ADVERSE REACTIONS

6.2 Postmarketing Experience
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In-depth Details for Importers, Exporters, and Buyers

In India, sildenafil 50 mg comes in tablet form with film coating.
It can be purchased with or without a prescription depending on local laws.
Always check the expiry date before taking any medication.
The pill should be taken with water, with or without food.
Combining sildenafil with high-fat meals may delay absorption.
Some users experience facial flushing after dosage.
Use caution and seek medical care if chest pain occurs.
Avoid grapefruit or grapefruit juice as it may interfere with sildenafil.
Regular exercise and a balanced diet support sexual health.

The safety and efficacy of combinations of sildenafil with other PDE5 Inhibitors, including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil, or other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended. There have been postmarketing reports of bleeding events in patients who have taken sildenafil. In addition, the combination of heparin and sildenafil had an additive effect on bleeding time in the anesthetized rabbit, but this interaction has not been studied in humans. The use of sildenafil offers no protection against sexually transmitted diseases. 6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling:Cardiovascular [see Warnings and Precautions (5.1)]Prolonged Erection and Priapism [see Warnings and Precautions (5.2)]Effects on the Eye [see Warnings and Precautions (5.3)]Hearing Loss [see Warnings and Precautions (5.4)]Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives [see Warnings and Precautions (5.5)]Adverse Reactions with the Concomitant Use of Ritonavir [see Warnings and Precautions (5.6)]Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies [see Warnings and Precautions (5.7)]Effects on Bleeding [see Warnings and Precautions (5.8)]Counseling Patients About Sexually Transmitted Diseases [see Warnings and Precautions (5.9)]The most common adverse reactions reported in clinical trials (> 2%) are headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, sildenafil citrate tables myalgia, nausea, dizziness, and rash.6.1 Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.Sildenafil was administered to over 3700 patients (aged 19-87 years) during pre-marketing clinical trials worldwide.

Sildenafil 50 mg is a widely accessible medication in India's healthcare market.
It is essential to understand potential drug interactions before use.
Some patients may experience dizziness or lightheadedness when standing.
Use caution when combining sildenafil with antihypertensive medications.
Avoid excessive alcohol consumption while using sildenafil.
Patients with a history of heart attacks should consult a doctor before use.
The medication does not provide protection against pregnancy or STDs.
Regular medical checkups help ensure safe and effective use of sildenafil.
Proper storage and handling ensure medication potency and safety.

Over 550 patients were treated for longer than one year.In placebo-controlled clinical studies, the discontinuation rate due to adverse reactions for sildenafil (2.5%) was not significantly different from placebo (2.3%).In fixed-dose studies, the incidence of some adverse reactions increased with dose. The type of adverse reactions in flexible-dose studies, which reflect the recommended dosage regimen, was similar to that for fixed dose studies.

Guideline Type	Details	Responsible Authority
Prescription Requirement	Must be prescribed by a licensed doctor	Indian Medical Council
Sale Restrictions	Online sale regulated, adherence to strict laws	Drug Control Department
Import Regulations	Must have import license for foreign medicines	Indian Customs
Advertising Rules	No misleading ads, claims must be substantiated	Advertising Standards Authority of India

At doses above the recommended dose range, adverse reactions were similar to those detailed in Table 1 below but generally were reported more frequently.Table 1: Adverse Reactions Reported by ≥2% of Patients Treated with Sildenafil and More Frequent than Placebo in Fixed-Dose Phase II/III Studies†Abnormal Vision: Mild to moderate in severity and transient, predominantly color tinge to vision, but also increased sensitivity to light, or blurred vision.When sildenafil was taken as recommended (on an as-needed basis) in flexible-dose, placebo-controlled clinical trials of two to twenty-six weeks duration, patients took sildenafil at least once weekly, and the following adverse reactions were reported:Table 2. Adverse Reactions Reported by ≥2% of Patients Treated with Sildenafil and More Frequent than Placebo in Flexible-Dose Phase II/III Studies†Abnormal Vision: Mild and transient, predominantly color tinge to vision, but also increased sensitivity to light or blurred vision. In these studies, only one patient discontinued due to abnormal vision.The following events occurred in <2% of patients in controlled clinical trials; a causal relationship to sildenafil is uncertain.

