Efficacy and safety of dapoxetine/sildenafil combination tablets in the treatment of men with premature ejaculation and concomitant erectile dysfunction-DAP-SPEED Study

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. 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)].

2.3 Dosage Adjustments in Specific Situations

Warnings for people with certain health conditions

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.

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Cialis Black	80mg	90 + 6 Pills	207.88€ 197.98€	Buy
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If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [ see Warnings and Precautions (5.2)].

Formulation	Strengths	Advantages	Notes
Tablets	50 mg, 100 mg sildenafil	Easy to dose, portable	Available by prescription
Dapoxetine Tablets	30 mg, 60 mg	Fast absorption, on-demand use	Prescription required
Combination Tablets	Fixed doses (e.g., 100/60 mg)	Simplifies treatment regimens	Under medical supervision

Physicians should inform patients not to take sildenafil tablets with other PDE5 inhibitors including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil. The safety and efficacy of sildenafil tablets with other PDE5 inhibitors, including REVATIO, have not been studied [ see Warnings and Precautions (5.7)].

Drug Label Information

Product Sodium Picosulfate Oral Solution BP 5 mg/5ml

Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered [ see Warnings and Precautions (5.9)]. PATIENT PACKAGE INSERT SILDENAFIL (sil-DEN-a-fil) TABLETSWhat 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).

Age and Dose Restrictions

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 dapoxetin sildenafil are not sure. 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.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. 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 nottake 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).

Product Sodium Picosulfate Tablets 10 mg

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.sudden vision loss in one or both eyes. 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). It is uncertain whether PDE5 inhibitors directly cause the vision loss. 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. 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 chronic-thromboembolic pulmonary hypertension.Tell all your healthcare providers that you takesildenafil 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. 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 are sildenafil tablets?Sildenafil tablets are 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 are not for use in women or children.It is not known if sildenafil tablets are safe and effective in women or children under 18 years of age.Who should not take sildenafil tablets?Do not take sildenafil tablets 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 pulmonary hypertensionhave 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 *, 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 tablets?

7.5 Alcohol

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 chronic-thromboembolic pulmonary hypertension.Tell all your healthcare providers that you takesildenafil 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. 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 are sildenafil tablets?Sildenafil tablets are 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 are not for use in women or children.It is not known if sildenafil tablets are safe and effective in women or children under 18 years of age.Who should not take sildenafil tablets?Do not take sildenafil tablets 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.

Prior authorization

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 pulmonary hypertensionhave 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 *, 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 tablets? Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. 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), saquinavir (Fortovase or Invirase) or atazanavir sulfate (Reyataz)some types of oral antifungal medicines, such as ketoconazole (Nizoral), and itraconozale (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 contain 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). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. 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), saquinavir (Fortovase or Invirase) or atazanavir sulfate (Reyataz)some types of oral antifungal medicines, such as ketoconazole (Nizoral), and itraconozale (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 contain sildenafil, which is the same medicine found in another drug called REVATIO.

• Sildenafil is contraindicated in patients taking alpha-blockers.
• Dapoxetine may cause mood changes or suicidal thoughts in rare cases.
• Combining these drugs can increase the risk of side effects.
• Use these medications only as prescribed by your healthcare provider.
• Patients should seek immediate medical attention for prolonged erections.
• Alcohol might exacerbate side effects like dizziness or hypotension.
• Combining sildenafil and dapoxetine requires medical supervision.
• Both meds are part of a broader approach to sexual health management.

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 dapoxetin sildenafil are not sure.

• Sildenafil can be combined with lifestyle changes for better results.
• Dapoxetine helps subjects gain better control during sexual activity.
• Use caution in hot weather as both drugs can cause dehydration.
• Patients should avoid grapefruit or high-fat foods around intake time.
• Sildenafil has been studied extensively for safety and efficacy.
• Dapoxetine's rapid onset makes it convenient for planned activity.
• These medications are not substitutes for safe sexual practices.
• Always follow the prescribed dosage and timing instructions.

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.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. 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 nottake 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.

Further information

Rarely reported side effects include:an erection that will not go away (priapism).

6.2 Postmarketing Experience

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. 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.

Foreign Names

If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [ see Warnings and 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. The safety and efficacy of sildenafil tablets with other PDE5 inhibitors, including REVATIO, have not been studied [ see Warnings and Precautions (5.7)]. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered [ see Warnings and Precautions (5.9)]. PATIENT PACKAGE INSERT SILDENAFIL (sil-DEN-a-fil) TABLETSWhat 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). 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.sudden vision loss in one or both eyes. 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).

• Sildenafil is not recommended for use by women.
• Dapoxetine is approved specifically for men with PE.
• Both drugs help improve sexual confidence and performance.
• Proper hydration can help mitigate side effects.
• Patients with retinal disorders should consult a healthcare professional.
• Use of these medications does not protect against sexually transmitted infections.
• Combining medications without medical guidance can be dangerous.
• Inform your doctor if you experience any adverse reactions.

It is uncertain whether PDE5 inhibitors directly cause the vision loss. 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.

5.6 Adverse Reactions with the Concomitant Use of Ritonavir

Some people may also have ringing in their ears (tinnitus) or dizziness. 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.

Interactions that increase your risk for side effects

You may report side effects to Rubicon Research Limited, Ambernath at 00-91-251-6619500 or 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. Some people may also have ringing in their ears (tinnitus) or dizziness. 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.

Parameter	Value	Description
Absorption Rate	Rapid	Peak plasma levels in about 30-120 min
Peak Concentration	90 minutes	Time to maximum plasma concentration
Half-Life	Approx. 4 hours	Duration in system for elimination
Metabolism	Liver (CYP3A4 enzyme)	Primary metabolic pathway
Excretion	Feces and urine	Removal route

Most, but not all, of these men had heart problems before taking sildenafil tablets.

• Sildenafil is a phosphodiesterase type 5 (PDE5) inhibitor.
• Dapoxetine is a selective serotonin reuptake inhibitor (SSRI).
• Both medications can be part of a comprehensive ED or PE treatment plan.
• Overdose symptoms include persistent erections or severe dizziness.
• Avoid using these tablets if you have recent cardiovascular events.
• Alcohol consumption should be minimized when using these medications.
• Patients should monitor for any unusual or severe side effects.
• Regular medical check-ups are recommended during treatment.

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 Rubicon Research Limited, Ambernath at 00-91-251-6619500 or 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.