Dutasteride is used to treat benign prostatic hyperplasia (BPH) in men with an enlarged prostate. Dutasteride helps improve urinary flow and may also reduce your need for prostate surgery later on.

dutasteride is for use in men only.

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

Dutasteride should never be taken by a woman or a child.

Dutasteride can cause birth defects if a woman is exposed to it during pregnancy. Dutasteride capsules should not be handled by a woman who is pregnant or may become pregnant.

Your doctor will perform tests to make sure you do not have other conditions that would prevent you from safely using dutasteride.

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

Take the medicine at the same time each day, with or without food.

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

It may take up to 6 months or longer before you receive the full benefit of taking dutasteride. Your doctor will determine how long to treat you with this medicine. Keep using the medication as directed.

You will need frequent medical tests.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Usual Adult Dose for Benign Prostatic Hyperplasia:

0.5 mg orally once a day

Use: Treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to reduce the risk of acute urinary retention (AUR) and BPH-related surgery.

You should not use dutasteride if you are allergic to dutasteride or finasteride.

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

Tell your doctor if you have ever had:

• liver disease.

Using dutasteride may increase your risk of developing prostate cancer. Your doctor will test your prostate specific antigen (PSA) to check for cancer while you are using this medicine.

Dutasteride is not for use by women, and this medicine can cause birth defects if a woman is exposed to it during pregnancy. Dutasteride 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.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Dutasteride capsules that are stored at high temperatures may become deformed or discolored. Dispose of any capsules that are deformed, discolored, or leaky.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Talk to your doctor about drinking grapefruit juice while taking this medicine.

Do not donate blood while taking dutasteride and for at least 6 months after your treatment ends. Dutasteride can be carried in the blood and could cause birth defects if a pregnant women receives a transfusion with blood that contains dutasteride.

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).

Common side effects of dutasteride may include:

• decreased libido (sex drive);

• decreased amount of semen released during sex;

• impotence (trouble getting or keeping an erection); or

• breast tenderness or enlargement.

The sexual side effects of dutasteride may continue after you stop taking this medicine. Talk to your doctor if you have concerns about these side effects.

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, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to dutasteride.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking dutasteride.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Jalyn® (containing Dutasteride, Tamsulosin)