Label: SILDENAFIL CITRATE- sildenafil tablet, film coated

Diary data in two of the studies (n=178) showed rates of successful intercourse per attempt of 70% for sildenafil tablets and 29% for placebo.Efficacy Results in Subpopulations in Controlled Clinical StudiesA review of population subgroups demonstrated efficacy regardless of baseline severity, etiology, race and age. Sildenafil citrate was effective in a broad range of ED patients, including those with a history of coronary artery disease, hypertension, other cardiac disease, peripheral vascular disease, diabetes mellitus, depression, coronary artery bypass graft (CABG), radical prostatectomy, transurethral resection of the prostate (TURP) and spinal cord injury, and in patients taking antidepressants/antipsychotics and anti-hypertensives/diuretics. In clinical studies, sildenafil tablets were assessed for its effect on the ability of men with erectile dysfunction (ED) to engage in sexual activity and in many cases specifically on the ability to achieve and maintain an erection sufficient for satisfactory sexual activity. The studies that established benefit demonstrated improvements in success rates for sexual intercourse compared with placebo. Effect of sildenafil tablets on Maintenance of Erection by Effect of Placebo on Maintenance of Erection by Effect of sildenafil tablets and Placebo on The frequency of patients reporting improvement of erections in response to a global question in four of the randomized, double-blind, parallel, placebo-controlled fixed dose studies (1797 patients) of 12 to 24 weeks duration is shown in Figure 7. In the titration studies (n=644) (with most patients eventually receiving 100 mg), results were similar.

Side Effect	Incidence (%)	Severity	Notes
Headache	25	Mild to moderate	Common, usually temporary
Flushing	18	Mild	Reddening of face
Nasal Congestion	12	Mild	Stuffy nose
Dizziness	10	Mild to moderate	Especially when standing up quickly
Vision Changes	8	Mild	Blue tint, blurred vision

Percentage of Patients Reporting an Improvement in Erections.

Drug Label Information

The patients in studies had varying degrees of ED. One-third to one-half of the subjects in these studies reported successful intercourse at least once during a 4-week, treatment-free run-in period.

• Sildenafil citrate may interact with certain antifungals and antibiotics, increasing side effects.
• Always review current medications with your healthcare provider before using sildenafil citrate.
• Report any adverse reactions immediately to prevent worsening health conditions.

During 3 to 6 months of double-blind treatment or longer-term (1 year), open-label studies, few patients withdrew from active treatment for any reason, including lack of effectiveness.

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At the end of the long-term study, 88% of patients reported that sildenafil tablets improved their erections. Men with untreated ED had relatively low baseline scores for all aspects of sexual liquid sildenafil citrate function measured (again using a 5-point scale) in the IIEF. Sildenafil tablets improved these aspects of sexual function: frequency, firmness and maintenance of erections; frequency of orgasm; frequency and level of desire; frequency, satisfaction and enjoyment of intercourse; and overall relationship satisfaction. One randomized, double-blind, flexible-dose, placebo-controlled study included only patients with erectile dysfunction attributed to complications of diabetes mellitus (n=268). Diary data indicated that on sildenafil tablets, 48% of intercourse attempts were successful versus 12% on placebo.

• Sildenafil citrate is available by prescription; do not buy unregulated versions.
• Dose adjustments are essential for individuals with liver or kidney impairment.
• Always adhere to prescribed guidelines when using sildenafil citrate.

One randomized, double-blind, placebo-controlled, crossover, flexible-dose (up to 100 mg) study of patients with erectile dysfunction resulting from spinal cord injury (n=178) was conducted.

• At 200mg, visual side effects like blue-green tint are more pronounced.
• This occurs because PDE6 in retinal rods is also inhibited at high doses.
• Transient light sensitivity and blurred vision may last several hours.
• Risk increases with dose; 200mg has higher incidence than 50mg or 100mg.
• In most cases, visual changes are reversible upon drug elimination.
• Patients with retinitis pigmentosa should avoid sildenafil altogether.
• NAION (non-arteritic ischemic optic neuropathy) risk is dose-independent.
• Annual eye exams may be advised for patients using high-dose sildenafil.
• Report any sudden vision loss immediately; it may be permanent.

Diary data indicated that on sildenafil tablets, 59% of attempts at sexual intercourse were successful compared to 13% on placebo.

