Product Information

Dutasteride and tamsulosin tablets

Dutasteride/ tamsulosin is used for:

Treating symptoms of benign prostatic hyperplasia (BPH) in men who have an enlarged prostate gland.

Dutasteride/tamsulosin is a 5 alpha-reductase inhibitor and alpha-blocker combination. The 5 alpha-reductase inhibitor (dutasteride) works by lowering levels of a hormone called dihydrotestosterone (DHT), which is a major cause of prostate growth. The alpha-blocker (tamsulosin) works by relaxing muscles in the prostate and bladder. Dutasteride/tamsulosin helps to decrease the size of the prostate and reduce symptoms of BPH.

Do NOT use dutasteride/ tamsulosin if:

• you are allergic to any ingredient in dutasteride/tamsulosin or to other 5 alpha-reductase inhibitors (eg, finasteride)
• the patient is a woman who is pregnant or may become pregnant
• the patient is a child
• you are taking another alpha-blocker (eg, prazosin)
• you are taking certain azole antifungals (eg, itraconazole, ketoconazole, posaconazole), HIV protease inhibitors (eg, ritonavir), certain macrolide antibiotics (eg, clarithromycin), nefazodone, or telithromycin

Contact your doctor or health care provider right away if any of these apply to you.

Dutasteride/ tamsulosin is used for:

Treating symptoms of benign prostatic hyperplasia (BPH) in men who have an enlarged prostate gland.

Dutasteride/tamsulosin is a 5 alpha-reductase inhibitor and alpha-blocker combination. The 5 alpha-reductase inhibitor (dutasteride) works by lowering levels of a hormone called dihydrotestosterone (DHT), which is a major cause of prostate growth. The alpha-blocker (tamsulosin) works by relaxing muscles in the prostate and bladder. Dutasteride/tamsulosin helps to decrease the size of the prostate and reduce symptoms of BPH.

Do NOT use dutasteride/ tamsulosin if:

• you are allergic to any ingredient in dutasteride/tamsulosin or to other 5 alpha-reductase inhibitors (eg, finasteride)
• the patient is a woman who is pregnant or may become pregnant
• the patient is a child
• you are taking another alpha-blocker (eg, prazosin)
• you are taking certain azole antifungals (eg, itraconazole, ketoconazole, posaconazole), HIV protease inhibitors (eg, ritonavir), certain macrolide antibiotics (eg, clarithromycin), nefazodone, or telithromycin

Contact your doctor or health care provider right away if any of these apply to you.

Before using dutasteride/ tamsulosin:

Some medical conditions may interact with dutasteride/tamsulosin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines or other substances
• if you have heart failure, kidney problems, urinary tract problems, or problems urinating
• if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any sulfonamide (sulfa) medicine, such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), probenecid, sulfamethoxazole, sulfonylureas (eg, glyburide), valdecoxib, or zonisamide
• if you will be having a certain type of eye surgery (cataract surgery)
• if you have a history of high or low blood pressure, prostate cancer, increased serum prostate-specific antigen (PSA) levels, abnormal liver function tests, or liver problems
• if you take medicine for high blood pressure

Some MEDICINES MAY INTERACT with dutasteride/tamsulosin. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Azole antifungals (eg, fluconazole, itraconazole, ketoconazole, posaconazole), cimetidine, fluoxetine, HIV protease inhibitors (eg, ritonavir), macrolide antibiotics (eg, clarithromycin, erythromycin), nefazodone, paroxetine, telithromycin, or terbinafine because they may increase the risk of dutasteride/tamsulosin's side effects
• Phosphodiesterase type 5 (PDE5) inhibitors (eg, sildenafil) or other medicines that contain alpha-blockers (eg, prazosin) because symptoms of low blood pressure (eg, severe dizziness, light-headedness, fainting) may occur
• Warfarin because the risk of side effects may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if dutasteride/tamsulosin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use dutasteride/ tamsulosin:

