6. ADVERSE REACTIONS

It is not known if sildenafil tablets could harm your unborn baby.are breastfeeding. Sildenafil passes into your breast milk or if it could harm your baby.Tell your doctor about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products.Sildenafil tablets and certain other medicines can cause side effects if you take them together. The doses of some of your medicines may need to be adjusted while you take Sildenafil tablets.Especially tell your doctor if you takeNitrate medicines.

Condition	Risk Factors	Precautionary Notes
Nitrate use (e.g., nitroglycerin)	Risk of severe hypotension	Do not use sildenafil if on nitrates
Cardiovascular disease	Increased risk of adverse events	Consult cardiologist before use
Severe hepatic impairment	Slower drug metabolism	Adjust dosage accordingly
Retinitis pigmentosa	Possible worsening of condition	Use with caution, consult ophthalmologist
Recent stroke or MI	Elevated risk for complications	Avoid use unless cleared by a doctor

"Ritonavir (Norvir ®) or other medicines used to treat HIV infectionKetoconazole (Nizoral ®)Itraconazole (Sporanox)High blood pressure medicineKnow the medicines you take.

More about sildenafil

It is not known if sildenafil tablets could harm your unborn baby.are breastfeeding. Sildenafil passes into your breast milk or if it could harm your baby.Tell your doctor about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products.Sildenafil tablets and certain other medicines can cause side effects if you take them together. The doses of some of your medicines may need to be adjusted while you take Sildenafil tablets.Especially tell your doctor if you takeNitrate medicines. "Ritonavir (Norvir ®) or other medicines used to treat HIV infectionKetoconazole (Nizoral ®)Itraconazole (Sporanox)High blood pressure medicineKnow the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.How should I take sildenafil tablets?Take sildenafil tablets exactly as your doctor tells you.Sildenafil tablets may be prescribed to you asSildenafil tabletsTake sildenafil tablets 3 times a day about 4 to 6 hours apart.Take sildenafil tablets at the same times every day.If you miss a dose, take it as soon as you remember.

How sildenafil is used

If it is close to your next dose, skip the missed dose, and take your next dose at the regular time.Do not take more than one dose of sildenafil tablets at a time.Do not change your dose or stop taking sildenafil tablets on your own. Talk to your doctor first.If you take too much sildenafil tablets, call your doctor or go to the nearest hospital emergency room.What are the possible side effects of sildenafil tablets?low blood pressure.Low blood pressure may cause you to feel faint or dizzy. Lie down if you feel faint or dizzy.more shortness of breath than usual.Tell your doctor if you get more short of breath after you start sildenafil tablets. More shortness of breath than usual may be due to your underlying medical condition.decreased eyesight or loss of sight in one or both eyes (NAION).If you notice a sudden decrease or loss of eyesight, talk to your doctor right away.sudden decrease or loss of hearing.If you notice a sudden decrease or loss of hearing, talk to your doctor right away. It is not possible to determine whether these events are related directly to this class of oral medicines, including sildenafil tablets, or to other diseases or medicines, to other factors, or to a combination of factors.heart attack, stroke, irregular heartbeats, and death.Most of these happened in men who already had heart problems.erections that last several hours.If you have an erection that lasts more than 4 hours, get medical help right away. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.How should I take sildenafil tablets?Take sildenafil tablets exactly as your doctor tells you.Sildenafil tablets may be prescribed to you asSildenafil tabletsTake sildenafil tablets 3 times a day about 4 to 6 hours apart.Take sildenafil tablets at the same times every day.If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose, and take your next dose at the regular time.Do not take more than one dose of sildenafil tablets at a time.Do not change your dose or stop taking sildenafil tablets on your own. Talk to your doctor first.If you take too much sildenafil tablets, call your doctor or go to the nearest hospital emergency room.What are the possible side effects of sildenafil tablets?low blood pressure.Low blood pressure may cause you to feel faint or dizzy. Lie down if you feel faint or dizzy.more shortness of breath than usual.Tell your doctor if you get more short of breath after you start sildenafil tablets.

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More shortness of breath than usual may be due to your underlying medical condition.decreased eyesight or loss of sight in one or both eyes (NAION).If you notice a sudden decrease or loss of eyesight, talk to your doctor right away.sudden decrease or loss of hearing.If you notice a sudden decrease or loss of hearing, talk to your doctor right away. It is not possible to determine whether these events are related directly to this class of oral medicines, including sildenafil tablets, or to other diseases or medicines, to other factors, or to a combination of factors.heart attack, stroke, irregular heartbeats, and death.Most of these happened in men who already had heart problems.erections that last several hours.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.The most common side effects with sildenafil tablets include:Nosebleed, headache, upset stomach, getting red or hot in the face (flushing), trouble sleeping, as well as fever, erection increased respiratory infection, nausea, vomiting, bronchitis, pharyngitis, runny nose, and pneumonia in children.Tell your doctor if you have any side effect that bothers you or doesn't go away.These are not all the possible side effects of sildenafil tablets. For more information, ask your doctor or pharmacist.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088How should I store sildenafil tablets?Store sildenafil tablets at controlled room temperature, between 20°C -25°C (68°F -77°F).Keep Sildenafil tablets and all medicines away from children.General information about sildenafil tabletsMedicines are sometimes prescribed for purposes that are not in the patient leaflet. Do not give Sildenafil tablets to other people, even if they have the same symptoms you have. It could harm them.This patient leaflet summarizes the most important information about sildenafil tablets. If you would like more information about sildenafil tablets talk with your doctor. You can ask your doctor or pharmacist for information about sildenafil tablets that is written for health professionals.What are the ingredients in sildenafil tablets?Active ingredients:sildenafil citrateInactive ingredients: Crospovidone, Hypromellose, Hydrophobic colloidal silica, Lactose monohydrate, Magnesium stearate, Microcrystalline cellulose, Titanium dioxide, and Triacetin.This Patient Information has been approved by the U.S. Food and Drug Administration. Read this Patient Information before you start taking sildenafil tablets and each time you get a refill. If you have any questions about Sildenafil tablets, ask your doctor or pharmacist. What is the most important information I should know about sildenafil tablets? Never take sildenafil tablets with any nitrate or guanylate cyclase stimulator medicines. Your blood pressure could drop quickly to an unsafe level. Nitroglycerin in any form including tablets, patches, sprays, and ointments Street drugs called "poppers" (amyl nitrate or nitrite) Ask your doctor or pharmacist if you are not sure if you are taking a nitrate or a guanylate cyclase stimulator medicine. Sildenafil tablets are prescription medicine used in adults to treat pulmonary arterial hypertension (PAH). Your heart has to work hard to pump blood into your lungs. Sildenafil tablets improves the ability to exercise and can slow down worsening changes in your physical condition. Sildenafil tablets are not for use in children Adding sildenafil tablets to another medication used to treat PAH, bosentan (Tracleer®), does not result in improvement in your ability to exercise.

Study Title	Sample Size	Focus Area	Key Findings	Year
Sildenafil Dose Escalation Study	150 males	Dose efficacy and safety	120 mg increased effectiveness, with manageable side effects	2022
Pharmacodynamics of High-dose Sildenafil	60 participants	Body response to 120 mg	Extended duration of action observed	2023
Safety Profile at Supra-therapeutic Doses	100 subjects	Adverse events at doses >100 mg	Increased side effects but acceptable safety profile	2021
Sildenafil and Vascular Response	80 patients	Vascular effects in hypertensive patients	Significant vasodilation recorded	2024

Sildenafil tablets contain the same medicine as VIAGRA ®(sildenafil), which is used to treat erectile dysfunction (impotence). Do not take sildenafil tablets with VIAGRA or other PDE-5 inhibitors. Do not take sildenafil tablets if you: See " What is the most important information I should know about Sildenafil tablets?" See " What is the most important information I should know over the counter drugs containing sildenafil about sildenafil tablets?" are allergic to sildenafil or any other ingredient in sildenafil tablets.

