4 CONTRAINDICATIONS

Sildenafil > sildenafil film tablet


Concomitant Use with Drugs Which Lower Blood Pressure Physicians should advise patients of the potential for SILDENAFIL TABLETS to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications. Therefore, when SILDENAFIL TABLETS is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating SILDENAFIL TABLETS treatment and SILDENAFIL TABLETS should be initiated at the lowest dose [see Warnings and Precautions (5.5)].

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Physicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. Patients who experience symptoms (e.g., angina pectoris, dizziness, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician [see Warnings and Precautions (5.1)].

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Physicians should advise patients to stop use of all PDE5 inhibitors, including SILDENAFIL TABLETS, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a "crowded" optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitor, including SILDENAFIL TABLETS, for this uncommon condition [see Warnings and Precautions (5.3) and Adverse Reactions (6.2)].

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It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Warnings and Precautions (5.4) and Adverse Reactions (6.2)]. Physicians should warn patients that prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of SILDENAFIL TABLETS.

  • Sildenafil film tablets are often used for pulmonary arterial hypertension off-label.
  • They work by relaxing blood vessels to improve blood flow.
  • Medical guidance is essential for off-label or long-term use.

If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [see Warnings and sildenafil 20 mg prescription Precautions (5.2)].

Data availability statement

Physicians should inform patients not to take SILDENAFIL TABLETS with other PDE5 inhibitors including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil.

  • These tablets provide a discreet alternative to traditional pills.
  • They are designed to dissolve quickly in the mouth or be swallowed.
  • Suitable for people who have difficulty swallowing capsules.

The safety and efficacy of SILDENAFIL TABLETS with other PDE5 inhibitors, including REVATIO, have not been studied [see Warnings and Precautions (5.7)]. Patient Information Sildenafil Tablet (sil-DEN-a-fil tab-lets) What is the most important information I should know about SILDENAFIL TABLETS?SILDENAFIL TABLETS can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. Do not take SILDENAFIL TABLETS if you take any other medicines called "nitrates." Nitrates are used to treat chest pain (angina).

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Ask your doctor if your heart is healthy enough to handle the extra strain of having sex.SILDENAFIL TABLETS does not protect you or your partner from getting sexually transmitted diseases, including HIV—the virus that causes AIDS.What is SILDENAFIL TABLETS?SILDENAFIL TABLETS is a prescription medicine used to treat erectile dysfunction (ED). You will not get an erection just by taking this medicine. SILDENAFIL TABLETS helps a man with erectile dysfunction get and keep an erection only when he is sexually excited (stimulated).SILDENAFIL TABLETS is not for use in women or children.It is not known if SILDENAFIL TABLETS is safe and effective in women or children under 18 years of age.Who should not take SILDENAFIL TABLETS?Do not take Sildenafil Tablet if you:take medicines called "nitrates" (such as nitroglycerin)use street drugs called "poppers" such as amyl nitrate or amyl nitrite, and butyl nitratetake any medicines called guanylate cyclase stimulators such as riociguat (Adempas)are allergic to sildenafil, as contained in SILDENAFIL TABLETS and REVATIO, or any of the ingredients in SILDENAFIL TABLETS. See the end of this leaflet for a complete list of ingredients in SILDENAFIL TABLETS.What should I tell my healthcare provider before taking SILDENAFIL TABLETS?Before you take SILDENAFIL TABLETS, tell your healthcare provider 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 failurehave had heart surgery within the last 6 monthshave had a strokehave low blood pressure, or high blood pressure that is not controlledhave a deformed penis shapehave had an erection that lasted for more than 4 hourshave problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemiahave retinitis pigmentosa, a rare genetic (runs in families) eye diseasehave ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION)have bleeding problemshave or have had stomach ulcershave liver problemshave kidney problems or are having kidney dialysishave any other medical conditionsTell your healthcare provider about all the medicines you take 1, including prescription and over-the-counter medicines, vitamins, and herbal supplements.SILDENAFIL TABLETS may affect the way other medicines work, and other medicines may affect the way SILDENAFIL TABLETS works causing side effects. Especially tell your healthcare provider if you take any of the following:medicines called nitrates (see " What is the most important information I should know about Sildenafil Tablet?" Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure.

