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This medication, Opsynvi (macitentan / tadalafil), carries important safety warnings and precautions. Please carefully review the following information and discuss any concerns with your healthcare provider.

• Pregnancy Warning: Opsynvi must not be used during pregnancy as it can cause serious harm to an unborn child. Female patients should enroll in the Macitentan-Containing Products REMS program and use reliable contraception while on this medication and for at least one month after the last dose. A pregnancy test is required before starting treatment. If you suspect pregnancy, inform your doctor immediately.

• Liver Health: This medication may affect liver function, potentially leading to liver failure. Liver function should be monitored with blood tests prior to and during treatment. Symptoms of liver issues include abdominal pain, jaundice, nausea, vomiting, or dark urine. Contact your healthcare provider if these occur.

• Blood Pressure Effects: Opsynvi can lower blood pressure, causing dizziness or lightheadedness. It is important to rise slowly from sitting or lying positions and sit down initially to prevent falls. Seek emergency assistance if you experience fainting, rapid breathing, irregular heartbeat, blurred vision, or cold, clammy skin. Risks are higher if you have heart issues, dehydration, or consume alcohol.

• Anemia Risk: The medication may reduce hemoglobin levels, leading to anemia. Discuss your history of anemia with your doctor to determine if Opsynvi is appropriate for you.

• Vision Concerns: Rarely, Opsynvi may cause vision problems, potentially leading to permanent damage. Conditions such as non-arteritic anterior ischemic optic neuropathy (NAION) have been reported. If you notice vision changes, contact your healthcare provider promptly.

• Hearing Loss: Some users of tadalafil have reported hearing loss, potentially accompanied by tinnitus or dizziness. If you experience changes in hearing, consult your doctor.

• Fluid Retention: Opsynvi can cause fluid retention, which can worsen heart conditions. If you have heart failure or experience symptoms like swelling or shortness of breath, inform your healthcare provider immediately.

• Drug Interactions: Avoid using Opsynvi with other PDE5 inhibitors, including other tadalafil formulations. Using multiple PDE5 inhibitors can increase side effects, such as dizziness and headaches.

• PVOD Warning: Opsynvi is not recommended for individuals with pulmonary vascular occlusive disease (PVOD) as it might exacerbate the condition. Seek medical advice if you experience persistent coughing, fatigue, or chest pain.

• Priapism Alert: Rare cases of prolonged or painful erections have been reported. Seek immediate medical attention if an erection lasts over four hours or becomes painful.

• Fertility Considerations: Opsynvi may affect sperm count, potentially impacting fertility. Discuss the implications with your doctor if you plan to have children.

Contraindications:

• Do not use Opsynvi if you are pregnant, have allergies to macitentan or tadalafil, or are taking nitrates or riociguat (Adempas).

Always consult with your healthcare provider to ensure safe and effective use of Opsynvi, and report any adverse effects or concerns promptly.

When taking this medication, you may encounter some common side effects such as runny or stuffy nose, sore throat, cough, chills, dizziness, lightheadedness, headaches, muscle pain, flushing, nausea, vomiting, or stomach upset. These symptoms are usually mild, but if they persist or worsen, consult your healthcare provider. To minimize dizziness or lightheadedness, rise slowly from a sitting or lying position.

Some individuals may experience fluid buildup or swelling, particularly in the legs, ankles, or feet, which could lead to unusual weight gain. Anemia, characterized by tiredness, rapid breathing, pale skin, shortness of breath, or fast heartbeat, may also occur. If you notice any of these signs, reach out to your healthcare provider.

Serious side effects, though rare, require immediate medical attention. Be alert for symptoms of liver problems, such as persistent nausea, dark urine, stomach pain, or yellowing of the eyes or skin. Sudden vision loss, known as NAION, or hearing loss, sometimes accompanied by ringing in the ears or dizziness, demands urgent care. Additionally, a painful or prolonged erection lasting more than four hours in males calls for immediate assistance to prevent permanent damage.

In rare cases, a severe allergic reaction could occur, with symptoms like rash, itching, swelling, severe dizziness, or trouble breathing. Seek emergency medical help if these arise. While this list covers many potential side effects, report any other unusual or persistent symptoms to your healthcare provider.

Certain medications may interact with macitentan/tadalafil, affecting its effectiveness or increasing side effects. Notable interactions include:

1. Serious Blood Pressure Drop: Combining macitentan/tadalafil with nitrates (such as nitroglycerin or isosorbide) or recreational drugs known as "poppers" (containing amyl or butyl nitrite) can cause a significant drop in blood pressure. This can result in dizziness, fainting, or in rare cases, a heart attack or stroke. It is crucial to avoid these substances during treatment and for 48 hours after the last dose.

2. Low Blood Pressure Risk: If you are on alpha blockers like doxazosin or tamsulosin for conditions such as an enlarged prostate or high blood pressure, there is a risk of your blood pressure dropping too low, leading to dizziness or fainting. Your healthcare provider may need to adjust your medications to reduce this risk.

3. Removal Interference: Some drugs can impact how macitentan/tadalafil is processed in your body. These include amiodarone, azole antifungals (e.g., itraconazole, ketoconazole), macrolide antibiotics (e.g., clarithromycin, erythromycin), cobicistat, certain HIV protease inhibitors (e.g., lopinavir, ritonavir), and rifamycins (e.g., rifampin).

4. Avoid Similar Medications: Do not take macitentan/tadalafil with other products containing tadalafil or similar medications used for erectile dysfunction or pulmonary hypertension, such as sildenafil or vardenafil, to prevent adverse effects.

Always consult your doctor or pharmacist before starting new medications.