Tadalafil Tablets (Erectile Dysfunction, BPH)

What is this medication?

TADALAFIL (tah DA la fil) treats erectile dysfunction (ED). It works by increasing blood flow to the penis, which helps to maintain an erection. It may also be used to treat symptoms of an enlarged prostate (benign prostatic hyperplasia).

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Adcirca, ALYQ, Cialis

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Abnormal penis shape or Peyronie disease
• Bleeding disorder
• Blood diseases, such as sickle cell anemia or leukemia
• Eye disease, such as retinitis pigmentosa
• Have had a heart attack
• Have had a painful and prolonged erection
• Have had a stroke
• Heart disease, such as angina, heart failure, irregular heartbeat or rhythm
• High or low blood pressure
• Stomach ulcers, other stomach or intestine problems
• Kidney disease
• Liver disease
• An unusual or allergic reaction to tadalafil, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. You may take this medication with or without meals. When this medication is used for erection problems, your care team may prescribe it to be taken once daily or as needed. If you are taking the medication as needed, you may be able to have sexual activity 30 minutes after taking it and for up to 36 hours after taking it. Whether you are taking the medication as needed or once daily, you should not take more than one dose per day. If you are taking this medication for symptoms of benign prostatic hyperplasia (BPH) or to treat both BPH and an erection problem, take the dose once daily at about the same time each day. Do not take your medication more often than directed.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you are taking this medication as needed for erection problems, this does not apply. If you miss a dose while taking this medication once daily for an erection problem, benign prostatic hyperplasia, or both, take it as soon as you remember, but do not take more than one dose per day.

What may interact with this medication?

Do not take this medication with any of the following:

• Nitrates, such as amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin
• Other medications for erectile dysfunction, such as avanafil, sildenafil, vardenafil
• Other tadalafil products
• Riociguat
• Vericiguat

This medication may also interact with the following:

• Alcohol
• Certain antibiotics, such as clarithromycin or erythromycin
• Certain antivirals for HIV or hepatitis
• Certain medications for blood pressure
• Certain medications for fungal infections, such as fluconazole, itraconazole, ketoconazole, voriconazole
• Certain medications for seizures, such as carbamazepine, phenytoin, phenobarbital
• Grapefruit juice
• Medications for prostate problems
• Rifabutin, rifampin, or rifapentine

Other medications may affect the way this medication works. Talk with your care team about all of the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

Using this medication does not protect you or your partner against HIV or other sexually transmitted infections (STIs).

Stop and call your care team right away if you have symptoms such as nausea, dizziness, or chest pain during sex.

Contact your care team right away if you have an erection that lasts longer than 4 hours or if it becomes painful. This may be a sign of a serious problem and must be treated right away to prevent permanent damage.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Hearing loss or ringing in ears
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
• Prolonged or painful erection
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Sudden vision loss in one or both eyes

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Back pain
• Facial flushing or redness
• Headache
• Muscle pain
• Runny or stuffy nose
• Upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.