Label: SILDENAFIL- sildenafil tablet, film coated

Sildenafil tablets are contraindicated in patients with a known hypersensitivity to sildenafil, as contained in sildenafil tablets and REVATIO, or any component of the tablet.

8.4 Pediatric Use

When vasodilators are used in combination, an additive effect on blood pressure may occur. In some patients, concomitant use of these two drug classes can lower blood pressure significantly[ see Drug Interactions (7.2)and Clinical Pharmacology (12.2)] leading to symptomatic hypotension (e.g., dizziness, lightheadedness, fainting).Consideration should be given to the following:• Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors. Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor.In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest dose [ see Dosage and Administration (2.3)].• In those patients already taking an optimized dose of a PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure when taking a PDE5 inhibitor.• Safety of combined use of PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive drugs.Anti-hypertensivesSildenafil tablets have systemic vasodilatory properties and may further lower blood pressure in patients taking anti-hypertensive medications.In a separate drug interaction study, when amlodipine, 5 mg or 10 mg, and sildenafil tablets, 100 mg were orally administered concomitantly to hypertensive patients mean additional blood pressure reduction of 8 mmHg systolic and 7 mmHg diastolic were noted [see Drug Interactions (7.3)and Clinical Pharmacology (12.2)].5.6 Adverse Reactions with the Concomitant Use of RitonavirThe concomitant administration of the protease inhibitor ritonavir substantially increases serum concentrations of sildenafil (11-fold increase in AUC). If sildenafil tablets are prescribed to patients taking ritonavir, caution should be used.

Marketing and sales

Data from subjects exposed to high systemic levels of sildenafil are limited. Decreased blood pressure, syncope, and prolonged erection were reported in sildenafil otc some healthy volunteers exposed to high doses of sildenafil (200 to 800 mg). 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) ] .5.7 Combination with other PDE5 Inhibitors or Other Erectile Dysfunction TherapiesThe safety and efficacy of combinations of sildenafil tablets 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. Such combinations may further lower blood pressure. Therefore, the use of such combinations is not recommended.5.8 Effects on BleedingThere have been postmarketing reports of bleeding events in patients who have taken sildenafil tablets. 5 WARNINGS AND PRECAUTIONS 5.1 CardiovascularThere is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Therefore, treatments for erectile dysfunction, including sildenafil tablets, should not be generally used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status.

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The evaluation of erectile dysfunctionshould include a determination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment.Sildenafil tablets have systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 8.4/5.5 mmHg),[ see Clinical Pharmacology (12.2)].While this normally would be expected to be of little consequence in most patients, prior to prescribing sildenafil tablets, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects, especially in combination with sexual activity.Use with caution in patients with the following underlying conditions which can be particularly sensitive to the actions of vasodilators including sildenafil tablets – those with left ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure.There are no controlled clinical data on the safety or efficacy of sildenafil tablets in the following groups; if prescribed, this should be done with caution.• Patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months;• Patients with resting hypotension (BP <90/50 mmHg) or hypertension (BP >170/110 mmHg);• Patients with cardiac failure or coronary artery disease causing unstable angina.5.2 Prolonged Erection and PriapismProlonged erection greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of sildenafil tablets.

5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives

In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance.

Medical uses

A causal relationship between sildenafil tablets and these events has not been established. In humans, sildenafil tablets have no effect on bleeding time when taken alone or with aspirin. However, in vitrostudies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside (a nitric oxide donor). In addition, the combination of heparin and sildenafil tablets had an additive effect on bleeding time in the anesthetized rabbit, but this interaction has not been studied in humans.The safety of sildenafil tablets is unknown in patients with bleeding disorders and patients with active peptic ulceration.5.9 Counseling Patients About Sexually Transmitted DiseasesThe use of sildenafil tablets offers no protection against sexually transmitted diseases.

What should I know about sildenafil before taking it?

If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.Sildenafil tablets should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia). However, there are no controlled clinical data on the safety or efficacy of sildenafil tablets in patients with sickle cell or related anemias.5.3 Effects on the EyePhysicians should advise patients to stop use of all phosphodiesterase type 5 (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 rare condition and a cause of decreased vision including permanent loss of vision, that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors.

