Physicians should discuss with patients the contraindication of sildenafil citrate with use of guanylate cyclase stimulators such as riociguat [ see Contraindications (4.3)].

• The 50mg dosage is common but adjustable based on individual response.
• Overdose symptoms include severe dizziness, fainting, or prolonged erection.
• Sildenafil can cause visual disturbances, such as blurred vision.
• Use caution when driving or operating machinery after taking.
• Always check the expiration date on the medication packaging.
• Consult a healthcare professional for any underlying health concerns.
• Avoid using grapefruit or grapefruit juice with sildenafil.
• Notify your doctor if you experience chest pain during use.

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. 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)].

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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)].

Physicians 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)]. 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)].

8.6 Renal Impairment

Stop taking sildenafil tablets and call your healthcare provider right away if you have sudden vision loss in one or both eyes.sudden hearing decrease or hearing loss.Some people may also have ringing in their ears (tinnitus) or dizziness.

Professional resources

PATIENT INFORMATION Dispense with Patient Information available at: (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 sildenafil citrate tablets 50 mg 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).

• Sildenafil citrate 50mg can be used in combination therapy for ED.
• It is vital to follow your doctor’s exact dose and timing instructions.
• Do not take sildenafil if you have a history of allergic reactions.
• Exercise caution if you experience chest pains while on the medication.
• Keep track of any side effects experienced and report them.
• Avoid physical activity immediately after taking the tablet if feeling dizzy.
• The medication does not protect against STDs; use barrier protection.
• Always inform your healthcare provider of all ongoing treatments and medications.

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. 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 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.

• Sildenafil citrate tablets 50mg are used to treat erectile dysfunction.
• These tablets work by increasing blood flow to the penis.
• Take sildenafil 50mg approximately 30 minutes before activity.
• Do not exceed one dose in a 24-hour period.
• Common side effects include headache and flushing.
• Sildenafil can interact with nitrates, causing dangerous drops in blood pressure.
• Store tablets in a cool, dry place away from direct sunlight.
• Consult a doctor before use, especially if you have heart conditions.

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.

Technical Product Specification Table

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 citrate drug 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.

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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 citrate drug 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.

Study 2: Sildenafil citrate with Doxazosin

Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.How should I take sildenafil tablets?Take sildenafil tablets exactly as your healthcare provider tells you to take it.Your healthcare provider will tell you how much sildenafil tablets to take and when to take it.Your healthcare provider may change your dose if needed.Take sildenafil tablets about 1 hour before sexual activity. You may take sildenafil tablets between 30 minutes to 4 hours before sexual activity if needed.Sildenafil tablets can be taken with or without food. If you take sildenafil tablets after a high fat meal (such as a cheeseburger and french fries), sildenafil tablets may take a little longer to start workingDo nottake sildenafil tablets more than 1 time a day.If you accidentally take too much sildenafil tablets, call your doctor or go to the nearest hospital emergency room right away.What are the possible side effects of sildenafil tablets?Sildenafil tablets can cause serious side effects.Rarely reported side effects include:an erection that will not go away (priapism).If you have an erection that lasts more than 4 hours, get medical help right away. If it is not treated right away, priapism can permanently damage your penis.sudden vision loss in one or both eyes.Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). It is uncertain whether PDE5 inhibitors directly cause the vision loss. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.How should I take sildenafil tablets?Take sildenafil tablets exactly as your healthcare provider tells you to take it.Your healthcare provider will tell you how much sildenafil tablets to take and when to take it.Your healthcare provider may change your dose if needed.Take sildenafil tablets about 1 hour before sexual activity. You may take sildenafil tablets between 30 minutes to 4 hours before sexual activity if needed.Sildenafil tablets can be taken with or without food. If you take sildenafil tablets after a high fat meal (such as a cheeseburger and french fries), sildenafil tablets may take a little longer to start workingDo nottake sildenafil tablets more than 1 time a day.If you accidentally take too much sildenafil tablets, call your doctor or go to the nearest hospital emergency room right away.What are the possible side effects of sildenafil tablets?Sildenafil tablets can cause serious side effects.Rarely reported side effects include:an erection that will not go away (priapism).If you have an erection that lasts more than 4 hours, get medical help right away.

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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)]. PATIENT INFORMATION Dispense with Patient Information available at: (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 sildenafil citrate tablets 50 mg 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.

Allergy warning

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. 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 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. If it is not treated right away, priapism can permanently damage your penis.sudden vision loss in one or both eyes.Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION).

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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)]. 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)].

Dosage for pulmonary arterial hypertension (PAH)

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 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)]. It is uncertain whether PDE5 inhibitors directly cause the vision loss. Stop taking sildenafil tablets and call your healthcare provider right away if you have sudden vision loss in one or both eyes.sudden hearing decrease or hearing loss.Some people may also have ringing in their ears (tinnitus) or dizziness.