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 tadalafil.

How to Use This Medicine:
Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the tablet whole. Do not split, break, or crush 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: If you take this medicine once a day, take a missed 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 also use riociguat or a nitrate medicine. Do not take other medicines that contain tadalafil or similar medicines, such as sildenafil or vardenafil.
• Some medicines and foods can affect how tadalafil works. Tell your doctor if you are using any of the following:
  
  • Bosentan, carbamazepine, erythromycin, indinavir, itraconazole, ketoconazole, phenobarbital, phenytoin, rifampin, ritonavir
  • Medicine to treat prostate problems or high blood pressure (including alfuzosin, amlodipine, bendroflumethiazide, candesartan, doxazosin, enalapril, losartan, metoprolol, tamsulosin, terazosin)
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, diabetes, high cholesterol, leukemia, multiple myeloma, sickle cell anemia, bleeding problems, a stomach ulcer, 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 smoke or drink alcohol.
• Tell any doctor who treats you that you take tadalafil.
• This medicine may cause the following problems:
  
  • Low blood pressure (especially if taken with other medicines that lower blood pressure)
  • Painful or prolonged erection
  • Hearing or vision problems
• 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
• Chest pain
• Lightheadedness, fainting
• Painful erection or an erection that lasts longer than 4 hours
• 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:

• Back or muscle pain
• Headache
• Stuffy or runny nose
• Upset stomach, nausea
• 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