TADALAFIL 5MG TEVA x28 Tablets

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019.

13.2 Animal Toxicology and/or Pharmacology

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. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment. Early birth safer for mother and baby in high blood pressure pregnancies 21 May 2026Planned early birth for pregnant women with high blood pressure cuts maternal complications by nearly half and reduces the risk of stillbirth, without increasing the likelihood of caesarean section, according to a new Cochrane review.

Outcome measures

Planned early birth for pregnant women with high blood pressure cuts maternal complications by nearly half and reduces the risk of stillbirth, without increasing the likelihood of caesarean section, according to a new Cochrane review. From evidence to impact: how Cochrane Thailand is turning research into practice 18 May 2026Discover the role Cochrane Thailand has played in closing the gap between evidence and outcomes. Designated as a WHO Collaborating Centre for Research Synthesis in Reproductive Health, the group has not only generated Cochrane reviews but has also translated those findings into national policy and clinical guidelines. Discover the role Cochrane Thailand has played in closing the gap between evidence and outcomes. Screening modestly reduces prostate cancer deaths 11 May 2026Blood tests to detect potential signs of prostate cancer likely reduce the risk of dying from prostate cancer, an updated Cochrane review finds. 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. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment. Early birth safer for mother and baby in high blood pressure pregnancies 21 May 2026Planned early birth for pregnant women with high blood pressure cuts maternal complications by nearly half and reduces the risk of stillbirth, without increasing the likelihood of caesarean section, according to a new Cochrane review.

What are Tadalafil Tablets

Once daily use is not recommended.See 17 for PATIENT COUNSELING INFORMATION.Revised: 6/2023 Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: (1) the signs and symptoms of benign prostatic hyperplasia (BPH) () ED and the signs and symptoms of BPH (ED/BPH) () If tadalafil tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks (). ED: Starting dose: 10 mg as needed prior to sexual activity. Not to be taken more than once per day (). ED: 2.5 mg taken once daily, without regard to timing of sexual activity. May increase to 5 mg based upon efficacy and tolerability ().

What are the serious side effects of tadalafil?

BPH: 5 mg, taken at approximately the same time every day () ED and BPH: 5 mg, taken at approximately the same time every day (, ) Tadalafil tablets may be taken without regard to food (). Administration of tadalafil tablets to patients using any form of organic nitrate is contraindicated. Tadalafil tablets were shown to potentiate the hypotensive effect of nitrates (). History of known serious hypersensitivity reaction to tadalafil tablets or ADCIRCA® (). Administration with guanylate cyclase (GC) stimulators, such as riociguat (). Planned early birth for pregnant women with high blood pressure cuts maternal complications by nearly half and reduces the risk of stillbirth, without increasing the likelihood of caesarean section, according to a new Cochrane review. From evidence to impact: how Cochrane Thailand is turning research into practice 18 May 2026Discover the role Cochrane Thailand has played in closing the gap between evidence and outcomes. Designated as a WHO Collaborating Centre for Research Synthesis in Reproductive Health, the group has not only generated Cochrane reviews but has also translated those findings into national policy and clinical guidelines. Discover the role Cochrane Thailand has played in closing the gap between evidence and outcomes. Screening modestly reduces prostate cancer deaths 11 May 2026Blood tests to detect potential signs of prostate cancer likely reduce the risk of dying from prostate cancer, an updated Cochrane review finds. This is a shift from the previous version of the review. Blood tests to detect potential signs of prostate cancer likely reduce the risk of dying from prostate cancer, an updated Cochrane review finds. If you are a consumer or patient please visit this version. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS.TADALAFIL tablets for oral use.Initial U.S. Approval: 2003RECENT MAJOR CHANGESWarnings and Precautions () 05/2017INDICATIONS AND USAGETadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: (1)•erectile dysfunction (ED) ()•the signs and symptoms of benign prostatic hyperplasia (BPH) ()•ED and the signs and symptoms of BPH (ED/BPH) ()If tadalafil tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks (). (1)DOSAGE AND ADMINISTRATION•Tadalafil tablets for use as needed:•ED: Starting dose: 10 mg as needed prior to sexual activity. Increase to 20 mg or decrease to 5 mg based upon efficacy/tolerability.