Sildenafil 50 mg is a popular erectile dysfunction medication available in India.
It is used to treat male impotence by increasing blood flow to the penis.
Sildenafil 50 mg is typically taken about 30-60 minutes before sexual activity.
The medication's effects can last for up to 4-6 hours.
It is available at many Indian pharmacies both online and offline.
Sildenafil 50 mg is often prescribed for men with ED aged 40-70.
The drug should be taken on an empty stomach for better absorption.
Possible side effects include headache, dizziness, and flushing.
Correct dosage and usage should be advised by a healthcare professional.

This analysis was performed retrospectively, and was not powered to detect any pre-specified difference in adverse reactions.6.2 Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of sildenafil.

6.2 Postmarketing Experience

7 DRUG INTERACTIONS 7.1 NitratesAdministration of sildenafil with nitric oxide donors such as organic nitrates or organic nitrites in any form is contraindicated. Consistent with its known effects on the nitric oxide/cGMP pathway, sildenafil was shown to potentiate the hypotensive effects of nitrates [see Dosage and Administration (2.3), Contraindications (4.1), Clinical Pharmacology (12.2)].7.2 Alpha-blockersUse caution when co-administering alpha-blockers with sildenafil because of potential additive blood pressurelowering effects.

If you were to talk to a doctor about sildenafil, what would you ask first?

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

In India, sildenafil 50 mg is available both as prescription and over-the-counter in some places.
It is crucial to follow the prescribed dosage to avoid overdose.
The medication works by blocking PDE5 enzymes in the body.
Common contraindications include heart disease and severe eyesight issues.
Sildenafil 50 mg can cause side effects like nasal congestion and upset stomach.
The drug is also explored for pulmonary hypertension treatment.
Many men prefer the 50 mg dose for a good balance of effectiveness and side effects.
Some users report prolonged erections beyond 4 hours as a medical emergency.
Regular check-ups are recommended for men using sildenafil frequently.

These events have been chosen for inclusion either due to their seriousness, reporting frequency, lack of clear alternative causation, or a sildenafil tablet manforce 50 mg combination of these factors.Cardiovascular and cerebrovascularSerious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, subarachnoid and intracerebral hemorrhages, and pulmonary hemorrhage have been reported post-marketing in temporal association with the use of sildenafil. Most, but not all, of these patients had preexisting cardiovascular risk factors. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of sildenafil without sexual activity.

Product	Dosage	Quantity + Bonus	Price
Viagra Generic	200mg	180 + 10 Pills	277.56€ 264.34€
Viagra Generic	50mg	20 Pills	40.52€ 38.59€
Kamagra	100mg	32 Pills	121.24€ 115.47€
Kamagra Polo	100mg	12 Pills	60.21€ 57.34€
Viagra Generic	50mg	270 + 8 Pills	198.48€ 189.03€
Viagra Generic	100mg	360 + 10 Pills	330.21€ 314.49€
Viagra Generic	100mg	60 + 4 Pills	96.36€ 91.77€
Kamagra Oral Jelly	100mg	110 + 9 Sachets	334.87€ 318.92€
Viagra Generic	100mg	120 + 6 Pills	149.50€ 142.38€
Viagra Generic	100mg	90 + 6 Pills	129.02€ 122.88€
Viagra Generic	150mg	60 + 4 Pills	111.25€ 105.95€
Viagra Generic	200mg	360 + 10 Pills	481.98€ 459.03€
Viagra Generic	25mg	360 + 10 Pills	213.68€ 203.50€

Others were reported to have occurred hours to days after the use of sildenafil events are related directly to sildenafil, to sexual activity, to the patient’s underlying cardiovascular disease, to a combination of these factors, or to other factors [see Warnings and Precautions (5.1) and Patient Counseling Information (17)].Hemic and Lymphatic: vaso-occlusive crisis: In a small, prematurely terminated study of REVATIO (sildenafil) in patients with pulmonary arterial hypertension (PAH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported in patients who received sildenafil than in those randomized to placebo. The clinical relevance of this finding to men treated with sildenafil for ED is not known.Nervous: seizure, seizure recurrence, anxiety, and transient global amnesia.Respiratory: epistaxisSpecial senses:Hearing: Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including sildenafil.

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Adverse Reactions Reported by ≥2% of Patients Treated with Sildenafil and More Frequent than Placebo in Flexible-Dose Phase II/III Studies†Abnormal Vision: Mild and transient, predominantly color tinge to vision, but also increased sensitivity to light or blurred vision. In these studies, only one patient discontinued due to abnormal vision.The following events occurred in <2% of patients in controlled clinical trials; a causal relationship to sildenafil is uncertain. This analysis was performed retrospectively, and was not powered to detect any pre-specified difference in adverse reactions.6.2 Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of sildenafil. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion either due to their seriousness, reporting frequency, lack of clear alternative causation, or a sildenafil tablet manforce 50 mg combination of these factors.Cardiovascular and cerebrovascularSerious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, subarachnoid and intracerebral hemorrhages, and pulmonary hemorrhage have been reported post-marketing in temporal association with the use of sildenafil.

