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The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional.

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Since high blood pressure in the lungs is a serious condition that can harm both a pregnant woman and her unborn baby, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, discuss with your doctor right away the benefits and risks of using this medication during pregnancy. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list male enhancement pill of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist.

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Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug are: Sildenafil can cause a serious drop in your blood pressure when used with nitrates. A serious drop in blood pressure can lead to dizziness, fainting, and rarely heart attack or stroke. Do not use sildenafil with any of the following: certain drugs used to treat chest pain/angina (nitrates such as nitroglycerin, isosorbide) recreational drugs called "poppers" containing amyl or butyl nitrite If you are also taking an alpha blocker medication (such as doxazosin, tamsulosin) to treat an enlarged prostate/BPH or high blood pressure, your blood pressure may get too low which can lead to dizziness or fainting. Your doctor may start treatment with a lower dose of sildenafil to minimize your risk of low blood pressure.

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Other medications can affect the removal of sildenafil from your body, which may affect how sildenafil works. Examples include azole antifungals (such as itraconazole, ketoconazole), macrolide antibiotics (such as clarithromycin, erythromycin), mifepristone, rifampin, ritonavir, among others. Do not take this medication with any other product that contains sildenafil or other similar medications for erectile dysfunction-ED or pulmonary hypertension (such as tadalafil, vardenafil). If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.

NDC Code(s): 13668-186-01, 13668-186-05, 13668-186-10, 13668-186-30, view more13668-186-40, 13668-187-01, 13668-187-05, 13668-187-10, 13668-187-18, 13668-187-30, 13668-188-01, 13668-188-05, 13668-188-10, 13668-188-30 If you are a consumer or patient please visit this version.

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively.

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Tell your doctor if your condition does not get better. Dizziness, headache, flushing, or stomach upset may occur. Vision changes such as increased sensitivity to light, blurred vision, or trouble telling blue and green colors apart may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

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Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Sexual activity may put extra strain on your heart, especially if you have heart problems. If you have heart problems and experience any of these serious side effects while having sex, stop and get medical help right away: Rarely, sudden decreased vision, or even permanent blindness, may occur in one or both eyes (NAION). If this serious problem occurs, stop taking sildenafil and get medical help right away.

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You have a slightly greater chance of developing NAION if you have heart disease, diabetes, high cholesterol, certain other eye problems ("crowded disk"), high blood pressure, if you are over 50, or if you smoke. Rarely, a sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness, may occur. Stop taking sildenafil and get medical help right away if these effects occur. Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur. See full prescribing information for SILDENAFIL TABLETS.SILDENAFIL tablets, for oral useInitial U.S. Approval:1998RECENT MAJOR CHANGESWarnings and Precautions, Effects on the Eye ( 5.3) 08/2017INDICATIONS AND USAGESildenafil citrate is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED).

(1)DOSAGE AND ADMINISTRATIONFor most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity.

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A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: itching/swelling (especially of the face/tongue/throat) This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at In Canada - Call your doctor for medical advice about side effects.

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You may report side effects to Health Canada at 1-866-234-2345. Before taking sildenafil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as heart attack or life-threatening irregular heartbeat in the erectile dysfunction treatment past 6 months, chest pain/angina, heart failure) penis conditions (such as angulation, fibrosis/scarring, Peyronie's disease) conditions that may increase the risk of priapism (such as sickle cell anemia, leukemia, multiple myeloma) eye problems (such as retinitis pigmentosa, sudden decreased vision, NAION) This drug may make you dizzy or cause vision problems.

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Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Talk to your doctor if you are using marijuana (cannabis). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, sildenafil should be used only when clearly needed. However, Sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity ( 2.1)Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg ( 2.1)Maximum recommended dosing frequency is once per day ( 2.1)DOSAGE FORMS AND STRENGTHSTablets: 25 mg, 50 mg and 100 mg ( 3)CONTRAINDICATIONSAdministration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. Sildenafil citrate was shown to potentiate the hypotensive effect of nitrates ( 4.1, 7.1, 12.2)Known hypersensitivity to sildenafil or any component of tablet ( 4.2)Administration with guanylate cyclase (GC) stimulators, such as riociguat ( 4.3)WARNINGS AND PRECAUTIONSPatients should not use sildenafil citrate if sexual activity is inadvisable due to cardiovascular status ( 5.1)Patients should seek emergency treatment if an erection lasts >4 hours.

• Heart disease
• Stroke history
• Low blood pressure
• Retinitis pigmentosa
• Nitrates
• Severe liver issues

Use sildenafil citrate with caution in patients predisposed to priapism ( 5.2)Patients should stop sildenafil tablets and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION).

Sildenafil Citrate Oral Solution 10 mg Grape Flavored 112 mL

US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe dizziness, fainting, painful/prolonged erection. Do not share this medication with others. Store at room temperature away from light and moisture.

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Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product.

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This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional sex with tablet for complete information about this product and your specific health needs. Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider. Sildenafil tablets should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION.

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Patients with a” crowded” optic disc may also be at an increased risk of NAION.

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( 5.3)Patients should stop sildenafil tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing ( 5.4)Caution is advised when Sildenafil citrate is co-administered with alpha- blockers or anti-hypertensives. Concomitant use may lead to hypotension ( 5.5)Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures.

In patients taking strong CYP inhibitors, such as ritonavir, sildenafil exposure is increased. Decrease in Sildenafil citrate dosage is recommended ( 2.4, 5.6)ADVERSE REACTIONSMost common adverse reactions (≥ 2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash ( 6.1).To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc.