Sildenafil Tablets (Pulmonary Hypertension)

What is this medication?

SILDENAFIL (sil DEN a fil) treats pulmonary arterial hypertension (PAH), a condition that causes high blood pressure in the lungs. It works by relaxing your blood vessels and lowering the blood pressure in your lungs, which makes it easier for your heart to pump blood to the rest of your body. It can also help you breathe easier and be more active.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Revatio

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Anatomical deformation of the penis, Peyronie's disease, or history of priapism (painful and prolonged erection)
• Bleeding disorders
• Eye disease, vision problems
• Heart disease
• High or low blood pressure
• History of blood diseases, like sickle cell anemia or leukemia
• Kidney disease
• Liver disease
• Pulmonary veno-occlusive disease (PVOD)
• Stomach ulcer
• An unusual or allergic reaction to sildenafil, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Take your doses at regular intervals about 4 to 6 hours apart. Do not take it more often than directed. Do not stop taking except on your care team's advice.

Talk to your care team regarding the use of this medication in children. This medication is not approved for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Cisapride
• Cobicistat
• Nitrates like amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin
• Riociguat
• Telaprevir

This medication may also interact with the following:

• Antiviral medications for HIV or AIDS
• Bosentan
• Certain medications for benign prostatic hyperplasia (BPH)
• Certain medications for blood pressure
• Certain medications for fungal infections like ketoconazole and itraconazole
• Cimetidine
• Erythromycin
• Rifampin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your care team if your symptoms do not start to get better or if they get worse.

Tell your care team right away if you have any change in your eyesight or hearing.

You may get dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Avoid alcoholic drinks; they can make you more dizzy.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Hearing loss or ringing in ears
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
• New or worsening shortness of breath
• Prolonged or painful erection
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Sudden vision loss in one or both eyes

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Facial flushing or redness
• Headache
• Nosebleed
• Runny or stuffy nose
• Trouble sleeping
• Upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of reach of children and pets.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.