14 CLINICAL STUDIES

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.

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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 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.

Premature ejaculation

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 dapoxetin sildenafil 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 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. 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.

• Sildenafil helps improve erectile response in men with ED.
• Dapoxetine may enhance control over ejaculation for men with PE.
• Combining sildenafil and dapoxetine can improve sexual satisfaction.
• Use sildenafil with caution in patients with heart conditions.
• Dapoxetine has a short half-life, suitable for on-demand use.
• Patients should avoid high-fat meals immediately before taking sildenafil.
• Dapoxetine should be taken with a full glass of water.
• Both drugs are contraindicated in patients with certain heart problems.

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?

Adverse effects

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. 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.

How sildenafil is used

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. This Patient Information has been approved by the U.S.

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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. 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.

Patients and Methods

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. Sildenafil tablets are prescription medicine used to treat erectile dysfunction (ED). Food and Drug Administration.

• Sildenafil's patent expiration has increased availability of generics.
• Dapoxetine is relatively newer, approved in the early 2000s.
• Lifestyle factors like smoking can impact medication effectiveness.
• Both medications have different mechanisms of action.
• Dapoxetine's efficacy is confirmed through multiple clinical trials.
• Sildenafil may cause temporary visual disturbances.
• Proper dosage timing enhances effectiveness and safety.
• Always discard expired medications safely to avoid misuse.

*The other brands listed are trademarks of their respective owners and are not trademarks of Rubicon Research Limited.

• Consistent use of sildenafil can help maintain erectile function.
• Dapoxetine provides a pharmacological solution for PE.
• Both products should be stored in a cool, dry place away from children.
• Side effects may diminish with continued use or dose adjustment.
• Some patients may require alternative therapies if side effects occur.
• Clinical guidelines recommend consultation before combining treatments.
• Dapoxetine's short half-life minimizes residual effects.
• Patients should inform healthcare providers about all current medications.

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

• 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.

- 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.

5.9 Counseling Patients about Sexually Transmitted Diseases

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? Sildenafil tablets can cause serious side effects. an erection that will not go away (priapism).

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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 tadalafil with dapoxetine online 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. 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) Exports To: United States Of America Australia United Kingdom Canada France United States Of America Australia United Kingdom Canada France We are one of the foremost Exporter & specialized of Pharmaceutical Tablets, Pharmaceutical Injections, Pharmaceutical Cream, Pharmaceutical Gel, Pharmaceutical Ointment, Pharmaceutical Lotion, Isotroin-20 Capsules,Isotroin-20 Capsules and much more.

7.2 Alpha-blockers

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.