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Generic Name: Sildenafil Tablets (PAH) (sil DEN a fil)
Brand Name: Revatio

Uses of Revatio:

  • It is used to treat high blood pressure in the lungs.
  • It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Revatio?

  • If you have an allergy to sildenafil or any other part of Revatio (sildenafil tablets (PAH)).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you use drugs called "poppers" like amyl nitrite and butyl nitrite.
  • If you are taking any of these drugs: Isosorbide dinitrate, isosorbide mononitrate, nitroglycerin, riociguat, or ritonavir.
  • If you are taking another drug that has the same drug in it.
  • If you are taking or will be taking another drug like this one.
  • If you have a health problem called pulmonary veno-occlusive disease (PVOD).

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Revatio with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Revatio?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how Revatio affects you.
  • To lower the chance of feeling dizzy or passing out, rise slowly over a few minutes when sitting or lying down. Be careful climbing stairs.
  • Do not take this medicine with other drugs used to treat a change in sex ability.
  • Talk with your doctor before you drink alcohol.
  • Very bad and sometimes deadly side effects like a heartbeat that does not feel normal, heart attack, stroke, and very bad high blood pressure have happened with Revatio. Talk with the doctor.
  • A very bad eye problem has rarely happened with this medicine. This may lead to a change in eyesight and sometimes loss of eyesight, which may not come back. Talk with the doctor.
  • If you are 65 or older, use Revatio with care. You could have more side effects.
  • This medicine is not approved for use in children. A higher rate of death has been seen in children as the dose of this medicine gets higher. However, your child's doctor may decide the benefits of taking Revatio may outweigh the risks. If your child has been given this medicine, talk with the doctor for information about the benefits and risks. Talk with the doctor if you have questions about giving Revatio to your child.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Revatio) best taken?

Use Revatio (sildenafil tablets (PAH)) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food.
  • Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
  • Take Revatio at the same time of day.
  • To gain the most benefit, do not miss doses.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

See also: Dosage Information (in more detail)

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Chest pain or pressure or a fast heartbeat.
  • A heartbeat that does not feel normal.
  • Dizziness or passing out.
  • Very bad headache.
  • Coughing up blood.
  • Very upset stomach or throwing up.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Change in eyesight.
  • Loss of eyesight.
  • Change in hearing.
  • Ringing in ears.
  • Memory problems or loss.
  • Seizures.
  • Shortness of breath.
  • Swelling in hands or feet.
  • Fever.
  • Call your doctor right away if you have a painful erection (hard penis) or an erection that lasts for longer than 4 hours. This may happen even when you are not having sex. If this is not treated right away, it may lead to lasting sex problems and you may not be able to have sex.

What are some other side effects of Revatio?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Loose stools (diarrhea).
  • Flushing.
  • Headache.
  • Belly pain or heartburn.
  • Upset stomach.
  • Stuffy nose.
  • Runny nose.
  • Muscle pain.
  • Redness.
  • Nosebleed.
  • Not able to sleep.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

See also: Side effects (in more detail)

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Revatio?

  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Revatio or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Revatio. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: September 6, 2017

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