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The incremental benefit of tadalafil tablets beyond 26 weeks is unknown. Table 20: Mean Total IPSS Changes in BPH Patients in a Tadalafil Tablets for Once Daily Use Study Together with Finasteride Figure 7: Mean Total IPSS Changes By Visit in BPH Patients Taking Tadalafil Tablets for Once Daily Use Together With Finasteride In the 404 patients who had both ED and BPH at baseline, changes in erectile function were assessed as key secondary endpoints using the EF domain of the IIEF questionnaire. A statistically significant improvement from baseline (tadalafil tablets/finasteride 13.7, placebo/finasteride 15.1) was observed at week 4 (tadalafil tablets/finasteride 3.7, placebo/finasteride -1.1; p<.001), week 12 (tadalafil tablets/finasteride 4.7, placebo/finasteride 0.6; p<.001), and week 26 (tadalafil tablets/finasteride 4.7, placebo/finasteride 0.0; p<.001).

Side Effects

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.

Benign prostatic hyperplasia

“See FDA-approved patient labeling (Patient Information)” Physicians should discuss with patients the contraindication of tadalafil 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. Patients should be counseled that the concomitant use of tadalafil tablets with GC stimulators may cause blood pressure to drop to an unsafe level. The efficacy and safety of tadalafil tablets for once daily use for the treatment of ED, and the signs and symptoms of BPH, in patients with both conditions was evaluated in one placebo-controlled, multinational, double-blind, parallel-arm study which randomized 606 patients to receive either tadalafil tablets 2.5 mg, 5 mg, for once daily use or placebo. In this study, the co-primary endpoints were total IPSS and the Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF). The efficacy results for patients with both ED and BPH, who received either tadalafil tablets 5 mg for once daily use or placebo (N=408) are shown in Tables 21 and 22 and Figure 8. Tadalafil tablets 5 mg for once daily use resulted in statistically significant improvements in the total IPSS and in the EF domain of the IIEF questionnaire. Tadalafil tablets 2.5 mg did not result in statistically significant improvement in the total IPSS. Table 21: Mean IPSS and IIEF EF Domain Changes in the Tadalafil Tablets 5 mg for Once Daily Use Study in Patients with ED and BPH Table 22: Mean SEP Question 3 Changes in the Tadalafil Tablets 5 mg for Once Daily Use Study in Patients with ED and BPH Tadalafil tablets for once daily use resulted in improvement in the IPSS total score at the first scheduled observation (week 2) and throughout the 12 weeks of treatment (see Figure 8). Figure 8: Mean IPSS Changes in ED/BPH Patients by Visit in Study L In this study, the effect of tadalafil tablets 5 mg once daily on Qmax was evaluated as a safety endpoint. 17 PATIENT COUNSELING INFORMATION “See FDA-approved patient labeling (Patient Information)”17.1 NitratesPhysicians should discuss with patients the contraindication of tadalafil tablets with regular and/or intermittent use of organic nitrates.

• Do not take tadalafil 5mg with nitrate medications.
• Alcohol may increase side effects or reduce effectiveness.
• Store at room temperature, away from moisture and heat.

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.

• Tadalafil 5mg is primarily used to treat erectile dysfunction.
• It works by relaxing blood vessels in the penis.
• Typically taken once daily for ongoing management.

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 tadalafil over the counter uk 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.

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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.

5.12 Effects on Bleeding

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.

• 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.

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.

Side Effect	Frequency	Severity	Additional Comments
Headache	Common	Mild	Usually resolves spontaneously
Indigestion	Common	Mild	May be reduced with food
Back Pain	Less common	Mild	Usually occurs with higher doses
Flushing	Common	Mild	Redness of face and neck
Dizziness	Less common	Moderate	Avoid driving if affected

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.

What It Contains

17 PATIENT COUNSELING INFORMATION “See FDA-approved patient labeling (Patient Information)”17.1 NitratesPhysicians should discuss with patients the contraindication of tadalafil 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.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 tadalafil over the counter uk 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 should I do if I miss a dose of tadalafil?

[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. 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. 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.

