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

Food and Drug Administration.Distributed by:Advagen Pharma Ltd.,East Windsor, NJ 08520, USAManufactured by:Rubicon Research Ltd.,Thane 421506, India.Rev.01,01/2026*The other brands listed are trademarks of their respective owners and are not trademarks of Rubicon Research Limited. The makers of these brands are not affiliated with and do not endorse Rubicon Research Limited or its products. What is the most important information I should know about sildenafil tablets?

Side effects

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." A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke.

Product	Dosage	Quantity + Bonus	Price
Priligy Generic Dapoxetine	60mg	30 + 6 Pills	106.65€ 101.57€	Buy
Priligy Generic Dapoxetine	60mg	120 + 10 Pills	341.26€ 325.01€	Buy
Priligy Generic Dapoxetine	60mg	60 + 8 Pills	183.06€ 174.34€	Buy
Levitra Generic	10mg	120 + 10 Pills	178.59€ 170.09€	Buy
Priligy Generic Dapoxetine	60mg	20 + 4 Pills	77.31€ 73.63€	Buy
Levitra Original	20mg	120 + 8 Pills	528.19€ 503.04€	Buy
Priligy Generic Dapoxetine	60mg	90 + 10 Pills	265.64€ 252.99€	Buy
Priligy Generic Dapoxetine	60mg	10 Pills	47.63€ 45.36€	Buy
Cialis Original	20mg	92 + 4 Pills	377.99€ 359.99€	Buy
Cialis Professional	20mg	20 Pills	78.33€ 74.60€	Buy
Priligy Generic Dapoxetine	60mg	180 + 10 Pills	494.76€ 471.20€	Buy

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.

How to Do Sildenafil Citrate and Dapoxetine Tablets Work

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. 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.

What’s the difference between sildenafil and Viagra?

General information about the safe and effective use of sildenafil tablets. Medicines are sometimes prescribed for purposes other tadalafil with dapoxetine tablets than those listed in a Patient Information leaflet. This Patient Information leaflet summarizes the most important information about sildenafil tablets. You can ask your healthcare provider or pharmacist for information about sildenafil tablets that is written for health professionals. What are the ingredients in 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.

Can I increase the dose of dapoxetine?

Food and Drug Administration.Distributed by:Advagen Pharma Ltd.,East Windsor, NJ 08520, USAManufactured by:Rubicon Research Ltd.,Thane 421506, India.Rev.01,01/2026*The other brands listed are trademarks of their respective owners and are not trademarks of Rubicon Research Limited. The makers of these brands are not affiliated with and do not endorse Rubicon Research Limited or its products. 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." 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.

Product Sertraline Tablets BP 25 mg

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 dapoxetine tadalafil tablets if your heart is healthy enough to handle the extra strain of having sex.

Depression and anxiety

Sildenafil tablets does not protect you or your partner from getting sexually transmitted diseases, including HIV—the virus that causes AIDS. Sildenafil tablets are prescription medicine used to treat erectile dysfunction (ED). 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. Ask your doctor dapoxetine tadalafil tablets 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. Sildenafil tablets are prescription medicine used to treat erectile dysfunction (ED). 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.

What is the satisfaction rate with dapoxetine?

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 working Do 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?

Product Sodium Picosulfate Tablets 10 mg

Sildenafil tablets can cause tab dapoxetine 30 mg serious side effects. 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.

Allergy warning

If you have these symptoms, stop taking sildenafil tablets and contact a doctor right away. The most common side effects of sildenafil tablets are: abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision In addition, heart attack, stroke, irregular heartbeats and death have happened rarely in men 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. It is not known if sildenafil tablets are safe and effective in women or children under 18 years of age.

Sildenafil Citrate + Dapoxetine HCl DC Grade

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 nitrate take 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 failure have had heart surgery within the last 6 months have low blood pressure, or high blood pressure that is not controlled have had an erection that lasted for more than 4 hours have problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemia have retinitis pigmentosa, a rare genetic (runs in families) eye disease have ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION) have kidney problems or are having kidney dialysis Tell 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.

Therapeutic Categories

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?") medicines called guanylate cyclase stimulators, such as riociguat (Adempas) medicines called alpha blockers such as Hytrin (terazosin HCl), Flomax (tamsulosin HCl), Cardura (doxazosin mesylate), Minipress (prazosin HCl), Uroxatral (alfuzosin HCl), Jalyn (dutasteride and tamsulosin HCl), or Rapaflo (silodosin). 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 erythromycin other medicines that treat high blood pressure Sildenafil tablets contain sildenafil, which is the same medicine found in another drug called REVATIO. 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.

