Label: VIAGRA- sildenafil citrate tablet, film coated

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. 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. You may take sildenafil between 30 minutes to 4 hours before sexual activity if needed.

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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. Tell your doctor if you get more short of breath after you start sildenafil.

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More shortness of breath than usual may be due to your underlying medical condition. Do not sildenafil 20 mg prescription take Viagra while also taking Revatio. These are not all of the possible side effects of sildenafil. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. 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. 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.

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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). 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.

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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 smoked or were over 50 years old. Stop taking sildenafil and call your healthcare provider right away if you havesudden vision loss in one or both eyes. If you have these symptoms, stop taking sildenafil and contact a doctor right away. In addition, heart attack, stroke, irregular heartbeats, and death have happened rarely in people taking sildenafil.

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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. Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex. 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.

5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives

REVATIO is used to treat a rare disease called pulmonary arterial hypertension (PAH). VIAGRA should not be used with REVATIO or with other PAH treatments containing sildenafil or any other PDE5 inhibitors (such as Adcirca® [tadalafil]) VIAGRA does not protect against sexually transmitted diseases, including HIV. The most common side effects of VIAGRA: headache; flushing; upset stomach; abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision; stuffy or runny nose; back pain; muscle pain; nausea; dizziness; rash. VIAGRA, REVATIO, and CARDURA are registered trademarks of Viatris Specialty LLC, a Viatris Company. All other trademarks are the property of their respective owners.

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Viagra® (sildenafil citrate) is prescription medicine used to treat erectile dysfunction (ED). VIAGRA is not for women or children. Please see Full Prescribing Information and Patient Information. 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.

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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. 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. You may take sildenafil between 30 minutes and 4 hours before sexual activity if needed. Do not take more than once 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.

4.2 Hypersensitivity Reactions

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. Sildenafil is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Take sildenafil exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets.

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

• Many OTC "herbal" formulas claim to enhance sexual performance containing Sildenafil.
• OTC Sildenafil products are sometimes sold as libido boosters for men.
• Buyers should verify the legitimacy of OTC products claiming to contain Sildenafil.
• OTC Sildenafil may be found in health stores or online pharmacies.
• It's important to check for FDA or equivalent approval before purchasing OTC Sildenafil.
• OTC Sildenafil often lacks clear dosage information on packaging.
• The risk of drug interactions increases with OTC Sildenafil from unknown sources.
• Some OTC formulations contain undeclared Sildenafil, posing health risks.
• OTC Sildenafil use without medical supervision can lead to adverse events.
• Psychoactive effects may occur if OTC Sildenafil is combined with other drugs.
• OTC Sildenafil can cause priapism if used improperly and in high doses.

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).

• Don’t rely solely on OTC Sildenafil for erectile difficulties; consult a doctor.
• Some OTC Sildenafil products are obtained from unregulated sources online.
• Use caution with OTC Sildenafil to avoid counterfeit or contaminated products.
• Be aware of possible legal risks associated with purchasing OTC Sildenafil.
• OTC Sildenafil might not be suitable for men with cardiovascular issues.
• Using OTC Sildenafil without guidance can lead to serious health problems.
• OTC Sildenafil drugs often claim to be "safe" without scientific backing.
• Verify ingredients and sources when considering OTC Sildenafil options.
• OTC Sildenafil may cause unexpected drug interactions with other medications.
• It’s safer to seek medical advice rather than self-medicating with OTC Sildenafil.
• Some OTC Sildenafil products may be illegal in certain jurisdictions.

When sildenafil is used for ED, it is used as needed, so you are not likely to miss a dose. 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. Drinking alcohol with sildenafil can cause side effects. 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.