Tadalafil (Eqv-Adcirca)

Tadalafil (Eqv-Adcirca) is used in adult men to treat erectile dysfunction (impotence) and symptoms of benign prostatic hypertrophy (enlarged prostate).

Tadalafil (Eqv-Adcirca) can also be used in men and women to treat pulmonary arterial hypertension (PAH) and improve exercise capacity.

Do not take Tadalafil (Eqv-Adcirca) for erectile dysfunction and symptoms of enlarged prostate if you are taking Tadalafil (Eqv-Adcirca) for pulmonary arterial hypertension.

Tadalafil (Eqv-Adcirca) may also be used for other reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally adjust your dose. Use the medicine exactly as directed.

Your dose may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using it exactly as directed on the label or as prescribed by your doctor.

When taking Tadalafil (Eqv-Adcirca) for erectile dysfunction, take it when needed, about 30 minutes before sexual activity. The medicine can help you achieve an erection when sexual stimulation occurs. An erection will not happen just by taking a pill.

If you take Tadalafil (Eqv-Adcirca) once a day, take it at the same time each day, with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

Shake the oral suspension (liquid) for 30 seconds before you measure a dose. Measure a dose using the supplied measuring device (not a kitchen spoon).

Do not use this medication more than once per day.

Do not change your Tadalafil (Eqv-Adcirca) dose or stop taking this medicine. Follow your doctor's dosing instructions very carefully.

If you receive medical care for heart problems, inform your caregivers when you last took Tadalafil (Eqv-Adcirca).

This medicine does not prevent the spread of sexually transmitted diseases such as human immunodeficiency virus (HIV).

Store at room temperature away from moisture and heat.

Some medicines can cause harmful or serious effects when taken with Tadalafil (Eqv-Adcirca). Inform your doctor about all the other medicines you are using.

Stop using Tadalafil (Eqv-Adcirca) and seek emergency medical help if you experience sudden vision loss or hearing issues.

Get emergency medical help immediately if you have nausea, chest pain, or dizziness while having sex.

You should not take Tadalafil (Eqv-Adcirca) if you are allergic to it, or if you are taking other medicines for pulmonary arterial hypertension, such as riociguat (Adempas).

Do not take Tadalafil (Eqv-Adcirca) if you are also using certain medicines for chest pain or heart problems called nitrates. These include nitroglycerin, isosorbide dinitrate, and isosorbide mononitrate. Nitrates are also found in some recreational drugs such as amyl nitrate, butyl nitrate, or nitrite ("poppers"). Taking Tadalafil (Eqv-Adcirca) with a nitrate can cause a sudden and serious drop in blood pressure.

Some Tadalafil (Eqv-Adcirca) can stay in your bloodstream for 2 or more days after each dose you take (longer if you have liver or kidney disease). Avoid using nitrates during this time.

Tell your doctor if you have or have ever had:

• heart problems (chest pain, a heart rhythm disorder, congestive heart failure);
• a heart attack or stroke;
• pulmonary hypertension;
• bleeding problems;
• uncontrolled high or low blood pressure;
• retinitis pigmentosa (an inherited eye condition);
• problems with hearing or vision;
• a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;
• pulmonary veno-occlusive disease (PVOD);
• a penis deformity (such as Peyronie's disease);
• priapism (an erection that is painful or lasts longer than 4 hours);
• a stomach ulcer;
• if you have been told you should not have sexual intercourse for health reasons;
• liver disease; or
• kidney disease (or if you are on dialysis).

It is not known if Tadalafil (Eqv-Adcirca) will harm an unborn baby. However, having pulmonary hypertension during pregnancy may cause complications or medical problems such as heart failure and stroke in both mother and baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using Tadalafil (Eqv-Adcirca).

Not approved for use by anyone younger than 18 years old.

Get emergency medical help if you notice signs of an allergic reaction (hives, trouble breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using Tadalafil (Eqv-Adcirca) and call your doctor right away if you experience:

• severe vision problems, including sudden vision loss;
• feeling faint, as if you might pass out;
• ringing in your ears or sudden hearing loss;
• a painful erection or one that lasts longer than 4 hours; or
• symptoms of a heart attack—chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.

Get emergency medical help if you have nausea, chest pain, or dizziness during sex.

Common side effects of Tadalafil (Eqv-Adcirca) may include:

• headache;
• feeling light-headed;
• flushing (warmth, redness, or tingling sensation);
• nausea, upset stomach;
• runny or stuffy nose; or
• muscle pain, back pain, pain in your arms or legs.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Take the medicine as soon as you remember, but skip the missed dose if it's nearly time for your next dose. Do not take two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid drinking alcohol. Alcohol can lower your blood pressure even more and may increase your risk of headache, dizziness, or fainting.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Grapefruit may interact with Tadalafil (Eqv-Adcirca) and cause side effects. Avoid consuming grapefruit products.

Sometimes it is not safe to use certain medicines together. Some drugs can change how much of another drug is in your blood, which may increase side effects or make the medicines less effective.

Tell your doctor about all your other medicines, especially:

• medicine to treat erectile dysfunction (impotence) or pulmonary arterial hypertension—riociguat, bosentan, avanafil, sildenafil, or vardenafil;
• medicine to treat chest pain—isosorbide mononitrate, isosorbide dinitrate, nitroglycerin;
• medicine to treat high blood pressure or enlarged prostate—alfuzosin, doxazosin, prazosin, terazosin, silodosin, tamsulosin;
• an antibiotic—clarithromycin, erythromycin, rifampin, or telithromycin;
• antifungal medicine—itraconazole, ketoconazole;
• HIV/AIDS medications—ritonavir and others;
• seizure medicine—carbamazepine, phenytoin, phenobarbital; or
• any other blood pressure medication.

This list is not complete, and many other drugs may affect Tadalafil (Eqv-Adcirca). This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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