Premature ejaculation

Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine. 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. 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 nitrate take 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.

Condition	Recommended Dosage	Onset Time	Duration of Effect	Additional Notes
Erectile Dysfunction	100 mg sildenafil	30-60 min	4-6 hours	Take 30 min before activity
Premature Ejaculation	60 mg dapoxetine	1-3 hours	1-2 hours	May be taken daily or on demand
Combined Use for Both Conditions	As prescribed	Varies	Varies	Under medical supervision

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 failure have had heart surgery within the last 6 months have low blood pressure, or high blood pressure that is not controlled have had an erection that lasted for more than 4 hours have problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemia have retinitis pigmentosa, a rare genetic (runs in families) eye disease have ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION) have kidney problems or are having kidney dialysis Tell your healthcare provider about all the medicines you take *, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Point	Explanation	Additional Tips
Take as directed	Follow prescribed dose and timing	Do not exceed recommended dose
Avoid alcohol	Can impair effectiveness and increase side effects	Limit or abstain before use
Report adverse effects	Seek medical attention if serious reactions occur	Especially priapism or severe dizziness
Ensure medical consultation	Before starting, especially if on other meds	For personalized advice

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?") medicines called guanylate cyclase stimulators, such as riociguat (Adempas) medicines called alpha blockers such as Hytrin (terazosin HCl), Flomax (tamsulosin HCl), Cardura (doxazosin mesylate), Minipress (prazosin HCl), Uroxatral (alfuzosin HCl), Jalyn (dutasteride and tamsulosin HCl), or Rapaflo (silodosin). 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 erythromycin other medicines that treat high blood pressure Sildenafil tablets contain sildenafil, which is the same medicine found in another drug called REVATIO. Sildenafil tablets should not be used with REVATIO or with other PAH treatments containing sildenafil or any other PDE5 inhibitors (such as Adcirca [tadalafil]).

• 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.

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine. 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.

• Sildenafil's effects last approximately 4-6 hours.
• Dapoxetine's onset is rapid, within 1-3 hours of intake.
• Side effects of sildenafil may include nasal congestion and visual changes.
• Dapoxetine may cause dry mouth and sweating as side effects.
• Combining these drugs might increase the risk of side effects.
• Usage should be based on a healthcare provider’s assessment.
• Patients with kidney or liver issues need dosage adjustments.
• Proper storage of medications is essential to maintain efficacy.

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 working Do 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.

Limitations of the study

This Patient Information has been approved by the U.S. Food and Drug Administration. *The other brands listed are trademarks of their respective owners and are not trademarks of Rubicon Research Limited. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL Sildenafil Tablets 25 mg - NDC 72888-015-30 - 30 Tablets LabelSildenafil Tablets 25 mg - NDC 72888-015-05 - 500 Tablets LabelSildenafil Tablets 50 mg - NDC 72888-016-30 - 30 Tablets LabelSildenafil Tablets 50 mg - NDC 72888-016-01 - 100 Tablets LabelSildenafil Tablets 50 mg - NDC 72888-016-00 - 1000 Tablets LabelSildenafil Tablets 100 mg - NDC 72888-017-30 - 30 Tablets LabelSildenafil Tablets 100 mg - NDC 72888-017-01 - 100 Tablets LabelSildenafil Tablets 100 mg - NDC 72888-017-00 - 1000 Tablets Label Sildenafil Tablets 25 mg - NDC 72888-015-30 - 30 Tablets Label Sildenafil Tablets 25 mg - NDC 72888-015-05 - 500 Tablets Label Sildenafil Tablets 50 mg - NDC 72888-016-30 - 30 Tablets Label Sildenafil Tablets 50 mg - NDC 72888-016-01 - 100 Tablets Label Sildenafil Tablets 50 mg - NDC 72888-016-00 - 1000 Tablets Label Sildenafil Tablets 100 mg - NDC 72888-017-30 - 30 Tablets Label Sildenafil Tablets 100 mg - NDC 72888-017-01 - 100 Tablets Label Sildenafil Tablets 100 mg - NDC 72888-017-00 - 1000 Tablets Label INGREDIENTS AND APPEARANCE Inactive IngredientsCROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)SILICON DIOXIDE (UNII: ETJ7Z6XBU4)HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)MAGNESIUM STEARATE (UNII: 70097M6I30)CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)TITANIUM DIOXIDE (UNII: 15FIX9V2JP)TRIACETIN (UNII: XHX3C3X673)FD&C BLUE NO. 2 (UNII: L06K8R7DQK)Product CharacteristicsColorblueScoreno scoreShapeOVAL (biconvex)Size17mmFlavorImprint CodeR;100ContainsPackagingNDC:72888-017-3030 in 1 BOTTLE; Type 0: Not a Combination Product06/17/2021NDC:72888-017-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/17/2021NDC:72888-017-001000 in 1 BOTTLE; Type 0: Not a Combination Product11/08/2021Marketing InformationANDAANDA20488206/17/2021Labeler - Advagen Pharma Ltd (051627256)Registrant - Rubicon Research Limited (918629544)EstablishmentRubicon Research Limited677604197manufacture(72888-015, 72888-016, 72888-017) , analysis(72888-015, 72888-016, 72888-017) , pack(72888-015, 72888-016, 72888-017) What are the possible side effects of sildenafil tablets? Sildenafil tablets can cause tab dapoxetine 30 mg serious side effects. 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. If you have these symptoms, stop taking sildenafil tablets and contact a doctor right away. The most common side effects of sildenafil tablets are: abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision In 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

