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This document provides crucial safety guidelines regarding the use of tadalafil (Adcirca). It is important to familiarize yourself with this information and discuss any concerns with your healthcare provider.

• Low Blood Pressure: Tadalafil may cause temporary decreases in blood pressure, especially in individuals with certain heart conditions or those on blood pressure medications. This can lead to dizziness and an increased risk of falls. Exercise caution when transitioning from sitting or lying down. Avoid taking tadalafil within 48 hours of using nitrates for chest pain, and refrain from alcohol consumption while on this medication, as it can exacerbate low blood pressure. Inform your healthcare provider if dizziness persists.

• Prolonged or Painful Erection (Priapism): Rarely, males may experience an erection lasting over 4 hours, which can result in permanent penile damage if untreated. Seek immediate medical attention if you have an erection lasting more than 4 hours or experience pain during an erection. Individuals with conditions like sickle cell anemia, multiple myeloma, leukemia, or certain penile conditions are at higher risk.

• Vision Changes: Sudden vision changes can occur with PDE-5 inhibitors such as tadalafil. Seek emergency care if you experience these symptoms. Those over 50, with high blood sugar, high blood pressure, heart disease, high cholesterol, smokers, or individuals with a history of eye problems, particularly those with a "crowded" optic disc, should be cautious. Inform your prescriber of your complete medical history before using tadalafil.

• Hearing Loss: Some users have reported hearing loss, occasionally accompanied by tinnitus or dizziness. Promptly seek medical attention if you notice any changes in hearing.

• Avoidance with Other PDE-5 Inhibitors: Do not combine tadalafil (Adcirca) with other PDE-5 inhibitors like sildenafil (Viagra), vardenafil (Levitra), or avanafil (Stendra), as this can lead to significant blood pressure drops and increased side effects.

• Risks with Specific Heart Conditions: Tadalafil is not recommended for those with pulmonary vascular occlusive disease (PVOD), a rare condition affecting lung and heart blood flow. Although not thoroughly studied in PVOD patients, tadalafil may worsen the condition. Seek immediate medical help if you experience severe fatigue or breathlessness.

Contraindications: Avoid using tadalafil (Adcirca) if you are taking nitrates or guanylate cyclase stimulators like riociguat (Adempas), as these combinations pose serious health risks. Always consult your healthcare provider if you fit these criteria.

When taking this medication, some individuals may experience mild side effects. These can include headaches, muscle pain, flushing, nausea, and a stuffy or runny nose. Occasionally, users report an upset stomach, sore throat, or respiratory infections such as colds or bronchitis. Back pain and discomfort in the hands and feet are also possible, but these effects are generally not severe and often resolve on their own. If they persist or worsen, consult your healthcare provider.

However, there are rare but serious side effects that require immediate medical attention. These include sudden vision changes or loss in one or both eyes, which could indicate a condition called NAION, particularly if you have risk factors such as heart disease or diabetes. Another severe issue is a sudden decrease or loss of hearing, potentially accompanied by ringing in the ears or dizziness. Males might experience a prolonged or painful erection lasting more than four hours, which needs urgent medical intervention to prevent lasting damage. Additionally, signs of severe allergic reactions, such as rash, swelling of the face or throat, severe dizziness, or trouble breathing, should be addressed promptly.

While most side effects are not serious, it's crucial to be aware of these potential reactions and seek medical advice if they occur. Remember, this summary does not cover all possible side effects, so discussing any concerns with your healthcare provider is advisable.

Tadalafil can interact with several other medications, and it's important to discuss all the drugs you are taking with your healthcare provider. Notably, tadalafil should not be used with nitrates, such as nitroglycerin or isosorbide, or recreational drugs known as "poppers" containing amyl or butyl nitrite, as this combination can cause a dangerous drop in blood pressure, leading to dizziness, fainting, or even heart attack or stroke. Avoid using tadalafil with similar medications for erectile dysfunction or pulmonary hypertension like sildenafil or vardenafil.

If you are taking medications like riociguat or vericiguat, or have been prescribed alpha blockers like doxazosin or tamsulosin for conditions such as an enlarged prostate or high blood pressure, be cautious. These combinations may lower your blood pressure significantly, causing dizziness or fainting. Your doctor might adjust your dosage to reduce these risks.

Certain drugs can affect how tadalafil is processed in your body, potentially altering its effectiveness. These include some antifungals (like itraconazole and ketoconazole), macrolide antibiotics (such as clarithromycin and erythromycin), HIV protease inhibitors (including ritonavir and lopinavir), rifampin, and others. Always inform your doctor about all the medications and supplements you are taking to ensure safe use of tadalafil.