When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to dutasteride, tamsulosin, or similar medicines, such as finasteride.

How to Use This Medicine:
Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Swallow the capsule whole. Do not chew or open it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how dutasteride/tamsulosin works. Tell your doctor if you are also using any of the following:
  
  • Cimetidine, ciprofloxacin, erythromycin, ketoconazole, paroxetine, ritonavir, or terbinafine
  • Medicine for erectile dysfunction (such as sildenafil, vardenafil, tadalafil)
  • A blood thinner (such as warfarin)
  .

Warnings While Using This Medicine:

• Women who are pregnant should avoid touching or handling this medicine because it can harm an unborn male baby. If a pregnant woman gets this medicine on her skin, wash the area immediately with soap and water.
• Tell your doctor if you have liver disease, low blood pressure, or an allergy to sulfa drugs.
• This medicine may cause the following problems:
  
  • Increased risk of high-grade prostate cancer
  • Painful erection that does not go away
  • Serious eye problems in patients who have cataract surgery
• This medicine may make you dizzy. Do not drive or do anything else that could be dangerous until you know how this medicine affect you. Stand or sit up slowly if you feel lightheaded or dizzy.
• Do not donate blood for at least 6 months after you stop taking this medicine.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Decrease in how much or how often you urinate
• Feeling of constant movement of self or surroundings
• Lightheadedness, dizziness, fainting
• Painful, prolonged erection

If you notice these less serious side effects, talk with your doctor:

• Decrease or change in your sexual desire
• Trouble having or keeping an erection, other sexual problems

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088