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. 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 tadalafil with dapoxetine tablets than those listed in a Patient Information leaflet. This Patient Information leaflet summarizes the most important information about sildenafil tablets. You can ask your healthcare provider or pharmacist for information about sildenafil tablets that is written for health professionals. What are the ingredients in sildenafil tablets? This Patient Information has been approved by the U.S.

• 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.

Food and Drug Administration. *The other brands listed are trademarks of their respective owners and are not trademarks of Rubicon Research Limited. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL Sildenafil Tablets 25 mg - NDC 72888-015-30 - 30 Tablets LabelSildenafil Tablets 25 mg - NDC 72888-015-05 - 500 Tablets LabelSildenafil Tablets 50 mg - NDC 72888-016-30 - 30 Tablets LabelSildenafil Tablets 50 mg - NDC 72888-016-01 - 100 Tablets LabelSildenafil Tablets 50 mg - NDC 72888-016-00 - 1000 Tablets LabelSildenafil Tablets 100 mg - NDC 72888-017-30 - 30 Tablets LabelSildenafil Tablets 100 mg - NDC 72888-017-01 - 100 Tablets LabelSildenafil Tablets 100 mg - NDC 72888-017-00 - 1000 Tablets Label Sildenafil Tablets 25 mg - NDC 72888-015-30 - 30 Tablets Label Sildenafil Tablets 25 mg - NDC 72888-015-05 - 500 Tablets Label Sildenafil Tablets 50 mg - NDC 72888-016-30 - 30 Tablets Label Sildenafil Tablets 50 mg - NDC 72888-016-01 - 100 Tablets Label Sildenafil Tablets 50 mg - NDC 72888-016-00 - 1000 Tablets Label Sildenafil Tablets 100 mg - NDC 72888-017-30 - 30 Tablets Label Sildenafil Tablets 100 mg - NDC 72888-017-01 - 100 Tablets Label Sildenafil Tablets 100 mg - NDC 72888-017-00 - 1000 Tablets Label INGREDIENTS AND APPEARANCE Inactive IngredientsCROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)SILICON DIOXIDE (UNII: ETJ7Z6XBU4)HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)MAGNESIUM STEARATE (UNII: 70097M6I30)CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)TITANIUM DIOXIDE (UNII: 15FIX9V2JP)TRIACETIN (UNII: XHX3C3X673)FD&C BLUE NO. 2 (UNII: L06K8R7DQK)Product CharacteristicsColorblueScoreno scoreShapeOVAL (biconvex)Size17mmFlavorImprint CodeR;100ContainsPackagingNDC:72888-017-3030 in 1 BOTTLE; Type 0: Not a Combination Product06/17/2021NDC:72888-017-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/17/2021NDC:72888-017-001000 in 1 BOTTLE; Type 0: Not a Combination Product11/08/2021Marketing InformationANDAANDA20488206/17/2021Labeler - Advagen Pharma Ltd (051627256)Registrant - Rubicon Research Limited (918629544)EstablishmentRubicon Research Limited677604197manufacture(72888-015, 72888-016, 72888-017) , analysis(72888-015, 72888-016, 72888-017) , pack(72888-015, 72888-016, 72888-017)