8.7 Hepatic Impairment

Sildenafil tablets are contraindicated in patients with a known hypersensitivity to sildenafil, as contained in sildenafil tablets and REVATIO, or any component of the tablet. 5 WARNINGS AND PRECAUTIONS 5.1 CardiovascularThere is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Therefore, treatments for erectile dysfunction, including sildenafil tablets, should not be generally used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status. The evaluation of erectile dysfunctionshould include a determination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment.Sildenafil tablets have systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 8.4/5.5 mmHg),[ see Clinical Pharmacology (12.2)].While this normally would be expected to be of little consequence in most patients, prior to prescribing sildenafil tablets, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects, especially in combination with sexual activity.Use with caution in patients with the following underlying conditions which can be particularly sensitive to the actions of vasodilators including sildenafil tablets – those with left ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure.There are no controlled clinical data on the safety or efficacy of sildenafil tablets in the following groups; if prescribed, this should be done with caution.• Patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months;• Patients with resting hypotension (BP <90/50 mmHg) or hypertension (BP >170/110 mmHg);• Patients with cardiac failure or coronary artery disease causing unstable angina.5.2 Prolonged Erection and PriapismProlonged erection greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of sildenafil tablets. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance.

Liver impairment

If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.Sildenafil tablets should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia). However, there are no controlled clinical data on the safety or efficacy of sildenafil tablets in patients with sickle cell or related anemias.5.3 Effects on the EyePhysicians should advise patients to stop use of all phosphodiesterase type 5 (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 rare condition and a cause of decreased vision including permanent loss of vision, that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors. Based on published literature, the annual incidence of NAION is 2.5 to 11.8 cases per 100,000 in males aged ≥ 50. An observational case-crossover study evaluated the risk of NAION when PDE5 inhibitor use, as a class, occurred immediately before NAION onset (within 5 half-lives), compared to PDE5 inhibitor use in a prior time period. Based on published literature, the annual incidence of NAION is 2.5 to 11.8 cases per 100,000 in males aged ≥ 50. An observational case-crossover study evaluated the risk of NAION when PDE5 inhibitor use, as a class, occurred immediately before NAION onset (within 5 half-lives), compared to PDE5 inhibitor use in a prior time period.

7.1 Nitrates

The results suggest an approximate 2-fold increase in the risk of NAION, with a risk estimate of 2.15 (95% CI 1.06, 4.34). A similar study reported a consistent result, with a sildenafil citrate tablet risk estimate of 2.27 (95% CI 0.99, 5.20). Other risk factors for NAION, such as the presence of “crowded” optic disc, may have contributed to the occurrence of NAION in these studies. Neither the rare post-marketing reports, nor the association of PDE5 inhibitor use and NAION in the observational studies, substantiate a causal relationship between PDE5 inhibitor use and NAION [see Adverse Reactions (6.2)].Physicians should consider whether their patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors. Individuals who have already experienced NAION are at increased risk of NAION recurrence.

Who should not take sildenafil?

Therefore, PDE5 inhibitors, including sildenafil tablets, should be used with caution in these patients and only when the anticipated benefits outweigh the risks. Individuals with “crowded” optic disc are also considered at greater risk for NAION compared to the general population, however, evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including sildenafil tablets, for this uncommon condition.There are no controlled clinical data on the safety or efficacy of sildenafil tablets in patients with retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases); if prescribed, this should be done with caution.5.4 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. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including sildenafil tablets. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [ see Adverse Reactions (6.1, 6.2)].5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensivesAlpha-blockersCaution is advised when PDE5 inhibitors are co-administered with alpha-blockers. PDE5 inhibitors, including sildenafil tablets, and alpha-adrenergic blocking sildenafil 50g agents are both vasodilators with blood pressure lowering effects. The results suggest an approximate 2-fold increase in the risk of NAION, with a risk estimate of 2.15 (95% CI 1.06, 4.34). A similar study reported a consistent result, with a sildenafil citrate tablet risk estimate of 2.27 (95% CI 0.99, 5.20).

12.2 Pharmacodynamics

Other risk factors for NAION, such as the presence of “crowded” optic disc, may have contributed to the occurrence of NAION in these studies. Neither the rare post-marketing reports, nor the association of PDE5 inhibitor use and NAION in the observational studies, substantiate a causal relationship between PDE5 inhibitor use and NAION [see Adverse Reactions (6.2)].Physicians should consider whether their patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors. Individuals who have already experienced NAION are at increased risk of NAION recurrence. Therefore, PDE5 inhibitors, including sildenafil tablets, should be used with caution in these patients and only when the anticipated benefits outweigh the risks. Individuals with “crowded” optic disc are also considered at greater risk for NAION compared to the general population, however, evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including sildenafil tablets, for this uncommon condition.There are no controlled clinical data on the safety or efficacy of sildenafil tablets in patients with retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases); if prescribed, this should be done with caution.5.4 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. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including sildenafil tablets.

