5 WARNINGS AND PRECAUTIONS

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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How SuppliedTadalafil tablets USP 2.5 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘336’ on one side and plain on other side.NDC Number Size62332-177-30 bottle of 30 Tablets with child-resistant closure62332-177-71 bottle of 500 Tablets62332-177-91 bottle of 1000 Tablets62332-177-15 30 Tablets (2 blisters of 15 tablets)Tadalafil tablets USP 5 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘337’ on one side and plain on other side.NDC Number Size62332-178-30 bottle of 30 Tablets with child-resistant closure62332-178-71 bottle of 500 Tablets62332-178-91 bottle of 1000 Tablets62332-178-15 30 Tablets (2 blisters of 15 tablets)Tadalafil tablets USP 10 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘338’ on one side and plain on other side.NDC Number Size62332-179-30 bottle of 30 Tablets with child-resistant closure62332-179-71 bottle of 500 Tablets62332-179-91 bottle of 1000 TabletsTadalafil tablets USP 20 mg are yellow to light yellow, oval shaped, beveled edge, coated tablets debossed with ‘L339’ on one side and plain on other side.NDC Number Size62332-180-30 bottle of 30 Tablets with child-resistant closure62332-180-71 bottle of 500 Tablets62332-180-91 bottle of 1000 Tablets Tadalafil tablets USP 2.5 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘336’ on one side and plain on other side.

Ingredient Amount per Dose Purpose Notes
Tadalafil 20 mg Active ingredient, vasodilator Main component for ED
Microcrystalline Cellulose - Filler Binds ingredients
Magnesium Stearate - Excipient Improves pill stability
Titanium Dioxide - Coloring agent Provides yellow color

62332-177-30 bottle of 30 Tablets with child-resistant closure Tadalafil tablets USP 5 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘337’ on one side and plain on other side. 62332-178-30 bottle of 30 Tablets with child-resistant closure Tadalafil tablets USP 10 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘338’ on one side and plain on other side.

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62332-179-30 bottle of 30 Tablets with child-resistant closure Tadalafil tablets USP 20 mg are yellow to light yellow, oval shaped, beveled edge, coated tablets debossed with ‘L339’ on one side and plain on other side. 62332-180-30 bottle of 30 Tablets with child-resistant closure 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.

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Cialis Generic2.5mg90 + 6 Pills112.43€ 107.08€
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Cialis Original20mg64 + 4 Pills274.18€ 261.12€
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Cialis Generic2.5mg30 + 4 Pills51.95€ 49.48€
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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 10mg cialis price following intake of tadalafil tablets.

1.4 Limitation of Use

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How SuppliedTadalafil tablets USP 2.5 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘336’ on one side and plain on other side.NDC Number Size62332-177-30 bottle of 30 Tablets with child-resistant closure62332-177-71 bottle of 500 Tablets62332-177-91 bottle of 1000 Tablets62332-177-15 30 Tablets (2 blisters of 15 tablets)Tadalafil tablets USP 5 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘337’ on one side and plain on other side.NDC Number Size62332-178-30 bottle of 30 Tablets with child-resistant closure62332-178-71 bottle of 500 Tablets62332-178-91 bottle of 1000 Tablets62332-178-15 30 Tablets (2 blisters of 15 tablets)Tadalafil tablets USP 10 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘338’ on one side and plain on other side.NDC Number Size62332-179-30 bottle of 30 Tablets with child-resistant closure62332-179-71 bottle of 500 Tablets62332-179-91 bottle of 1000 TabletsTadalafil tablets USP 20 mg are yellow to light yellow, oval shaped, beveled edge, coated tablets debossed with ‘L339’ on one side and plain on other side.NDC Number Size62332-180-30 bottle of 30 Tablets with child-resistant closure62332-180-71 bottle of 500 Tablets62332-180-91 bottle of 1000 Tablets Tadalafil tablets USP 2.5 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘336’ on one side and plain on other side. 62332-177-30 bottle of 30 Tablets with child-resistant closure Tadalafil tablets USP 5 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘337’ on one side and plain on other side. 62332-178-30 bottle of 30 Tablets with child-resistant closure Tadalafil tablets USP 10 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘338’ on one side and plain on other side. 62332-179-30 bottle of 30 Tablets with child-resistant closure Tadalafil tablets USP 20 mg are yellow to light yellow, oval shaped, beveled edge, coated tablets debossed with ‘L339’ on one side and plain on other side. 62332-180-30 bottle of 30 Tablets with child-resistant closure 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.

