Pronunciation:

fin-AS-ter-ide, ta-DAL-a-fil

Brand Names:

• Entadfi

Dosage Forms:

• Capsule

Classifications:

Therapeutic—

Benign Prostatic Hypertrophy Agent

Pharmacologic—

5-Alpha Reductase Inhibitor

Uses of This Medicine:

Note: Women who are pregnant or may become pregnant should not use this medicine or handle the crushed or open capsules. Finasteride can cause birth defects in male babies.

Finasteride and tadalafil combination is used to treat men with benign prostatic hyperplasia (BPH). BPH is caused by an enlarged prostate. Men with BPH usually have difficulty urinating, a decreased flow of urination, hesitation at the beginning of urination, and a need to get up at night to urinate. This medicine will make these symptoms less severe and reduce the chance that prostate surgery will be needed.

Finasteride blocks the action of an enzyme called 5-alpha-reductase. This enzyme changes testosterone to another hormone that causes the prostate to grow. It will increase testosterone levels in the body, which decreases prostate size. The effect of finasteride will only last as long as the medicine is taken.

Tadalafil belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. These medicines prevent an enzyme called phosphodiesterase type-5 from working too quickly. The prostate is one of the areas where this enzyme works.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of finasteride and tadalafil combination in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of finasteride and tadalafil combination in the elderly. However, elderly patients are more sensitive to the effects (eg, diarrhea) of this medicine than younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amyl Nitrite
• Boceprevir
• Erythrityl Tetranitrate
• Isosorbide Dinitrate
• Isosorbide Mononitrate
• Nitroglycerin
• Pentaerythritol Tetranitrate
• Propatyl Nitrate
• Riociguat
• Telaprevir
• Vericiguat

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfuzosin
• Atazanavir
• Bunazosin
• Clarithromycin
• Cobicistat
• Conivaptan
• Darunavir
• Erythromycin
• Fosamprenavir
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Lenacapavir
• Lopinavir
• Moxisylyte
• Nefazodone
• Nelfinavir
• Nirmatrelvir
• Phenoxybenzamine
• Phentolamine
• Posaconazole
• Prazosin
• Ritonavir
• Saquinavir
• Simeprevir
• Simvastatin
• Tamsulosin
• Telithromycin
• Terazosin
• Tipranavir
• Trimazosin
• Urapidil
• Voriconazole

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Doxazosin
• Rifampin
• Silodosin
• St John's Wort

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal penis, including curved penis and birth defects of the penis (eg, angulation, cavernosal fibrosis, Peyronie’s disease) or
• Leukemia (blood related cancer) or
• Multiple myeloma (blood related cancer) or
• Sickle-cell anemia (blood disorder)—Use with caution. May increase risk of unwanted side effects (eg, prolonged erection of the penis).

• Age greater than 50 years or
• Low cup to disc ratio (eye condition also called "crowded disc")—Use with caution. May increase risk for non–arteritic anterior ischemic optic neuropathy (NAION).

• Angina (severe chest pain) or
• Arrhythmia (irregular heartbeat), uncontrolled or
• Heart attack (within the last 3 months or 90 days) or
• Heart failure (within the last 6 months) or
• Hypertension (high blood pressure), uncontrolled or
• Hypotension (low blood pressure) or
• Retinal disorders (eye problem) or
• Retinitis pigmentosa (an inherited eye disorder) or
• Stroke (within the last 6 months)—Should not be used in patients with these conditions.

• Bleeding disorders or
• Stomach ulcers—Use must be determined by your doctor. May increase your risk of bleeding.

• Diabetes or
• Kidney disease or
• Liver disease, mild or moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Non–arteritic anterior ischemic optic neuropathy (NAION, serious eye condition) in one or both eyes, history of—Use with caution. May increase your risk of getting NAION again.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may need to take this medicine for up to 26 weeks to see full effect. The medicine will not cure BPH, but it does help reduce the size of the prostate and improve symptoms.

Take this medicine without food. Take this medicine at the same time each day.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For benign prostatic hyperplasia:
    • Adults—One capsule once a day for 26 weeks. Each capsule contains 5 milligrams (mg) of finasteride and 5 mg of tadalafil.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Women and children should not use this medicine. Women who are pregnant or may become pregnant should not handle crushed or open capsules. Finasteride can be absorbed through the skin and cause birth defects in male babies. If a woman does come in contact with this medicine, the affected area should be washed right away with soap and water.

