Read this Patient Information before you start taking sildenafil 20 mg (Revatio) and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about sildenafil, ask your doctor or pharmacist.
What is the most important information I should know about sildenafil 20 mg tablets (Revatio)?
Never take sildenafil with any nitrate 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)
Ask your doctor or pharmacist if you are not sure if you are taking a nitrate medicine.
What is sildenafil 20 mg tablets (Revatio)?
20 mg sildenafil 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. It improves the ability to exercise and can slow down worsening changes in your physical condition.
- Sildenafil is not for use in children
- Adding sildenafil to another medication used to treat PAH, bosentan (Tracleer®), does not result in improvement in your ability to exercise.
- 20 mg sildenafil tablets contain the same medicine as VIAGRA® (sildenafil), which is used to treat erectile dysfunction (impotence). Do not take 20 mg sildenafil tablets with VIAGRA or other PDE-5 inhibitors.
Who should not take sildenafil 20 mg tablets (Revatio)?
Do not take sildenafil if you:
- Take any medicines called nitrates, often prescribed for chest pain, or guanylate cyclase stimulators like Adempas (riociguat) for pulmonary hypertension. Your blood pressure could drop to an unsafe level
- Are allergic to sildenafil, as contained in VIAGRA® and REVATIO®
- You’ve ever had blockage of veins in your lungs, which is called pulmonary veno-occlusive disease
- Are a women or a child
Before you take sildenafil, tell your healthcare provider if you:
- Have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve, or heart failure
- Have had heart surgery within the last 6 months
- Have pulmonary hypertension
- Have had a stroke
- Have low blood pressure, or high blood pressure that is not controlled
- Have a deformed penis shape
- Have had an erection that lasted for more than 4 hours
- Have problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemia
- Have retinitis pigmentosa, a rare genetic (runs in families) eye disease
- Have ever had severe vision loss, including an eye problem called NAION
- Have bleeding problems
- Have or have had stomach or intestinal ulcers
- Have liver problems
- Have kidney problems or are having kidney dialysis
- Have any problem with the shape of your penis or Peyronie’s disease
- Have any other medical conditions
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Sildenafil may affect the way other medicines work, and other medicines may affect the way sildenafil works, causing side effects.
Especially tell your healthcare provider if you take any of the following:
- Medicines called nitrates
- Medicines called guanylate cyclase stimulators such as Adempas® (riociguat)
- Medicines called alpha-blockers such as Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl), Cardura® (doxazosin mesylate), Minipress® (prazosin HCl), Uroxatral® (alfuzosin HCl), Jalyn® (dutasteride and tamsulosin HCl), or Rapaflo® (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of VIAGRA® with alpha-blockers can lead to a drop in blood pressure or to fainting
- Medicines called HIV protease inhibitors, such as ritonavir (Norvir®), indinavir sulfate (Crixivan®), saquinavir (Fortovase® or Invirase®), or atazanavir sulfate (Reyataz®)
- Oral antifungal medicines, such as ketoconazole (Nizoral®) and itraconazole (Sporanox®)
- Antibiotics, such as clarithromycin (Biaxin®), telithromycin (Ketek®), or erythromycin
- Other medicines that treat high blood pressure
- K antagonists (like coumadin or warfarin)
- Other medicines or treatments for ED
- Sildenafil is the same medicine found in VIAGRA® and REVATIO®. REVATIO® is used to treat a rare disease called pulmonary arterial hypertension (PAH). VIAGRA® should not be used with REVATIO® or with other PAH treatments containing sildenafil or any other PDE5 inhibitors (such as Adcirca [tadalafil])
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.
Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.
How should I take sildenafil 20 mg tablets (Revatio)?
- Take sildenafil exactly as your doctor tells you.
- Sildenafil may be prescribed to you as tablets or an oral suspension
- Take sildenafil tablet or oral suspension 3 times a day about 4 to 6 hours apart
- Take sildenafil tablets or oral suspension at the same times every day.
- Sildenafil oral suspension will be mixed for you by your pharmacist. Do not mix sildenafil 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 sildenafil at a time.
- Do not change your dose or stop taking sildenafil on your own. Talk to your doctor first.
- If you take too much sildenafil, call your doctor or go to the nearest hospital
What are the possible side effects of sildenafil 20 mg tablets (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. Tell your doctor right away if you have an erection that lasts more than 4 hours.
The most common side effects with sildenafil 20 mg tablets (Revatio) include:
- upset stomach
- getting red or hot in the face (flushing)
- trouble sleeping
- erection increased
- respiratory infection
- runny nose
- 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.
How should I store sildenafil 20 mg tablets (Revatio)?
- Store tablets at controlled room temperature, between 20°C -25°C (68°F to 77°F).
- Store 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 oral suspension.
- Throw away oral suspension after 60 days.
- Keep all medicines away from children.
General information about sildenafil 20 mg tablets (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.
What are the ingredients in sildenafil 20 mg tablets (Revatio)?
Active ingredients: sildenafil citrate
Inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, lactose monohydrate, and triacetin