14 CLINICAL STUDIES

What are the ingredients in Sildenafil for Oral Suspension? Inactive ingredients: sorbitol, citric acid anhydrous, sucralose, sodium citrate dihydrate, xanthan gum, titanium dioxide , sodium benzoate, colloidal silicon dioxide anhydrous, and grape flavor This Patient Information has been approved by the U.S.

Highlights of Prescribing Information

Throw away Sildenafil for Oral Suspension after 60 days. Keep Sildenafil for Oral Suspension and all medicines away from children. General information about Sildenafil for Oral Suspension Medicines are sometimes prescribed for purposes that are not in the patient leaflet. This patient leaflet summarizes the most important information about Sildenafil for Oral Suspension. You can ask your doctor or pharmacist for information about Sildenafil for Oral Suspension that is written for health professionals. Food and Drug Administration Trademarks are the property of their respective owners.

INSTRUCTIONS FOR USE Instructions for UseSildenafil (sil den’ a fil) for Oral SuspensionRead this Instructions for Use for Sildenafil for Oral Suspension before you start taking and each time you get a refill.

7 DRUG INTERACTIONS

Tell your doctor about all of your medical conditions, including if you have heart problems such as angina (chest pain), heart failure, irregular heartbeats, or have had a heart attack have a disease called pulmonary veno-occlusive disease (PVOD) have high or low blood pressure or blood circulation problems have an eye problem called retinitis pigmentosa have or had loss of sight in one or both eyes have any problem with the shape of your penis or Peyronie's disease have any blood cell problems such sickle cell anemia have a stomach ulcer or any bleeding problems are pregnant or planning to become pregnant. It is not known if Sildenafil for Oral Suspension could harm your unborn baby. Sildenafil for Oral Suspension passes into your breast milk, it is not known if it could harm your baby. Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal products. The doses of some of your medicines may need to be adjusted while you take Sildenafil for Oral Suspension.

What’s the difference between sildenafil and Viagra?

Especially tell your doctor if you take See "What is the most important information I should know about Sildenafil for Oral Suspension?" Ritonavir (Norvir®) or other medicines used to treat HIV infection Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine. How should I take Sildenafil for Oral Suspension? Take Sildenafil for Oral Suspension exactly as your doctor tells you. Take Sildenafil for Oral Suspension 3 times a day about 4 to 6 hours apart Take Sildenafil for Oral Suspension at the same times every day. Sildenafil for Oral Suspension will be mixed for you by your pharmacist. This information does not take the place of talking to your doctor about your medical condition or your treatment.Important information:Your pharmacist should tell you how to measure Sildenafil for Oral Suspension by using the oral syringe provided in the pack.Sildenafil for Oral Suspension should only be given using the oral syringe supplied with each pack.Sildenafil for Oral Suspension should not be mixed with any other medicine or flavoring.Supplies you will need to take Sildenafil for Oral Suspension:Bottle of Sildenafil for Oral Suspension with syringe adaptor fitted in neck of bottleOral syringe (as supplied by pharmacist). (See Figure A)Figure AFigure AShake the bottle of Sildenafil for Oral Suspension for 10 seconds before each use.

• Sildenafil syrup is an off-label form of erectile dysfunction medication.
• It's designed for easier ingestion compared to tablets.
• Not approved by most regulatory agencies for syrup form.
• Dosing and safety information are less documented for syrup.
• Usually, sildenafil is available in tablet form, not syrup.

Open the bottle by pushing downward on the cap and twisting it in the direction of the arrow (counter-clockwise).

• Manufacturing of sildenafil syrup requires specialized equipment.
• The syrup form must undergo stability testing before release.
• Some formulations may include sweeteners to improve taste.
• Off-label compounding can carry legal and safety risks.
• Clinicians should carefully consider risks before prescribing syrup.

(See Figure B)Figure BFigure BInsert the tip of the oral syringe into the adaptor while the bottle is upright, on a flat surface. Fully push down (depress) the plunger of the syringe.

(See Figure C)Figure CFigure CTurn the bottle upside down while holding the oral syringe in place. Slowly pull back the plunger of the oral syringe until the bottom of the plunger is even with the graduation markings on the syringe for the prescribed dose for you.

5.3 Epistaxis

It is not possible to determine whether these events are related directly to this class of oral medicines, including Sildenafil for Oral Suspension, or to other diseases or medicines, to other factors, or to a combination of factors. heart attack, stroke, irregular heartbeats, and death. Most of these happened in men who already had heart problems. If it is not treated right away, priapism can permanently damage your penis. The most common side effects with Sildenafil for Oral Suspension include: Nosebleed, headache, upset stomach, getting red or hot in the face (flushing), trouble sleeping, as well as fever, erection increased, respiratory infection, nausea, vomiting, bronchitis, pharyngitis, runny nose, and pneumonia in children.

Does sildenafil interact with foods or drinks?