12.1 Mechanism of Action

Across all trials, sildenafil tablets improved the erections of 43% of radical prostatectomy patients compared to 15% on placebo.

8.5 Geriatric Use

Efficacy Results in Subpopulations in Controlled Clinical Studies 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil tablets, USP are supplied as green, oval-shaped, beveled edge, biconvex, film-coated tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil and debossed on the obverse and reverse sides as follows:Recommended Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Sildenafil tablets, USP are supplied as green, oval-shaped, beveled edge, biconvex, film-coated tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil and debossed on the obverse and reverse sides as follows: Recommended Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). 17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information)NitratesPhysicians should discuss with patients the contraindication of sildenafil tablets with regular and/or intermittent use of nitric oxide donors, such as organic nitrates or organic nitrites in any form [see Contraindications (4.1)].Guanylate Cyclase (GC) StimulatorsPhysicians should discuss with patients the contraindication of sildenafil tablets with use of guanylate cyclase stimulators such as riociguat [see Contraindications (4.3)].Concomitant Use with Drugs Which Lower Blood PressurePhysicians should advise patients of the potential for sildenafil tablets to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications. Concomitant administration of sildenafil tablets and an alpha-blocker may lead to symptomatic hypotension in some patients. Therefore, when sildenafil tablets are co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating sildenafil tablets treatment and sildenafil tablets should be initiated at the lowest dose [see Warnings and Precautions (5.5)].Cardiovascular ConsiderationsPhysicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors.

Sildenafil Oral Film for ED

Patients who experience symptoms (e.g., angina pectoris, dizziness, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician [see Warnings and Precautions (5.1)].Sudden Loss of VisionPhysicians should advise patients to stop use of all PDE5 inhibitors, including sildenafil tablets, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including possible permanent loss of vision, that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors. Physicians should discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a “crowded” optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitor, including sildenafil tablets, for this uncommon condition [see Warnings and Precautions (5.3) and Adverse Reactions (6.2)].Sudden Hearing LossPhysicians should advise patients to stop taking PDE5 inhibitors, including sildenafil tablets, and seek prompt medical attention in the event of sudden decrease or loss of hearing. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Warnings and Precautions (5.4) and Adverse Reactions (6.2)].PriapismPhysicians should warn patients that prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of sildenafil tablets. Subgroup analyses of responses to a global improvement question in patients with psychogenic etiology in two fixed-dose studies (total sildenafil 20 mg prescription n=179) and two titration studies (total n=149) showed 84% of sildenafil tablets patients reported improvement in erections compared with 26% of placebo. Diary data in two of the studies (n=178) showed rates of successful intercourse per attempt of 70% for sildenafil tablets and 29% for placebo. Efficacy Results in Subpopulations in Controlled Clinical Studies 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil tablets, USP are supplied as green, oval-shaped, beveled edge, biconvex, film-coated tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil and debossed on the obverse and reverse sides as follows:Recommended Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Sildenafil tablets, USP are supplied as green, oval-shaped, beveled edge, biconvex, film-coated tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil and debossed on the obverse and reverse sides as follows: Recommended Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). 17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information)NitratesPhysicians should discuss with patients the contraindication of sildenafil tablets with regular and/or intermittent use of nitric oxide donors, such as organic nitrates or organic nitrites in any form [see Contraindications (4.1)].Guanylate Cyclase (GC) StimulatorsPhysicians should discuss with patients the contraindication of sildenafil tablets with use of guanylate cyclase stimulators such as riociguat [see Contraindications (4.3)].Concomitant Use with Drugs Which Lower Blood PressurePhysicians should advise patients of the potential for sildenafil tablets to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications. Concomitant administration of sildenafil tablets and an alpha-blocker may lead to symptomatic hypotension in some patients. Therefore, when sildenafil tablets are co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating sildenafil tablets treatment and sildenafil tablets should be initiated at the lowest dose [see Warnings and Precautions (5.5)].Cardiovascular ConsiderationsPhysicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. Patients who experience symptoms (e.g., angina pectoris, dizziness, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician [see Warnings and Precautions (5.1)].Sudden Loss of VisionPhysicians should advise patients to stop use of all PDE5 inhibitors, including sildenafil tablets, and seek medical attention in the event of a sudden loss of vision in one or both eyes.

