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This document contains crucial safety information regarding the use of Entadfi (finasteride/tadalafil). Please read carefully and consult your healthcare provider with any questions or concerns.

• Heart Conditions: Entadfi is not recommended for individuals with certain heart issues, including recent heart failure, stroke (within the last 6 months), heart attack (within the last 3 months), uncontrolled irregular heart rhythm, or chest pain during sexual activity. The safety of Entadfi in these populations has not been established. Discuss with your doctor if you have a heart condition.

• Drug Interactions: Avoid using Entadfi if you are currently taking nitrate medications, such as nitroglycerin, as this can lead to dangerously low blood pressure. If you require nitrate therapy for chest pain, wait at least 48 hours after your last dose of Entadfi. Seek immediate medical assistance if you experience chest pain and inform your healthcare provider about your recent Entadfi usage.

• Blood Pressure: Entadfi may cause a drop in blood pressure, especially when combined with other blood pressure-lowering medications or alpha blockers like prazosin, doxazosin, and terazosin. Discontinue alpha blockers at least one day before starting Entadfi. Also, limit alcohol consumption and avoid concurrent use with nitrates or guanylate cyclase stimulators to prevent severe hypotension.

• Prostate Cancer Risk: Finasteride, a component of Entadfi, could increase the risk of prostate cancer, particularly in males over 55 with a PSA level of 3 ng/mL or lower. Regular screening for prostate cancer should be conducted before and throughout Entadfi therapy.

• Pregnancy Precautions: Pregnant individuals should avoid handling crushed or opened Entadfi capsules due to the risk of harm to unborn male babies. If contact occurs, wash the area thoroughly with soap and water and consult with an obstetrician-gynecologist immediately.

• Priapism: Though rare, Entadfi can result in prolonged erections lasting over 4 hours, which may be painful and lead to permanent damage. Seek emergency medical attention if this occurs.

• Vision Changes: Sudden changes in vision in one or both eyes require immediate medical evaluation as this could result in permanent damage. Discuss any history of eye problems with your healthcare provider before starting Entadfi.

• Hearing Loss: Some patients have reported sudden hearing loss, sometimes accompanied by tinnitus or dizziness. Contact a healthcare professional if you experience any hearing changes.

• Contraindications: Do not use Entadfi with nitrates, guanylate cyclase stimulators, or during pregnancy, as it is not approved for use in females.

Ensure you follow all medical advice and report any adverse effects to your healthcare provider promptly.

When taking this medication, some individuals may experience common side effects such as a decreased sex drive, trouble with erections, or changes in ejaculation. These effects are generally mild and include headaches, upset stomach, back pain, muscle pain, nasal congestion, flushing, and dizziness. To minimize dizziness, especially when rising from a sitting or lying position, it is advisable to do so slowly. While these side effects are usually not serious, it is important to consult your healthcare provider if they persist or worsen.

There are rare but serious side effects that require immediate medical attention. These include changes in breast size or shape, pain in the testicles, and alterations in color vision. If you have heart problems, sexual activity may pose additional risks, and symptoms such as chest, jaw, or left arm pain, shortness of breath, dizziness, or nausea during sex warrant urgent medical care. Rarely, individuals may experience sudden vision loss or hearing issues, including ringing in the ears and dizziness, which necessitate stopping the medication and seeking immediate help.

In extremely rare cases, a painful or prolonged erection lasting four or more hours can occur, and immediate medical intervention is crucial to prevent lasting damage. Although severe allergic reactions are uncommon, symptoms such as rash, itching, swelling (particularly of the face, tongue, or throat), severe dizziness, or difficulty breathing require urgent medical attention. Always discuss any unexpected side effects with your healthcare provider to ensure your safety.

Some medications and substances can interact with this drug, affecting its effectiveness or leading to adverse effects. These include alpha blockers like doxazosin and tamsulosin, nitrates such as nitroglycerin and isosorbide, and recreational drugs known as poppers, which contain amyl or butyl nitrite. Additionally, drugs like riociguat and vericiguat can also interact with this medication.

Certain medications may influence how your body processes finasteride/tadalafil, potentially altering its effectiveness. These include azole antifungals (e.g., itraconazole, ketoconazole), macrolide antibiotics (e.g., clarithromycin, erythromycin), HIV protease inhibitors (e.g., fosamprenavir), rifampin, and ritonavir.

Avoid taking this medication with other products containing tadalafil or similar drugs used for erectile dysfunction or pulmonary hypertension, such as sildenafil and vardenafil.

This medication can also affect certain laboratory tests, such as PSA levels, leading to inaccurate results. Ensure that all your healthcare providers and lab personnel are aware that you are using this medication.