Entadfi is a prescription medicine taken by mouth for the treatment of men with symptoms of benign prostatic hyperplasia (BPH).

BPH is a condition that happens in men, where the prostate gland enlarges which can cause urinary symptoms.

Entadfi is for use by men only.

Entadfi can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. You could get dizzy, faint, or have a heart attack or stroke. Never take Entadfi with any nitrate or guanylate cyclase stimulator medicines.

Do not take Entadfi if you take any medicines called “nitrates.” Nitrates are commonly used to treat angina. Angina is a symptom of heart disease and can cause pain in your chest, jaw, or down your arm.

• Medicines called nitrates include nitroglycerin that is found in tablets, sprays, ointments, pastes, or patches. Nitrates can also be found in other medicines such as isosorbide dinitrate or isosorbide mononitrate. Some recreational drugs called “poppers” also contain nitrates, such as amyl nitrite and butyl nitrite.

Do not take Entadfi if you take medicines called guanylate cyclase stimulators which include:

• Riociguat (Adempas®) a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension.

Ask your healthcare provider or pharmacist if you are not sure if any of your medicines are nitrates or guanylate cyclase stimulators, such as riociguat.

Do not take Entadfi if you are a woman who is pregnant or may potentially be pregnant.

• Entadfi may harm your unborn baby. Do not touch or handle crushed or open Entadfi capsules (See Who Should Not Take Entadfi? and Warning about Entadfi and pregnancy).

Tell all of your healthcare providers that you take Entadfi. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took Entadfi.

After taking a single capsule, the tadalafil active ingredient of Entadfi remains in your body for more than 2 days. The active ingredient can remain longer if you have problems with your kidneys or liver, or you are taking certain other medications (see What other drugs will affect Entadfi?).

Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease.

See also Entadfi side effects.

You should see your doctor regularly while taking Entadfi. Follow your doctor's advice about when to have these checkups.

Checking for prostate cancer. Your doctor has prescribed Entadfi for BPH and not for treatment of prostate cancer - but a man can have BPH and prostate cancer at the same time. Your doctor may continue checking for prostate cancer while you take Entadfi.

About Prostate-Specific Antigen (PSA). Your doctor may have done a blood test called PSA for the screening of prostate cancer. Because Entadfi decreases PSA levels, you should tell your doctor(s) that you are taking Entadfi. Changes in PSA levels will need to be evaluated by your doctor(s). Any increase in follow-up PSA levels from their lowest point may signal the presence of prostate cancer and should be evaluated, even if the test results are still within the normal range. You should also tell your doctor if you have not been taking Entadfi as prescribed because this may affect the PSA test results. For more information, talk to your doctor.

• Take Entadfi exactly as your healthcare provider prescribes it.
• Entadfi should be taken without food.
• If you take too much or overdose, call your healthcare provider or emergency room right away.
• Do not take Entadfi more than one time each day.
• Take one Entadfi capsule every day at about the same time of day.
• If you miss a dose, you may take it when you remember but do not take more than one dose per day.
• Do not share Entadfi with anyone else; it was prescribed only for you.

Usual Adult Dose for Benign Prostatic Hyperplasia

- One capsule (finasteride 5 mg and tadalafil 5 mg) orally once daily.

- Use: to initiate treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate for up to 26 weeks.

Entadfi is for use by MEN only.

Do not take Entadfi if you:

• are a woman who is pregnant or may potentially be pregnant. Entadfi may harm your unborn baby. Do not touch or handle crushed or open Entadfi capsules (see Warning about Entadfi and pregnancy).
• take any medicines called "nitrates".
• use recreational drugs called “poppers” like amyl nitrite and butyl nitrite. (See Important information).
• take any medicines called guanylate cyclase stimulators, such as riociguat.
• are allergic to Entadfi or Adcirca®, or any of its ingredients. See the end of this page for a complete list of ingredients. Symptoms of an allergic reaction may include:
  • rash
  • hives
  • swelling of the lips, tongue, or throat
  • difficulty breathing or swallowing

Call your healthcare provider or get help right away if you have any of the symptoms of an allergic reaction listed above.

