Dutasteride and tamsulosin is a combination medicine used to treat benign prostatic hyperplasia (BPH) in men with an enlarged prostate.

Dutasteride and tamsulosin may also be used for purposes not listed in this medication guide.

dutasteride and tamsulosin should never be handled or taken by a woman, a child, or a teenager.

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

Take dutasteride and tamsulosin 30 minutes after a meal, at the same time each day.

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

You will need medical tests to check your prostate specific antigen (PSA).

Store at room temperature away from moisture and heat.

Usual Adult Dose for Benign Prostatic Hyperplasia:

Dutasteride 0.5 mg-Tamsulosin 0.4 mg orally once a day approximately 30 minutes after the same meal each day

Use: Treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate.

You should not use this medicine if you are allergic to dutasteride, finasteride, or tamsulosin.

You should not take this medicine while you are taking tamsulosin (Flomax) or similar medicines, such as alfuzosin, doxazosin, prazosin, silodosin, or terazosin.

Dutasteride and tamsulosin should never be taken by a woman, a child, or a teenager. Dutasteride can be absorbed through the skin, and women or children should not be permitted to handle dutasteride and tamsulosin capsules.

This medicine is not for use by women. This medicine can cause birth defects. The capsules should not be handled by a woman who is pregnant or who may become pregnant.

If a woman accidentally comes into contact with this medication from a leaking capsule, wash the area with soap and water right away.

Tell your doctor if you have ever had:

• high or low blood pressure;

• liver or kidney disease;

• prostate cancer; or

• an allergy to sulfa drugs.

Using this medicine may increase your risk of developing prostate cancer. Ask your doctor about this risk.

Dutasteride and tamsulosin can affect your pupils. If you need eye surgery, tell the surgeon about your use of this medicine, even if you no longer take it.

Take your dose as soon as you can, but only within 30 minutes after a meal. Skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Call your doctor if you miss your doses for several days in a row.

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

Avoid taking medicines for erectile dysfunction (sildenafil, avanafil, Viagra, Cialis, and others).

Do not donate blood while taking dutasteride and tamsulosin and for at least 6 months after your last dose. Dutasteride could cause birth defects if a pregnant women receives a transfusion with blood that contains this medicine.

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

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

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).

Dutasteride and tamsulosin may cause serious side effects. Stop using dutasteride and tamsulosin and call your doctor at once if you have:

• a light-headed feeling, like you might pass out; or

• penis erection that is painful or lasts 4 hours or longer.

Common side effects of dutasteride and tamsulosin may include:

• decreased libido (sex drive);

• decreased amount of semen released during sex;

• impotence (trouble getting or keeping an erection);

• breast tenderness or enlargement;

• dizziness; or

• runny nose.

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 medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may affect dutasteride and tamsulosin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.