What should I know about sildenafil before taking it?

In some patients, the use of SILDENAFIL TABLETS with alpha-blockers can lead to a drop in blood pressure or to fainting.medicines called HIV protease inhibitors, such as ritonavir (Norvir), indinavir sulfate (Crixivan), sildenafil citrate tablets 50 mg saquinavir (Fortovase or Invirase) or atazanavir sulfate (Reyataz)some types of oral antifungal medicines, such as ketoconazole (Nizoral), and itraconazole (Sporanox)some types of antibiotics, such as clarithromycin (Biaxin), telithromycin (Ketek), or erythromycinother medicines that treat high blood pressureother medicines or treatments for EDSILDENAFIL TABLETS contains sildenafil, which is the same medicine found in another drug called REVATIO. REVATIO is used to treat a rare disease called pulmonary arterial hypertension (PAH). SILDENAFIL TABLETS should not be used with REVATIO or with other PAH treatments containing sildenafil or any other PDE5 inhibitors (such as Adcirca [tadalafil]).Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.How should I take SILDENAFIL TABLETS?• Take SILDENAFIL TABLETS exactly as your healthcare provider tells you to take it.Your healthcare provider will tell you how much SILDENAFIL TABLETS to take and when to take it.Your healthcare provider may change your dose if needed.Your healthcare provider may change your dose if needed.Take SILDENAFIL TABLETS about 1 hour before sexual activity. You may take SILDENAFIL TABLETS between 30 minutes to 4 hours before sexual activity if needed.SILDENAFIL TABLETS can be taken with or without food.

2.1 Recommended Dosage

If you take SILDENAFIL TABLETS after a high fat meal (such as a cheeseburger and french fries), SILDENAFIL TABLETS may take a little longer to start workingDo not take SILDENAFIL TABLETS more than 1 time a day.If you accidentally take too much SILDENAFIL TABLETS, call your doctor or go to the nearest hospital emergency room right away.What are the possible side effects of SILDENAFIL TABLETS?SILDENAFIL TABLETS can cause serious side effects. Rarely reported side effects include:an erection that will not go away (priapism). If it is not treated right away, priapism can permanently damage your penis.sudden vision loss in one or both eyes. Stop taking SILDENAFIL TABLETS and call your healthcare provider right away if you have sudden vision loss in one or both eyes.sudden hearing decrease or hearing loss. If you have these symptoms, stop taking SILDENAFIL TABLETS and contact a doctor right away.The most common side effects of SILDENAFIL TABLETS are:headacheflushingupset stomachabnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred visionstuffy or runny noseback painmuscle painnauseadizzinessrashIn addition, heart attack, stroke, irregular heartbeats and death have happened rarely in men taking SILDENAFIL TABLETS. A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke.Do not take SILDENAFIL TABLETS if you take medicines called guanylate cyclase stimulators which include:• Riociguat (Adempas®) a medicine that treats pulmonary arterial hypertension and chronicthromboembolic pulmonary hypertension.Tell all your healthcare providers that you take SILDENAFIL TABLETS. 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 TABLETS.Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, 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.

Side Effect Frequency Severity
Headache Very common Mild
Flushing Common Mild
Dyspepsia Common Mild
Nasal Congestion Common Mild
Dizziness Less common Mild

Ask your doctor if your heart is healthy enough to handle the extra strain of having sex.SILDENAFIL TABLETS does not protect you or your partner from getting sexually transmitted diseases, including HIV—the virus that causes AIDS.What is SILDENAFIL TABLETS?SILDENAFIL TABLETS is a prescription medicine used to treat erectile dysfunction (ED). You will not get an erection just by taking this medicine.

