Important Safety Info | REVATIO® (sildenafil) | Safety Info

IMPORTANT SAFETY INFORMATION AND INDICATION

DO NOT take REVATIO with any nitrate medicines or with riociguat (Adempas®), a soluble guanylate cyclase (sGC) stimulator medicine. If you take any medicines that contain nitrates, daily or just once in a while (like nitroglycerin for chest pain), or riociguat, a soluble guanylate cyclase (sGC) stimulator medicine, your blood pressure could drop quickly to an unsafe level.

Do not take REVATIO if you are allergic to sildenafil or any other ingredient in REVATIO. REVATIO is not for use in children.

REVATIO contains the same medicine as VIAGRA® (sildenafil), which is used to treat erectile dysfunction (impotence). Do not take REVATIO with VIAGRA or other PDE5 inhibitors.

Adding REVATIO to another medication used to treat PAH, bosentan (Tracleer®), does not result in improvement in your ability to exercise.

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

Tell your healthcare provider if you have any blood cell problems including sickle cell anemia. Tell your doctor if you have any problem with the shape of your penis or Peyronie’s disease.

REVATIO is not recommended for patients taking ritonavir (to treat HIV infection) or antifungal medicines, such as ketoconazole and itraconazole. Tell your doctor about all of the medicines you take. REVATIO and certain other medicines can cause side effects if you take them together. Tell your doctor if you are taking blood pressure–lowering drugs or alpha-blockers for prostate.

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

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.

Sudden decrease or loss of hearing has been reported in people taking PDE5 inhibitors, including REVATIO. It is not possible to determine whether these events are related directly to the PDE5 inhibitors or to other factors. If you take a PDE5 inhibitor, including REVATIO, and experience a sudden decrease or loss of hearing, contact a doctor right away.

Tell your doctor if you have an eye problem called retinitis pigmentosa or you had loss of sight in one or both eyes.

Men who took PDE5 inhibitors for erectile dysfunction had a sudden decrease or loss of sight in one or both eyes (NAION). If you take a PDE5 inhibitor, including REVATIO, and have a sudden decrease or loss of eyesight, call your doctor right away.

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.

Tell your doctor if you are pregnant or planning to become pregnant. It is not known if REVATIO could harm your unborn baby.

Tell your healthcare provider if you are breastfeeding. REVATIO passes into your breast milk, it is not known if it could harm your baby.

The most common side effects of REVATIO are nosebleeds, headache, upset stomach, flushing, and trouble sleeping, as well as fever, erection increased, respiratory infection, nausea, vomiting, bronchitis, pharyngitis, runny nose, and pneumonia in children.

INDICATION

REVATIO is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH). With PAH, the blood pressure in your lungs is too high. Your heart has to work hard to pump blood into your lungs. REVATIO improves the ability to exercise and slow down worsening changes in your physical condition.

Limitation of Use: Adding REVATIO to another medication used to treat PAH, bosentan (Tracleer®), does not result in improvement in your ability to exercise.

Adempas® is a registered trade mark of Bayer HealthCare Pharmaceuticals. Tracleer® is a registered trade mark of Actelion Pharmaceuticals Ltd.

Please see Full Prescribing Information and Patient Information.

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