Do not use Dapoxetine if:

• you are allergic to any ingredient in Dapoxetine
• you have been advised by your doctor to avoid sexual activity because of heart problems
• you are taking nitrates (eg, isosorbide, nitroglycerin) in any form (eg, tablet, capsule, patch, ointment), or nitroprusside
• you use certain recreational drugs called “poppers” (eg, amyl nitrate or nitrite, butyl nitrate or nitrite).

Contact your doctor or health care provider right away if any of these apply to you.

Some medical conditions may interact with Dapoxetine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a deformed penis (eg, Peyronie disease), blood cell problems (eg, leukemia, sickle cell anemia), or any other condition that may increase the risk of a prolonged erection (priapism)
• if you have a history of a prolonged (more than 4 hours) or painful erection (priapism)
• if you have a history of liver or kidney problems, high or low blood pressure, ulcers, bleeding problems, heart problems (eg, heart failure, irregular heartbeat), or blood vessel problems
• if you have a history of heart attack, stroke, or life-threatening irregular heartbeat, especially within the past 6 months.

Some medicines may interact with Dapoxetine. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Alpha-blockers (eg, doxazosin), medicines for high blood pressure, nitrates (eg, isosorbide, nitroglycerin), or nitroprusside because severe low blood pressure with dizziness, lightheadedness, and fainting may occur
• Azole antifungals (eg, itraconazole, ketoconazole), H₂ antagonists (eg, cimetidine), HIV protease inhibitors (eg, ritonavir, saquinavir), macrolide antibiotics (eg, erythromycin), narcotic analgesics (eg, dihydrocodeine), or telithromycin because they may increase the risk of Dapoxetine’s side effects
• Bosentan or rifampin because they may decrease Dapoxetine’s effectiveness.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Dapoxetine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

• Dapoxetine may cause dizziness, drowsiness, fainting. These effects may be worse if you take it with alcohol or certain medicines. Use Dapoxetine with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.
• Dapoxetine may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Patients with heart problems who take Dapoxetine may be at increased risk for heart-related side effects, including heart attack or stroke. Symptoms of a heart attack may include chest, shoulder, neck, or jaw pain; numbness of an arm or leg; severe dizziness, headache, nausea, stomach pain, or vomiting; fainting; or vision changes. Symptoms of a stroke may include confusion, vision or speech changes, one-sided weakness, or fainting. Contact your doctor or seek medical attention right away if you experience these symptoms.
• Dapoxetine may rarely cause a prolonged (eg, more than 4 hours) or painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if you have an erection that lasts more than 4 hours.
• Dapoxetine does not stop the spread of HIV or other sexually transmitted diseases (STDs) to others through sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection or an STD.
• Dapoxetine will not prevent pregnancy. If your partner may become pregnant and you wish to avoid pregnancy, be sure to use an effective form of birth control.
• Dapoxetinemay uncommonly cause mild, temporary vision changes (eg, blurred vision, sensitivity to light, blue/green color tint to vision). Contact your doctor if vision changes persist or are severe.
• Do not use other medicines or treatments for ED while you are taking Dapoxetine without first checking with your doctor.
• Use Dapoxetine with caution in the elderly; they may be more sensitive to its effects.
• Dapoxetine is not recommended for use in patients younger 18 years.