Brand Name

May increase to 5 mg based upon efficacy and tolerability ().•BPH: 5 mg, taken at approximately the same time every day ()•ED and BPH: 5 mg, taken at approximately the same time every day (, )•Tadalafil tablets may be taken without regard to food ().DOSAGE FORMS AND STRENGTHSTablets: 2.5 mg, 5 mg, 10 mg, 20 mg (). (3)CONTRAINDICATIONS•Administration of tadalafil tablets to patients using any form of organic nitrate is contraindicated. Tadalafil tablets were shown to potentiate the hypotensive effect of nitrates ().•History of known serious hypersensitivity reaction to tadalafil tablets or ADCIRCA® ().•Administration with guanylate cyclase (GC) stimulators, such as riociguat ().WARNINGS AND PRECAUTIONS•Patients should not use tadalafil tablets if sex is inadvisable due to cardiovascular status (5.1).•Use of tadalafil tablets with alpha-blockers, antihypertensives or substantial amounts of alcohol (≥5 units) may lead to hypotension (5.6, ).•Tadalafil tablets are not recommended in combination with alpha-blockers for the treatment of BPH because efficacy of the combination has not been adequately studied and because of the risk of blood pressure lowering. Caution is advised when tadalafil tablets are used as a treatment for ED in men taking alpha-blockers. (, 5.6, , )•Patients should seek emergency treatment if an erection lasts >4 hours.

Benign prostatic hyperplasia

Use tadalafil tablets with caution in patients predisposed to priapism ().•Patients should stop tadalafil tablets and seek medical care if a sudden erectile dysfunction pills tadalafil loss of vision occurs in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). Tadalafil tablets should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a “crowded” optic disc may also be at an increased risk of NAION (, ).•Patients should stop tadalafil tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing ().•Prior to initiating treatment with tadalafil tablets for BPH, consideration should be given to other urological conditions that may cause similar symptoms ().ADVERSE REACTIONSDRUG INTERACTIONS•Tadalafil tablets can potentiate the hypotensive effects of nitrates, alpha-blockers, antihypertensives or alcohol ().•CYP3A4 inhibitors (e.g. ketoconazole, ritonavir) increase tadalafil tablets exposure (, , ) requiring dose adjustment:•Tadalafil tablets for use as needed: no more than 10 mg every 72 hours•Tadalafil tablets for once daily use: dose not to exceed 2.5 mg•CYP3A4 inducers (e.g. rifampin) decrease tadalafil tablets exposure ().USE IN SPECIFIC POPULATIONSHepatic Impairment (2.6, , ):•Mild or Moderate: Dosage adjustment may be needed.•Severe: Use is not recommended.Renal Impairment (2.6, , ):•Patients with creatinine clearance 30 to 50 mL/min: Dosage adjustment may be needed.•Patients with creatinine clearance less than 30 mL/min or on hemodialysis: For use as needed: Dose should not exceed 5 mg every 72 hours. Improves erectile function compared to placebo up to 36 hours post dose. Not to be taken more than tadacip 20 mg tadalafil once per day ().•Tadalafil tablets for once daily use:•ED: 2.5 mg taken once daily, without regard to timing of sexual activity. May increase to 5 mg based upon efficacy and tolerability ().•BPH: 5 mg, taken at approximately the same time every day ()•ED and BPH: 5 mg, taken at approximately the same time every day (, )•Tadalafil tablets may be taken without regard to food ().DOSAGE FORMS AND STRENGTHSTablets: 2.5 mg, 5 mg, 10 mg, 20 mg ().

5.10 Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4)

News The First "Mab" Biotech Pharmaceutical to be Locally Manufactured in Türkiye Will Bear the Mark of AbdiBio from the Cellular Level

(3)CONTRAINDICATIONS•Administration of tadalafil tablets to patients using any form of organic nitrate is contraindicated. Tadalafil tablets were shown to potentiate the hypotensive effect of nitrates ().•History of known serious hypersensitivity reaction to tadalafil tablets or ADCIRCA® ().•Administration with guanylate cyclase (GC) stimulators, such as riociguat ().WARNINGS AND PRECAUTIONS•Patients should not use tadalafil tablets if sex is inadvisable due to cardiovascular status (5.1).•Use of tadalafil tablets with alpha-blockers, antihypertensives or substantial amounts of alcohol (≥5 units) may lead to hypotension (5.6, ).•Tadalafil tablets are not recommended in combination with alpha-blockers for the treatment of BPH because efficacy of the combination has not been adequately studied and because of the risk of blood pressure lowering.