4. Can I import Sildenafil Capsules from India?

Most, but not all, of these patients had preexisting cardiovascular risk factors. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of sildenafil without sexual activity. Others were reported to have occurred hours to days after the use of sildenafil events are related directly to sildenafil, to sexual activity, to the patient’s underlying cardiovascular disease, to a combination of these factors, or to other factors [see Warnings and Precautions (5.1) and Patient Counseling Information (17)].Hemic and Lymphatic: vaso-occlusive crisis: In a small, prematurely terminated study of REVATIO (sildenafil) in patients with pulmonary arterial hypertension (PAH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported in patients who received sildenafil than in those randomized to placebo. The clinical relevance of this finding to men treated with sildenafil for ED is not known.Nervous: seizure, seizure recurrence, anxiety, and transient global amnesia.Respiratory: epistaxisSpecial senses:Hearing: Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including sildenafil. In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events.

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In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of sildenafil, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors [see Warnings and Precautions (5.4) and Patient Counseling Information (17)].Ocular: diplopia, temporary vision loss/decreased vision, ocular redness or bloodshot appearance, ocular burning, ocular swelling/pressure, increased intraocular pressure, retinal edema, retinal vascular disease or bleeding, and vitreous traction/detachment.Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely post-marketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including sildenafil. Most, but not all, of these patients had underlying anatomic or vascular risk factors for developing NAION, including but not necessarily limited to: low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking [see Warnings and Precautions (5.3) and Patient Counseling Information (17)].Urogenital: prolonged erection, priapism [see Warnings and Precautions (5.2) and Patient Counseling Information (17)], and hematuria. The following are discussed in more detail in other sections of the labeling: Cardiovascular [see Warnings and Precautions (5.1)] Prolonged Erection and Priapism [see Warnings and Precautions (5.2)] Effects on the Eye [see Warnings and Precautions (5.3)] Hearing Loss [see Warnings and Precautions (5.4)] Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives [see Warnings and Precautions (5.5)] Adverse Reactions with the Concomitant Use of Ritonavir [see Warnings and Precautions (5.6)] Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies [see Warnings and Precautions (5.7)] Effects on Bleeding [see Warnings and Precautions (5.8)] Counseling Patients About Sexually Transmitted Diseases [see Warnings and Precautions (5.9)] The most common adverse sildenafil citrate tablets 50 mg reactions reported in clinical trials (> 2%) are headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Dangerous Interactions

Table 1: Adverse Reactions Reported by ≥2% of Patients Treated with Sildenafil and More Frequent than Placebo in Fixed-Dose Phase II/III Studies †Abnormal Vision: Mild to moderate in severity and transient, predominantly color tinge to vision, but also increased sensitivity to light, or blurred vision. †Abnormal Vision: Mild and transient, predominantly color tinge to vision, but also increased sensitivity to light or blurred vision. In these studies, only one patient discontinued due to abnormal vision. The following adverse reactions have been identified during post approval use of sildenafil. These events have been chosen for inclusion either due to their seriousness, reporting frequency, lack of clear alternative causation, or a combination of these factors. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of sildenafil, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors [see Warnings and Precautions (5.4) and Patient Counseling Information (17)].Ocular: diplopia, temporary vision loss/decreased vision, ocular redness or bloodshot appearance, ocular burning, ocular swelling/pressure, increased intraocular pressure, retinal edema, retinal vascular disease or bleeding, and vitreous traction/detachment.Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely post-marketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including sildenafil. Most, but not all, of these patients had underlying anatomic or vascular risk factors for developing NAION, including but not necessarily limited to: low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking [see Warnings and Precautions (5.3) and Patient Counseling Information (17)].Urogenital: prolonged erection, priapism [see Warnings and Precautions (5.2) and Patient Counseling Information (17)], and hematuria. The following are discussed in more detail in other sections of the labeling: Cardiovascular [see Warnings and Precautions (5.1)] Prolonged Erection and Priapism [see Warnings and Precautions (5.2)] Effects on the Eye [see Warnings and Precautions (5.3)] Hearing Loss [see Warnings and Precautions (5.4)] Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives [see Warnings and Precautions (5.5)] Adverse Reactions with the Concomitant Use of Ritonavir [see Warnings and Precautions (5.6)] Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies [see Warnings and Precautions (5.7)] Effects on Bleeding [see Warnings and Precautions (5.8)] Counseling Patients About Sexually Transmitted Diseases [see Warnings and Precautions (5.9)] The most common adverse sildenafil citrate tablets 50 mg reactions reported in clinical trials (> 2%) are headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In-depth Details for Importers, Exporters, and Buyers