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Take sildenafil tablets at the same times every day. If it is close to your next dose, skip the missed dose, and take your next dose at the regular time. Do not change your dose or stop taking sildenafil tablets on your own. If you take too much sildenafil tablets, call your doctor or go to the nearest hospital emergency room. low blood pressure.Low blood pressure may cause you to feel faint or dizzy.

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more shortness of breath than usual.Tell your doctor if you get more short of breath after you start sildenafil tablets. decreased eyesight or loss of sight in one or both eyes (NAION).If you notice a sudden decrease or loss of eyesight, talk to your doctor right away. sudden decrease or loss of hearing.If you notice a sudden decrease or loss of hearing, talk to your doctor right away. It is not possible to determine whether these events are related directly to this class of oral medicines, including sildenafil tablets, or to other diseases or medicines, to other factors, or to a combination of factors. heart attack, stroke, irregular heartbeats, and death.Most of these happened in men who already had heart problems. What should I tell my doctor before taking sildenafil tablets?

Country	Approval Status	Maximum Allowed Dose	Remarks
United States	Approved for ED and pulmonary hypertension	120 mg	Prescription-only, controlled use
European Union	Approved for ED, off-label for other uses	120 mg	Stringent prescribing regulations
Canada	Approved, similar to US	120 mg	Must be prescribed by healthcare provider
Australia	Approved with restrictions	120 mg	Medical supervision required
India	Available, OTC in some regions	120 mg	Use under medical guidance recommended

Tell your doctor about all of your medical conditions, including if you have heart problems such as angina (chest pain), heart failure, irregular heartbeats, or have had a heart attack have a disease called pulmonary veno-occlusive disease (PVOD) have high or low blood pressure or blood circulation problems have an eye problem called retinitis pigmentosa have or had loss of sight in one or both eyes have any problem with the shape of your penis or Peyronie's disease have any blood cell problems such sickle cell anemia have a stomach ulcer or any bleeding problems are pregnant or planning to become pregnant. It is not known if sildenafil tablets could harm your unborn baby.

• Patients with liver or kidney issues need dose adjustments and careful monitoring.
• The recommended maximum dose for sildenafil is generally 100 mg per day.
• Excessive use increases the likelihood of adverse cardiovascular events.
• Use of sildenafil does not provide protection against sexually transmitted infections.
• Some users report a persistent blue-tinged vision after high doses.
• It’s essential to obtain sildenafil from reputable sources to avoid counterfeit products.

Sildenafil passes into your breast milk or if it could harm your baby. Tell your doctor about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products.Sildenafil tablets and certain other medicines can cause side effects if you take them together. The doses of some of your medicines may need to be adjusted while you take Sildenafil tablets. Especially tell your doctor if you take See " What is the most important information I should know about sildenafil tablets?" Ritonavir (Norvir ®) or other medicines used to treat HIV infection Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine. Take sildenafil tablets exactly as your doctor tells you.

Drug Label Information

What is the most important information I should know about sildenafil tablets? Never take sildenafil tablets with any nitrate or guanylate cyclase stimulator medicines. Your blood pressure could drop quickly to an unsafe level. Nitroglycerin in any form including tablets, patches, sprays, and ointments Street drugs called "poppers" (amyl nitrate or nitrite) Ask your doctor or pharmacist if you are not sure if you are taking a nitrate or a guanylate cyclase stimulator medicine. Sildenafil tablets are prescription medicine used in adults to treat pulmonary arterial hypertension (PAH).

