Revatio

What is Revatio?

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 can slow down worsening changes in your physical condition.

• Revatio is not for use in children
• Adding Revatio to another medication used to treat PAH, bosentan (Tracleer), does not result in improvement in your ability to exercise.

Revatio contains the same medicine as Viagra (sildenafil), which is used to treat erectile dysfunction (impotence). Do not take Revatio with Viagra or other PDE-5 inhibitors.

What is the most important information I should know about Revatio?

Never take Revatio with any nitrate or guanylate cyclase stimulator medicines. Your blood pressure could drop quickly to an unsafe level.

Nitrate medicines include:

• Medicines that treat chest pain (angina)
• Nitroglycerin in any form including tablets, patches, sprays, and ointments
• Isosorbide mononitrate or dinitrate
• Street drugs called "poppers" (amyl nitrate or nitrite)

Guanylate cyclase stimulators include:

• Riociguat (Adempas)

Ask your doctor or pharmacist if you are not sure if you are taking a nitrate or a guanylate cyclase stimulator medicine.

Who should not take Revatio?

Do not take Revatio if you:

• take nitrate medicines. See “What is the most important information I should know about Revatio?"
• take guanylate cyclase stimulator medicines. See “What is the most important information I should know about Revatio?"
• are allergic to sildenafil or any other ingredient in Revatio. See “What are the ingredients in Revatio?"

What should I tell my healthcare provider before taking Revatio?

Tell your doctor about all of your medical conditions, including if you

• have heart problems such as angina (chest pain), heart failure, irregular heartbeats, or have had a heart attack
• have a disease called pulmonary veno-occlusive disease (PVOD)
• have high or low blood pressure or blood circulation problems
• have an eye problem called retinitis pigmentosa
• have or had loss of sight in one or both eyes
• have any problem with the shape of your penis or Peyronie's disease
• have any blood cell problems such sickle cell anemia
• have a stomach ulcer or any bleeding problems
• are pregnant or planning to become pregnant. It is not known if Revatio could harm your unborn baby.
• are breastfeeding. Revatio passes into your breast milk, it is not known if it could harm your baby.

Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal products. Revatio and certain other medicines can cause side effects if you take them together. The doses of some of your medicines may need to be adjusted while you take Revatio.

Especially tell your doctor if you take

• Nitrate medicines. See “What is the most important information I should know about Revatio?"
• Riociguat (Adempas). See “What is the most important information I should know about Revatio?"
• Ritonavir (Norvir) or other medicines used to treat HIV infection
• Ketoconazole (Nizoral)
• Itraconazole (Sporanox)
• High blood pressure medicine

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

How should I take Revatio?

• Take Revatio exactly as your doctor tells you.

Revatio may be prescribed to you as

• Revatio tablets or Revatio oral suspension
• Take Revatio tablet or oral suspension 3 times a day about 4 to 6 hours apart
• Take Revatio tablets or oral suspension at the same times every day.
• Revatio oral suspension will be mixed for you by your pharmacist. Do not mix Revatio oral suspension with other medicine or flavoring. Shake well for at least 10 seconds before each dose.
• If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose, and take your next dose at the regular time.
• Do not take more than one dose of Revatio at a time.
• Do not change your dose or stop taking Revatio on your own. Talk to your doctor first.
• If you take too much Revatio, call your doctor or go to the nearest hospital emergency room.

What are the possible side effects of Revatio?

• low blood pressure. Low blood pressure may cause you to feel faint or dizzy. Lie down if you feel faint or dizzy.
• more shortness of breath than usual. Tell your doctor if you get more short of breath after you start Revatio. More shortness of breath than usual may be due to your underlying medical condition.
• decreased eyesight or loss of sight in one or both eyes (NAION). If you notice a sudden decrease or loss of eyesight, talk to your doctor right away.
• sudden decrease or loss of hearing. If you notice a sudden decrease or loss of hearing, talk to your doctor right away. It is not possible to determine whether these events are related directly to this class of oral medicines, including Revatio, or to other diseases or medicines, to other factors, or to a combination of factors.
• heart attack, stroke, irregular heartbeats, and death. Most of these happened in men who already had heart problems.
• erections that last several hours. If you have an erection that lasts more than 4 hours, get medical help right away. If it is not treated right away, priapism can permanently damage your penis.

The most common side effects with Revatio include:

Nosebleed, headache, upset stomach, getting red or hot in the face (flushing), trouble sleeping, as well as fever, erection increased, respiratory infection, nausea, vomiting, bronchitis, pharyngitis, runny nose, and pneumonia in children.

Tell your doctor if you have any side effect that bothers you or doesn't go away.

These are not all the possible side effects of Revatio. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Revatio

Medicines are sometimes prescribed for purposes that are not in the patient leaflet. Do not use Revatio for a condition for which it was not prescribed. Do not give Revatio to other people, even if they have the same symptoms you have. It could harm them.

This patient leaflet summarizes the most important information about Revatio. If you would like more information about Revatio talk with your doctor. You can ask your doctor or pharmacist for information about Revatio that is written for health professionals.

For more information go to www.Revatio.com or call 1-800-879-3477.

How should I store Revatio?

• Store Revatio tablets at controlled room temperature, between 20°C –25°C (68°F to 77°F).
• Store Revatio constituted oral suspension below 30°C (86°F) or in a refrigerator between 2°C to 8°C (36°F to 46°F).
• Do not freeze Revatio oral suspension.
• Throw away Revatio oral suspension after 60 days.
• Keep Revatio and all medicines away from children.

What are the ingredients in Revatio?

Active ingredients: sildenafil citrate

Inactive ingredients:

Tablets: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, lactose monohydrate, and triacetin

Oral solution: sorbitol, citric acid anhydrous, sucralose, sodium citrate dihydrate, xanthan gum, titanium dioxide, sodium benzoate, colloidal silicon dioxide anhydrous, and grape flavor