Do not use this medicine if you are also using riociguat or a nitrate medicine, often used to treat angina (chest pain). Nitrate medicines include nitroglycerin, isosorbide, Imdur®, Nitro-Bid®, Nitrostat®, Nitro-Dur®, Transderm Nitro®, Nitrol® Ointment, and Nitrolingual® Spray. Some illegal ("street") drugs called "poppers" (eg, amyl nitrate, butyl nitrate, or nitrite) also contain nitrates. If you need to use a nitrate medicine, take it at least 48 hours after your last dose of this medicine.

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.

It is important to tell your doctor about any heart problems you have now or may have had in the past. This medicine can cause serious side effects in patients with heart problems.

This medicine will not prevent prostate cancer but may increase your risk of developing high-grade prostate cancer. Tell your doctor if you have concerns about this risk.

Check with your doctor right away if you have a sudden decrease in hearing or loss of hearing, which may be accompanied by dizziness and ringing in the ears.

If you experience sudden loss of vision in one or both eyes, contact your doctor immediately.

If you experience a prolonged erection for more than 4 hours or a painful erection for more than 6 hours, contact your doctor immediately. This condition may require prompt medical treatment to prevent serious and permanent damage to your penis.

This medicine may cause serious allergic and skin reactions, including angioedema, Stevens-Johnson syndrome, and exfoliative dermatitis. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, cracked, dry, or scaly skin, chills, cough, crusting, irritation, or reddening of the skin, diarrhea, itching, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swelling, or unusual tiredness or weakness.

Do not drink excessive amounts of alcohol (eg, 5 or more glasses of wine or 5 or more shots of whiskey) when taking this medicine. When taken in excess, alcohol can increase your chances of getting a headache or dizziness, increase your heart rate, or lower your blood pressure.

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.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Chills

cold sweats

confusion

dizziness, faintness, or lightheadedness when getting up from lying or sitting position

Less common

Arm, back, or jaw pain

bloody urine

blurred vision

burning, dry, or itching eyes

chest pain, discomfort, tightness, or heaviness

continuing ringing or buzzing or other unexplained noise the in ears

decreased amount of urine

discharge, excessive tearing

eye pain

fainting

fast, pounding, or irregular heartbeat or pulse

hearing loss

increased blood pressure

increased thirst

loss of appetite

lower back or side pain

nausea

redness, pain, or swelling of the eye, eyelid, or inner lining the of eyelid

sweating

swelling of the face, hands, fingers, ankles, feet, or lower legs

trouble breathing

unusual tiredness or weakness

vomiting

weight gain

Incidence not known

Blindness

blistering, peeling, or loosening of the skin

change in vision

clear or bloody discharge from nipple

cough

decreased vision

dimpling of the breast skin

fever

hives, itching, skin rash

inverted nipple

irritation

joint pain, stiffness, or swelling

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

lump in the breast or under the arm

painful or prolonged erection of the penis

persistent crusting or scaling of the nipple

red irritated eyes

red skin lesions, often with a purple center

redness of the skin

redness or swelling of the breast

sore on the skin of the breast that does not heal

sore throat

sores, ulcers, or white spots in the mouth or on the lips

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Change or problem with discharge of semen

decreased interest in sexual intercourse

inability to have or keep an erection

lack or loss of strength

loss in sexual ability, desire, drive, or performance

Less common

Acid or sour stomach

belching

bleeding from the rectum or bloody stools

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

burning feeling in the chest or stomach

difficulty in moving

difficulty swallowing

dry mouth

feeling of constant movement of self or surroundings

headache

heartburn

indigestion

muscle aches, cramps, pains, or stiffness

pain in the arms or legs

pain or burning in the throat

sensation of spinning

sleepiness or unusual drowsiness

sneezing

stomach upset

stuffy or runny nose

swelling of the breasts or breast soreness in both females and males

swollen joints

Rare

Breast enlargement

Incidence not known

Discouragement

feeling sad or empty

irritability

lack of appetite

loss of interest or pleasure

tiredness

trouble concentrating

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.