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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 citrate. 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, 25 mg, 50 mg and 100 mg with other PDE5 inhibitors including sildenafil tablets, 20 mg or other pulmonary arterial hypertension (PAH) treatments containing sildenafil. Sildenafil is also marketed as sildenafil tablets, 20 mg for the treatment of PAH.

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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 citrate. 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, 25 mg, 50 mg and 100 mg with other PDE5 inhibitors including sildenafil tablets, 20 mg or other pulmonary arterial hypertension (PAH) treatments containing sildenafil. Sildenafil is also marketed as sildenafil tablets, 20 mg for the treatment of PAH. The safety and efficacy of sildenafil tablets, 25 mg, 50 mg and 100 mg with other PDE5 inhibitors, including sildenafil tablets, 20 mg, have not been studied [ see Warnings and Precautions (5.7)].Sexually Transmitted DiseaseThe use of sildenafil citrate 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)].Manufactured by:Torrent Pharmaceuticals LTD., India.Manufactured for:Torrent Pharma INC., Basking Ridge, NJ 07920.8106707 Revised: January 2026 Advise the patient to read the FDA-approved patient labeling (Patient Information).

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Physicians should discuss with patients the contraindication of sildenafil citrate with regular and/or intermittent use of nitric oxide donors, such as organic nitrates or organic nitrites in any form [ see Contraindications (4.1)]. Physicians should discuss with patients the contraindication of sildenafil citrate with use of guanylate cyclase stimulators such as riociguat [ see Contraindications (4.3)]. Concomitant Use with Drugs Which Lower Blood Pressure Physicians should advise patients of the potential for sildenafil citrate to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications. Therefore, when sildenafil citrate is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating sildenafil citrate treatment and sildenafil citrate should be initiated at the lowest dose [ see Warnings and Precautions (5.5)]. Physicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. The safety and efficacy of sildenafil tablets, 25 mg, 50 mg and 100 mg with other PDE5 inhibitors, including sildenafil tablets, 20 mg, have not been studied [ see Warnings and Precautions (5.7)].Sexually Transmitted DiseaseThe use of sildenafil citrate 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)].Manufactured by:Torrent Pharmaceuticals LTD., India.Manufactured for:Torrent Pharma INC., Basking Ridge, NJ 07920.8106707 Revised: January 2026 Advise the patient to read the FDA-approved patient labeling (Patient Information). Physicians should discuss with patients the contraindication of sildenafil citrate with regular and/or intermittent use of nitric oxide donors, such as organic nitrates or organic nitrites in any form [ see Contraindications (4.1)].

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Physicians should discuss with patients the contraindication of sildenafil citrate with use of guanylate cyclase stimulators such as riociguat [ see Contraindications (4.3)]. Concomitant Use with Drugs Which Lower Blood Pressure Physicians should advise patients of the potential for sildenafil citrate to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications. Therefore, when sildenafil citrate is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating sildenafil citrate treatment and sildenafil citrate should be initiated at the lowest dose [ see Warnings and Precautions (5.5)].

Warnings and Precautions

Physicians 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)]. Physicians should advise patients to stop use of all PDE5 inhibitors, including sildenafil citrate, and seek medical attention in the event of a sudden loss of vision in one or both eyes. 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 citrate, for this uncommon condition [ see Warnings and Precautions (5.3) and Adverse Reactions (6.2)]. 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)].

Side Effect Severity Occurrence Rate Recommended Action
Headache Mild 20% Hydrate, take analgesics
Flushing Mild 15% Cool environment
Dizziness Mild to Moderate 10% Sit or lie down
Nasal Congestion Mild 12% Use decongestants
Nausea Mild 8% Eat before use

Physicians should warn patients that prolonged erections greater than 4 hours and priapism (painful erections greater than buy cenforce pills 6 hours in duration) have been reported infrequently since market approval of sildenafil citrate. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [ see Warnings and Precautions (5.2)]. Physicians should inform patients not to take sildenafil tablets, 25 mg, 50 mg and 100 mg with other PDE5 inhibitors including sildenafil tablets, 20 mg or other pulmonary arterial hypertension (PAH) treatments containing sildenafil. The safety and efficacy of sildenafil tablets, 25 mg, 50 mg and 100 mg with other PDE5 inhibitors, including sildenafil tablets, 20 mg, have not been studied [ see Warnings and Precautions (5.7)]. 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)]. Torrent Pharma INC., Basking Ridge, NJ 07920.

