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Safety Information Side effects As with any drug, REVATIO may cause side effects. In studies, the side effects reported most were: Nosebleeds Headache Upset stomach Flushing (feeling “red in the face” or a “head rush” feeling) Trouble sleeping Very few people had to stop taking REVATIO because of side effects. Be sure to let your doctor know if you have any side effects while taking REVATIO. Who should not take REVATIO? Only your doctor can decide if REVATIO is right for you. REVATIO is not right for everyone. You should never take REVATIO if you take medicines with nitrates in them — this includes nitroglycerin for chest pain. You should also not take REVATIO if you are taking certain drugs for HIV, such as ritonavir. Do not take REVATIO with antifungals such as ketoconazole and itraconazole. If you have ever had blockage of veins in your lungs, which is called pulmonary veno-occlusive disease (PVOD), REVATIO is not recommended for you. REVATIO and other medicines Tell your doctor about any medicines or health products you are now taking. If you take any of the medicines listed below, your doctor may need to adjust your dose. Alpha-blockers Barbiturates Bosentan Carbamazepine Rifabutin Rifampin Phenytoin Vitamin K antagonists Certain HIV medicines What should I tell my doctor before starting REVATIO? Discuss your health status with your doctor to see if REVATIO is right for you. Tell your doctor if you have or ever had: Heart problems such as heart attack, stroke, irregular heartbeat, or chest pain (angina) Problems with high or low blood pressure or blood circulation An eye problem called retinitis pigmentosa Severe liver or kidney disease Any disease or problem with the shape of the penis Any blood problems such as sickle cell anemia or cancer of blood cells or bone marrow A stomach ulcer or any bleeding problem Also tell your doctor if you are pregnant, could be pregnant, or are breast-feeding. The effects of REVATIO in these patients are not known. Next: Your Prescription for REVATIO

Important Safety Information

REVATIO is prescribed to treat pulmonary arterial hypertension (WHO Group I) to improve exercise ability. REVATIO has not been studied in patients taking bosentan.

If you take any medicines that contain nitrates (like nitroglycerin for chest pain) — daily or just once in a while — you should NOT take REVATIO.

REVATIO is not recommended for patients taking ritonavir or antifungal medicines, such as ketoconazole and itraconazole. If you are taking REVATIO with bosentan or medicines like barbiturates, carbamazepine, phenytoin, efavirenz, nevirapine, rifampin or rifabutin, your doctor may adjust your dose. Also, tell your doctor if you are taking alpha-blockers for prostate or blood pressure problems.

If you have ever had blockage of veins in your lungs, which is called pulmonary veno-occlusive disease, REVATIO is not recommended for you. If you feel dizzy, have chest pain, or discomfort while taking REVATIO, tell a doctor right away. Also, discuss your general health with your doctor, including if you ever had problems with low blood pressure or blood circulation.

Patients who did not take part in the clinical trial were those who have had: a heart attack, stroke, or life-threatening irregular heartbeat within the last 6 months; chest pain; blood pressure greater than 170/110; eye discoloration; or patients on bosentan.

The safety of REVATIO is not known in patients with bleeding problems and those with stomach ulcers. If you have a condition like these, tell your doctor.

Taking vitamin K antagonists (like coumadin or warfarin) with REVATIO may increase risk of nosebleeds. Tell your doctor if you take such medicines.

In rare cases, men who took PDE5 inhibitors for erectile dysfunction had a sudden decrease or loss of sight in one or both eyes. It is not possible to know if these cases are related directly to these medicines or something else. If you take a PDE5 inhibitor, including REVATIO, and have a sudden decrease or loss of vision, call your doctor right away.

Although rare, erections that last for more than four hours may occur with all drugs in this class. Call a doctor right away if this happens to you. Erections that last more than six hours may lead to long-term loss of potency.

The most common side effects of REVATIO are nosebleeds, headache, upset stomach, flushing, and trouble sleeping.

At doses more than the approved 20 milligrams 3 times a day, some side effects increased. These included flushing, loose stools, muscle pain, and visual disturbances.

Please See Full Prescribing Information for REVATIO