14 CLINICAL STUDIES

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sildenafil in the elderly.

Key facts

Appropriate studies have not been performed on the relationship of age to the effects of sildenafil in children younger than 1 year of age. Safety and efficacy have not been established. Sildenafil should never be used in children for erectile dysfunction. In general, sildenafil should not be used for pulmonary arterial hypertension in children, especially for chronic use. Use of sildenafil oral film is not sildenafil 100mg blue pill indicated for use in the pediatric population. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving sildenafil. There are no adequate studies in women for determining infant risk when using this medication during breastfeeding.

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Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

8.4 Pediatric Use

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 20° to 25°C (68° to 77°F).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.

Are you currently using Sildenafil (Viagra, Revatio)?

It may harm them.This Patient Information leaflet summarizes the most important information about sildenafil tablets. 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 citrate, USPInactive ingredients:croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin.This Patient Information has been approved by the U.S. Food and Drug Administration.Manufactured for:Camber Pharmaceuticals, Inc.,Piscataway, NJ 08854by: HETERO TMHetero Labs LimitedJeedimetla, Hyderabad - 500 055, India.Revised: 12/2025*All brands listed are the registered trademarks of their respective owners and are not trademarks of Hetero Labs Limited. The makers of these brands are not affiliated with and do not endorse Hetero Labs Limited or its products.

How does sildenafil work (mechanism of action)?

*All brands listed are the registered trademarks of their respective owners and are not trademarks of Hetero Labs Limited. Sildenafil is used to treat erectile dysfunction (also called sexual impotence). Sildenafil belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. These medicines prevent an enzyme called phosphodiesterase type-5 from working too quickly. The penis is one of the areas where this enzyme works. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below.

5.9 Counseling Patients About Sexually Transmitted Diseases

Erectile dysfunction is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. When a man is sexually stimulated, his body's normal response is to increase blood flow to his penis to produce an erection. By controlling the enzyme, sildenafil helps to maintain an erection after the penis is stroked. Without physical action to the penis, such as that occurring during sexual intercourse, sildenafil will not work to cause an erection. Sildenafil is also used in both men and women to treat the symptoms of pulmonary arterial hypertension.

How is sildenafil supplied (dosage forms)?

This is a type of high blood pressure that occurs between the heart and the lungs. When hypertension occurs in the lungs, the heart must work harder to pump enough blood through the lungs. Sildenafil works on the PDE5 enzyme in the lungs to relax the blood vessels. This will increase the supply of blood to the lungs and reduce the workload of the heart. This medicine is available only sildenafil citrate tablets 150 mg with your doctor's prescription.

Does sildenafil interact with foods or drinks?

This product is available in the following dosage forms: In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

• The pink sildenafil pill can improve confidence during intimacy.
• It may cause vision changes such as blurred eyesight.
• Use caution if you have heart or blood pressure conditions.
• Sildenafil can interact with certain medications.
• Adherence to medical advice ensures safe use.
• The pill should be used only once in a 24-hour period.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases.

• Users should avoid heavy meals close to pill intake.
• Sildenafil pink pill can sometimes cause a headache or flushing.
• It may improve sexual confidence and reduce anxiety.
• Store the pink pill out of reach of children.
• Its effectiveness can be influenced by other health factors.
• Regular health check-ups are recommended during use.

If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur.

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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• other medicines or treatments for ED• sildenafil 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.• 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.

Liver impairment

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

Altitude sickness

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 sildenafil otc loss in one or both eyes.• sudden hearing decrease or hearing loss. 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:• headache• flushing• upset stomach• abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision• stuffy or runny nose• back pain• muscle pain• nausea• dizziness• rashIn 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. Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases.

Side Effect	Frequency	Severity	Common Symptoms	Recommendations
Headache	Common	Mild to moderate	Throbbing head pain	OTC pain relief suggested
Flushing	Common	Mild	Skin redness	Usually temporary
Nasal Congestion	Occasionally	Mild	Stuffy nose	May reduce dose if persistent
Vision Changes (blurred)	Less common	Mild	Slight blurring or blue tinge	Consult doctor if severe
Priapism	Rare	Severe	Prolonged erection (>4 hrs)	Seek emergency medical care

If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Sildenafil pink pill is a prescribed medication in many regions.
• It should not be taken with heavy alcohol consumption.
• The pill is designed to improve quality of life for men with ED.
• Possible allergic reactions should be reported immediately.
• It is important to discuss potential side effects with your doctor.
• The pink sildenafil pill has revolutionized ED treatment options.