Finasteride; Tadalafil Oral Capsules

What is this medication?

FINASTERIDE; TADALAFIL (fi NAS teer ide; tah DA la fil) treats benign prostatic hyperplasia (BPH). It works by decreasing an enlarged prostate gland in men, improving urine flow and decreasing urine retention.

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

COMMON BRAND NAME(S): ENTADFI

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

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

• Anatomical deformation of the penis, Peyronie's disease, or history of priapism (painful and prolonged erection)
• Bleeding disorder
• Eye or vision problems, including a rare inherited eye disease called retinitis pigmentosa
• Heart disease
• High blood pressure
• History of irregular heartbeat
• History of stroke
• Low blood pressure
• History of blood diseases, like sickle cell anemia or leukemia
• Kidney disease
• Liver disease
• Stomach ulcers, other stomach or intestine problems
• An unusual or allergic reaction to tadalafil, finasteride, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Take it on an empty stomach, at least 30 minutes before and 2 hours after food. Keep taking it unless your care team tells you to stop.

Talk to your health care provider about the use of this medication in children. It is not approved for use in children.

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 miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following medications:

• Nitrates like amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin
• Medications for erectile dysfunction like avanafil, sildenafil, vardenafil
• Other finasteride (Proscar, Propecia) or tadalafil (Adcirca, Cialis) products
• Riociguat
• Vericiguat

This medication may also interact with the following medications:

• Alcohol
• Certain antibiotics like erythromycin or clarithromycin
• Certain antivirals for HIV or hepatitis
• Certain medicines called alpha-blockers, like doxazosin, prazosin, silodosin, tamsulosin
• Certain medications for high blood pressure
• Certain medicines for fungal infections like ketoconazole, itraconazole, posaconazole, or voriconazole
• Certain medications used for seizures like carbamazepine, phenytoin, and phenobarbital
• Grapefruit juice
• Rifampin
• Saw palmetto
• St. John's Wort or other dietary supplements

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. It may be some time before you see the benefit from this medication.

You may need blood work while you are taking this medication. For example, your care team may have you take a blood test called PSA for the screening of prostate cancer. Make sure your care team knows you are taking this medication before you take a PSA test.

If you notice any changes in your vision while taking this drug, call your care team as soon as possible. Stop using this medication and call your care team right away if you have a loss of sight in one or both eyes.

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.

If you experience symptoms of nausea, dizziness, chest pain, or arm pain upon initiation of sexual activity after taking this medication, you should refrain from further activity and call your doctor or health care professional as soon as possible.

Do not drink alcohol to excess (examples, 5 glasses of wine or 5 shots of whiskey) when taking this medication. When taken in excess, alcohol can increase your chances of getting a headache or getting dizzy, increasing your heart rate or lowering your blood pressure.

Women who are pregnant or may become pregnant should not handle crushed or opened capsules. The finasteride component of the medication could harm the unborn baby. If a pregnant woman comes into contact with crushed or open capsules she should wash the area with soap and water right away and follow up with her care team.

Do not donate blood while you are taking this medication. Ask your care team when it is safe to donate blood after you stop taking it.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Breast swelling, tenderness
• Changes in vision
• Chest pain
• Decreased hearing
• Fast, irregular heartbeat
• Low blood pressure—dizziness; feeling faint or lightheaded, falls; unusually weak or tired
• Males: prolonged or painful erection
• Pain in the testicles

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

• Back pain
• Changes in sex drive or performance
• Flushing
• Headache
• Indigestion
• Muscle cramps, pain
• Reduced amount of semen released during sex
• Stuffy, runny 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 and pets.

Store between 15 and 30 degrees C (59 and 86 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.