To decrease the chance of adverse reactions in patients taking ritonavir, a decrease in sildenafil dosage is recommended [see Dosage and Administration (2.4), Drug Interactions (7.4), and Clinical Pharmacology (12.3)]. The safety and efficacy of combinations of sildenafil with other PDE5 Inhibitors, including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil, or other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended. There have been postmarketing reports of bleeding events in patients who have taken sildenafil. In addition, the combination of heparin and sildenafil had an additive effect on bleeding time in the anesthetized rabbit, but this interaction has not been studied in humans.

What should I do if I accidentally use too much sildenafil?

The use of sildenafil offers no protection against sexually transmitted diseases. 6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling:Cardiovascular [see Warnings and Precautions (5.1)]Prolonged Erection and Priapism [see Warnings and Precautions (5.2)]Effects on the Eye [see Warnings and Precautions (5.3)]Hearing Loss [see Warnings and Precautions (5.4)]Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives [see Warnings and Precautions (5.5)]Adverse Reactions with the Concomitant Use of Ritonavir [see Warnings and Precautions (5.6)]Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies [see Warnings and Precautions (5.7)]Effects on Bleeding [see Warnings and Precautions (5.8)]Counseling Patients About Sexually Transmitted Diseases [see Warnings and Precautions (5.9)]The most common adverse reactions reported in clinical trials (> 2%) are headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, sildenafil citrate tables myalgia, nausea, dizziness, and rash.6.1 Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.Sildenafil was administered to over 3700 patients (aged 19-87 years) during pre-marketing clinical trials worldwide. Over 550 patients were treated for longer than one year.In placebo-controlled clinical studies, the discontinuation rate due to adverse reactions for sildenafil (2.5%) was not significantly different from placebo (2.3%).In fixed-dose studies, the incidence of some adverse reactions increased with dose. The type of adverse reactions in flexible-dose studies, which reflect the recommended dosage regimen, was similar to that for fixed dose studies. At doses above the recommended dose range, adverse reactions were similar to those detailed in Table 1 below but generally were reported more frequently.Table 1: Adverse Reactions Reported by ≥2% of Patients Treated with Sildenafil and More Frequent than Placebo in Fixed-Dose Phase II/III Studies†Abnormal Vision: Mild to moderate in severity and transient, predominantly color tinge to vision, but also increased sensitivity to light, or blurred vision.When sildenafil was taken as recommended (on an as-needed basis) in flexible-dose, placebo-controlled clinical trials of two to twenty-six weeks duration, patients took sildenafil at least once weekly, and the following adverse reactions were reported:Table 2. Table 1: Adverse Reactions Reported by ≥2% of Patients Treated with Sildenafil and More Frequent than Placebo in Fixed-Dose Phase II/III Studies †Abnormal Vision: Mild to moderate in severity and transient, predominantly color tinge to vision, but also increased sensitivity to light, or blurred vision. †Abnormal Vision: Mild and transient, predominantly color tinge to vision, but also increased sensitivity to light or blurred vision.

Age Group	Percentage of Users	Common Usage Reasons	Health Considerations
30-40 years	35%	Erectile dysfunction following lifestyle changes	Generally healthy, mild side effects
41-50 years	40%	Onset of age-related ED	Monitor blood pressure and cardiovascular health
51+ years	25%	Chronic health conditions, ED	Under medical supervision recommended

In these studies, only one patient discontinued due to abnormal vision. The following adverse reactions have been identified during post approval use of sildenafil. These events have been chosen for inclusion either due to their seriousness, reporting frequency, lack of clear alternative causation, or a combination of these factors. 7 DRUG INTERACTIONS 7.1 NitratesAdministration of sildenafil with nitric oxide donors such as organic nitrates or organic nitrites in any form is contraindicated. Consistent with its known effects on the nitric oxide/cGMP pathway, sildenafil was shown to potentiate the hypotensive effects of nitrates [see Dosage and Administration (2.3), Contraindications (4.1), Clinical Pharmacology (12.2)].7.2 Alpha-blockersUse caution when co-administering alpha-blockers with sildenafil because of potential additive blood pressurelowering effects.