Sildenafil is a weak inhibitor of cytochrome P450 isoenzymes - 1A2, 2C9, 2C19, 2D6, 2E1, and 3A4 (IC50> 150 μmol). When taking sildenafil at recommended doses, its C max is about 1 micromolar, so it is unlikely that sildenafil can affect the clearance of the substrates of these isoenzymes.
Sildenafil enhances the hypotensive effect of nitrates, both with prolonged use of the latter, and with their appointment for acute indications. In this regard, the use of sildenafil in combination with nitrates or nitric oxide donors is contraindicated.
While taking α-adrenergic blocker doxazosin (4 mg and 8 mg) and sildenafil (50 mg and 100 mg) in patients with benign prostatic hyperplasia with stable hemodynamics, the average additional decrease in systolic / diatonic blood pressure in the supine position was 9/5 mm Hg st. and 8/4 mm Hg. st. respectively, and in the standing position - 11/4 mm Hg. st. and 4/5 mm Hg. st. respectively. Rare cases of the development of symptomatic postural hypotension, manifested in the form of dizziness (without fainting), have been reported in these patients. In individual sensitive patients receiving α-blockers, the simultaneous use of sildenafil can lead to symptomatic hypotension.
There are no signs of significant interactions with tolbutamide (250 mg) or warfarin (40 mg), which are metabolized by the cytochrome CYP2C9 isoenzyme.
Sildenafil (100 mg) has no effect on the pharmacokinetics of HIV protease inhibitors, saquinavir and ritonavir, which are substrates of the cytochrome CYP3A4 isoenzyme, at their constant level in the blood.
The simultaneous use of sildenafil in the equilibrium state (80 mg three times a day) leads to an increase in the AUC and Cmax of bosentan (125 mg twice a day) by 49.8% and 12%, respectively.
Sildenafil (50 mg) does not cause an additional increase in bleeding time when taking acetylsalicylic acid (150 mg).
Sildenafil (50 mg) does not enhance the hypotensive effect of alcohol in healthy volunteers with an average blood alcohol concentration of 0.08% on average (80 mg / dl).
In patients with arterial hypertension, there were no signs of interaction of sildenafil (100 mg) with amlodipine. The average additional decrease in blood pressure in the prone position is 8 mm Hg. st. (systolic) and 7 mm Hg. st. (diastolic). The use of sildenafil in combination with antihypertensive drugs does not lead to additional side effects.

Special instructions

For the diagnosis of erectile dysfunction, the determination of their possible causes and the choice of adequate treatment, it is necessary to gather a full medical history and conduct a thorough physical examination.
Erectile dysfunction treatments should be used with caution in patients with anatomical deformation of the penis (angulation, cavernous fibrosis, Peyronie's disease), or in patients with risk factors for priapism (sickle cell anemia, multiple myeloma, leukemia, thrombocythemia) (see "C caution ")
During postmarketing studies, cases of prolonged erection and priapism have been reported. If an erection persists for more than 4 hours, you should immediately seek medical attention. If priapism therapy was not carried out immediately, it can cause damage to the tissues of the penis and irreversible loss of potency.
Drugs intended for the treatment of erectile dysfunction should not be given to men for whom sexual activity is undesirable.
Sexual activity poses a certain risk in the presence of heart disease, so before starting any therapy for erectile dysfunction, the doctor should refer the patient to an examination of the cardiovascular system. Sexual activity is undesirable in patients with heart failure, unstable angina, suffered a stroke or myocardial infarction, life-threatening arrhythmias, arterial hypertension (BP> 170/100 mmHg) or hypotension (BP <90/50 mm RT) for the last 6 months. Art.) (see section Contraindications ").
Clinical studies have shown no differences in the incidence of myocardial infarction (1.1 per 100 people per year) or the mortality rate from cardiovascular diseases (0.3 per 100 people per year) in patients who received sildenafil, compared with patients receiving placebo.

Cardiovascular complications

During post-marketing use of sildenafil for the treatment of erectile dysfunction was reported adverse events such as serious cardiovascular events (including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, hemorrhagic stroke, transient ischemic attack, hypertension and hypotension ), which had a temporary connection with the use of sildenafil. Most of these patients, but not all of them, had risk factors for cardiovascular complications. Many of these adverse events were observed shortly after sexual activity, and some of them were observed after taking sildenafil without subsequent sexual activity. It is not possible to establish the existence of a direct connection between the observed adverse events and the specified or other factors.

