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It’s recommended that you avoid tadalafil if you’re taking any of the following medications: Some categories of medications known to interact with tadalafil include: When taking tadalafil, it’s often recommended that you avoid grapefruit juice and minimize your use of tobacco or alcohol since they can interact with the medication. Discuss your tobacco and alcohol habits with your doctor before taking any type of PDE5 inhibitor. Tadalafil is the affordable, generic version of brand-name Cialis. Cialis was originally created and is produced by the pharmaceutical company Eli Lilly. Generic tadalafil became available in 2018 after the patent protection ended. Both brand-name Cialis and tadalafil have been shown to be safe and provide the same treatment effects for erectile dysfunction, but tadalafil is available for a fraction of the price of Cialis. The side effects of generic Cialis are similar to the side effects of Cialis. Rare, but very serious, side effects include low blood pressure, vision problems, and priapism. If you are experiencing any of these side effects, especially the more serious side effects, it is worth talking with your doctor as soon as possible to discuss your side effects. When tadalafil is taken as needed for ED, it can start working within 30 to 45 minutes. It typically reaches peak effect 2 hours after it’s taken. But in some cases, it can still be effective up to 36 hours after it was taken. Like other ED drugs that are taken as needed for ED, it must be taken in advance of when you plan to be sexually active to give it time to start working. There are several options to treat ED aside from oral medications like tadalafil, including: erectile dysfunction pump (penis or vacuum pump) sex therapy for emotional, psychological, and relationship issues related to ED Generic versions of Cialis have been available since 2018 under the name tadalafil. A long list of companies has been FDA approved to produce tadalafil for treating ED and BPH. Generic versions of Cialis that are FDA-approved are equally as effective and safe as brand-name Cialis. Generic versions are often less than half the cost. If you are a consumer or patient please visit this version. See full prescribing information for TADALAFIL TABLETS.TADALAFIL tablets, for oral administrationInitial U.S. Approval: 2003INDICATIONS AND USAGETadalafil tablets are phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%).

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( 1.1)DOSAGE AND ADMINISTRATIONDOSAGE FORMS AND STRENGTHSTablets (not scored): 20 mg ( 3).CONTRAINDICATIONSWARNINGS AND PRECAUTIONSHypotension: Carefully consider whether patients with certain underlying cardiovascular disease could be adversely affected by vasodilatory effects of tadalafil. Not recommended in patients with pulmonary veno-occlusive disease. ( 5.1, 5.2)Effects on the eye: Sudden loss of vision could be a sign of non-arteritic ischemic optic neuropathy (NAION) and may be permanent . ( 5.3)Hearing impairment: Cases buy cialis online no prescription canada of sudden decrease or loss of hearing have been reported with CIALIS.

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( 5.4)Concomitant PDE5 inhibitors: Avoid use with CIALIS or other PDE5 inhibitors.

Before Using

Hypotension: Carefully consider whether patients with certain underlying cardiovascular disease could be adversely affected by vasodilatory effects of tadalafil. Effects on the eye: Sudden loss of vision could be a sign of non-arteritic ischemic optic neuropathy (NAION) and may be permanent . Hearing impairment: Cases of sudden decrease or loss of hearing have been reported with CIALIS. Concomitant PDE5 inhibitors: Avoid use with CIALIS or other PDE5 inhibitors. Prolonged erection: Advise patients to seek emergency treatment if an erection lasts >4 hours.

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The most common adverse reaction is headache. To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. at 1-800-912-9561 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 INDICATIONS AND USAGE1.1 Pulmonary Arterial Hypertension2 DOSAGE AND ADMINISTRATION2.1 Pulmonary Arterial Hypertension2.2 Dose Adjustment in Renal Impairment2.3 Dose Adjustment in Hepatic Impairment2.4 Dose Adjustment for Use with Ritonavir3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Concomitant Organic Nitrates4.2 Concomitant Guanylate Cyclase (GC) Stimulators4.3 Hypersensitivity Reactions5 WARNINGS AND PRECAUTIONS5.1 Hypotension5.2 Worsening Pulmonary Vascular Occlusive Disease5.3 Visual Loss5.4 Hearing Impairment5.5 Combination with Other PDE5 Inhibitors5.6 Prolonged Erection6 ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Nitrates7.2 Alpha-Blockers7.3 Antihypertensives7.4 Alcohol7.5 CYP3A Inhibitors/Inducers8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.3 Females and Males of Reproductive Potential8.4 Pediatric Use8.5 Geriatric Use8.6 Renal Impairment8.7 Hepatic Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility13.2 Animal Toxicology and/or Pharmacology14 CLINICAL STUDIES14.1 Tadalafil tablets for Pulmonary Arterial Hypertension14.2 Long-Term Treatment of Pulmonary Arterial Hypertension16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied16.2 Storage17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed. 1 INDICATIONS AND USAGE 1.1 Pulmonary Arterial HypertensionTadalafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group generic cialis soft 20mg 1) to improve exercise ability.