Drug Class	Interaction Effect	Notes
Nitrates	Severe hypotension	Contraindicated
Alpha-blockers	Additive blood pressure lowering	Use caution, monitor BP
CYP3A4 inhibitors	Increased tadalafil levels	Dose adjustment may be needed
Antibiotics (e.g., erythromycin)	Potential increased levels	Monitor for side effects
Other PDE5 inhibitors	Possible additive effects	Do not combine

“See FDA-approved patient labeling (Patient Information)” Physicians should discuss with patients the contraindication of tadalafil tablets with regular and/or intermittent use of organic nitrates.

• The drug is available by prescription only.
• It is essential to discuss health history with your doctor.
• Not suitable for individuals with certain eye or heart conditions.

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)].

1.4 Limitation of Use

Physicians should discuss with patients the contraindication of tadalafil tablets with any use of a GC stimulator, such as riociguat, for pulmonary arterial hypertension.

17.10 Sexually Transmitted Disease

The incremental benefit of tadalafil tablets beyond 26 weeks is unknown. Table 20: Mean Total IPSS Changes in BPH Patients in a Tadalafil Tablets for Once Daily Use Study Together with Finasteride Figure 7: Mean Total IPSS Changes By Visit in BPH Patients Taking Tadalafil Tablets for Once Daily Use Together With Finasteride In the 404 patients who had both ED and BPH at baseline, changes in erectile function were assessed as key secondary endpoints using the EF domain of the IIEF questionnaire. A statistically significant improvement from baseline (tadalafil tablets/finasteride 13.7, placebo/finasteride 15.1) was observed at week 4 (tadalafil tablets/finasteride 3.7, placebo/finasteride -1.1; p<.001), week 12 (tadalafil tablets/finasteride 4.7, placebo/finasteride 0.6; p<.001), and week 26 (tadalafil tablets/finasteride 4.7, placebo/finasteride 0.0; p<.001). The efficacy and safety of tadalafil tablets for once daily use for the treatment of ED, and the signs and symptoms of BPH, in patients with both conditions was evaluated in one placebo-controlled, multinational, double-blind, parallel-arm study which randomized 606 patients to receive either tadalafil tablets 2.5 mg, 5 mg, for once daily use or placebo. In this study, the co-primary endpoints were total IPSS and the Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF).

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The efficacy results for patients with both ED and BPH, who received either tadalafil tablets 5 mg for once daily use or placebo (N=408) are shown in Tables 21 and 22 and Figure 8. Tadalafil tablets 5 mg for once daily use resulted in statistically significant improvements in the total IPSS and in the EF domain of the IIEF questionnaire. Tadalafil tablets 2.5 mg did not result in statistically significant improvement in the total IPSS. Table 21: Mean IPSS and IIEF EF Domain Changes in the Tadalafil Tablets 5 mg for Once Daily Use Study in Patients with ED and BPH Table 22: Mean SEP Question 3 Changes in the Tadalafil Tablets 5 mg for Once Daily Use Study in Patients with ED and BPH Tadalafil tablets for once daily use resulted in improvement in the IPSS total score at the first scheduled observation (week 2) and throughout the 12 weeks of treatment (see Figure 8). Figure 8: Mean IPSS Changes in ED/BPH Patients by Visit in Study L In this study, the effect of tadalafil tablets 5 mg once daily on Qmax was evaluated as a safety endpoint. Patients should be counseled that the concomitant use of tadalafil tablets with GC stimulators may cause blood pressure to drop to an unsafe level.

Available Strengths & Forms

Physicians should consider the potential cardiac risk of sexual activity in patients with preexisting cardiovascular disease.

Aspect	Details
Recommended Dose	5 mg once daily
Timing of Dose	With or without food, same time daily
Missed Dose	Take as soon as remembered, do not double dose
Duration of Use	As prescribed, typically long-term
Overdose	Seek medical attention; symptoms may include headache, dizziness

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.

GPhC Regulated Pharmacy

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.

Product ACETYLSALICYLIC ACID /100 mg Enteric Coated Tablet

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