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Ingredient Name: DUTASTERIDE (doo-TAS-ter-ide) and TAMSULOSIN (tam-SOO-loe-sin)
Drug Manufacturer: GSK
Common Uses: This medicine is a 5 alpha-reductase inhibitor and alpha-blocker combination. This medicine is used for treating symptoms of benign prostatic hyperplasia (BPH) in men who have an enlarged prostate gland.
Before Using This Medicine: Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are taking certain azole antifungals (eg, itraconazole, ketoconazole, posaconazole), HIV protease inhibitors (eg, ritonavir), certain macrolide antibiotics (eg, clarithromycin), nefazodone, telithromycin, or another alpha-blocker (eg, prazosin). ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking azole antifungals (eg, fluconazole), cimetidine, fluoxetine, macrolide antibiotics (eg, erythromycin), paroxetine, phosphodiesterase (PDE) type-5 inhibitors (eg, sildenafil), terbinafine, warfarin, or medicine for high blood pressure. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including heart failure, kidney problems, urinary tract problems, problems urinating, or a history of high or low blood pressure, prostate cancer, increased serum prostate-specific antigen (PSA) levels, liver problems, abnormal liver function tests, allergies, pregnancy, or breast-feeding. Tell your doctor 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), sulfonylureas (eg, glyburide), probenecid, sulfamethoxazole, valdecoxib, or zonisamide. Tell your doctor if you will be having a certain type of eye surgery (cataract surgery). USE OF THIS MEDICINE IS NOT RECOMMENDED if the patient is a woman who is pregnant or may become pregnant, or the patient is a child. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
How to Use This Medicine: Follow the directions for taking this medicine provided by your doctor. AN ADDITIONAL PATIENT INFORMATION LEAFLET is available with this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this information. TAKE THIS MEDICINE BY MOUTH ABOUT 30 MINUTES AFTER THE SAME MEAL EACH DAY. SWALLOW THIS MEDICINE WHOLE. Do not break, crush, chew, or open before swallowing. Do not take capsules that are cracked, deformed, discolored, or leaking. This medicine can irritate your lips, mouth, and throat. TAKE THIS MEDICINE ON A REGULAR SCHEDULE to get the most benefit from it. Taking this medicine at the same time each day will help you remember to take it. STORE THIS MEDICINE at room temperature between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. KEEP THIS MEDICINE out of the reach of children and away from pets. CONTINUE TO TAKE THIS MEDICINE even if you feel well. Do not miss any doses. IF YOU MISS A DOSE of this medicine, 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 THIS MEDICINE for several days in a row, contact your doctor for instructions.
Cautions: DO NOT USE THIS MEDICINE if you are allergic to any ingredient in this medicine or to other 5 alpha-reductase inhibitors (eg, finasteride). THIS MEDICINE 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 this medicine. LAB TESTS AND MEDICAL EXAMS may be performed while you take this medicine. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. TELL YOUR DOCTOR OR DENTIST that you take this medicine before you receive any medical or dental care, emergency care, or surgery (including eye surgery for cataracts). THIS MEDICINE MAY CAUSE DROWSINESS, DIZZINESS, BLURRED VISION, LIGHTHEADEDNESS, OR FAINTING. These effects may be worse if you take it with alcohol or certain medicines. Use this medicine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. THIS MEDICINE MAY CAUSE DIZZINESS, LIGHTHEADEDNESS, 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. THIS MEDICINE 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. This medicine 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. THIS MEDICINE 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 this medicine. This is to prevent a pregnant woman from being exposed to it through a blood transfusion. THIS MEDICINE MAY INCREASE the risk of a certain type of prostate cancer. Discuss any questions or concerns with your doctor. THIS MEDICINE MAY DECREASE the amount of semen released during sex. However, the effect of this medicine on fertility is not known. Discuss any questions or concerns with your doctor. 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 this medicine. THIS MEDICINE 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. BEFORE YOU BEGIN TAKING ANY NEW MEDICINES, either prescription or over-the-counter, check with your doctor or pharmacist. PREGNANCY andBREAST-FEEDING: This medicine is not approved for use in women. This medicine may cause harm to the fetus. It is not known if this medicine is found in breast milk.
Possible Side Effects: SIDE EFFECTS that may occur while taking this medicine include back pain; cough; decreased amount of semen released during ejaculation; diarrhea; dizziness; drowsiness; headache; lightheadedness; mild sore throat; runny or stuffy nose; sinus inflammation; trouble sleeping; or weakness. If they continue or are bothersome, check with your doctor. THIS MEDICINE 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 this medicine, contact your doctor. RARELY, THERE HAVE BEEN cases of male breast cancer reported in patients taking dutasteride (an ingredient of this medicine). 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. CONTACT YOUR DOCTOR IMMEDIATELY if you experience 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 lightheadedness; or shortness of breath. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; or unusual hoarseness. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Overdose: IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately. Symptoms may include fainting, or severe or persistent dizziness or lightheadedness.
Additional Information: DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.
Copyright 2012 Wolters Kluwer Health, Inc.
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