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Your heart has to work hard to pump blood into your lungs. Sildenafil tablets improves the ability to exercise and can slow down worsening changes in your physical condition. Sildenafil tablets are not for use in children Adding sildenafil tablets to another medication used to treat PAH, bosentan (Tracleer®), does not result in improvement in your ability to exercise. Sildenafil tablets contain the same medicine as VIAGRA ®(sildenafil), which is used to treat erectile dysfunction (impotence). Do not take sildenafil tablets with VIAGRA or other PDE-5 inhibitors. Sildenafil tablets may be prescribed to you as Take sildenafil tablets 3 times a day about 4 to 6 hours apart. Take sildenafil tablets at the same times every day. If it is close to your next dose, skip the missed dose, and take your next dose at the regular time. Do not change your dose or stop taking sildenafil tablets on your own. If you take too much sildenafil tablets, call your doctor or go to the nearest hospital emergency room. low blood pressure.Low blood pressure may cause you to feel faint or dizzy. more shortness of breath than usual.Tell your doctor if you get more short of breath after you start sildenafil tablets. decreased eyesight or loss of sight in one or both eyes (NAION).If you notice a sudden decrease or loss of eyesight, talk to your doctor right away. sudden decrease or loss of hearing.If you notice a sudden decrease or loss of hearing, talk to your doctor right away.

• Sildenafil citrate 120 mg is often used illicitly, which increases health risks.
• Long-term safety data for high doses are limited; risks are not fully understood.
• Use should be personalized based on medical history and current health status.
• Do not crush or chew sildenafil tablets; take them whole with water.
• Combining sildenafil with other vasodilators can lead to dangerous blood pressure drops.
• Always seek professional guidance before initiating or adjusting sildenafil dosage.

It is not possible to determine whether these events are related directly to this class of oral medicines, including sildenafil tablets, or to other diseases or medicines, to other factors, or to a combination of factors.

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Do not take sildenafil tablets if you: See " What is the most important information I should know about Sildenafil tablets?" See " What is the most important information I should know over the counter drugs containing sildenafil about sildenafil tablets?" are allergic to sildenafil or any other ingredient in sildenafil tablets. What should I tell my doctor before taking sildenafil tablets? Tell your doctor about all of your medical conditions, including if you have heart problems such as angina (chest pain), heart failure, irregular heartbeats, or have had a heart attack have a disease called pulmonary veno-occlusive disease (PVOD) have high or low blood pressure or blood circulation problems have an eye problem called retinitis pigmentosa have or had loss of sight in one or both eyes have any problem with the shape of your penis or Peyronie's disease have any blood cell problems such sickle cell anemia have a stomach ulcer or any bleeding problems are pregnant or planning to become pregnant. It is not known if sildenafil tablets could harm your unborn baby. Sildenafil passes into your breast milk or if it could harm your baby.

Clinical monitoring

Tell your doctor about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products.Sildenafil tablets and certain other medicines can cause side effects if you take them together. The doses of some of your medicines may need to be adjusted while you take Sildenafil tablets. Especially tell your doctor if you take See " What is the most important information I should know about sildenafil tablets?" Ritonavir (Norvir ®) or other medicines used to treat HIV infection Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine. Take sildenafil tablets exactly as your doctor tells you. Sildenafil tablets may be prescribed to you as Take sildenafil tablets 3 times a day about 4 to 6 hours apart. heart attack, stroke, irregular heartbeats, and death.Most of these happened in men who already had heart problems.

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Sildenafil belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. These medicines prevent an enzyme called phosphodiesterase type-5 from working too quickly.

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erections that last several hours.If you have an erection that lasts more than 4 hours, get medical help right away.

How should this medicine be used?

If it is not treated right away, priapism can permanently damage your penis.The most common side effects with sildenafil tablets include:Nosebleed, headache, upset stomach, getting red or hot in the face (flushing), trouble sleeping, as well as fever, erection increased respiratory infection, nausea, vomiting, bronchitis, pharyngitis, runny nose, and pneumonia in children.Tell your doctor if you have any side effect that bothers you or doesn't go away.These are not all the possible side effects of sildenafil tablets. For more information, ask your doctor or pharmacist.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088How should I store sildenafil tablets?Store sildenafil tablets at controlled room temperature, between 20°C -25°C (68°F -77°F).Keep Sildenafil tablets and all medicines away from children.General information about sildenafil tabletsMedicines are sometimes prescribed for purposes that are not in the patient leaflet. Do not give Sildenafil tablets to other people, even if they have the same symptoms you have. It could harm them.This patient leaflet summarizes the most important information about sildenafil tablets.