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Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of sildenafil tablets with alpha-blockers can lead to a drop in blood pressure or to fainting.medicines called HIV protease inhibitors, such as ritonavir (Norvir), indinavir sulfate (Crixivan), saquinavir (Fortovase or Invirase) or atazanavir sulfate (Reyataz)some types of oral antifungal medicines, such as ketoconazole (Nizoral), and itraconazole (Sporanox)some types of antibiotics, such as clarithromycin (Biaxin), telithromycin (Ketek), or erythromycinother medicines that treat high blood pressureother medicines or treatments for EDSildenafil tablets, 25 mg, 50 mg and 100 mg contains sildenafil, which is the same medicine found in another drug called Sildenafil tablets, 20 mg. Sildenafil tablets, 20 mg is used to treat a rare disease called pulmonary arterial hypertension (PAH). Sildenafil tablets, 25 mg, 50 mg and 100 mg should not be used with Sildenafil tablets, 20 mg or with other PAH treatments containing sildenafil or any other PDE5 inhibitors (such as Adcirca [tadalafil]).Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.Know the medicines you take.

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PATIENT INFORMATION Sildenafil (sil DEN a fil) Citrate 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).

12.3 Pharmacokinetics

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)]. Physicians should advise patients to stop use of all PDE5 inhibitors, including sildenafil citrate, and seek medical attention in the event of a sudden loss of vision in one or both eyes. 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 citrate, for this uncommon condition [ see Warnings and Precautions (5.3) and Adverse Reactions (6.2)]. 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)]. Physicians should warn patients that prolonged erections greater than 4 hours and priapism (painful erections greater than buy cenforce pills 6 hours in duration) have been reported infrequently since market approval of sildenafil citrate.

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If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [ see Warnings and Precautions (5.2)]. Physicians should inform patients not to take sildenafil tablets, 25 mg, 50 mg and 100 mg with other PDE5 inhibitors including sildenafil tablets, 20 mg or other pulmonary arterial hypertension (PAH) treatments containing sildenafil. The safety and efficacy of sildenafil tablets, 25 mg, 50 mg and 100 mg with other PDE5 inhibitors, including sildenafil tablets, 20 mg, have not been studied [ see Warnings and Precautions (5.7)]. 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)]. Torrent Pharma INC., Basking Ridge, NJ 07920. 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.

  • Oral tablets
  • Soft gels
  • Chews
  • Liquids
  • Dissolvable strips
  • Injection

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. Ask your doctor if your heart is healthy enough to handle the extra strain of having sex.Sildenafil tablets does not protect you or your partner from getting sexually transmitted diseases, including HIV - the virus that causes AIDS.What are sildenafil fildena 100mg tablets?Sildenafil tablets is a prescription medicine used to treat erectile dysfunction (ED). You will not get an erection just by taking this medicine. Sildenafil tablets helps a man with erectile dysfunction get and keep an erection only when he is sexually excited (stimulated).Sildenafil tablets is not for use in women or children.It is not known if Sildenafil tablets is safe and effective in women or children under 18 years of age.Who should not take sildenafil tablet?Do not take sildenafil tablets if you:take medicines called nitrates (such as nitroglycerin)use street drugs called “poppers” such as amyl nitrate or amyl nitrite, and butyl nitratetake any medicines called guanylate cyclase stimulators such as riociguat (Adempas)are allergic to sildenafil, as contained in Sildenafil tablets, 25 mg, 50 mg and 100 mg and Sildenafil tablets, 20 mg or any of the ingredients in Sildenafil tablets. See the end of this leaflet for a complete list of ingredients in Sildenafil tablets.What should I tell my healthcare provider before taking sildenafil tablets?Before you take Sildenafil tablets, tell your healthcare provider if you:have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve or heart failurehave had heart surgery within the last 6 monthshave pulmonary hypertensionhave had a strokehave low blood pressure, or high blood pressure that is not controlledhave a deformed penis shapehave had an erection that lasted for more than 4 hourshave problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemiahave retinitis pigmentosa, a rare genetic (runs in families) eye diseasehave ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION)have bleeding problemshave or have had stomach ulcershave liver problemshave kidney problems or are having kidney dialysishave any other medical conditionsTell your healthcare provider about all the medicines you take*, including prescription and over-the-counter medicines, vitamins, and herbal supplements.Sildenafil tablets may affect the way other medicines work, and other medicines may affect the way Sildenafil tablets works causing side effects.