• Do not use erectile dysfunction (ED) medicines or ED treatments while taking Entadfi (unless you discuss with your healthcare provider).
• Do not drink too much alcohol when taking Entadfi (for example, 5 glasses of wine or 5 shots of whiskey). Drinking too much alcohol can increase your chances of getting a headache or getting dizzy, increasing your heart rate, or lowering your blood pressure.

See Important Information.

The most common side effects with tadalafil, an active ingredient in Entadfi, are: headache, indigestion, back pain, muscle aches, flushing, and stuffy or runny nose. These side effects usually go away after a few hours. Men who get back pain and muscle aches usually get it 12 to 24 hours after taking Entadfi. Back pain and muscle aches usually go away within 2 days.

The most common side effects with finasteride monotherapy are: trouble getting or keeping an erection (impotence), decrease in sex drive, decreased volume of ejaculate, ejaculation disorders, and enlarged or painful breast. You should promptly report to your doctor any changes in your breasts such as lumps, pain or nipple discharge.

Call your healthcare provider if you get any side effect that bothers you or one that does not go away.

Uncommon side effects with tadalafil, an active ingredient in Entadfi include:

An erection that won’t go away (priapism). If you get an erection that lasts more than 4 hours, get medical help right away. Priapism must be treated as soon as possible or lasting damage can happen to your penis, including the inability to have erections.

Color vision changes, such as seeing a blue tinge (shade) to objects or having difficulty telling the difference between the colors blue and green.

In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including tadalafil) reported a sudden decrease or loss of vision in one or both eyes. It is uncertain whether PDE5 inhibitors directly cause the vision loss. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including Entadfi, and call a healthcare provider right away.

Sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness, has been rarely reported in people taking PDE5 inhibitors, including tadalafil. It is not possible to determine whether these events are related directly to the PDE5 inhibitors, to other diseases or medications, to other factors, or to a combination of factors. If you experience these symptoms, stop taking Entadfi and contact a healthcare provider right away.

The following have been reported in general use with finasteride 5 mg, an active ingredient in Entadfi, and finasteride at lower doses:

• allergic reactions, including rash, itching, hives, and swelling of the lips, tongue, throat, and face
• rarely, some men may have testicular pain
• blood in semen
• trouble getting or keeping an erection that continued after stopping the medication
• problems with ejaculation that continued after stopping the medication
• male infertility and/or poor quality of semen. Improvement in the quality of semen has been reported after stopping the medication.
• depression
• decrease in sex drive that continued after stopping the medication
• in rare cases, male breast cancer has been reported.

These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist.

Tell your healthcare provider about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Entadfi and other medicines may affect each other. Always check with your healthcare provider before starting or stopping any medicines. Especially tell your healthcare provider if you take any of the following*:

• medicines called nitrates (see Important Information)
• medicines called guanylate cyclase stimulators, such as riociguat (Adempas®), used to treat pulmonary hypertension
• medicines called alpha blockers. These include Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl), Cardura® (doxazosin mesylate), Minipress® (prazosin HCl), Uroxatral® (alfuzosin HCl), Jalyn® (dutasteride and tamsulosin HCl) or Rapaflo® (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. If Entadfi is taken with certain alpha blockers, your blood pressure could suddenly drop. You could get dizzy or faint.
• medicines to treat high blood pressure (hypertension)
• medicines called HIV protease inhibitors, such as ritonavir (Norvir®, Kaletra®)
• some types of oral antifungals such as ketoconazole (Nizoral®), itraconazole (Sporanox®)
• some types of antibiotics such as clarithromycin (Biaxin®), telithromycin (Ketek®), erythromycin (several brand names exist. Please consult your healthcare provider to determine if you are taking this medicine).
• medicines or treatments for ED.
• Tadalafil is also marketed as Adcirca for the treatment of pulmonary arterial hypertension. Do not take both Entadfi and Adcirca. Do not take sildenafil citrate (Revatio®) with Entadfi.