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Tadalafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. 2 DOSAGE AND ADMINISTRATION 2.1 Pulmonary Arterial HypertensionThe recommended dose of Tadalafil tablets is 40 mg (two 20 mg tablets) taken once daily with or without food. Dividing the dose (40 mg) over the course of the day is not recommended.2.2 Dose Adjustment in Renal ImpairmentMild (creatinine clearance 51 to 80 mL/min) or moderate (creatinine clearance 31 to 50 mL/min): Start dosing at 20 mg once daily. Increase to 40 mg once daily based on individual tolerability.Severe (creatinine clearance <30 mL/min and on hemodialysis): Avoid use of tadalafil tablets because of increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis [see Use in Specific Populations ( 8.6)] .2.3 Dose Adjustment in Hepatic ImpairmentMild or moderate (Child Pugh Class A or B): Because of limited clinical experience in patients with mild to moderate hepatic cirrhosis, consider a starting dose of 20 mg once per day.Severe (Child Pugh Class C): Patients with severe hepatic cirrhosis have not been studied. Avoid use of tadalafil tablets [see Use in Specific Populations ( 8.7)] .2.4 Dose Adjustment for Use with RitonavirCo-administration of Tadalafil Tablets in Patients on RitonavirIn patients receiving ritonavir for at least one week, start tadalafil tablets at 20 mg once daily. ( 5.5)Prolonged erection: Advise patients to seek emergency treatment if an erection lasts >4 hours. ( 5.6)ADVERSE REACTIONSThe most common adverse reaction is headache. ( 6.1).To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. at 1-800-912-9561 or FDA at 1-800-FDA-1088 or IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 12/2025 Tadalafil tablets are phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Hypotension: Carefully consider whether patients with certain underlying cardiovascular disease could be adversely affected by vasodilatory effects of tadalafil. Effects on the eye: Sudden loss of vision could be a sign of non-arteritic ischemic optic neuropathy (NAION) and may be permanent . Hearing impairment: Cases of sudden decrease or loss of hearing have been reported with CIALIS. Concomitant PDE5 inhibitors: Avoid use with CIALIS or other PDE5 inhibitors. Prolonged erection: Advise patients to seek emergency treatment if an erection lasts >4 hours.

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The most common adverse reaction is headache. To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. at 1-800-912-9561 or FDA at 1-800-FDA-1088 or See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

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Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE1.1 Pulmonary Arterial Hypertension2 DOSAGE AND ADMINISTRATION2.1 Pulmonary Arterial Hypertension2.2 Dose Adjustment in Renal Impairment2.3 Dose Adjustment in Hepatic Impairment2.4 Dose Adjustment for Use with Ritonavir3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Concomitant Organic Nitrates4.2 Concomitant Guanylate Cyclase (GC) Stimulators4.3 Hypersensitivity Reactions5 WARNINGS AND PRECAUTIONS5.1 Hypotension5.2 Worsening Pulmonary Vascular Occlusive Disease5.3 Visual Loss5.4 Hearing Impairment5.5 Combination with Other PDE5 Inhibitors5.6 Prolonged Erection6 ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Nitrates7.2 Alpha-Blockers7.3 Antihypertensives7.4 Alcohol7.5 CYP3A Inhibitors/Inducers8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.3 Females and Males of Reproductive Potential8.4 Pediatric Use8.5 Geriatric Use8.6 Renal Impairment8.7 Hepatic Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility13.2 Animal Toxicology and/or Pharmacology14 CLINICAL STUDIES14.1 Tadalafil tablets for Pulmonary Arterial Hypertension14.2 Long-Term Treatment of Pulmonary Arterial Hypertension16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied16.2 Storage17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed. 1 INDICATIONS AND USAGE 1.1 Pulmonary Arterial HypertensionTadalafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group generic cialis soft 20mg 1) to improve exercise ability.

Key takeaways

Increase to 40 mg once daily based upon individual tolerability [see Drug Interactions ( 7.5) and Clinical Pharmacology ( 12.3)] .Co-administration of Ritonavir in Patients on Tadalafil TabletsAvoid use of tadalafil tablets during the initiation of ritonavir. Stop tadalafil tablets at least 24 hours prior to starting ritonavir. After at least one week following the initiation of ritonavir, resume tadalafil tablets at 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability [see Drug Interactions ( 7.5) and Clinical Pharmacology ( 12.3)] . The recommended dose of Tadalafil tablets is 40 mg (two 20 mg tablets) taken once daily with or without food.

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Dividing the dose (40 mg) over the course of the day is not recommended. Mild (creatinine clearance 51 to 80 mL/min) or moderate (creatinine clearance 31 to 50 mL/min): Start dosing at 20 mg once daily. Increase to 40 mg once daily based on individual tolerability. Severe (creatinine clearance <30 mL/min and on hemodialysis): Avoid use of tadalafil tablets because of increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis [see Use in Specific Populations ( 8.6)] . Mild or moderate (Child Pugh Class A or B): Because of limited clinical experience in patients with mild to moderate hepatic cirrhosis, consider a starting dose of 20 mg once per day.

Disease interaction

Severe (Child Pugh Class C): Patients with severe hepatic cirrhosis have not been studied. Avoid use of tadalafil tablets [see Use in Specific Populations ( 8.7)] . Co-administration of Tadalafil Tablets in Patients on Ritonavir In patients receiving ritonavir for at least one week, start tadalafil tablets at 20 mg once daily. Co-administration of Ritonavir in Patients on Tadalafil Tablets Avoid use of tadalafil tablets during the initiation of ritonavir. 4 CONTRAINDICATIONS 4.1 Concomitant Organic NitratesTadalafil is contraindicated in patients who are using any form of organic nitrate, either regularly or intermittently. Tadalafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability.

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

2 DOSAGE AND ADMINISTRATION 2.1 Pulmonary Arterial HypertensionThe recommended dose of Tadalafil tablets is 40 mg (two 20 mg tablets) taken once daily with or without food.

1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia

Dividing the dose (40 mg) over the course of the day is not recommended.2.2 Dose Adjustment in Renal ImpairmentMild (creatinine clearance 51 to 80 mL/min) or moderate (creatinine clearance 31 to 50 mL/min): Start dosing at 20 mg once daily. Increase to 40 mg once daily based on individual tolerability.Severe (creatinine clearance <30 mL/min and on hemodialysis): Avoid use of tadalafil tablets because of increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis [see Use in Specific Populations ( 8.6)] .2.3 Dose Adjustment in Hepatic ImpairmentMild or moderate (Child Pugh Class A or B): Because of limited clinical experience in patients with mild to moderate hepatic cirrhosis, consider a starting dose of 20 mg once per day.Severe (Child Pugh Class C): Patients with severe hepatic cirrhosis have not been studied. Avoid use of tadalafil tablets [see Use in Specific Populations ( 8.7)] .2.4 Dose Adjustment for Use with RitonavirCo-administration of Tadalafil Tablets in Patients on RitonavirIn patients receiving ritonavir for at least one week, start tadalafil tablets at 20 mg once daily.

Cialis Precautions

Increase to 40 mg once daily based upon individual tolerability [see Drug Interactions ( 7.5) and Clinical Pharmacology ( 12.3)] .Co-administration of Ritonavir in Patients on Tadalafil TabletsAvoid use of tadalafil tablets during the initiation of ritonavir. Stop tadalafil tablets at least 24 hours prior to starting ritonavir. After at least one week following the initiation of ritonavir, resume tadalafil tablets at 20 mg once daily.

Understanding ED

Generic versions of Cialis that are FDA-approved are equally as effective and safe as brand-name Cialis. Generic versions are often less than half the cost. If you are a consumer or patient please visit this version. See full prescribing information for TADALAFIL TABLETS.TADALAFIL tablets, for oral administrationInitial U.S. Approval: 2003INDICATIONS AND USAGETadalafil tablets are phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability.

