Revatio(TM) sildenafil

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REVATIO (sildenafil) is a treatment for pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability, help lessen symptoms, and slow down worsening changes in your physical condition. REVATIO has not been studied in patients taking bosentan.

REVATIO comes in a 20-mg pill that is taken 3 times a day. It is only available by prescription from your doctor. The recommended dose of REVATIO is 20 mg three times a day.

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.

Talk to your doctor to see if REVATIO is right for you.

Next: Understanding PAH

Indication

REVATIO (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. REVATIO improves the ability to exercise and slow down worsening changes in your physical condition.

Important Safety Information

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

REVATIO is not for use in children.

It is not known if REVATIO is effective for the treatment of PAH in people who are also taking a medicine called bosentan.

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.

REVATIO is not recommended for patients taking ritonavir 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. It is not known if REVATIO passes into your breast milk or if it could harm your baby.

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

*Terms and Conditions

By using the REVATIO $4 Co-pay Value Card, you acknowledge that you currently meet the eligibility criteria and will comply with the following terms and conditions. Offer is not valid for prescriptions that are eligible to be reimbursed, in whole or in part, by Medicaid, Medicare, or other federal or state health care programs (including any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico formerly known as “La Reforma de Salud”). Offer is not valid for prescriptions that are eligible to be reimbursed by private insurance plans or other health or pharmacy benefit programs that reimburse you for the entire cost of your prescription drugs. By using the Card, patients will receive savings of up to $100 per fill and pay a minimum of $4 per fill. The Card is good for a maximum of $1,200 per year. After a maximum of $1,200, patient will pay monthly out-of-pocket costs. The Card may be used once per month for the life of the program. You must deduct the value of the Card from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf. Card is not valid for Massachusetts residents whose prescriptions are covered in whole or in part by third-party insurance, or where otherwise prohibited by law. Card cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription. Card will be accepted only at participating pharmacies. Card is not health insurance. Offer good only in the US and Puerto Rico. Card is limited to 1 per person during this offering period and is not transferable. Pfizer reserves the right to rescind, revoke, or amend this offer without notice. No membership fee. Offer expires 12/31/2013.

For further information call 1-800-382-7060, or visit www.REVATIO.com.
Pfizer Inc, 235 E. 42nd Street, New York, NY 10017

Please See Full Prescribing and Patient Information for REVATIO

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Pfizer Helpful Answers
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Pfizer Inc.
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RVU562611-01. April 2013.

The product information provided in this site is intended only for residents of the United States. The products discussed herein may have different product labeling in different countries.

This product information is intended only for residents of the United States.

The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient.