6. ADVERSE REACTIONS

CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13.

• Alcohol can interact with sildenafil, reducing its effectiveness and increasing side effects.
• Avoid alcohol consumption when planning to use sildenafil.
• Always inform your doctor about alcohol use prior to prescription.

NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility14.

8.1 Pregnancy

• Sildenafil tablets can be taken with or without food. 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. Sildenafil tablets can cause serious side effects . Rarely reported side effects include: • an erection that will not go away (priapism).

7.1 Nitrates

• 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 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: • 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 • rash In 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.

5.8 Effects on Bleeding

It is not known if sildenafil tablets caused these problems. • 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. Do not give sildenafil tablets to other people, even if they have the same symptoms that you have. PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed.

INDICATIONS AND USAGE Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening.

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( 5.9)ADVERSE REACTIONSMost common adverse reactions greater than or equal to 3% and more frequent than placebo were epistaxis, headache, dyspepsia, flushing, insomnia, erythema, dyspnea, and rhinitis. ( 6.1, 6.2)To report SUSPECTED ADVERSE REACTIONS, contact Advagen Pharma Ltd, at 888-413-0949 or FDA at 1-800-FDA-1088 or INTERACTIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 9/2024 Sildenafil tablets are phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening. Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity. Tablets: 20 mg three times a day, 4 to 6 hours apart ( 2.1) Increased mortality with increasing doses in pediatric patients. Pulmonary hypertension secondary to sickle cell disease: Sildenafil may cause serious vaso-occlusive crises.

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To report SUSPECTED ADVERSE REACTIONS, contact Advagen Pharma Ltd, at 888-413-0949 or FDA at 1-800-FDA-1088 or See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1. WARNINGS AND PRECAUTIONS5.1 Mortality with Pediatric Use5.2 Hypotension5.3 Worsening Pulmonary Vascular Occlusive Disease5.4 Epistaxis5.5 Visual Loss5.6 Hearing Loss5.7 Combination with other PDE-5 inhibitors5.8 Priapism5.9 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Anemia6. ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience7. USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.4 Pediatric Use8.5 Geriatric Use8.6 Patients with Hepatic Impairment8.7 Patients with Renal Impairment10. The delay in clinical worsening was demonstrated when Sildenafil tablets were added to background epoprostenol therapy [see Clinical

• The usual starting dose of sildenafil for ED is 50 mg, but 20 mg may be prescribed for some patients.
• Prescription requirements ensure safe usage and proper dosing based on health conditions.
• Always follow a doctor’s instructions when taking sildenafil 20 mg.

Studies (14)].Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association

What should I do if I forget a dose?

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. This Patient Information has been approved by the U.S. Food and Drug Administration. All brands listed are the registered trademarks of their respective owners and are not trademarks of sildenafil spray Evaric Pharmaceuticals, Inc.

Sildenafil Tablets Dosage and Administration

Revised: 08/2019 Cialis vs Viagra - What's the difference between them? HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS.SILDENAFIL tablets, for oral useInitial U.S. Approval: 1998INDICATIONS AND USAGESildenafil tablets are phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening. ( 1)Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity.

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( 1, 14)DOSAGE AND ADMINISTRATIONTablets: 20 mg three times a day, 4 to 6 hours apart ( 2.1)DOSAGE FORMS AND STRENGTHSTablets: 20 mg ( 3)CONTRAINDICATIONSWARNINGS AND PRECAUTIONSIncreased mortality with increasing doses in pediatric patients. ( 5.1)Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. ( 5.2)Use in pulmonary veno-occlusive disease may cause pulmonary edema and is not recommended. ( 5.3)Hearing or visual impairment: Seek medical attention if sudden decrease or loss of vision or hearing occurs. ( 5.5, 5.6)Pulmonary hypertension secondary to sickle cell disease: Sildenafil may cause serious vaso-occlusive crises. (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity [see Clinical Studies (14)].

5.8 Priapism

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. 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 pulmonary hypertension • have had a stroke • have low blood pressure, or high blood pressure that is not controlled • have a deformed penis shape • 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 bleeding problems • have or have had stomach ulcers • have liver problems • have kidney problems or are having kidney dialysis • have any other medical conditions Tell your healthcare provider about all the medicines you take*,including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Allergy warning

Sildenafil tablets may affect the way other medicines work, and other medicines may affect the way sildenafil tablet 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. • 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. Sildenafil tablets should not be used with REVATIO or with other PAH treatments containing sildenafil or any other PDE5 inhibitors (such as Adcirca [tadalafil]).

2.3 Dosage Adjustments in Specific Situations

• 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.