• Sildenafil 200mg should be taken exactly as prescribed; never double dose.
• If a dose is missed, do not take two tablets at once.
• Spacing doses 24 hours apart is mandatory to avoid accumulation.
• Monitor your blood pressure regularly if you have hypertension.
• Watch for signs of allergic reaction: hives, difficulty breathing, swelling.
• Stop use and contact a doctor if you experience sudden vision/hearing loss.
• Keep a log of side effects to discuss with your physician.
• Do not drive if you feel dizzy or have visual disturbances.
• Inform all healthcare providers, including dentists, that you take 200mg.

Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including possible permanent loss of vision, that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors. Physicians should discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a “crowded” optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitor, including sildenafil tablets, for this uncommon condition [see Warnings and Precautions (5.3) and Adverse Reactions (6.2)].Sudden Hearing LossPhysicians should advise patients to stop taking PDE5 inhibitors, including sildenafil tablets, and seek prompt medical attention in the event of sudden decrease or loss of hearing. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Warnings and Precautions (5.4) and Adverse Reactions (6.2)].PriapismPhysicians should warn patients that prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of sildenafil tablets.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [see Warnings and Precautions (5.2)].Avoid Use with other PDE5 InhibitorsPhysicians should inform patients not to take sildenafil tablets with other PDE5 inhibitors including REVATIO or other pulmonary arterial hypertension (PAH) sildenafil products over the counter treatments containing sildenafil. Sildenafil is also marketed as REVATIO for the treatment of PAH.

4.1 Nitrates

Diary data in two of the studies (n=178) showed rates of successful intercourse per attempt of 70% for sildenafil tablets and 29% for placebo.Efficacy Results in Subpopulations in Controlled Clinical StudiesA review of population subgroups demonstrated efficacy regardless of baseline severity, etiology, race and age. Sildenafil citrate was effective in a broad range of ED patients, including those with a history of coronary artery disease, hypertension, other cardiac disease, peripheral vascular disease, diabetes mellitus, depression, coronary artery bypass graft (CABG), radical prostatectomy, transurethral resection of the prostate (TURP) and spinal cord injury, and in patients taking antidepressants/antipsychotics and anti-hypertensives/diuretics. In clinical studies, sildenafil tablets were assessed for its effect on the ability of men with erectile dysfunction (ED) to engage in sexual activity and in many cases specifically on the ability to achieve and maintain an erection sufficient for satisfactory sexual activity. The studies that established benefit demonstrated improvements in success rates for sexual intercourse compared with placebo. Effect of sildenafil tablets on Maintenance of Erection by Effect of Placebo on Maintenance of Erection by Effect of sildenafil tablets and Placebo on The frequency of patients reporting improvement of erections in response to a global question in four of the randomized, double-blind, parallel, placebo-controlled fixed dose studies (1797 patients) of 12 to 24 weeks duration is shown in Figure 7.

GENERIC NAME OF THE MEDICINAL PRODUCT:

In the titration studies (n=644) (with most patients eventually receiving 100 mg), results were similar. Percentage of Patients Reporting an Improvement in Erections. The patients in studies had varying degrees of ED. One-third to one-half of the subjects in these studies reported successful intercourse at least once during a 4-week, treatment-free run-in period. During 3 to 6 months of double-blind treatment or longer-term (1 year), open-label studies, few patients withdrew from active treatment for any reason, including lack of effectiveness. The safety and efficacy of sildenafil tablets with other PDE5 inhibitors, including REVATIO, have not been studied [see Warnings and Precautions (5.7)].Sexually Transmitted DiseaseThe use of sildenafil tablets offers no protection against sexually transmitted diseases.

Storage Condition	Details	Shelf Life	Precautions
Temperature	Store below 30°C (86°F), in a dry place	2 years	Protect from moisture and heat
Packaging	Keep in original container, tight seal		Keep out of reach of children
Light Exposure	Store in a dark place		Prevent degradation from light
Handling	Avoid crushing or splitting tablets		Use with clean, dry hands

Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered [see Warnings and Precautions (5.9)].Product of IndiaManufactured by:Ajanta Pharma LimitedIndiaManufactured for:Quallent Pharmaceuticals Health LLCGrand Cayman, Cayman IslandsRevised: 11/2025 Advise the patient to read the FDA-approved patient labeling (Patient Information) Concomitant Use with Drugs Which Lower Blood Pressure Patient Information Sildenafil (sil den' a fil )tablets, USPWhat is the most important information I should know about sildenafil tablets?Sildenafil tablets can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines.

7.5 Alcohol

If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [see Warnings and Precautions (5.2)].Avoid Use with other PDE5 InhibitorsPhysicians should inform patients not to take sildenafil tablets with other PDE5 inhibitors including REVATIO or other pulmonary arterial hypertension (PAH) sildenafil products over the counter treatments containing sildenafil. Sildenafil is also marketed as REVATIO for the treatment of PAH. The safety and efficacy of sildenafil tablets with other PDE5 inhibitors, including REVATIO, have not been studied [see Warnings and Precautions (5.7)].Sexually Transmitted DiseaseThe use of sildenafil tablets offers no protection against sexually transmitted diseases. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered [see Warnings and Precautions (5.9)].Product of IndiaManufactured by:Ajanta Pharma LimitedIndiaManufactured for:Quallent Pharmaceuticals Health LLCGrand Cayman, Cayman IslandsRevised: 11/2025 Advise the patient to read the FDA-approved patient labeling (Patient Information) Concomitant Use with Drugs Which Lower Blood Pressure Patient Information Sildenafil (sil den' a fil )tablets, USPWhat is the most important information I should know about sildenafil tablets?Sildenafil tablets can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. Do not take sildenafil tablets if you take any other medicines called “nitrates.” Nitrates are used to treat chest pain (angina).

5. Target Countries & Export Markets

A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke.Do not take sildenafil tablets if you take medicines called guanylate cyclase stimulators which include:Riociguat (Adempas®) a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension.Tell all your healthcare providers that you take sildenafil tablets. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took sildenafil tablets.Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex.Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. Do not take sildenafil tablets if you take any other medicines called “nitrates.” Nitrates are used to treat chest pain (angina).

Contraindication	Explanation	Alternative Action
Use with Nitrates	Risk of severe hypotension	Avoid combined use
Severe Liver Impairment	Reduced metabolism, increased side effects	Consult healthcare provider
Hypotension (<90/60 mm Hg)	Sildenafil can lower blood pressure further	Monitor blood pressure before use
Recent Stroke or Heart Attack	Increased cardiovascular risk	Medical consultation prior to use
Allergic Reaction to Sildenafil	Risk of anaphylaxis	Discontinue use, seek medical advice

A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke.Do not take sildenafil tablets if you take medicines called guanylate cyclase stimulators which include:Riociguat (Adempas®) a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension.Tell all your healthcare providers that you take sildenafil tablets.

About the Company

At the end of the long-term study, 88% of patients reported that sildenafil tablets improved their erections. Men with untreated ED had relatively low baseline scores for all aspects of sexual liquid sildenafil citrate function measured (again using a 5-point scale) in the IIEF. Sildenafil tablets improved these aspects of sexual function: frequency, firmness and maintenance of erections; frequency of orgasm; frequency and level of desire; frequency, satisfaction and enjoyment of intercourse; and overall relationship satisfaction. One randomized, double-blind, flexible-dose, placebo-controlled study included only patients with erectile dysfunction attributed to complications of diabetes mellitus (n=268). Diary data indicated that on sildenafil tablets, 48% of intercourse attempts were successful versus 12% on placebo.

How is sildenafil supplied (dosage forms)?

One randomized, double-blind, placebo-controlled, crossover, flexible-dose (up to 100 mg) study of patients with erectile dysfunction resulting from spinal cord injury (n=178) was conducted. Diary data indicated that on sildenafil tablets, 59% of attempts at sexual intercourse were successful compared to 13% on placebo. Across all trials, sildenafil tablets improved the erections of 43% of radical prostatectomy patients compared to 15% on placebo. Subgroup analyses of responses to a global improvement question in patients with psychogenic etiology in two fixed-dose studies (total sildenafil 20 mg prescription n=179) and two titration studies (total n=149) showed 84% of sildenafil tablets patients reported improvement in erections compared with 26% of placebo. Diary data in two of the studies (n=178) showed rates of successful intercourse per attempt of 70% for sildenafil tablets and 29% for placebo. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took sildenafil tablets.Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex.Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease.