1 INDICATIONS AND USAGE

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• The medication is not intended for use by women or children.
• Effectiveness may vary depending on individual health and age.
• Regular exercise and healthy lifestyle can improve outcomes.

Patient Information has been approved by the U.S.

Related/similar drugs

Sildenafil Tablets USP, 20 mg, are supplied as white to off-white, round shaped film-coated tablets with debossing ‘AN 351’ on one side and plain on the other side, containing sildenafil citrate, USP equivalent to the nominally indicated amount of sildenafil. NDC 50268-717-15 (10 tablets per card, 5 cards per carton) Recommended Storage for Sildenafil Tablets, USP: Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. 17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling ( Patient Information).Inform patients of contraindication of sildenafil citrate with regular and/or intermittent use of organic nitrates.Inform patients that sildenafil is also marketed as VIAGRA for erectile dysfunction. Advise patients taking sildenafil citrate not to take VIAGRA or other PDE-5 inhibitors.Advise patients to seek immediate medical attention for a sudden loss of vision in one or both eyes while taking sildenafil citrate. Such an event may be a sign of NAION.Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil citrate.

Other Medical Problems

These events may be accompanied by tinnitus and dizziness.All trademarks listed are the property of their respective owner.Manufactured by:AvKAREPulaski, TN 38478Mfg. See FDA-approved patient labeling ( Patient Information). Inform patients of contraindication of sildenafil citrate with regular and/or intermittent use of organic nitrates. Inform patients that sildenafil is also marketed as VIAGRA for erectile dysfunction. Advise patients taking sildenafil citrate not to take VIAGRA or other PDE-5 inhibitors.

Incidence not known

Advise patients to seek immediate medical attention for a sudden loss of vision in one or both eyes while taking sildenafil citrate. Such an event may be a sign of NAION. Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil citrate. These events may be accompanied by tinnitus and dizziness. All trademarks listed are the property of their respective owner. Food and Drug AdministrationManufactured by:AvKAREPulaski, TN 38478Mfg.

Read this Patient Information before you start taking

4.2 Hypersensitivity Reactions

See “What is the most important information I should know about sildenafil tablets?”Riociguat (Adempas). See “What is the most important information I should know about sildenafil tablets?”Ritonavir (Norvir ®) or other medicines used to treat HIV infectionKetoconazole (Nizoral ®)Itraconazole (Sporanox)High blood pressure medicineKnow the medicines you take. 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 tablets?Take sildenafil tablets exactly as your doctor tells you.Sildenafil citrate may be prescribed to you asSildenafil tabletsTake sildenafil tablets 3 times a day about 4 to 6 hours apart.Take sildenafil tablets at the same times every day.If you miss a dose, take it as soon as you remember. 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 tablets at a time.Do not change your dose or stop taking sildenafil tablets on your own. Talk to your doctor first.If you take too much sildenafil tablets, call your doctor or go to the nearest hospital emergency room.What are the possible side effects of sildenafil tablets?low blood pressure.

Sildenafil may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

Low blood pressure may cause sildenafil 100 mg cost you to feel faint or dizzy. Lie down if you feel faint or dizzy.more shortness of breath than usual. Tell your doctor if you get more short of breath after you start sildenafil tablets. 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.sudden decrease or loss of hearing.

Pulmonary Arterial Hypertension

If you notice a sudden decrease or loss of hearing, talk to your doctor right away. It is not possible to determine whether these events are related directly to this class of oral medicines, including sildenafil tablets, 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.erections that last several hours. If it is not treated right away, priapism can permanently damage your penis.The most common side effects with sildenafil tablets 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.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 tablets. For more information, ask your doctor or pharmacist.Call your doctor for medical advice about side effects. sildenafil tablets and each time you get a refill. If you have any questions about

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

You may report side effects to FDA at 1-800-FDA-1088.How should I store sildenafil tablets?Store sildenafil tablets at controlled room temperature, between 20°C to 25°C (68°F to 77°F).Keep sildenafil tablets and all medicines away from children.General information about sildenafil tabletsMedicines are sometimes prescribed for purposes that are not in the patient leaflet. Do not give sildenafil tablets 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 tablets. If you would like more information about sildenafil tablets, talk with your doctor. You can ask your doctor or pharmacist for information about sildenafil tablets that is written for health professionals.For more information go to or call 1-855-361-3993.What are the ingredients in sildenafil tablets?Active ingredients: sildenafil citrate, USPInactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.This product’s label may have been updated. sildenafil tablets, ask your doctor or pharmacist.

What is the most important information

• Do not exceed one tablet per 24 hours to avoid side effects.
• Consult a doctor before starting sildenafil, especially if you have heart issues.
• Avoid alcohol and fat-rich meals around the time of intake.

I should know about sildenafil tablets?

What are Floradix Tablets?

PATIENT INFORMATION Sildenafil (sil-DEN-a-fil) Tablets, USPRead this Patient Information before you start taking sildenafil tablets and each time you get a refill. This information does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about sildenafil tablets, ask your doctor or pharmacist.What is the most important information I should know about sildenafil tablets?Never take sildenafil tablets with any nitrate or guanylate cyclase stimulator medicines. Your blood pressure could drop quickly to an unsafe level. Nitrate medicines include:Medicines that treat chest pain (angina)Nitroglycerin in any form including tablets, patches, sprays, and ointmentsIsosorbide mononitrate or dinitrateStreet drugs called “poppers” (amyl nitrate or nitrite)Guanylate cyclase stimulators include:Riociguat (Adempas)Ask your doctor or pharmacist if you are not sure if you are taking a nitrate or a guanylate cyclase stimulator medicine.What are sildenafil tablets?Sildenafil tablets are a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH).

Some Tips for Sildenafil

With PAH, the blood pressure in your lungs is too high. Your heart has to work hard to pump blood into your lungs.Sildenafil tablets improves the ability to exercise and can slow down worsening changes in your physical condition.Sildenafil tablets are not for use in childrenAdding sildenafil tablets to another medication used to treat PAH, does not result in improvement in your ability to exercise.Sildenafil tablets contain the same medicine as VIAGRA ® (sildenafil), which is used to treat erectile dysfunction (impotence). Do not take sildenafil tablets with VIAGRA or other PDE-5 inhibitors.Who should not take sildenafil tablets?Do not take sildenafil tablets if you:take nitrate medicines. See “What is the most sildenafil products over the counter important information I should know about sildenafil tablets?”take guanylate cyclase stimulator medicines. See “What is the most important information I should know about sildenafil tablets?”are allergic to sildenafil or any other ingredient in sildenafil tablets.

Common Effects

See “What are the ingredients in sildenafil tablets?” at the end of this leaflet.What should I tell my doctor before taking sildenafil tablets?Tell your doctor about all of your medical conditions, including if youhave heart problems such as angina (chest pain), heart failure, irregular heartbeats, or have had a heart attackhave a disease called pulmonary veno-occlusive disease (PVOD)have high or low blood pressure or blood circulation problemshave an eye problem called retinitis pigmentosahave or had loss of sight in one or both eyeshave any problem with the shape of your penis or Peyronie’s diseasehave any blood cell problems such as sickle cell anemiahave a stomach ulcer or any bleeding problemsare pregnant or planning to become pregnant. It is not known if sildenafil tablets could harm your unborn baby.are breastfeeding. It is not known if sildenafil citrate passes into your breast milk or 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. Sildenafil tablets and certain other medicines can cause side effects if you take them together. The doses of some of your medicines may need to be adjusted while you take sildenafil tablets.Especially tell your doctor if you takeNitrate medicines.