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Patient Information | ENTADFI® (en-TAD-fee) | (finasteride and tadalafil) capsules for oral use
What Is ENTADFI?
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.
What is the most important information I should know about ENTADFI?
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 “A 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 “Can other medicines 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 “What are the possible side effects of ENTADFI?”
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.
Who should NOT take ENTADFI?
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 “A warning about ENTADFI and pregnancy”).
- take any medicines called “nitrates”.
- use recreational drugs called “poppers” like amyl nitrite and butyl nitrite. (See “What is the most important information I should know about ENTADFI?”)
- 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 leaflet for a complete list of ingredients in ENTADFI. Symptoms of an allergic reaction may include:
- 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.
A warning about ENTADFI and pregnancy:
Women who are or may potentially be pregnant must not use ENTADFI. They should also not handle crushed or open capsules of ENTADFI.
If a woman who is pregnant with a male baby absorbs finasteride, one of the active ingredients in ENTADFI, after oral use or through the skin, it may cause the male baby to be born with abnormalities of the sex organs. If a woman who is pregnant comes into contact with the active ingredient in ENTADFI, a doctor should be consulted.
What should I tell my healthcare provider before taking ENTADFI?
ENTADFI is not right for everyone. Only your healthcare provider and you can decide if ENTADFI is right for you. Before taking ENTADFI, tell your healthcare provider about all your medical problems, including if you:
- have heart problems such as angina, heart failure, irregular heartbeats, or have had a heart attack
- have pulmonary hypertension
- have low blood pressure or have high blood pressure that is not controlled
- have had a stroke
- have liver problems
- have kidney problems or require dialysis
- have retinitis pigmentosa, a rare genetic (runs in families) eye disease
- have ever had severe vision loss, including a condition called NAION
- have stomach ulcers
- have a bleeding problem
- have a deformed penis shape or Peyronie’s disease
- have had an erection that lasted more than 4 hours
- have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia
Can other medicines affect ENTADFI?
Tell your healthcare provider about all the medicines you take including prescription and non prescription 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 “What is the most important information I should know about ENTADFI?”)
- 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.
How should I take ENTADFI?
- Take ENTADFI exactly as your healthcare provider prescribes it.
- ENTADFI should be taken without food.
- If you take too much ENTADFI, 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.
What should I avoid while taking ENTADFI?
- 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.
What are the possible side effects of ENTADFI?
See “What is the most important information I should know about ENTADFI?”
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.
- 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 of ENTADFI. For more information, ask your healthcare provider or pharmacist.
How should I store ENTADFI?
Store ENTADFI at room temperature between 59° and 86°F (15° and 30°C).
Keep ENTADFI and all medicines out of the reach of children.
Women should not handle crushed or open ENTADFI capsules when they are pregnant or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus.
General information about ENTADFI:
Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use ENTADFI for a condition for which it was not prescribed. Do not give ENTADFI to other people, even if they have the same symptoms that you have. It may harm them.
This is a summary of the most important information about ENTADFI. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ENTADFI that is written for health providers. For more information you can also visit verupharma.com, or call 1-866-936-8233.
What are the ingredients in ENTADFI?
Active Ingredients: finasteride and tadalafil
Inactive Ingredients: carrageenan, hypromellose, lactose monohydrate, potassium chloride, sodium starch glycolate, sodium lauryl sulfate, silicified microcrystalline cellulose, colloidal silicon dioxide, titanium dioxide, and magnesium stearate.
What is BPH?
BPH is an enlargement of the prostate gland. The prostate is located below the bladder. As the prostate enlarges, it may slowly restrict the flow of urine. This can lead to symptoms such as:
- a weak or interrupted urinary stream
- a feeling that you cannot empty your bladder completely
- a feeling of delay or hesitation when you start to urinate
- a need to urinate often, especially at night
- a feeling that you must urinate right away.
In some men, BPH can lead to serious problems, including urinary tract infections, a sudden inability to pass urine (acute urinary retention), as well as the need for surgery.
What ENTADFI does:
ENTADFI contains finasteride and tadalafil. Finasteride lowers levels of a hormone called DHT (dihydrotestosterone), which is a cause of prostate growth. Lowering DHT leads to shrinkage of the enlarged prostate gland in most men. This can lead to gradual improvement in urine flow and symptoms over the next several months. ENTADFI will help reduce the risk of developing a sudden inability to pass urine (urinary retention) and the need for surgery related to an enlarged prostate. Tadalafil may reduce BPH symptoms by inhibiting the action of an enzyme called PDE5 (phosphodiesterase 5), which relaxes the smooth muscle found in the part of the prostate that surrounds the urethra resulting in the release of the restriction to the flow of urine through the urethra. However, since each case of BPH is different, you should know that:
- Even though the prostate shrinks, you may NOT notice an improvement in urine flow or symptoms.
- You may need to take ENTADFI for up to 26 weeks to see whether it improves your symptoms.
- Therapy with ENTADFI may reduce your risk for a sudden inability to pass urine and empty your bladder and the need for surgery for an enlarged prostate.
This Patient Information has been approved by the U.S. Food and Drug Administration
*The brands listed are trademarks of their respective owners and are not trademarks of Veru Inc. The makers of these brands are not affiliated with and do not endorse Veru Inc. or its products.
Revision Date: 12/21