Caution is advised when tadalafil tablets are used as a treatment for ED in men taking alpha-blockers. (, 5.6, , )•Patients should seek emergency treatment if an erection lasts >4 hours. Use tadalafil tablets with caution in patients predisposed to priapism ().•Patients should stop tadalafil tablets and seek medical care if a sudden erectile dysfunction pills tadalafil loss of vision occurs in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). Tadalafil tablets should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION.

• 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 with a “crowded” optic disc may also be at an increased risk of NAION (, ).•Patients should stop tadalafil tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing ().•Prior to initiating treatment with tadalafil tablets for BPH, consideration should be given to other urological conditions that may cause similar symptoms ().ADVERSE REACTIONSDRUG INTERACTIONS•Tadalafil tablets can potentiate the hypotensive effects of nitrates, alpha-blockers, antihypertensives or alcohol ().•CYP3A4 inhibitors (e.g. ketoconazole, ritonavir) increase tadalafil tablets exposure (, , ) requiring dose adjustment:•Tadalafil tablets for use as needed: no more than 10 mg every 72 hours•Tadalafil tablets for once daily use: dose not to exceed 2.5 mg•CYP3A4 inducers (e.g. rifampin) decrease tadalafil tablets exposure ().USE IN SPECIFIC POPULATIONSHepatic Impairment (2.6, , ):•Mild or Moderate: Dosage adjustment may be needed.•Severe: Use is not recommended.Renal Impairment (2.6, , ):•Patients with creatinine clearance 30 to 50 mL/min: Dosage adjustment may be needed.•Patients with creatinine clearance less than 30 mL/min or on hemodialysis: For use as needed: Dose should not exceed 5 mg every 72 hours. Once daily use is not recommended.See 17 for PATIENT COUNSELING INFORMATION.Revised: 6/2023 Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: (1) the signs and symptoms of benign prostatic hyperplasia (BPH) () ED and the signs and symptoms of BPH (ED/BPH) () If tadalafil tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks (). ED: Starting dose: 10 mg as needed prior to sexual activity. Not to be taken more than once per day ().

17.4 Concomitant Use with Drugs Which Lower Blood Pressure

This is a shift from the previous version of the review. Blood tests to detect potential signs of prostate cancer likely reduce the risk of dying from prostate cancer, an updated Cochrane review finds. If you are a consumer or patient please visit this version. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS.TADALAFIL tablets for oral use.Initial U.S.

Tadalafil form

Approval: 2003RECENT MAJOR CHANGESWarnings and Precautions () 05/2017INDICATIONS AND USAGETadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: (1)•erectile dysfunction (ED) ()•the signs and symptoms of benign prostatic hyperplasia (BPH) ()•ED and the signs and symptoms of BPH (ED/BPH) ()If tadalafil tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks (). (1)DOSAGE AND ADMINISTRATION•Tadalafil tablets for use as needed:•ED: Starting dose: 10 mg as needed prior to sexual activity. Increase to 20 mg or decrease to 5 mg based upon efficacy/tolerability. Improves erectile function compared to placebo up to 36 hours post dose. Not to be taken more than tadacip 20 mg tadalafil once per day ().•Tadalafil tablets for once daily use:•ED: 2.5 mg taken once daily, without regard to timing of sexual activity. ED: 2.5 mg taken once daily, without regard to timing of sexual activity. May increase to 5 mg based upon efficacy and tolerability (). BPH: 5 mg, taken at approximately the same time every day () ED and BPH: 5 mg, taken at approximately the same time every day (, ) Tadalafil tablets may be taken without regard to food (). Administration of tadalafil tablets to patients using any form of organic nitrate is contraindicated.

• In rare cases, tadalafil can cause vision changes.
• Allergic reactions may include rash, swelling, or difficulty breathing.
• Seek medical advice if side effects are severe or persistent.

Tadalafil tablets were shown to potentiate the hypotensive effect of nitrates (). History of known serious hypersensitivity reaction to tadalafil tablets or ADCIRCA® (). Administration with guanylate cyclase (GC) stimulators, such as riociguat (). Patients should not use tadalafil tablets if sex is inadvisable due to cardiovascular status (5.1).

