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Patients should be counseled that concomitant use of tadalafil tablets with nitrates could cause blood pressure to suddenly drop to an unsafe level, resulting in dizziness, syncope, or even heart attack or stroke.Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of tadalafil tablets. Therefore, patients who experience anginal chest pain after taking tadalafil tablets should seek immediate medical attention [see Contraindications () and Warnings and Precautions (5.1)].17.2 Guanylate Cyclase (GC) StimulatorsPhysicians should discuss with patients the contraindication of tadalafil tablets with any use of a GC stimulator, such as riociguat, for pulmonary arterial hypertension.

5.3 Prolonged Erection

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Patients should be counseled that the concomitant use of tadalafil tablets with GC stimulators may cause blood pressure to drop to an unsafe level.17.3 Cardiovascular ConsiderationsPhysicians should consider the potential cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Physicians should advise patients who experience symptoms upon initiation of sexual activity to refrain from further sexual activity and seek immediate medical attention [see Warnings and Precautions (5.1)].17.4 Concomitant Use with Drugs Which Lower Blood PressurePhysicians should discuss with patients the potential for tadalafil tablets to augment the blood-pressure-lowering effect of alpha-blockers, and antihypertensive medications [see Warnings and Precautions (5.6), Drug Interactions (), and Clinical Pharmacology ()].17.5 Potential for Drug Interactions When Taking Tadalafil Tablets for Once Daily UsePhysicians should discuss with patients the clinical implications of continuous exposure to tadalafil when prescribing tadalafil tablets for once daily use, especially the potential for interactions with medications (e.g., nitrates, alpha-blockers, antihypertensives and potent inhibitors of cytochrome P450 3A4) and with substantial consumption of alcohol. [see Dosage and Administration (), Warnings and Precautions (5.6), Drug Interactions (, ), Clinical Pharmacology (), and Clinical Studies ()].17.6 PriapismThere have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds.

Physicians should advise patients who have an erection lasting greater than 4 hours, whether painful or not, to seek emergency medical attention.17.7 Sudden Loss of VisionPhysicians should advise patients to stop use of all PDE5 inhibitors, including tadalafil tablets, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision, including possible permanent loss of vision, that has been reported rarely postmarketing in temporal association with the use of all PDE5 inhibitors.

Important Notes

Physicians should advise patients who experience symptoms upon initiation of sexual activity to refrain from further sexual activity and seek immediate medical attention [see Warnings and Precautions (5.1)]. Physicians should discuss with patients the potential for tadalafil tablets to augment the blood-pressure-lowering effect of alpha-blockers, and antihypertensive medications [see Warnings and Precautions (5.6), Drug Interactions (), and Clinical Pharmacology ()]. Physicians should discuss with patients the clinical implications of continuous exposure to tadalafil when prescribing tadalafil tablets for once daily use, especially the potential for interactions with medications (e.g., nitrates, alpha-blockers, antihypertensives and potent inhibitors of cytochrome P450 3A4) and with substantial consumption of alcohol. [see Dosage and Administration (), Warnings and Precautions (5.6), Drug Interactions (, ), Clinical Pharmacology (), and Clinical Studies ()]. Physicians should advise patients who have an erection lasting greater than 4 hours, whether painful or not, to seek emergency medical attention.

Outcome measures

Physicians should advise patients to stop use of all PDE5 inhibitors, including tadalafil tablets, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a “crowded” optic tadalafil 20mg price disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including tadalafil tablets, for this uncommon condition [see Warnings and Precautions () and Adverse Reactions ()]. Therefore, physicians should inform patients that substantial consumption of alcohol (e.g., 5 units or greater) in combination with tadalafil tablets can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache [see Warnings and Precautions (), Drug Interactions (), and Clinical Pharmacology ()]. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV) should be considered. Physicians should instruct patients on the appropriate administration of tadalafil tablets to allow optimal use. Physicians should discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a “crowded” optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including tadalafil tablets, for this uncommon condition [see Warnings and Precautions () and Adverse Reactions ()].17.8 Sudden Hearing LossPhysicians should advise patients to stop taking PDE5 inhibitors, including tadalafil tablets, and seek prompt medical attention in the event of sudden decrease or loss of hearing.

What special precautions should I follow?

Therefore, physicians should inform patients that substantial consumption of alcohol (e.g., 5 units or greater) in combination with tadalafil tablets can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache [see Warnings and Precautions (), Drug Interactions (), and Clinical Pharmacology ()].17.10 Sexually Transmitted DiseaseThe use of tadalafil tablets offers no protection against sexually transmitted diseases. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV) should be considered.17.11 Recommended AdministrationPhysicians should instruct patients on the appropriate administration of tadalafil tablets to allow optimal use.For tadalafil tablets for use as needed in men with ED, patients should be instructed to take one tablet at least 30 minutes before anticipated sexual activity. In most patients, the ability to have sexual intercourse is improved for up to 36 hours.For tadalafil tablets for once daily use in men with ED or ED/BPH, patients should be instructed to take one tablet at approximately the same time every day without regard for the timing of sexual activity. Tadalafil tablets are effective at improving erectile function over the course of therapy.For tadalafil tablets for once daily use in men with BPH, patients should be instructed to take one tablet at approximately the same time every day.Dispense with Patient Information available at: by:Solco Healthcare US, LLCSomerset, NJ 08873, USAManufactured by:Zhejiang Huahai Pharmaceutical Co., Ltd.Xunqiao, Linhai, Zhejiang 317024, ChinaRevised: 03/2025203258-04Repackaged By: Preferred Pharmaceuticals Inc. “See FDA-approved patient labeling (Patient Information)” Physicians should discuss with patients the contraindication of tadalafil tadalafil 40mg tablets with regular and/or intermittent use of organic nitrates.