Hypotension

Sildenafil has a systemic vasodilating effect, leading to a transient decrease in blood pressure, which is not a clinically significant event and does not lead to any consequences for the majority of Nazis. However, before prescribing sildenafil, the physician should carefully evaluate the risk of possible undesirable manifestations of the vasodilating action in patients with appropriate diseases, especially against the background of sexual activity.
Increased susceptibility to vasodilators is observed in patients with obstruction of the left ventricular output tract (aortic stenosis, hypertrophic obstructive cardiomyopathy), as well as with rarely encountered multiple systemic atrophy syndrome, manifested by a severe dysregulation of blood pressure in the autonomic nervous system.
Since the combined use of sildenafil and α-blockers can lead to symptomatic hypotension in individual sensitive patients, sildenafil should be used with caution in patients taking α-blockers (see the section "Interaction with other drugs"). To minimize the risk of postural hypotension in patients taking α-blockers, taking sildenafil should be started only after stabilization of hemodynamic parameters in these patients is achieved. It is also necessary to consider the feasibility of reducing the initial dose of sildenafil (see the section "Dosage and administration"). The physician should inform patients of what action should be taken in case of symptoms of postural hypotension.

Visual impairment

In rare cases, during post-registration use of all PDE5 inhibitors, including sildenafil, nonarteritis anterior ischemic optic nerve neuropathy (NPINZN) was reported - a rare disease and cause of loss or loss of vision. Most of these patients had risk factors, in particular a decrease in the ratio of excavation diameters and optic nerve head ("stagnant disc"), over 50 years of age, diabetes, hypertension, coronary heart disease, hyperlipidemia and smoking. In an observational study, it was assessed whether the recent use of drugs of the class of PDE5 inhibitors is related to the acute onset of NPINSN. The results indicate an approximately 2-fold increase in the risk of NPINZN within 5 elimination half-lives after the use of a PDE5 inhibitor. According to published literature data, the annual incidence of NPINSN is 2.5-11.8 cases per 100,000 men aged ≥ 50 years in the general population.
Patients should be advised to discontinue sildenafil therapy in the event of a sudden loss of vision and immediately consult a physician. Persons who have already had a case of an NPINZN have an increased risk of a recurrence of NPINZN. Therefore, the physician should discuss this risk with such patients and discuss with them the potential chance of adverse effects of PDE5 inhibitors. PDE5 inhibitors, including sildenafil, in these patients should be used with caution and only in situations where the expected benefit outweighs the risk.
A small number of patients with hereditary retinitis pigmentosa have genetically determined dysfunctions of retinal phosphodieseterases. There is no information about the safety of using sildenafil in patients with retinitis pigmentosa, so the drug should be used with caution (see the section "With caution").

Hearing loss

In some post-marketing and clinical studies reported cases of sudden deterioration or hearing loss associated with the use of all PDE5 inhibitors, including sildenafil, most of these patients had risk factors for sudden deterioration or loss of hearing. There is no causal relationship between the use of PDE5 inhibitors and the sudden deterioration of hearing or hearing loss. In the event of a sudden deterioration in hearing or hearing loss with sildenafil intake, you should immediately consult a doctor.

Bleeding

Sildenafil enhances the antiplatelet effect of sodium nitroprusside, a nitric oxide donator, on human platelets in vitro. There are no data on the safety of using sildenafil in patients with a tendency to bleeding or exacerbation of gastric ulcer and duodenal ulcer, so these patients should use sildenafil with caution (see the section "Caution").
The incidence of nasal bleeding in patients with pulmonary hypertension associated with diffuse connective tissue diseases was higher (sildenafil 12.9%, placebo 0%) than in patients with primary pulmonary hypertension (sildenafil 3.0%, placebo 2.4%) . In patients receiving sildenafil in combination with a vitamin K antagonist, the frequency of nosebleeds was higher (8.8%) than in patients not taking a vitamin K antagonist (1.7%).
Use in conjunction with other means of treating erectile dysfunction.
The safety and efficacy of sildenafil together with other PDE5 inhibitors or other drugs for the treatment of pulmonary hypertension containing sildenafil (for example, Revacio®) or other means of treating erectile dysfunction have not been studied, therefore, the use of such combinations is not recommended (see the section "Anti-indications").
Impact on the ability to drive trans. Wed and fur .:
Since when taking sildenafil may develop dizziness, lower blood pressure, the development of chromatopsia, blurred vision, etc. side effects, caution should be exercised when driving and engaging in other potentially hazardous activities that require increased concentration and psychomotor reactions. You should also be attentive to the individual action of the drug in these situations, especially at the beginning of treatment and when changing the dosage regimen.

Form release / dosage

Tablets, film coated, 50 mg and 100 mg.
Packaging:
On 1 tablet in a bag (sachet) from a film combined on the basis of polymeric films and aluminum foil.
On 15 tablets (for a dosage of 100 mg) in a blister strip packaging from a film of polyvinyl chloride and flexible packaging made on the basis of aluminum foil.
On 1, 2, 4, 10 bags (sachets) or on 1 blister strip packaging together with the application instruction are placed in a pack from a cardboard.

Storage conditions

Store at a temperature not higher than 25 ° С.
Keep out of the reach of children.
Shelf life - 3 years.
Do not use after the expiration date printed on the package.

Pharmacy Sale Conditions

You don't need a prescription to buy Effex Sildenafil.