Author information

Patients should not use tadalafil tablets if sex is inadvisable due to cardiovascular status (5.1). Use of tadalafil tablets with alpha-blockers, antihypertensives or substantial amounts of alcohol (≥5 units) may lead to hypotension (5.6, ). Tadalafil tablets are not recommended in combination with alpha-blockers for the treatment of BPH because efficacy of the combination has not been adequately studied and because of the risk of blood pressure lowering. Patients should seek emergency treatment if an erection lasts >4 hours. Use tadalafil tadalafil 2 5 mg tablets with caution in patients predisposed to priapism ().

News Abdi İbrahim Receives 'Equal Opportunity Model' Certificate for Women's Employment

Patients should stop tadalafil tablets and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). Patients with a “crowded” optic disc may also be at an increased risk of NAION (, ). Patients should stop tadalafil tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing (). Prior to initiating treatment with tadalafil tablets for BPH, consideration should be given to other urological conditions that may cause similar symptoms (). Tadalafil tablets can potentiate the hypotensive effects of nitrates, alpha-blockers, antihypertensives or alcohol (). Use of tadalafil tablets with alpha-blockers, antihypertensives or substantial amounts of alcohol (≥5 units) may lead to hypotension (5.6, ). Tadalafil tablets are not recommended in combination with alpha-blockers for the treatment of BPH because efficacy of the combination has not been adequately studied and because of the risk of blood pressure lowering.

• Tadalafil 5mg has a duration of action up to 36 hours.
• It can improve spontaneous sexual activity.
• Dosage adjustments may be necessary for certain health conditions.

Patients should seek emergency treatment if an erection lasts >4 hours. Use tadalafil tadalafil 2 5 mg tablets with caution in patients predisposed to priapism (). Patients should stop tadalafil tablets and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). Patients with a “crowded” optic disc may also be at an increased risk of NAION (, ). Patients should stop tadalafil tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing (). Prior to initiating treatment with tadalafil tablets for BPH, consideration should be given to other urological conditions that may cause similar symptoms (). Tadalafil tablets can potentiate the hypotensive effects of nitrates, alpha-blockers, antihypertensives or alcohol (). ketoconazole, ritonavir) increase tadalafil tablets exposure (, , ) requiring dose adjustment: Tadalafil tablets for use as needed: no more than 10 mg every 72 hours Tadalafil tablets for once daily use: dose not to exceed 2.5 mg Mild or Moderate: Dosage adjustment may be needed.

8.1 Pregnancy

ketoconazole, ritonavir) increase tadalafil tablets exposure (, , ) requiring dose adjustment: Tadalafil tablets for use as needed: no more than 10 mg every 72 hours Tadalafil tablets for once daily use: dose not to exceed 2.5 mg Mild or Moderate: Dosage adjustment may be needed. Patients with creatinine clearance 30 to 50 mL/min: Dosage adjustment may be needed. Patients with creatinine clearance less than 30 mL/min or on hemodialysis: For use as needed: Dose should not exceed 5 mg every 72 hours. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE1.1 Erectile Dysfunction1.2 Benign Prostatic Hyperplasia1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia1.4 Limitation of Use2 DOSAGE AND ADMINISTRATION2.1 Tadalafil Tablets for Use as Needed for Erectile Dysfunction2.2 Tadalafil Tablets for Once Daily Use for Erectile Dysfunction2.3 Tadalafil Tablets for Once Daily Use for Benign Prostatic Hyperplasia2.4 Tadalafil Tablets for Once Daily Use for Erectile Dysfunction and Benign Prostatic Hyperplasia2.5 Use with Food2.6 Use in Specific Populations2.7 Concomitant Medications3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Nitrates4.2 Hypersensitivity Reactions4.3 Concomitant Guanylate Cyclase (GC) Stimulators5 WARNINGS AND PRECAUTIONS5.1 Cardiovascular5.2 Potential for Drug Interactions When Taking Tadalafil Tablets for Once Daily Use5.3 Prolonged Erection5.4 Effects on the Eye5.5 Sudden Hearing Loss5.6 Alpha-blockers and Antihypertensives5.7 Renal Impairment5.8 Hepatic Impairment5.9 Alcohol5.10 Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4)5.11 Combination with Other PDE5 Inhibitors or Erectile Dysfunction Therapies5.12 Effects on Bleeding5.13 Counseling Patients About Sexually Transmitted Diseases5.14 Consideration of Other Urological Conditions Prior to Initiating Treatment for BPH6 ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Potential for Pharmacodynamic Interactions with Tadalafil Tablets7.2 Potential for Other Drugs to Affect Tadalafil Tablets7.3 Potential for Tadalafil Tablets to Affect Other Drugs8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.3 Females and Males of Reproductive Potential8.4 Pediatric Use8.5 Geriatric Use8.6 Hepatic Impairment8.7 Renal 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 Use as Needed for ED14.2 Tadalafil Tablets for Once Daily Use for ED14.3 Tadalafil Tablets 5 mg for Once Daily Use for Benign Prostatic Hyperplasia (BPH)14.4 Tadalafil Tablets 5 mg for Once Daily Use for ED and BPH16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied16.2 Storage17 PATIENT COUNSELING INFORMATION17.1 Nitrates17.2 Guanylate Cyclase (GC) Stimulators17.3 Cardiovascular Considerations17.4 Concomitant Use with Drugs Which Lower Blood Pressure17.5 Potential for Drug Interactions When Taking Tadalafil Tablets for Once Daily Use17.6 Priapism17.7 Sudden Loss of Vision17.8 Sudden Hearing Loss17.9 Alcohol17.10 Sexually Transmitted Disease17.11 Recommended Administration*Sections or subsections omitted from the full prescribing information are not listed.