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Patients should be counseled that concomitant use of tadalafil tablets with nitrates could cause blood pressure to suddenly drop to an unsafe level, resulting in dizziness, syncope, or even heart attack or stroke. Therefore, patients who experience anginal chest pain after taking tadalafil tablets should seek immediate medical attention [see Contraindications () and Warnings and Precautions (5.1)]. Physicians should discuss with patients the contraindication of tadalafil tablets with any use of a GC stimulator, such as riociguat, for pulmonary arterial hypertension. Patients should be counseled that the concomitant use of tadalafil tablets with GC stimulators may cause blood pressure to drop to an unsafe level. Physicians should consider the potential cardiac risk of sexual activity in patients with preexisting cardiovascular disease. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Adverse Reactions (, )].17.9 AlcoholPatients should be made aware that both alcohol and tadalafil tablets, a PDE5 inhibitor, act as mild vasodilators. Therefore, physicians should inform patients that substantial consumption of alcohol (e.g., 5 units or greater) in combination with tadalafil tablets can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache [see Warnings and Precautions (), Drug Interactions (), and Clinical Pharmacology ()].17.10 Sexually Transmitted DiseaseThe use of tadalafil tablets offers no protection against sexually transmitted diseases.

Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV) should be considered.17.11 Recommended AdministrationPhysicians should instruct patients on the appropriate administration of tadalafil tablets to allow optimal use.For tadalafil tablets for use as needed in men with ED, patients should be instructed to take one tablet at least 30 minutes before anticipated sexual activity. In most patients, the ability to have sexual intercourse is improved for up to 36 hours.For tadalafil tablets for once daily use in men with ED or ED/BPH, patients should be instructed to take one tablet at approximately the same time every day without regard for the timing of sexual activity. Tadalafil tablets are effective at improving erectile function over the course of therapy.For tadalafil tablets for once daily use in men with BPH, patients should be instructed to take one tablet at approximately the same time every day.Dispense with Patient Information available at: by:Solco Healthcare US, LLCSomerset, NJ 08873, USAManufactured by:Zhejiang Huahai Pharmaceutical Co., Ltd.Xunqiao, Linhai, Zhejiang 317024, ChinaRevised: 03/2025203258-04Repackaged By: Preferred Pharmaceuticals Inc. “See FDA-approved patient labeling (Patient Information)” Physicians should discuss with patients the contraindication of tadalafil tadalafil 40mg tablets with regular and/or intermittent use of organic nitrates. Patients should be counseled that concomitant use of tadalafil tablets with nitrates could cause blood pressure to suddenly drop to an unsafe level, resulting in dizziness, syncope, or even heart attack or stroke. Therefore, patients who experience anginal chest pain after taking tadalafil tablets should seek immediate medical attention [see Contraindications () and Warnings and Precautions (5.1)]. Physicians should discuss with patients the contraindication of tadalafil tablets with any use of a GC stimulator, such as riociguat, for pulmonary arterial hypertension.

5.9 Alcohol

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Patients should be counseled that the concomitant use of tadalafil tablets with GC stimulators may cause blood pressure to drop to an unsafe level. Physicians should consider the potential cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Physicians should advise patients who experience symptoms upon initiation of sexual activity to refrain from further sexual activity and seek immediate medical attention [see Warnings and Precautions (5.1)].

Physicians should discuss with patients the potential for tadalafil tablets to augment the blood-pressure-lowering effect of alpha-blockers, and antihypertensive medications [see Warnings and Precautions (5.6), Drug Interactions (), and Clinical Pharmacology ()]. Physicians should discuss with patients the clinical implications of continuous exposure to tadalafil when prescribing tadalafil tablets for once daily use, especially the potential for interactions with medications (e.g., nitrates, alpha-blockers, antihypertensives and potent inhibitors of cytochrome P450 3A4) and with substantial consumption of alcohol.

What can cause erectile dysfunction?

Limitation of study

[see Dosage and Administration (), Warnings and Precautions (5.6), Drug Interactions (, ), Clinical Pharmacology (), and Clinical Studies ()]. Physicians should advise patients who have an erection lasting greater than 4 hours, whether painful or not, to seek emergency medical attention.

• The medication can be taken with or without food.
• Common side effects include headache and flushing.
• Consult your doctor before starting tadalafil 5mg.

