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

finasteride and tadalafil is for use in men only.

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

Taking finasteride and tadalafil with certain other medicines can cause a sudden and serious decrease in blood pressure.

Do not take finasteride and tadalafil if you also use riociguat, or a nitrate drug such as nitroglycerin, isosorbide dinitrate, isosorbide mononitrate, or recreational drugs such as "poppers."

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

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take one finasteride and tadalafil capsule every day without food at about the same time for up to 26 weeks.

Do not take finasteride and tadalafil more than one time each day.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using finasteride and tadalafil.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Benign Prostatic Hyperplasia:

Usual dose: 1 capsule (containing finasteride 5 mg and tadalafil 5 mg) orally once daily
Duration of therapy: up to 26 weeks

Comment:
-To be taken at approximately the same time every day on an empty stomach.

Use: Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate

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 finasteride and tadalafil 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.

Take the medicine as soon as you can. Do not take more than one dose per day.

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

Drinking alcohol with finasteride and tadalafil can cause side effects.

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).

Finasteride and tadalafil may cause serious side effects. 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.

Finasteride and tadalafil may cause serious side effects. 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 of finasteride and tadalafil 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.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your current medicines. Many drugs can affect finasteride and tadalafil, especially:

• medicines to treat erectile dysfunction or pulmonary arterial hypertension;

• drugs to treat high blood pressure or a prostate disorder;

• an antibiotic such as clarithromycin, erythromycin, rifampin, or telithromycin;

• antifungal medicine such as ketoconazole or itraconazole; or

• medicine to treat HIV/AIDS, such as ritonavir and others.

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