Sildenafil 100mg + Dapoxetine 60mg

You can ask your healthcare provider or pharmacist for information about sildenafil tablets that is written for health professionals.

Further information

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. Do not use sildenafil tablets for a condition for which it was not prescribed. Do not give sildenafil tablets to other people, even if they have the same symptoms that you have. It may harm them.This Patient Information leaflet summarizes the most important information about sildenafil tablets.

Sildenafil and dapoxetine

If you would like more information, talk with your healthcare provider. 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?Active ingredient:Sildenafil citrateInactive ingredients:crospovidone, hydrophobic colloidal silica, hypromellose, lactose monohydrate, magnesium stearate VG, microcrystalline cellulose, titanium dioxide, triacetin and FD&C Blue# 2/ Indigo Carmine Aluminium.This Patient Information has been approved by the U.S. 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?

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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. 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. What are the ingredients in sildenafil tablets?

• 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.

This Patient Information has been approved by the U.S. Food and Drug Administration.

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8.5 Geriatric Use

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. 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).

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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. 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?

Sildenafil vs. tadalafil

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. 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 dapoxetine 5mg 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. 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

• Sildenafil was first approved by the FDA in 1998.
• Dapoxetine was developed specifically for premature ejaculation treatment.
• Both drugs are available in tablet form for oral administration.
• Use of sildenafil may be affected by certain eye conditions.
• Dapoxetine is absorbed quickly and metabolized mainly in the liver.
• Patients should follow the dosage instructions strictly.
• Avoid taking sildenafil with large quantities of grapefruit juice.
• Dapoxetine has been shown to be effective in clinical trials.

- 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

7.4 Ritonavir and other CYP3A4 inhibitors

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. 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.

Interactions that increase your risk for side effects

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 working Do nottake sildenafil tablets more than 1 time a day.

Warnings for other groups

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. an erection that will not go away (priapism). If it is not treated right away, priapism can permanently damage your penis. - 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

Aspect	Details	Recommendations
Abuse potential	Moderate, especially for recreational purposes	Use only as prescribed
Dependence	Rare, but psychological reliance possible	Monitor usage, seek help if needed
Withdrawal symptoms	Not well-documented, but consult doctor if discontinuing	Gradual tapering may be advised

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

Additional information

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. It is not known if sildenafil tablets caused these problems.

Product Sodium Picosulfate Tablets 10 mg

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. 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.

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

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. This Patient Information leaflet summarizes the most important information about sildenafil tablets.