Product Information

Dutasteride capsule

What is this medicine?

DUTASTERIDE is used to treat benign prostatic hyperplasia (BPH) in men. This is a condition that causes you to have an enlarged prostate. This medicine helps to control your symptoms, decrease urinary retention, and reduces your risk of needing surgery.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• liver disease
• prostate cancer
• an unusual or allergic reaction to dutasteride, finasteride, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I take this medicine?

Take this medicine by mouth with a glass of water. Do not cut, crush, chew or open this medicine. You can take this medicine with or without food. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, you can take it later that day. If you do not remember until the next day, take only that day's dose. Do not take double or extra doses. Try taking the dose at the same time every day to help you remember to take your dose.

What may interact with this medicine?

• cimetidine
• ciprofloxacin
• clarithromycin, erythromycin, or troleandomycin
• diltiazem, nicardipine, or verapamil
• some antifungal medicines like ketoconazole, itraconazole, voriconazole
• some medicines for HIV

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking this medicine?

Do not donate blood while you are taking this medicine. This will prevent giving this medicine to a pregnant female through a blood transfusion. Ask your doctor or health care professional when it is safe to donate blood after you stop taking this medicine.

Contact your doctor or health care professional if your symptoms do not start to get better. You may need to take this medicine for 6 to 12 months to get the best results.

Women who are pregnant or may get pregnant must not handle this medicine. The active ingredient could harm the unborn baby. If a pregnant woman or woman who may become pregnant comes into contact with a leaking capsule, she should wash the exposed area of skin with soap and water immediately and check with her doctor or health care professional.

This medicine can interfere with PSA laboratory tests for prostate cancer. If you are scheduled to have a lab test for prostate cancer, tell your doctor or health care professional that you are taking this medicine.

What side effects may I notice from this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• changes in breast like lumps, pain or fluids leaking from the nipple
• pain in the testicles

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• change in sex drive or performance

This list may not describe all possible side effects.

Where can I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep container tightly closed. Throw away any unused medicine after the expiration date.