Physicians should advise patients to stop use of all PDE5 inhibitors, including tadalafil tablets, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a “crowded” optic tadalafil 20mg price disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including tadalafil tablets, for this uncommon condition [see Warnings and Precautions () and Adverse Reactions ()].

4.1 Nitrates

Patients should be counseled that concomitant use of tadalafil tablets with nitrates could cause blood pressure to suddenly drop to an unsafe level, resulting in dizziness, syncope, or even heart attack or stroke.Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of tadalafil tablets. Therefore, patients who experience anginal chest pain after taking tadalafil tablets should seek immediate medical attention [see Contraindications () and Warnings and Precautions (5.1)].17.2 Guanylate Cyclase (GC) StimulatorsPhysicians should discuss with patients the contraindication of tadalafil tablets with any use of a GC stimulator, such as riociguat, for pulmonary arterial hypertension. Patients should be counseled that the concomitant use of tadalafil tablets with GC stimulators may cause blood pressure to drop to an unsafe level.17.3 Cardiovascular ConsiderationsPhysicians should consider the potential cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Physicians should advise patients who experience symptoms upon initiation of sexual activity to refrain from further sexual activity and seek immediate medical attention [see Warnings and Precautions (5.1)].17.4 Concomitant Use with Drugs Which Lower Blood PressurePhysicians should discuss with patients the potential for tadalafil tablets to augment the blood-pressure-lowering effect of alpha-blockers, and antihypertensive medications [see Warnings and Precautions (5.6), Drug Interactions (), and Clinical Pharmacology ()].17.5 Potential for Drug Interactions When Taking Tadalafil Tablets for Once Daily UsePhysicians should discuss with patients the clinical implications of continuous exposure to tadalafil when prescribing tadalafil tablets for once daily use, especially the potential for interactions with medications (e.g., nitrates, alpha-blockers, antihypertensives and potent inhibitors of cytochrome P450 3A4) and with substantial consumption of alcohol. [see Dosage and Administration (), Warnings and Precautions (5.6), Drug Interactions (, ), Clinical Pharmacology (), and Clinical Studies ()].17.6 PriapismThere have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds.

Publisher’s Note

Physicians should advise patients who have an erection lasting greater than 4 hours, whether painful or not, to seek emergency medical attention.17.7 Sudden Loss of VisionPhysicians should advise patients to stop use of all PDE5 inhibitors, including tadalafil tablets, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision, including possible permanent loss of vision, that has been reported rarely postmarketing in temporal association with the use of all PDE5 inhibitors. Physicians should discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a “crowded” optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including tadalafil tablets, for this uncommon condition [see Warnings and Precautions () and Adverse Reactions ()].17.8 Sudden Hearing LossPhysicians should advise patients to stop taking PDE5 inhibitors, including tadalafil tablets, and seek prompt medical attention in the event of sudden decrease or loss of hearing. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Adverse Reactions (, )].17.9 AlcoholPatients should be made aware that both alcohol and tadalafil tablets, a PDE5 inhibitor, act as mild vasodilators. Therefore, physicians should inform patients that substantial consumption of alcohol (e.g., 5 units or greater) in combination with tadalafil tablets can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache [see Warnings and Precautions (), Drug Interactions (), and Clinical Pharmacology ()]. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV) should be considered. Physicians should instruct patients on the appropriate administration of tadalafil tablets to allow optimal use. For tadalafil tablets for use as needed in men with ED, patients should be instructed to take one tablet at least 30 minutes before anticipated sexual activity. In most patients, the ability to have sexual intercourse is improved for up to 36 hours.

• Use caution when operating vehicles after taking tadalafil.
• Report any persistent side effects to your healthcare provider.
• Tadalafil 5mg is not intended for use in women.

For tadalafil tablets for once daily use in men with ED or ED/BPH, patients should be instructed to take one tablet at approximately the same time every day without regard for the timing of sexual activity.

• Some people may experience nasal congestion or dizziness.
• Use caution when combining with other erectile dysfunction drugs.
• Always keep medication out of reach of children.

Tadalafil tablets are effective at improving erectile function over the course of therapy. For tadalafil tablets for once daily use in men with BPH, patients should be instructed to take one tablet at approximately the same time every day. PATIENT INFORMATION Tadalafil Tablets, USP(ta DAL a fil)Dispense with Patient Information available at: this important information before you start taking tadalafil tablets and each time you get a refill.

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For tadalafil tablets for use as needed in men with ED, patients should be instructed to take one tablet at least 30 minutes before anticipated sexual activity. In most patients, the ability to have sexual intercourse is improved for up to 36 hours. For tadalafil tablets for once daily use in men with ED or ED/BPH, patients should be instructed to take one tablet at approximately the same time every day without regard for the timing of sexual activity. Tadalafil tablets are effective at improving erectile function over the course of therapy. For tadalafil tablets for once daily use in men with BPH, patients should be instructed to take one tablet at approximately the same time every day.

Key takeaways

PATIENT INFORMATION Tadalafil Tablets, USP(ta DAL a fil)Dispense with Patient Information available at: this important information before you start taking tadalafil tablets and each time you get a refill.