Additionally, in order to ensure healthcare providers have access to the PPEs they need, the McGuff Company is temporarily limiting PPEs to healthcare providers.

Country/Region	Approval Status	Prescription Required	Notes
USA	Approved by FDA	Yes	Prescription only
European Union	Approved by EMA	Yes	Prescription required
Canada	Approved by Health Canada	Yes	Prescription needed
Australia	TGA approval	Yes	Prescription mandatory

As always, please feel free to reach out to our McGuff Customer Service team with any questions that you may have. If you are a consumer or patient please visit this version.

Does Either Medication Reverse ED?

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 of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist.

Erectile Dysfunction

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 adjust your medications to minimize your risk of low blood pressure. HIGHLIGHTS OF PRESCRIBING INFORMATION Sildenafil Tablets, USPRx OnlyThese highlights do not include all the information needed to use SILDENAFIL sildenafil cenforce TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS.SILDENAFIL tablets, for oral useInitial U.S. Approval: 1998RECENT MAJOR CHANGESWarnings and Precautions, Visual Loss (5.5) 07/2017INDICATIONS AND USAGESildenafil tablets are a 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.

Sildenafil 20 mg tablets are used primarily to treat erectile dysfunction.
They work by increasing blood flow to the penis.
Typically, the medication is taken 30-60 minutes before activity.
The effects of sildenafil can last up to 4-6 hours.
Do not take more than one tablet per day.

Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with NYHA Functional Class II-III symptoms. Etiologies were idiopathic (71%) or associated with connective tissue disease (25%).

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(1)DOSAGE AND ADMINISTRATIONTablet: 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. Not recommended for use in pediatric patients.

Frequently asked questions

Other medications can affect the removal of sildenafil from your body, which may affect how sildenafil works. 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. US residents can call 1-800-222-1222.

What should I do if I miss a dose of sildenafil?

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. Lab and/or medical tests (such as eye exams, blood pressure) may be done while you are taking this medication. If you miss a dose, take it as soon as you remember. (5.1)Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy.

Sildenafil 20 mg is one of several available dosages.
Be aware of potential side effects like dizziness and nausea.
Inform your doctor about any heart history before use.
Do not take sildenafil if you have recently had a stroke.
Follow instructions precisely to ensure safe and effective use.

(5.2)Use in pulmonary veno-occlusive disease may cause pulmonary edema and is not recommended.

8.7 Patients with Renal Impairment

You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment. If you can't find what you were looking for, please contact us using one of the methods below so we can better serve you. Due to the Coronavirus (COVID-19) outbreak worldwide, the global demand for some Personal Protective Equipment (PPE) is exceeding current supply availability. In addition, the manufacturing of the PPE and many other wound care/infection prevention products have been impacted by the global response to the Coronavirus. While you may see product availability reduction in the near-term, please be assured that we at McGuff Medical are continuing to work diligently to ensure an uninterrupted supply of products and alternative products to you. (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 citrate may cause serious vaso-occlusive crises. (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.

5.4 Visual Loss

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 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) other lung conditions (such as pulmonary veno-occlusive disease) This drug may make you dizzy or cause vision problems.

Usual Geriatric Dose for:

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. (6.1, 6.2)To report SUSPECTED ADVERSE REACTIONS, contact AvKARE, Inc.

Comparing Which Lasts Longer

If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up. Store at room temperature away from light and moisture. Keep all medications away from children and pets.

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

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. This information does not assure that this product is safe, effective, or appropriate for you. at 1-855-361-3993 or FDA at 1-800-FDA-1088 or INTERACTIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 10/2018 Warnings and Precautions, Visual Loss (5.5) 07/2017 Sildenafil tablets are a 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. Tablet: 20 mg three times a day, 4 to 6 hours apart (2.1) Increased mortality with increasing doses in pediatric patients. Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. Use in pulmonary veno-occlusive disease may cause pulmonary edema and is not recommended.

Condition	Details
Temperature	Store below 25°C (77°F)
Humidity	Keep in a dry place, away from moisture
Light Exposure	Store in a dark place, protect from light
Child Safety	Keep out of reach of children

Hearing or visual impairment: Seek medical attention if sudden decrease or loss of vision or hearing occurs. Pulmonary hypertension secondary to sickle cell disease: Sildenafil citrate may cause serious vaso-occlusive crises.

Medication Type	Interaction Effect	Risk Level	Recommendation
Nitrates	Severe hypotension	High	Do not combine
Alpha-blockers	Increased risk of blood pressure drop	Moderate	Use under medical supervision
CYP3A4 inhibitors	Increased sildenafil levels	Moderate	Adjust dose or avoid
Ritonavir	Elevated risk of side effects	High	Consult healthcare provider

Most common adverse reactions greater than or equal to 3% and more frequent than placebo were epistaxis, headache, dyspepsia, flushing, insomnia, erythema, dyspnea, and rhinitis.

Further information

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 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. The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. To report SUSPECTED ADVERSE REACTIONS, contact AvKARE, Inc. at 1-855-361-3993 or FDA at 1-800-FDA-1088 or See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Using sildenafil will not cause an erection without sexual stimulation.
The medication's effectiveness varies among individuals.
It can be used in men with diabetes-related erectile issues.
Combining sildenafil with recreational drugs can be dangerous.
Always consult healthcare providers for personalized advice.

Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*RECENT MAJOR CHANGES1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION2.1 sildenafil 100g Sildenafil Tablets3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS5 WARNINGS AND PRECAUTIONS5.1 Hypotension5.2 Worsening Pulmonary Vascular Occlusive Disease5.3 Epistaxis5.4 Visual Loss5.5 Hearing Loss5.6 Combination with other PDE-5 Inhibitors5.7 Priapism5.8 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Anemia6 ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.4 Pediatric Use8.5 Geriatric Use8.6 Patients with Hepatic Impairment8.7 Patients with Renal Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility14 CLINICAL STUDIES16 HOW SUPPLIED/STORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed.