Dutasteride; Tamsulosin oral tablets

What is this medicine?

DUTASTERIDE; TAMSULOSIN (doo TAS teer ide; tam SOO loe sin) is 2 drugs in one capsule used together to treat benign prostatic hyperplasia (BPH) in men with enlarged prostate. It works by relaxing muscles in the prostate and bladder neck. This improves urine flow and reduces BPH symptoms.

How should I use this medicine?

Take this medicine by mouth about 30 minutes after the same meal every day. Follow the directions on the prescription label. Swallow the capsules whole with a glass of water. Do not crush, chew, or open capsules. Do not use or touch this medicine if your capsules are deformed, discolored, or leaking. Do not take your medicine more often than directed. Do not stop taking your medicine unless your doctor tells you to.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

What side effects may I notice from receiving 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

• breathing problems

• changes in breast like lumps, pain or fluids leaking from the nipple

• change in vision

• feeling faint or lightheaded

• irregular heartbeat

• pain in the testicles

• prolonged or painful erection

• weakness

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

• back pain

• change in sex drive or performance

• changes in taste

• constipation, nausea or vomiting

• cough

• drowsy

• runny or stuffy nose

• trouble sleeping

What may interact with this medicine?

• antiviral medicines for HIV or AIDS

• boceprevir

• certain medicines for fungal infections like ketoconazole, itraconazole, voriconazole

• certain medicines for infection like erythromycin, telithromycin

• cimetidine

• diltiazem

• medicines for erectile disfunction like sildenafil, tadalafil, vardenafil

• medicines for blood pressure

• other alpha-blockers like alfuzosin, doxazosin, phentolamine, phenoxybenzamine, prazosin, terazosin

• paroxetine

• saw palmetto or other dietary supplements

• terbinafine

• verapamil

• warfarin

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. If you stop taking your medicine for several days or more, ask your doctor or health care professional what dose you should start back on.

Where should 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.

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

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

• advanced kidney disease

• advanced liver disease

• low blood pressure

• prostate cancer

• an unusual or allergic reaction to dutasteride, tamsulosin, sulfa drugs, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular check ups. You will need lab work done before you start this medicine and regularly while you are taking it. 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. Check your blood pressure as directed. Ask your health care professional what your blood pressure should be, and when you should contact him or her.

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.

Do not donate blood while you are taking this medicine or for 6 months after stopping 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.

This medicine may make you feel dizzy or lightheaded. This is more likely to happen after the first dose, after an increase in dose, or during hot weather or exercise. Drinking alcohol and taking some medicines can make this worse. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not sit or stand up quickly. If you begin to feel dizzy, sit down until you feel better. These effects can decrease once your body adjusts to the medicine.

Contact your doctor or health care professional right away if you have an erection that lasts longer than 4 hours or if it becomes painful. This may be a sign of a serious problem and must be treated right away to prevent permanent damage.

If you are thinking of having cataract surgery, tell your eye surgeon that you have taken this medicine.