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SILDENAFIL TABLETS helps a man with erectile dysfunction get and keep an erection only when he is sexually excited (stimulated).SILDENAFIL TABLETS is not for use in women or children.It is not known if SILDENAFIL TABLETS is safe and effective in women or children under 18 years of age.Who should not take SILDENAFIL TABLETS?Do not take Sildenafil Tablet if you:take medicines called "nitrates" (such as nitroglycerin)use street drugs called "poppers" such as amyl nitrate or amyl nitrite, and butyl nitratetake any medicines called guanylate cyclase stimulators such as riociguat (Adempas)are allergic to sildenafil, as contained in SILDENAFIL TABLETS and REVATIO, or any of the ingredients in SILDENAFIL TABLETS.

  • Common side effects include headache, flushing, and nasal congestion.
  • Serious side effects are rare but may include vision changes or priapism.
  • Always consult with a healthcare provider before use.

See the end of this leaflet for a complete list of ingredients in SILDENAFIL TABLETS.What should I tell my healthcare provider before taking SILDENAFIL TABLETS?Before you take SILDENAFIL TABLETS, tell your healthcare provider 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 failurehave had heart surgery within the last 6 monthshave had a strokehave low blood pressure, or high blood pressure that is not controlledhave a deformed penis shapehave had an erection that lasted for more than 4 hourshave problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemiahave retinitis pigmentosa, a rare genetic (runs in families) eye diseasehave ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION)have bleeding problemshave or have had stomach ulcershave liver problemshave kidney problems or are having kidney dialysishave any other medical conditionsTell your healthcare provider about all the medicines you take 1, including prescription and over-the-counter medicines, vitamins, and herbal supplements.SILDENAFIL TABLETS may affect the way other medicines work, and other medicines may affect the way SILDENAFIL TABLETS works causing side effects.

Step Description
Granulation Mixing active and excipients, forming granules
Compression Compressing into tablets
Coating Applying film coating
Quality Control Testing for potency, disintegration, purity

Especially tell your healthcare provider if you take any of the following:medicines called nitrates (see " What is the most important information I should know about Sildenafil Tablet?" Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure.

  • Sildenafil film tablets are available by prescription only.
  • They may interact with nitrates, causing dangerous blood pressure drops.
  • Alcohol can impair the effectiveness of these tablets.

In some patients, the use of SILDENAFIL TABLETS with alpha-blockers can lead to a drop in blood pressure or to fainting.medicines called HIV protease inhibitors, such as ritonavir (Norvir), indinavir sulfate (Crixivan), sildenafil citrate tablets 50 mg saquinavir (Fortovase or Invirase) or atazanavir sulfate (Reyataz)some types of oral antifungal medicines, such as ketoconazole (Nizoral), and itraconazole (Sporanox)some types of antibiotics, such as clarithromycin (Biaxin), telithromycin (Ketek), or erythromycinother medicines that treat high blood pressureother medicines or treatments for EDSILDENAFIL TABLETS contains sildenafil, which is the same medicine found in another drug called REVATIO. REVATIO is used to treat a rare disease called pulmonary arterial hypertension (PAH). SILDENAFIL TABLETS should not be used with REVATIO or with other PAH treatments containing sildenafil or any other PDE5 inhibitors (such as Adcirca [tadalafil]).Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.How should I take SILDENAFIL TABLETS?• Take SILDENAFIL TABLETS exactly as your healthcare provider tells you to take it.Your healthcare provider will tell you how much SILDENAFIL TABLETS to take and when to take it.Your healthcare provider may change your dose if needed.Your healthcare provider may change your dose if needed.Take SILDENAFIL TABLETS about 1 hour before sexual activity.

Non-medical use

Most, but not all, of these men had heart problems before taking SILDENAFIL TABLETS. It is not known if SILDENAFIL TABLETS caused these problems.Tell your healthcare provider if you have any side effect that bothers you or does not go away.These are not all the possible side effects of SILDENAFIL TABLETS. For more information, ask your healthcare provider or pharmacist.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.How should I store SILDENAFIL TABLETS?Store SILDENAFIL TABLETS at room temperature between 68°F to 77°F (20°C to 25°C).Keep SILDENAFIL TABLETS and all medicines out of the reach of children.General information about the safe and effective use of SILDENAFIL TABLETS.Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