5.1 Cardiovascular

It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [ see Adverse Reactions (6.1, 6.2)].5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensivesAlpha-blockersCaution is advised when PDE5 inhibitors are co-administered with alpha-blockers. PDE5 inhibitors, including sildenafil tablets, and alpha-adrenergic blocking sildenafil 50g agents are both vasodilators with blood pressure lowering effects.

• Sildenafil works by inhibiting PDE5 enzyme activity.
• The pink pill typically lasts 4 to 6 hours.
• It’s essential to follow prescribed dosage instructions.
• Off-label uses include pulmonary hypertension treatment.
• The pill should be stored in a cool, dry place.
• Generic versions of sildenafil are usually cheaper.

When vasodilators are used in combination, an additive effect on blood pressure may occur.

Condition	Ideal Range	Notes
Temperature	20-25°C (68-77°F)	Keep away from heat & moisture
Humidity	Below 60% humidity	Prevent degradation
Light Exposure	Store in dark, opaque container	Prevent color or potency loss
Container	Airtight, child-resistant container	Keep out of reach of children

In some patients, concomitant use of these two drug classes can lower blood pressure significantly[ see Drug Interactions (7.2)and Clinical Pharmacology (12.2)] leading to symptomatic hypotension (e.g., dizziness, lightheadedness, fainting).Consideration should be given to the following:• Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors. Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor.In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest dose [ see Dosage and Administration (2.3)].• In those patients already taking an optimized dose of a PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose.

Dosage	Typical Use	Onset Time	Duration of Effect	Notes
25 mg	For mild ED or as a starting dose	30-60 min	Up to 4 hours	Lower side effects potential
50 mg	Standard dose for most patients	30-60 min	Up to 6 hours	Effective for ED
100 mg	Maximum recommended dose	30-60 min	Up to 6 hours	Higher risk of side effects

Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure when taking a PDE5 inhibitor.• Safety of combined use of PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive drugs.Anti-hypertensivesSildenafil tablets have systemic vasodilatory properties and may further lower blood pressure in patients taking anti-hypertensive medications.In a separate drug interaction study, when amlodipine, 5 mg or 10 mg, and sildenafil tablets, 100 mg were orally administered concomitantly to hypertensive patients mean additional blood pressure reduction of 8 mmHg systolic and 7 mmHg diastolic were noted [see Drug Interactions (7.3)and Clinical Pharmacology (12.2)].5.6 Adverse Reactions with the Concomitant Use of RitonavirThe concomitant administration of the protease inhibitor ritonavir substantially increases serum concentrations of sildenafil (11-fold increase in AUC).

• Sildenafil pink pill may be contraindicated for some health conditions.
• Always inform your doctor of current medications before use.
• It can cause side effects like dizziness or stomach upset.
• Combining it with other ED medications is dangerous.
• Sildenafil should be taken on an empty stomach for best results.
• The medication is not a hormone and does not alter testosterone.

If sildenafil tablets are prescribed to patients taking ritonavir, caution should be used. Data from subjects exposed to high systemic levels of sildenafil are limited. Decreased blood pressure, syncope, and prolonged erection were reported in sildenafil otc some healthy volunteers exposed to high doses of sildenafil (200 to 800 mg). 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) ] .5.7 Combination with other PDE5 Inhibitors or Other Erectile Dysfunction TherapiesThe safety and efficacy of combinations of sildenafil tablets 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.

• Side effects may include dizziness, nasal congestion, or upset stomach.
• Alcohol can reduce the effectiveness of sildenafil.
• If an erection lasts more than 4 hours, seek medical help.
• The pink pill is sometimes used recreationally, which is risky.
• Do not take the pill if you have severe heart issues.
• Always check for medical hash compatibility before use.

Such combinations may further lower blood pressure. Therefore, the use of such combinations is not recommended.5.8 Effects on BleedingThere have been postmarketing reports of bleeding events in patients who have taken sildenafil tablets.

• Users should avoid heavy meals close to pill intake.
• Sildenafil pink pill can sometimes cause a headache or flushing.
• It may improve sexual confidence and reduce anxiety.
• Store the pink pill out of reach of children.
• Its effectiveness can be influenced by other health factors.
• Regular health check-ups are recommended during use.

A causal relationship between sildenafil tablets and these events has not been established. In humans, sildenafil tablets have no effect on bleeding time when taken alone or with aspirin. However, in vitrostudies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside (a nitric oxide donor). In addition, the combination of heparin and sildenafil tablets had an additive effect on bleeding time in the anesthetized rabbit, but this interaction has not been studied in humans.The safety of sildenafil tablets is unknown in patients with bleeding disorders and patients with active peptic ulceration.5.9 Counseling Patients About Sexually Transmitted DiseasesThe use of sildenafil tablets offers no protection against sexually transmitted diseases.