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Studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%). ( 1.1)DOSAGE AND ADMINISTRATIONDOSAGE FORMS AND STRENGTHSTablets (not scored): 20 mg ( 3).CONTRAINDICATIONSWARNINGS AND PRECAUTIONSHypotension: Carefully consider whether patients with certain underlying cardiovascular disease could be adversely affected by vasodilatory effects of tadalafil. Not recommended in patients with pulmonary veno-occlusive disease. ( 5.1, 5.2)Effects on the eye: Sudden loss of vision could be a sign of non-arteritic ischemic optic neuropathy (NAION) and may be permanent . ( 5.3)Hearing impairment: Cases buy cialis online no prescription canada of sudden decrease or loss of hearing have been reported with CIALIS.

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( 5.4)Concomitant PDE5 inhibitors: Avoid use with CIALIS or other PDE5 inhibitors. ( 5.5)Prolonged erection: Advise patients to seek emergency treatment if an erection lasts >4 hours. ( 5.6)ADVERSE REACTIONSThe most common adverse reaction is headache. ( 6.1).To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. at 1-800-912-9561 or FDA at 1-800-FDA-1088 or IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 12/2025 Tadalafil tablets are phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Increase to 40 mg once daily based upon individual tolerability [see Drug Interactions ( 7.5) and Clinical Pharmacology ( 12.3)] . The recommended dose of Tadalafil tablets is 40 mg (two 20 mg tablets) taken once daily with or without food. Dividing the dose (40 mg) over the course of the day is not recommended. Mild (creatinine clearance 51 to 80 mL/min) or moderate (creatinine clearance 31 to 50 mL/min): Start dosing at 20 mg once daily. Increase to 40 mg once daily based on individual tolerability. Severe (creatinine clearance <30 mL/min and on hemodialysis): Avoid use of tadalafil tablets because of increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis [see Use in Specific Populations ( 8.6)] . Mild or moderate (Child Pugh Class A or B): Because of limited clinical experience in patients with mild to moderate hepatic cirrhosis, consider a starting dose of 20 mg once per day.

Potential for Interaction

It’s recommended that you avoid tadalafil if you’re taking any of the following medications: Some categories of medications known to interact with tadalafil include: When taking tadalafil, it’s often recommended that you avoid grapefruit juice and minimize your use of tobacco or alcohol since they can interact with the medication. Discuss your tobacco and alcohol habits with your doctor before taking any type of PDE5 inhibitor. Tadalafil is the affordable, generic version of brand-name Cialis. Cialis was originally created and is produced by the pharmaceutical company Eli Lilly. Generic tadalafil became available in 2018 after the patent protection ended.

Check with your doctor if you have or have had:

Both brand-name Cialis and tadalafil have been shown to be safe and provide the same treatment effects for erectile dysfunction, but tadalafil is available for a fraction of the price of Cialis. The side effects of generic Cialis are similar to the side effects of Cialis. Rare, but very serious, side effects include low blood pressure, vision problems, and priapism. If you are experiencing any of these side effects, especially the more serious side effects, it is worth talking with your doctor as soon as possible to discuss your side effects. When tadalafil is taken as needed for ED, it can start working within 30 to 45 minutes.

If you take too much CIALIS

It typically reaches peak effect 2 hours after it’s taken. But in some cases, it can still be effective up to 36 hours after it was taken. Like other ED drugs that are taken as needed for ED, it must be taken in advance of when you plan to be sexually active to give it time to start working. There are several options to treat ED aside from oral medications like tadalafil, including: erectile dysfunction pump (penis or vacuum pump) sex therapy for emotional, psychological, and relationship issues related to ED Generic versions of Cialis have been available since 2018 under the name tadalafil. A long list of companies has been FDA approved to produce tadalafil for treating ED and BPH. Severe (Child Pugh Class C): Patients with severe hepatic cirrhosis have not been studied. Avoid use of tadalafil tablets [see Use in Specific Populations ( 8.7)] . Co-administration of Tadalafil Tablets in Patients on Ritonavir In patients receiving ritonavir for at least one week, start tadalafil tablets at 20 mg once daily. Co-administration of Ritonavir in Patients on Tadalafil Tablets Avoid use of tadalafil tablets during the initiation of ritonavir. 4 CONTRAINDICATIONS 4.1 Concomitant Organic NitratesTadalafil is contraindicated in patients who are using any form of organic nitrate, either regularly or intermittently.