Sildenafil

Generic Name: Sildenafil Tablets 25 mg, 50 mg, 100 mg (sil-DEN-a-fil)
Brand Name: Viagra

Sildenafil is used for:

Treating erectile dysfunction (ED). It may also be used for other conditions as determined by your doctor.

Sildenafil is a phosphodiesterase inhibitor. It works by helping to increase blood flow into the penis during sexual stimulation. This helps you to achieve and maintain an erection.

Do NOT use Sildenafil if:

you are allergic to any ingredient in Sildenafil
you have been advised by your doctor to avoid sexual activity because of heart problems
you are taking nitrates (eg, isosorbide, nitroglycerin) in any form (eg, tablet, capsule, patch, ointment) or nitroprusside
you use certain recreational drugs called "poppers" (eg, amyl nitrate, butyl nitrate)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Sildenafil :

Some medical conditions may interact with Sildenafil . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have a deformed penis (eg, Peyronie disease, cavernosal fibrosis), blood problems (eg, sickle cell anemia, leukemia, multiple myeloma), or any other condition that may increase the risk of a prolonged erection (eg, priapism)
if you have a history of certain eye problems (eg, retinitis pigmentosa, sudden vision loss, optic neuropathy, macular degeneration)
if you have a history of liver or kidney problems, high or low blood pressure, ulcers, bleeding problems, heart problems (eg, heart failure, irregular heartbeat, aortic stenosis, angina), or blood vessel problems
if you have a history of heart attack, stroke, or life-threatening irregular heartbeat, especially within the past 6 months

Some MEDICINES MAY INTERACT with Sildenafil . Tell your health care provider if you are taking any other medicines, especially any of the following:

Alpha-blockers (eg, doxazosin), amlodipine, medicines for high blood pressure, nitrates (eg, isosorbide, nitroglycerin), or nitroprusside because severe low blood pressure with dizziness, lightheadedness, and fainting may occur
Azole antifungals (eg, itraconazole), cimetidine, H₂ agonists (eg, famotidine), HIV protease inhibitors (eg, ritonavir), macrolide antibiotics (eg, erythromycin), or telithromycin because they may increase the risk of Sildenafil 's side effects
Bosentan or rifampin because they may decrease Sildenafil 's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sildenafil may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Sildenafil :

Use Sildenafil as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Sildenafil . Talk to your pharmacist if you have questions about this information.
Take Sildenafil by mouth with or without food. Sildenafil may not work as quickly if you take it with a high-fat meal.
Sildenafil is usually taken about 1 hour before sexual activity. However, it may be taken anywhere from 4 hours to ½ hour before sexual activity. Talk with your doctor about the best way to take Sildenafil .
Do not take Sildenafil more often than once daily, or as directed by your doctor.
If you miss a dose of Sildenafil and you still intend to engage in sexual activity, take it as soon as you remember. Continue to take it as directed by your doctor.

Ask your health care provider any questions you may have about how to use Sildenafil .

Important safety information:

Sildenafil may cause dizziness, drowsiness, fainting, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Sildenafil with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Sildenafil may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
Patients with heart problems who take Sildenafil may be at increased risk for heart-related side effects, including heart attack or stroke. Symptoms of a heart attack may include chest, shoulder, neck, or jaw pain; numbness of an arm or leg; severe dizziness, headache, nausea, stomach pain, or vomiting; fainting; or vision changes. Symptoms of a stroke may include confusion, vision or speech changes, one-sided weakness, or fainting. Contact your doctor or seek medical attention right away if you experience these symptoms.
Sildenafil may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.
Do not use other medicines or treatments for erectile dysfunction while you are taking Sildenafil .
Sildenafil does not stop the spread of HIV or other sexually transmitted diseases (STDs) to others through sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection or an STD.
Sildenafil will not prevent pregnancy. If your partner may become pregnant and you wish to avoid pregnancy, be sure to use an effective form of birth control.
Use Sildenafil with caution in the ELDERLY; they may be more sensitive to its effects.
Sildenafil is not recommended for use in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: Sildenafil is not approved for use in women. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sildenafil while you are pregnant. It is not known if Sildenafil is found in breast milk. If you are or will be breast-feeding while you use Sildenafil , check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Sildenafil :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; flushing; headache; heartburn; mild, temporary vision changes (eg, blurred vision, sensitivity to light, blue/green color tint to vision); stuffy nose; upset stomach.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fainting; fast or irregular heartbeat; painful or prolonged erection; ringing in the ears; seizure; severe or persistent dizziness; severe or persistent vision changes; sudden decrease or loss of vision in one or both eyes; sudden hearing loss.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include chest pain; fainting; prolonged erection; severe dizziness.

Proper storage of Sildenafil :

Store Sildenafil at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sildenafil out of the reach of children and away from pets.

General information:

If you have any questions about Sildenafil , please talk with your doctor, pharmacist, or other health care provider.
Sildenafil is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Sildenafil . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: October 1, 2008

Database Edition 08.4.1.001