Active Ingredients: Sildenafil

Important Safety Information for Sildenafil

Contraindications:

• Do not take sildenafil if you are also using a nitrate drug for chest pain or heart problems, including nitroglycerin, isosorbide dinitrate, isosorbide mononitrate, and some recreational drugs such as "poppers". Taking sildenafil with a nitrate medicine can cause a sudden and serious decrease in blood pressure.

• Some medicines can cause unwanted or dangerous effects when used with sildenafil. Tell your doctor about all your current medicines, especially riociguat (Adempas). Do not take sildenafil with riociguat.
• Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis.
• Stop using sildenafil and get emergency medical help if you have sudden vision loss. Sildenafil can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking sildenafil, most of whom also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old. It is not clear whether this medicine is the actual cause of vision loss. Do not give this medication to anyone under 18 years old without medical advice.

Before taking this medication:

You should not use sildenafil if you are allergic to it, or:

• If you take other medicines to treat pulmonary arterial hypertension, such as riociguat (Adempas).
• If you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin, isosorbide dinitrate, and isosorbide mononitrate. Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking sildenafil with a nitrate medicine can cause a sudden and serious decrease in blood pressure.

To make sure sildenafil is safe for you, tell your doctor if you have ever had:

• Heart problems (chest pain, a heart rhythm disorder, heart attack)
• High or low blood pressure
• Blood circulation problems
• Retinitis pigmentosa (an inherited condition of the eye)
• Blindness in one or both eyes
• Bleeding problems
• A stomach ulcer
• Pulmonary veno-occlusive disease (PVOD)
• Liver or kidney disease
• A blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia
• A physical deformity of the penis (such as Peyronie's disease)
• If you have been told you should not have sexual intercourse for health reasons.

Drug Interactions:

• Nitrates: Nitroglycerin, isosorbide dinitrate, isosorbide mononitrate, and some recreational drugs such as "poppers". Taking a nitrate medicine with Sildenafil can cause a dangerous decrease in blood pressure.
• Guanylate cyclase stimulators: Adempas® (riociguat)
• Alpha-blockers: Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl), Cardura® (doxazosin mesylate), Minipress® (prazosin HCl), Uroxatral® (alfuzosin HCl), Jalyn® (dutasteride and tamsulosin HCl), or Rapaflo® (silodosin)
• HIV protease inhibitors: ritonavir (Norvir®), indinavir sulfate (Crixivan®), saquinavir (Fortovase® or Invirase®), or atazanavir sulfate (Reyataz®)
• Oral antifungal medicines: ketoconazole (Nizoral®) and itraconazole (Sporanox®)
• Antibiotics: clarithromycin (Biaxin®), telithromycin (Ketek®), or erythromycin
• Other medicines that treat high blood pressure
• Other medicines or treatments for ED
• Viagra® and generic Viagra® also contain sildenafil, sildenafil is also found in a drug called Revatio® used for pulmonary arterial hypertension (PAH). Do not use sildenafil with Viagra®, Revatio®, or with any other PDE5 inhibitor or erectile dysfunction treatment.

Side Effects:

Get emergency medical help if you have signs of an allergic reaction to sildenafil:

• Hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Stop taking sildenafil and get emergency medical help if you have:

• heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating
• vision changes or sudden vision loss
• erection is painful or lasts longer than 4 hours (prolonged erection can damage the penis)
• ringing in your ears, or sudden hearing loss
• irregular heartbeat
• swelling in your hands, ankles, or feet
• shortness of breath
• seizure (convulsions)
• a light-headed feeling, like you might pass out

Common sildenafil side effects may include:

• flushing (warmth, redness, or tingly feeling)
• headache, dizziness
• heartburn, nausea, or upset stomach
• abnormal vision (blurred vision, changes in color vision)
• runny or stuffy nose, nosebleeds
• sleep problems (insomnia)
• muscle pain, back pain

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Additional Resources

The following links provide further information of the potential risks and benefits of this medication:

• Official Sildenafil PDR
• FDA Sildenafil Prescribing Information

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