  • Sildenafil
  • Tadalafil
  • Vardenafil
  • Avanafil
  • Udenafil
  • Tadanafil

Especially tell your healthcare provider if you take any of the following:medicines called nitrates (see “What is the most important information I should know about Sildenafil tablets?”)medicines called guanylate cyclase stimulators, such as riociguat (Adempas)medicines called alpha blockers such as Hytrin (terazosin HCl), Flomax (tamsulosin HCl), Cardura (doxazosin mesylate), Minipress (prazosin HCl), Uroxatral (alfuzosin HCl), Jalyn (dutasteride and tamsulosin HCl), or Rapaflo (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of sildenafil tablets with alpha-blockers can lead to a drop in blood pressure or to fainting.medicines called HIV protease inhibitors, such as ritonavir (Norvir), indinavir sulfate (Crixivan), saquinavir (Fortovase or Invirase) or atazanavir sulfate (Reyataz)some types of oral antifungal medicines, such as ketoconazole (Nizoral), and itraconazole (Sporanox)some types of antibiotics, such as clarithromycin (Biaxin), telithromycin (Ketek), or erythromycinother medicines that treat high blood pressureother medicines or treatments for EDSildenafil tablets, 25 mg, 50 mg and 100 mg contains sildenafil, which is the same medicine found in another drug called Sildenafil tablets, 20 mg. Sildenafil tablets, 20 mg is used to treat a rare disease called pulmonary arterial hypertension (PAH). Sildenafil tablets, 25 mg, 50 mg and 100 mg should not be used with Sildenafil tablets, 20 mg or with other PAH treatments containing sildenafil or any other PDE5 inhibitors (such as Adcirca [tadalafil]).Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.Know the medicines you take.

7.4 Ritonavir and other CYP3A4 inhibitors

PATIENT INFORMATION Sildenafil (sil DEN a fil) Citrate 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). 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.

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Ask your doctor if your heart is healthy enough to handle the extra strain of having sex.Sildenafil tablets does not protect you or your partner from getting sexually transmitted diseases, including HIV - the virus that causes AIDS.What are sildenafil fildena 100mg tablets?Sildenafil tablets is a prescription medicine used to treat erectile dysfunction (ED). You will not get an erection just by taking this medicine. Sildenafil tablets helps a man with erectile dysfunction get and keep an erection only when he is sexually excited (stimulated).Sildenafil tablets is not for use in women or children.It is not known if Sildenafil tablets is safe and effective in women or children under 18 years of age.Who should not take sildenafil tablet?Do not take sildenafil tablets if you:take medicines called nitrates (such as nitroglycerin)use street drugs called “poppers” such as amyl nitrate or amyl nitrite, and butyl nitratetake any medicines called guanylate cyclase stimulators such as riociguat (Adempas)are allergic to sildenafil, as contained in Sildenafil tablets, 25 mg, 50 mg and 100 mg and Sildenafil tablets, 20 mg or any of the ingredients in Sildenafil tablets. See the end of this leaflet for a complete list of ingredients in Sildenafil tablets.What should I tell my healthcare provider before taking sildenafil tablets?Before you take Sildenafil tablets, tell your healthcare provider if you:have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve or heart failurehave had heart surgery within the last 6 monthshave pulmonary hypertensionhave had a strokehave low blood pressure, or high blood pressure that is not controlledhave a deformed penis shapehave had an erection that lasted for more than 4 hourshave problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemiahave retinitis pigmentosa, a rare genetic (runs in families) eye diseasehave ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION)have bleeding problemshave or have had stomach ulcershave liver problemshave kidney problems or are having kidney dialysishave any other medical conditionsTell your healthcare provider about all the medicines you take*, including prescription and over-the-counter medicines, vitamins, and herbal supplements.Sildenafil tablets may affect the way other medicines work, and other medicines may affect the way Sildenafil tablets works causing side effects. Especially tell your healthcare provider if you take any of the following:medicines called nitrates (see “What is the most important information I should know about Sildenafil tablets?”)medicines called guanylate cyclase stimulators, such as riociguat (Adempas)medicines called alpha blockers such as Hytrin (terazosin HCl), Flomax (tamsulosin HCl), Cardura (doxazosin mesylate), Minipress (prazosin HCl), Uroxatral (alfuzosin HCl), Jalyn (dutasteride and tamsulosin HCl), or Rapaflo (silodosin).