Drinking alcohol

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 10mg cialis price following intake of tadalafil tablets. Therefore, patients who experience anginal chest pain after taking tadalafil tablets should seek immediate medical attention [see Contraindications (4.1) 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 (7.1), and Clinical Pharmacology (12.2)].17.5 Potential for Drug Interactions When Taking Tadalafil Tablet for Once Daily UsePhysicians should discuss with patients the clinical implications of continuous exposure to tadalafil when prescribing tadalafil tablet 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 (2.7), Warnings and Precautions (5.6), Drug Interactions (7.1, 7.2), Clinical Pharmacology (12.2), and Clinical Studies (14.2)].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.

What are the side effects of tadalafil (generic Cialis)?

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 chep cialis this uncommon condition [see Warnings and Precautions (5.4) and Adverse Reactions (6.2)].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 (6.1, 6.2)].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 (5.9), Drug Interactions (7.1), and Clinical Pharmacology (12.2)].17.10 Sexually Transmitted DiseaseThe use of tadalafil tablets offers no protection against sexually transmitted diseases. Therefore, patients who experience anginal chest pain after taking tadalafil tablets should seek immediate medical attention [see Contraindications (4.1) 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 (7.1), and Clinical Pharmacology (12.2)].17.5 Potential for Drug Interactions When Taking Tadalafil Tablet for Once Daily UsePhysicians should discuss with patients the clinical implications of continuous exposure to tadalafil when prescribing tadalafil tablet 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 (2.7), Warnings and Precautions (5.6), Drug Interactions (7.1, 7.2), Clinical Pharmacology (12.2), and Clinical Studies (14.2)].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.

5.7 Renal Impairment

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 tablet 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 tablet for once daily use in men with BPH, patients should be instructed to take one tablet at approximately the same time every day.Trademarks are the property of their respective owners.Manufactured by:Alembic Pharmaceuticals Limited(Formulation Division),Panelav 389350, Gujarat, IndiaManufactured for:Alembic Pharmaceuticals, Inc.Bedminster, NJ 07921, USARevised: 02/2025 “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 (4.1) and Warnings and Precautions (5.1)].

Patient resources

Physicians should discuss with patients the contraindication of tadalafil tablets with any use of a GC stimulator, such 20mg cialis pill 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. 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 (7.1), and Clinical Pharmacology (12.2)].

What should I tell my healthcare provider before using tadalafil?

Physicians should discuss with patients the clinical implications of continuous exposure to tadalafil when prescribing tadalafil tablet 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 (2.7), Warnings and Precautions (5.6), Drug Interactions (7.1, 7.2), Clinical Pharmacology (12.2), and Clinical Studies (14.2)]. 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 chep cialis this uncommon condition [see Warnings and Precautions (5.4) and Adverse Reactions (6.2)].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 (6.1, 6.2)].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 (5.9), Drug Interactions (7.1), and Clinical Pharmacology (12.2)].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.

8.4 Pediatric Use

Tadalafil: the science

How much to take

In most patients, the ability to have sexual intercourse is improved for up to 36 hours.For tadalafil tablet 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 tablet for once daily use in men with BPH, patients should be instructed to take one tablet at approximately the same time every day.Trademarks are the property of their respective owners.Manufactured by:Alembic Pharmaceuticals Limited(Formulation Division),Panelav 389350, Gujarat, IndiaManufactured for:Alembic Pharmaceuticals, Inc.Bedminster, NJ 07921, USARevised: 02/2025 “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 (4.1) and Warnings and Precautions (5.1)]. Physicians should discuss with patients the contraindication of tadalafil tablets with any use of a GC stimulator, such 20mg cialis pill 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.

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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 (7.1), and Clinical Pharmacology (12.2)]. Physicians should discuss with patients the clinical implications of continuous exposure to tadalafil when prescribing tadalafil tablet 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 (2.7), Warnings and Precautions (5.6), Drug Interactions (7.1, 7.2), Clinical Pharmacology (12.2), and Clinical Studies (14.2)].