Do NOT use Tadalis SX if:

• you are allergic to any ingredient in Tadalis SX
• you have severe kidney or liver problems, certain hereditary eye problems (eg, retinitis pigmentosa), or if you are on dialysis
• you have pulmonary veno-occlusive disease (PVOD)
• you take a nitrate (eg, isosorbide, nitroglycerin) in any form (eg, tablet, capsule, patch, spray, ointment), or nitroprusside
• you take another medicine that contains tadalafil, another PDE5 inhibitor (eg, sildenafil, vardenafil), an azole antifungal (eg, itraconazole, ketoconazole), or rifampin
• 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 Tadalis SX. 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 history of a prolonged (more than 4 hours) or painful erection (priapism)
• if you have a deformed penis (eg, Peyronie disease, cavernosal fibrosis), certain blood cell problems (eg, sickle cell anemia, leukemia, multiple myeloma), or other conditions that may increase the risk of a prolonged or painful erection (priapism)
• if you have low blood pressure, uncontrolled high blood pressure, blood vessel problems, angina (chest pain), heart problems (eg, heart valve disease, congestive heart failure, irregular heartbeat) or a history of these conditions
• if you have a history of heart attack, stroke, life-threatening irregular heartbeat, liver or kidney problems, dialysis, ulcers, or bleeding problems
• if you have a history of eye or vision problems (eg, decreased vision or vision loss, optic nerve problems, retina problems) or hearing problems (eg, ringing in the ears, decreased hearing, hearing loss)
• if you take medicine for erectile dysfunction (ED).

Some medicines may interact with Tadalis SX. 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, or nitrates (eg, isosorbide, nitroglycerin) because severe low blood pressure with dizziness, lightheadedness, and fainting may occur
• Azole antifungals (eg, itraconazole, ketoconazole), HIV protease inhibitors (eg, ritonavir), macrolide antibiotics (eg, erythromycin), or telithromycin because they may increase the risk of Tadalis SX's side effects
• Barbiturates (eg, phenobarbital), bosentan, carbamazepine, hydantoins (eg, phenytoin), or rifampin because they may decrease Tadalis SX's effectiveness.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tadalis SX 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:

• Tadalis SX may cause dizziness, drowsiness, fainting, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Tadalis SX with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.
• Tadalis SX 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.
• Do not drink large amounts of alcohol (eg, 4 or 5 drinks or more) while you take Tadalis SX. Doing so may increase your risk of dizziness, headache, fast heartbeat, and low blood pressure.
• Patients with heart problems who take Tadalis SX 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.
• Tadalis SX may rarely cause a prolonged (eg, longer 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 this happens.
• Tadalis SX may 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.
• Rarely, an eye problem called nonarteritic anterior ischemic optic neuropathy (NAION) has been reported in patients who took Tadalis SX. This may lead to decreased vision or permanent loss of vision in some cases. If you notice a sudden decrease in vision or loss of vision in one or both eyes, contact your doctor right away.
• Sudden decreases in hearing and loss of hearing have been reported in some patients who have taken Tadalis SX. Sometimes they also noticed ringing in the ears or dizziness. If you notice a sudden decrease or loss of hearing, contact your doctor right away.
• Do not use medicines or treatments for ED while you are taking Tadalis SX without first checking with your doctor.
• Use Tadalis SX with caution in the elderly; they may be more sensitive to its effects.
• Use Tadalis SX with extreme caution in children younger 18 years; safety and effectiveness in children have not been confirmed.

All medicines may cause side effects, but many people have no, or minor, side effects.

Check with your doctor if any of these most common side effects persist or become bothersome:

Flushing; headache; heartburn; mild pain in the arms, legs, or back; muscle pain; nausea; stomach upset; stuffy nose.

Seek medical attention right away if any of these severe side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; fainting; fast or irregular heartbeat; memory loss; numbness in arm or leg; one-sided weakness; prolonged, painful erection; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe or persistent back or muscle pain; severe or persistent dizziness; severe or persistent vision changes; shortness of breath or wheezing; slurred speech; sudden decrease or loss of hearing; sudden decrease or loss of vision in one or both eyes; sudden, severe headache or vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.