Sildenafil oral suspension

What is this medicine?

SILDENAFIL (sil DEN a fil) is used to treat pulmonary arterial hypertension. This is a serious heart and lung condition. This medicine helps to improve symptoms and quality of life.

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Shake well for at least 10 seconds before using. Do not mix this medicine with other medicine or flavoring. This medicine should only be given using the oral syringe provided in the pack. 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 doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• changes in vision

• chest pain

• decreased hearing

• fast, irregular heartbeat

• men: prolonged or painful erection (lasting more than 4 hours)

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

• facial flushing

• headache

• nosebleed

• trouble sleeping

• upset stomach

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• cisapride

• cobicistat

• nitrates like amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin

• riociguat

• telaprevir

This medicine may also interact with the following medications:

• antiviral medicines for HIV or AIDS

• bosentan

• certain medicines for benign prostatic hyperplasia (BPH)

• certain medicines for blood pressure

• certain medicines for fungal infections like ketoconazole and itraconazole

• cimetidine

• erythromycin

• rifampin

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.

Where should I keep my medicine?

Keep out of the reach of children.

After this medicine is mixed by your pharmacist, store it below 30 degrees C (86 degrees F) or in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze. Throw away any unused medicine after 60 days.

What should I tell my health care provider before I take this medicine?

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 medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

Tell your doctor or health care professional 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 medicine 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.