USE IN SPECIFIC POPULATIONS

Do not take more than once sildenafil softgel capsule a day. If you take too much sildenafil, call your healthcare provider or go to the nearest hospital emergency room right away. Do not remove the film from the pouch unless ready for immediate use. Do not handle the oral film with wet hands. See the Vybrique Prescribing Information for more information about how to take sildenafil oral film.

Side Effect	Frequency	Severity	Description
Headache	Common	Mild	Usually resolves within a few hours
Flushing	Common	Mild	Warm sensation, redness of face
Dyspepsia (Indigestion)	Common	Mild	Gastrointestinal discomfort
Vision Changes	Less common	Mild	Blurred vision, color vision alterations
Nasal Congestion	Less common	Mild	Stuffiness or runny nose
Priapism	Rare	Severe	Prolonged, painful erection (<4 hours)

Take sildenafil exactly as it was prescribed for you.

Condition	Use of Sildenafil 50mg	Additional Notes
Erectile Dysfunction (ED)	Yes	Primary approved use
Pulmonary Arterial Hypertension	Sometimes	Off-label use with doctor approval
Raynaud's Phenomenon	Experimental	Limited evidence
High Altitude Pulmonary Edema	Experimental	Under clinical evaluation

Follow all directions on your prescription label and read all medication guides or instruction sheets.

Adverse effects

If you take sildenafil after a high-fat meal (such as a cheeseburger and fries), sildenafil may take a little longer to start working. If you accidentally take too much sildenafil, call your doctor or go to the nearest hospital emergency room right away. Sildenafil can help you have an erection when sexual stimulation occurs. An erection will not occur just by taking a pill. During sexual activity, if you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away.

Pulmonary hypertension

You could be having a serious side effect of sildenafil. Take sildenafil oral film (Vybrique) exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much sildenafil to take and when to take it. Take sildenafil by mouth about 1 hour before sexual activity. You may take sildenafil between 30 minutes and 4 hours before sexual activity if needed. Do not change your dose or stop taking this medicine on your own. Take sildenafil tablet or oral suspension 3 times a day, about 4 to 6 hours apart. Take at approximately the same times every day.

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Sildenafil oral suspension will be mixed for you by your pharmacist.

What happens if I overdose?

Tell your doctor if you get more short of breath after you start sildenafil. More shortness of breath than usual may be due to your underlying medical condition. Do not take Viagra while also taking Revatio. Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of sildenafil.

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Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Have allergies to sildenafil, Viagra, Revatio, Vybrique, or any of the ingredients in the sildenafil formulation you are taking Take other medicines for pulmonary arterial hypertension, such as riociguat (Adempas) Take other medicines for pulmonary arterial hypertension, such as riociguat (Adempas) Take other medicines that lower your blood pressure, such as nitroglycerin, isosorbide dinitrate, isosorbide mononitrate, and some recreational drugs that also contain nitrates, such as "poppers". To make sure sildenafil is safe for you, tell your healthcare provider about all your medical conditions, including if you have: Or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve, or heart failure Had heart surgery within the last 6 months Low blood pressure, or high blood pressure that is not controlled A physical deformity of the penis (such as Peyronie's disease) Been told you should not have sexual intercourse for health reasons and you are a male Had an erection that lasted for more than 4 hours Problems with your blood cells, such as sickle cell anemia, multiple myeloma, or leukemia Retinitis pigmentosa, a rare genetic (runs in families) eye disease Ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION) Kidney problems or are having kidney dialysis Are pregnant or intending to become pregnant (for patients with PAH) Are breastfeeding or intending to breastfeed (for patients with PAH). Sildenafil for ED is not approved for males <18 years old. Do not mix with other medicines or flavorings. Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon). When sildenafil is used for ED, it is used as needed, so you are not likely to miss a dose.

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In addition, heart attack, stroke, irregular heartbeats, and death have happened rarely in people taking sildenafil. Most, but not all, of these people had heart problems before taking this medicine. It is not known if sildenafil caused these problems. Tell all your healthcare providers that you take sildenafil. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took sildenafil.

What should I do if I accidentally use too much sildenafil?

Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, sildenafil 50 mg tab or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. Sildenafil does not protect you or your partner from getting sexually transmitted diseases, including Human Immunodeficiency Virus (HIV). Sildenafil may cause low blood pressure, which may cause you to feel faint or dizzy. Lie down if you feel faint or dizzy. If you are taking sildenafil for PAH and you miss a dose, take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time. If you take too much sildenafil, call your doctor or go to the nearest hospital emergency room.

• Common side effects include headaches, flushing, and nasal congestion.
• Serious side effects like vision changes or priapism require urgent medical attention.
• Inform your doctor about any medications to prevent interactions.

Drinking alcohol with sildenafil can cause side effects.

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Pronunciation: sil-DEN-a-fil Generic name: sildenafil Brand names: Revatio, Viagra, Vybrique Dosage form: tablets (20 mg; 25 mg, 50 mg, 100 mg), injection (10 mg/12.5 mL), oral suspension (10 mg/mL), oral film (25 mg, 50 mg, 75 mg, 100 mg) Drug classes: Agents for pulmonary hypertension, Impotence medications Sildenafil is used to treat erectile dysfunction (ED) in adult men or pulmonary arterial hypertension (PAH) in adults and children, depending on the brand or formulation. Sildenafil tablets (25 mg, 50 mg, 100 mg; Viagra, generic) and sildenafil oral film (25 mg, 50 mg, 75 mg, 100 mg; Vybrique) are used for ED. Sildenafil tablets (20 mg; Revatio, generic), sildenafil oral suspension (Revatio, generic), and sildenafil injection (Revatio, generic) are used for PAH. Sildenafil is a phosphodiesterase type 5 (PDE5) inhibitor, which breaks down cyclic GMP and enhances nitric oxide (NO) -mediated smooth muscle relaxation. In erectile dysfunction (ED), this increases blood flow to penile tissue, facilitating an erection.

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In pulmonary arterial hypertension (PAH), it dilates pulmonary vessels by the same mechanism, reducing pulmonary blood pressure and improving exercise capacity. Sildenafil first gained FDA approval on March 27, 1998. 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. Grapefruit juice and products may interact with sildenafil, leading to unwanted side effects. Avoid using any other medicines to treat impotence, such as alprostadil or yohimbine, without first talking to your doctor. Tell your healthcare provider about all the medicines you take, including prescription and over-the-countermedicines, vitamins, and herbal supplements.

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Tell your doctor about all your current medicines, especially riociguat (Adempas). The most common side effects of sildenafil tablets for ED are: Abnormal vision, such as changes in color vision (such as having a blue color tinge) andblurred vision The most common side effects of sildenafil oral film for ED are: Abnormal vision, such as changes in color and blurred vision The most common side effects of sildenafil tablets/ oral suspension, and injection for PAH are: Sildenafil can cause the following serious side effects. If you have an erection that lasts more than 4 hours, get medical help right away. If it is not treated right away, priapism can permanently damage your penis. Sildenafil can decrease blood flow to the optic nerve of the eye, causing sudden vision loss.

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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 smoked or were over 50 years old. Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). Stop taking sildenafil and call your healthcare provider right away if you havesudden vision loss in one or both eyes. Some people may also have ringing in their ears (tinnitus) or dizziness. If you have these symptoms, stop taking sildenafil and contact a doctor right away. Sildenafil may affect the way other medicines work, and other medicines may affect the way sildenafil works, causing side effects.

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Sildenafil is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Women with pulmonary arterial hypertension should not stop taking sildenafil without talking to their doctor if they discover they are pregnant. It is not known whether sildenafil passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breastfeeding a baby.

Recreational use

Women with pulmonary arterial hypertension should not stop taking sildenafil without talking to their doctor. Take sildenafil oral tablets exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much to take and when to take it. Your healthcare provider may change your dose if needed. You may take sildenafil between 30 minutes to 4 hours before sexual activity if needed. Especially tell your healthcare provider if you take: Nitrates for chest pain or heart problems.

• Immediate medical help is needed if an erection lasts more than 4 hours.
• Do not share your medication with others to avoid health risks.
• Always disclose full medical history when consulting your healthcare provider.

This includes nitroglycerin, isosorbide dinitrate, and isosorbide mononitrate.