finasteride 5 mg-tadalafil 5 mg capsule

Generic name:
Finasteride/tadalafil - oral

Pronunciation
(fin-AS-ter-ide/ ta-DA-la-fil)

Brand name(s)
Entadfi

This combination medication contains 2 drugs: finasteride and tadalafil. It is used to treat signs and symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). This medication may help shrink an enlarged prostate and lessen symptoms of BPH such as difficulty starting urination, weak stream, feeling that the bladder is not completely emptied, and frequent urge to urinate (including at night). Finasteride works by decreasing the amount of a natural body hormone (DHT) that causes growth of the prostate. Tadalafil is thought to work by relaxing muscles in the prostate and bladder.

This medication is not approved for prevention of prostate cancer. It may increase the risk of developing serious prostate cancer. Talk to your doctor about the benefits and risks.

Women and children should not use this medication.

Read the Patient Information Leaflet if available from your pharmacist before you start taking finasteride/tadalafil and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth without food as directed by your doctor, usually once a day. Since the benefit of taking finasteride with tadalafil for BPH may lessen over time, this medication is not recommended to be taken for longer than 26 weeks. Talk to your doctor for details.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules. It may cause abnormal sex organ development in an unborn male infant.

Tell your doctor if your condition does not get better or if it gets worse.

Decreased sex drive, trouble getting or keeping an erection, or decreased amount of semen during sex may occur. Headache, upset stomach, back pain, muscle pain, stuffy nose, flushing, or dizziness may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• breast changes (such as enlargement, lumps, pain, nipple discharge)
• pain in the testicles
• color vision changes

Sexual activity may put extra strain on your heart, especially if you have heart problems. If you have heart problems and experience any of these serious side effects while having sex, stop and get medical help right away:

• chest/jaw/left arm pain
• shortness of breath
• dizziness
• nausea

Rarely, sudden decreased vision, or even permanent blindness, may occur in one or both eyes (NAION). If this serious problem occurs, stop taking this medication and get medical help right away. You have a slightly greater chance of developing NAION if you have heart disease, diabetes, high cholesterol, certain other eye problems ("crowded disk"), high blood pressure, if you are over 50, or if you smoke.

Rarely, a sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness, may occur. Stop taking this medication and get medical help right away if these effects occur.

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking this medication, tell your doctor or pharmacist if you are allergic to finasteride or tadalafil; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• heart problems (such as angina, heart failure, irregular heartbeat, previous heart attack)
• bleeding problems
• high or low blood pressure
• kidney disease
• liver disease
• stomach ulcers
• stroke
• penis conditions (such as angulation, Peyronie's disease)
• painful/prolonged erection (priapism)
• conditions that may increase the risk of priapism (such as sickle cell anemia, multiple myeloma, leukemia)
• eye problems (such as retinitis pigmentosa, sudden decreased vision, NAION)

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Finasteride should not be used by women, especially during pregnancy or breastfeeding. It may harm an unborn or breastfeeding baby. Consult your doctor if you have any questions.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• alpha blocker medication (such as doxazosin, tamsulosin)
• nitrates (such as nitroglycerin, isosorbide)
• recreational drugs called "poppers" that contain amyl or butyl nitrite
• riociguat
• vericiguat

Other medications can affect the removal of finasteride/tadalafil from your body, which may affect how this medication works. Examples include azole antifungals (such as itraconazole, ketoconazole), macrolide antibiotics (such as clarithromycin, erythromycin), HIV protease inhibitors (such as fosamprenavir), rifampin, ritonavir, among others.

Do not take this medication with any other product that contains tadalafil or other similar medications for erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, vardenafil).

This medication may interfere with certain lab tests (such as PSA levels), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as blood pressure, prostate exams, PSA levels) should be done while you are taking this medication. Keep all medical and lab appointments. Follow your doctor's instructions for examining your breasts and testicles, and report any lumps right away.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.