Finasteride and tadalafil is used to treat symptoms of benign prostatic hyperplasia (BPH) in men.

This medicine is for use in men only.

Finasteride and tadalafil may also be used for purposes not listed in this medication guide.

You should not use finasteride and tadalafil if you are allergic to it, or if you take:

• other medicines to treat pulmonary arterial hypertension, such as riociguat.

Do not take finasteride and tadalafil if you are also using a nitrate drug for chest pain or heart problems. 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 finasteride and tadalafil with a nitrate medicine can cause a sudden and serious decrease in blood pressure.

Finasteride and tadalafil is not for use in women.

Tell your doctor if you have ever had:

• heart problems (chest pain, a heart rhythm disorder, heart failure);
• pulmonary hypertension;
• a heart attack or stroke;
• high or low blood pressure;
• liver disease;
• kidney disease (or if you are on dialysis);
• retinitis pigmentosa (an inherited condition of the eye);
• vision problems;
• hearing problems;
• bleeding problems;
• a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;
• a physical deformity of the penis (such as Peyronie's disease), or an erection lasting longer than 4 hours; or
• a stomach ulcer.

Do not use finasteride and tadalafil during pregnancy. This medcine can cause birth defects if a woman is exposed to it during pregnancy. A crushed or open capsules of this medicine should not be handled by a woman who is pregnant or may become pregnant. The medicine from a broken capsule could be absorbed through the skin.

Use Finasteride And Tadalafil (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult 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).

Call your doctor at once if you have:

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• an erection is painful or lasts longer than 4 hours (prolonged erection can damage the penis); or
• a lump or pain in your breast, or nipple discharge.

Stop using finasteride and tadalafil and call your doctor at once if you have:

• ringing in your ears or sudden hearing loss; or
• vision changes or sudden vision loss.

Common side effects may include:

• headache;
• indigestion;
• back pain, muscle aches,
• loss of interest in sex, impotence, difficulty having an orgasm;
• enlarged or painful breasts;
• stuffy or runny nose; or
• flushing (sudden warmth, redness, or tingly feeling).

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.

Drinking alcohol with this medicine can cause side effects.