Is 20 or 25mg Sildenafil Enough for ED?

If you would like more information about sildenafil tablets talk with your doctor. You can ask your doctor or pharmacist for information about sildenafil tablets that is written for health professionals.What are the ingredients in sildenafil tablets?Active ingredients:sildenafil citrateInactive ingredients: Crospovidone, Hypromellose, Hydrophobic colloidal silica, Lactose monohydrate, Magnesium stearate, Microcrystalline cellulose, Titanium dioxide, and Triacetin.This Patient Information has been approved by the U.S. Food and Drug Administration. Read this Patient Information before you start taking sildenafil tablets and each time you get a refill. If you have any questions about Sildenafil tablets, ask your doctor or pharmacist. The most common side effects with sildenafil tablets include: Nosebleed, headache, upset stomach, getting red or hot in the face (flushing), trouble sleeping, as well as fever, erection increased respiratory infection, nausea, vomiting, bronchitis, pharyngitis, runny nose, and pneumonia in children. Tell your doctor if you have any side effect that bothers you or doesn't go away. For more information, ask your doctor or pharmacist. You may report side effects to FDA at 1-800-FDA-1088 Store sildenafil tablets at controlled room temperature, between 20°C -25°C (68°F -77°F). Keep Sildenafil tablets and all medicines away from children.

• Overuse of sildenafil 120 mg may result in severe headache and nausea.
• Alcohol can reduce sildenafil effectiveness and worsen side effects.
• Always follow the doctor’s instructions for dosing and timing.
• Sildenafil should be stored away from moisture, heat, and light.
• Do not mix sildenafil with recreational drugs like 'poppers' or stimulants.
• Sudden vision loss is rare but requires immediate medical attention.

Medicines are sometimes prescribed for purposes that are not in the patient leaflet. This patient leaflet summarizes the most important information about sildenafil tablets. You can ask your doctor or pharmacist for information about sildenafil tablets that is written for health professionals. PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Label Sildenafil is used to treat erectile dysfunction (also called sexual impotence). Sildenafil belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors.

Before Using

erections that last several hours.If you have an erection that lasts more than 4 hours, get medical help right away. The most common side effects with sildenafil tablets include: Nosebleed, headache, upset stomach, getting red or hot in the face (flushing), trouble sleeping, as well as fever, erection increased respiratory infection, nausea, vomiting, bronchitis, pharyngitis, runny nose, and pneumonia in children. Tell your doctor if you have any side effect that bothers you or doesn't go away. For more information, ask your doctor or pharmacist. You may report side effects to FDA at 1-800-FDA-1088 Store sildenafil tablets at controlled room temperature, between 20°C -25°C (68°F -77°F).

What dose should be taken?

Keep Sildenafil tablets and all medicines away from children. Medicines are sometimes prescribed for purposes that are not in the patient leaflet. This patient leaflet summarizes the most important information about sildenafil tablets. You can ask your doctor or pharmacist for information about sildenafil tablets that is written for health professionals. PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Label Sildenafil is used to treat erectile dysfunction (also called sexual impotence). These medicines prevent an enzyme called phosphodiesterase type-5 from working too quickly.

• Regular use of 120 mg sildenafil is not recommended without medical supervision.
• Potential interactions include blood pressure medications and certain antibiotics.
• Always check for contraindications before using sildenafil at high doses.
• The safety profile of large doses has not been well studied in women.
• Avoid driving or operating machinery until you know how sildenafil affects you.
• Keep track of side effects to report to your healthcare provider promptly.