Tell your doctor if you have any side effect that bothers you or doesn't go away. These are not all the possible side effects of Sildenafil for Oral Suspension. For more information, ask your doctor or pharmacist. How should I store Sildenafil for Oral Suspension? Store reconstituted Sildenafil for Oral Suspension below 30°C (86°F) or in a refrigerator between 2°C to 8°C (36°F to 46°F). Take your dose of Sildenafil for Oral Suspension exactly as prescribed by your doctor.

Non-medical use

Do not give Sildenafil for Oral Suspension to other people, even if they have the same symptoms you have. It could harm them.This patient leaflet summarizes the most important information about Sildenafil for Oral Suspension. If you would like more information about Sildenafil for Oral Suspension talk with your doctor. You can ask your doctor or pharmacist for information about Sildenafil for Oral Suspension that is written for health professionals.For more information 1-877-798-5944.What are the ingredients in Sildenafil for Oral Suspension?Active ingredients: sildenafil citrateInactive ingredients: sorbitol, citric acid anhydrous, sucralose, sodium citrate dihydrate, xanthan gum, titanium dioxide , sodium benzoate, colloidal silicon dioxide anhydrous, and grape flavorThis Patient Information has been approved by the U.S. Food and Drug AdministrationRevised: February 2020Trademarks are the property of their respective owners.

What should I tell my healthcare provider before taking sildenafil?

SILDENAFIL (sil den’ a fil) FOR ORAL SUSPENSION Read this Patient Information before you start taking Sildenafil for Oral Suspension and each time you get a refill. If you have any questions about Sildenafil for Oral Suspension, ask your doctor or pharmacist. What is the most important information I should know about Sildenafil for Oral Suspension? Never take Sildenafil for Oral Suspension with any nitrate or guanylate cyclase stimulator medicines. Your blood pressure could drop quickly to an unsafe level. If air bubbles can be seen, slowly push the oral suspension in the syringe back into the bottle.

Brand names

Shake well for at least 10 seconds before each dose. If it is close to your next dose, skip the missed dose, and take your next dose at the regular time. Do not take more than one dose of Sildenafil for Oral Suspension at a time. Do not change your dose or stop taking Sildenafil for Oral Suspension on your own. If you take too much Sildenafil for Oral canadian sildenafil citrate Suspension, call your doctor or go to the nearest hospital emergency room.

12.1 Sildenafil Oral Suspension Mechanism of Action

What are the possible side effects of Sildenafil for Oral Suspension? Lie down if you feel faint or dizzy. More shortness of breath than usual may be due to your underlying medical condition. decreased eyesight or loss of sight in one or both eyes (NAION). If you notice a sudden decrease or loss of eyesight, talk to your doctor right away. (See Figure D)Figure DFigure DTurn the bottle back upright with the oral syringe still in place. Remove the oral syringe from the bottle by pulling straight up on the barrel of the oral dosing syringe. (See Figure E)Figure EFigure EPut the tip of the oral syringe into your mouth. Point the tip of the oral syringe towards the inside of the cheek.

Slowly push down the plunger of the oral syringe. (See Figure F)Figure FFigure FReplace the cap on the bottle, leaving the bottle adaptor in place. Wash the oral syringe as instructed below.The syringe should be washed after each dose.

• Sildenafil can cause visual disturbances like blurred vision.
• Alcohol consumption may increase side effects when using sildenafil.
• The syrup should be stored at room temperature away from light.
• Patients should avoid heavy meals before taking sildenafil.
• Regular monitoring is recommended for long-term use.

(See Figure G)Figure GFigure GDry all parts with a clean paper towel.

What special precautions should I follow?

Nitroglycerin in any form including tablets, patches, sprays, and ointments Street drugs called "poppers" (amyl nitrate or nitrite) Ask your doctor or pharmacist if you are not sure if you are taking a nitrate or a guanylate cyclase stimulator medicine. Sildenafil for Oral Suspension is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH). Your heart has to work hard to pump blood into your lungs. Sildenafil for Oral Suspension improves the ability to exercise and can slow down worsening changes in your physical condition. Sildenafil for Oral Suspension is not for use in children Adding Sildenafil for Oral Suspension to another medication used to treat PAH, bosentan (Tracleer®), does not result in improvement in your ability to exercise.

Warnings for other groups

Sildenafil for Oral Suspension contains the same medicine as VIAGRA® (sildenafil), which is used to treat erectile dysfunction (impotence). Do not take Sildenafil for Oral Suspension with VIAGRA or other PDE-5 inhibitors. Who should not take Sildenafil for Oral Suspension? Do not take Sildenafil for Oral Suspension if you: See "What is the most important information I should know about Sildenafil for Oral Suspension?" See "What is the most important information I should know about Sildenafil for Oral Suspension?" are allergic to sildenafil or any other ingredient inSildenafil for Oral Suspension. What should I tell my doctor before taking Sildenafil for Oral Suspension? Store the syringe with Sildenafil for Oral Suspension in a clean safe place.Administer Sildenafil for Oral Suspension using the oral syringe supplied with each pack. Refer to the patient instructions for use for more detailed instructions for use.