Use dutasteride/tamsulosin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with dutasteride/tamsulosin. Talk to your pharmacist if you have questions about this information.
• Take dutasteride/tamsulosin by mouth about 30 minutes after the same meal each day.
• Swallow dutasteride/tamsulosin whole. Do not break, crush, chew, or open before swallowing. Do not take capsules that are cracked, deformed, discolored, or leaking. Dutasteride/tamsulosin can irritate your lips, mouth, and throat.
• Take dutasteride/tamsulosin on a regular schedule to get the most benefit from it. Taking dutasteride/tamsulosin at the same time each day will help you remember to take it.
• Continue to take dutasteride/tamsulosin even if you feel well. Do not miss any doses.
• If you miss a dose of dutasteride/tamsulosin, you may take the missed dose later that same day, 30 minutes after a meal. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss taking dutasteride/tamsulosin for several days, contact your doctor for instructions.

Ask your health care provider any questions you may have about how to use dutasteride/tamsulosin.

Important safety information:

• Dutasteride/tamsulosin may cause drowsiness, dizziness, blurred vision, light-headedness, or fainting. These effects may be worse if you take it with alcohol or certain medicines. Use dutasteride/tamsulosin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Dutasteride/tamsulosin may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Dutasteride/tamsulosin may increase the risk of certain birth defects, including abnormal formation of the genitals in male fetuses. Women who are pregnant or may become pregnant must NOT handle the capsules. Dutasteride/tamsulosin is absorbed through the skin and could result in unintended fetal exposure. If a woman who is pregnant or may become pregnant comes in contact with leaking capsules, the contact area should be washed immediately with soap and water. If contact occurs, tell your doctor at once.
• Dutasteride/tamsulosin stays in the bloodstream for 4 to 6 months after you stop taking it. Do not donate blood for at least 6 months after your last dose of dutasteride/tamsulosin. This is to prevent a pregnant woman from being exposed to it through a blood transfusion.
• Dutasteride/tamsulosin may increase the risk of a certain type of prostate cancer. Discuss any questions or concerns with your doctor.
• Dutasteride/tamsulosin may cause decreased sexual desire or ability (eg, decrease in sex drive, problems with ejaculation, difficulty in achieving or keeping an erection). If you develop decreased sexual desire or ability that continues or becomes bothersome, check with your doctor. If this effect continues after you stop dutasteride/tamsulosin, contact your doctor.
• Dutasteride/tamsulosin may decrease the amount of semen released during sex. However, the effect of dutasteride/tamsulosin on fertility is not known. Discuss any questions or concerns with your doctor.
• Rarely, there have been cases of male breast cancer reported in patients taking dutasteride (a component of dutasteride/tamsulosin). Discuss any questions or concerns with your doctor. Tell your doctor right away if you develop breast changes, such as lumps, pain, or nipple discharge.
• Check with your doctor about whether you should use a barrier method of birth control (eg, condoms) if you have sex with a pregnant woman while taking dutasteride/tamsulosin.
• Dutasteride/tamsulosin may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.
• Dutasteride/tamsulosin may interfere with certain lab tests, including PSA tests for the screening of prostate cancer . Be sure your doctor and lab personnel know you are taking dutasteride/tamsulosin.
• Tell your doctor or dentist that you take dutasteride/tamsulosin before you receive any medical or dental care, emergency care, or surgery (including eye surgery for cataracts).
• Lab tests and medical exams may be performed while you take dutasteride/tamsulosin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Dutasteride/tamsulosin should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Dutasteride/tamsulosin may cause harm to the fetus. It is not known if this medicine is found in breast milk. Dutasteride/tamsulosin is not approved for use in women.

Possible side effects of dutasteride/ tamsulosin:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; cough; decreased amount of semen released during ejaculation; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; headache; light-headedness; mild sore throat; runny or stuffy nose; sinus inflammation; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); blurred vision; breast enlargement, lumps, pain, or tenderness; chest pain; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; nipple discharge; prolonged, painful erection; red, swollen, blistered, or peeling skin; severe or persistent dizziness or light-headedness; shortness of breath.

This is not a complete list of all side effects that may occur.