Warnings and Precautions

Related treatment guides

You may take SILDENAFIL TABLETS between 30 minutes to 4 hours before sexual activity if needed.SILDENAFIL TABLETS can be taken with or without food. If you take SILDENAFIL TABLETS after a high fat meal (such as a cheeseburger and french fries), SILDENAFIL TABLETS may take a little longer to start workingDo not take SILDENAFIL TABLETS more than 1 time a day.If you accidentally take too much SILDENAFIL TABLETS, call your doctor or go to the nearest hospital emergency room right away.What are the possible side effects of SILDENAFIL TABLETS?SILDENAFIL TABLETS can cause serious side effects. Rarely reported side effects include:an erection that will not go away (priapism).

5.8 Effects on Bleeding

Concomitant Use with Drugs Which Lower Blood Pressure Physicians should advise patients of the potential for SILDENAFIL TABLETS to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications. Therefore, when SILDENAFIL TABLETS is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating SILDENAFIL TABLETS treatment and SILDENAFIL TABLETS should be initiated at the lowest dose [see Warnings and Precautions (5.5)]. Physicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. Patients who experience symptoms (e.g., angina pectoris, dizziness, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician [see Warnings and Precautions (5.1)]. Physicians should advise patients to stop use of all PDE5 inhibitors, including SILDENAFIL TABLETS, and seek medical attention in the event of a sudden loss of vision in one or both eyes.

2.2 DosageModificationsforDrug Interactions

Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a "crowded" optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitor, including SILDENAFIL TABLETS, for this uncommon condition [see Warnings and Precautions (5.3) and Adverse Reactions (6.2)]. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Warnings and Precautions (5.4) and Adverse Reactions (6.2)]. Physicians should warn patients that prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of SILDENAFIL TABLETS. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [see Warnings and sildenafil 20 mg prescription Precautions (5.2)]. Physicians should inform patients not to take SILDENAFIL TABLETS with other PDE5 inhibitors including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil.

Interactions that increase your risk for side effects

The safety and efficacy of SILDENAFIL TABLETS with other PDE5 inhibitors, including REVATIO, have not been studied [see Warnings and Precautions (5.7)]. Patient Information Sildenafil Tablet (sil-DEN-a-fil tab-lets) What is the most important information I should know about SILDENAFIL TABLETS?SILDENAFIL TABLETS can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. Do not take SILDENAFIL TABLETS if you take any other medicines called "nitrates." Nitrates are used to treat chest pain (angina). A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke.Do not take SILDENAFIL TABLETS if you take medicines called guanylate cyclase stimulators which include:• Riociguat (Adempas®) a medicine that treats pulmonary arterial hypertension and chronicthromboembolic pulmonary hypertension.Tell all your healthcare providers that you take SILDENAFIL TABLETS. 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 TABLETS.Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, 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. If it is not treated right away, priapism can permanently damage your penis.sudden vision loss in one or both eyes. Stop taking SILDENAFIL TABLETS and call your healthcare provider right away if you have sudden vision loss in one or both eyes.sudden hearing decrease or hearing loss. If you have these symptoms, stop taking SILDENAFIL TABLETS and contact a doctor right away.The most common side effects of SILDENAFIL TABLETS are:headacheflushingupset stomachabnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred visionstuffy or runny noseback painmuscle painnauseadizzinessrashIn addition, heart attack, stroke, irregular heartbeats and death have happened rarely in men taking SILDENAFIL TABLETS. Most, but not all, of these men had heart problems before taking SILDENAFIL TABLETS. It is not known if SILDENAFIL TABLETS caused these problems.Tell your healthcare provider if you have any side effect that bothers you or does not go away.These are not all the possible side effects of SILDENAFIL TABLETS. For more information, ask your healthcare provider or pharmacist.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.How should I store SILDENAFIL TABLETS?Store SILDENAFIL TABLETS at room temperature between 68°F to 77°F (20°C to 25°C).Keep SILDENAFIL TABLETS and all medicines out of the reach of children.General information about the safe and effective use of SILDENAFIL TABLETS.Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

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