Finasteride (fin-AS-ter-ide), Tadalafil (ta-DAL-a-fil)

Treats benign prostatic hyperplasia (enlarged prostate).

Brand Name(s):

Entadfi

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed. Take this medicine at the same time each day.
• It is best to take this medicine on an empty stomach.
• You may need to take this medicine for up to 26 weeks to see the full effect.
• 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.

• Do not use this medicine if you are also taking riociguat or a nitrate medicine. You may use a nitrate medicine at least 48 hours after your last dose of this medicine. Do not take other medicines that contain tadalafil or similar medicines, including sildenafil
• Some foods and medicines can affect how finasteride and tadalafil works. Tell your doctor if you are using any of the following:
  • Clarithromycin, dutasteride, erythromycin, itraconazole, ketoconazole, rifampin, ritonavir, silodosin, tamsulosin, telithromycin
  • Blood pressure medicine (including alfuzosin, amlodipine, bendrofluazide, doxazosin, enalapril, metoprolol, prazosin, terazosin)
  • Other medicine to treat prostate problems
• Do not have 5 or more alcohol-containing drinks in a short period of time while you are using this medicine.

Warnings While Using This Medicine:

• This medicine is not for use in women. 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 kidney disease, liver disease, lung or breathing problems, diabetes, high cholesterol, cancer (including leukemia, multiple myeloma), sickle cell anemia, bleeding problems, stomach ulcer, problems with your penis, or eye problems. Tell your doctor if you have angina or chest pain during sex, heart disease, heart rhythm problems, high or low blood pressure, or a history of heart attack or stroke. Also tell your doctor if you drink alcohol.
• Tell any doctor who treats you that you are using tadalafil.
• This medicine may cause the following problems:
  • Low blood pressure (especially if taken with other medicines that lower blood pressure)
  • Increased risk of high-grade prostate cancer
  • Painful or prolonged erection
  • Hearing or vision problems
• This medicine may affect the results of the prostate specific antigen (PSA) test, which may be used to detect prostate cancer. Make sure you tell all of your doctors that you are using this medicine.
• Some men who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. 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, or red skin rash
• Breast swelling, pain, or tenderness, or lumps, nipple discharge
• Chest pain, trouble breathing
• Lightheadedness, dizziness, fainting
• Painful erection or an erection that lasts longer than 4 hours with or without pain
• Sudden decrease in hearing or hearing loss, ringing in the ears, dizziness
• Sudden loss of vision

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

• Arm, leg, back, or muscle pain
• Decrease in the amount of semen, decrease or change in your sexual desire
• Headache
• Stuffy or runny nose
• Trouble having or keeping an erection, other sexual problems
• Upset stomach
• Warmth or redness in your face, neck, arms, or upper chest

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