Impact of patient characteristics and comorbidities on erectile function and treatment satisfaction during treatment with tadalafil OaD

Patients with creatinine clearance 30 to 50 mL/min: Dosage adjustment may be needed.

Patients with creatinine clearance less than 30 mL/min or on hemodialysis: For use as needed: Dose should not exceed 5 mg every 72 hours. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE1.1 Erectile Dysfunction1.2 Benign Prostatic Hyperplasia1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia1.4 Limitation of Use2 DOSAGE AND ADMINISTRATION2.1 Tadalafil Tablets for Use as Needed for Erectile Dysfunction2.2 Tadalafil Tablets for Once Daily Use for Erectile Dysfunction2.3 Tadalafil Tablets for Once Daily Use for Benign Prostatic Hyperplasia2.4 Tadalafil Tablets for Once Daily Use for Erectile Dysfunction and Benign Prostatic Hyperplasia2.5 Use with Food2.6 Use in Specific Populations2.7 Concomitant Medications3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Nitrates4.2 Hypersensitivity Reactions4.3 Concomitant Guanylate Cyclase (GC) Stimulators5 WARNINGS AND PRECAUTIONS5.1 Cardiovascular5.2 Potential for Drug Interactions When Taking Tadalafil Tablets for Once Daily Use5.3 Prolonged Erection5.4 Effects on the Eye5.5 Sudden Hearing Loss5.6 Alpha-blockers and Antihypertensives5.7 Renal Impairment5.8 Hepatic Impairment5.9 Alcohol5.10 Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4)5.11 Combination with Other PDE5 Inhibitors or Erectile Dysfunction Therapies5.12 Effects on Bleeding5.13 Counseling Patients About Sexually Transmitted Diseases5.14 Consideration of Other Urological Conditions Prior to Initiating Treatment for BPH6 ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Potential for Pharmacodynamic Interactions with Tadalafil Tablets7.2 Potential for Other Drugs to Affect Tadalafil Tablets7.3 Potential for Tadalafil Tablets to Affect Other Drugs8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.3 Females and Males of Reproductive Potential8.4 Pediatric Use8.5 Geriatric Use8.6 Hepatic Impairment8.7 Renal 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 Use as Needed for ED14.2 Tadalafil Tablets for Once Daily Use for ED14.3 Tadalafil Tablets 5 mg for Once Daily Use for Benign Prostatic Hyperplasia (BPH)14.4 Tadalafil Tablets 5 mg for Once Daily Use for ED and BPH16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied16.2 Storage17 PATIENT COUNSELING INFORMATION17.1 Nitrates17.2 Guanylate Cyclase (GC) Stimulators17.3 Cardiovascular Considerations17.4 Concomitant Use with Drugs Which Lower Blood Pressure17.5 Potential for Drug Interactions When Taking Tadalafil Tablets for Once Daily Use17.6 Priapism17.7 Sudden Loss of Vision17.8 Sudden Hearing Loss17.9 Alcohol17.10 Sexually Transmitted Disease17.11 Recommended Administration*Sections or subsections omitted from the full prescribing information are not listed.

• Overdose signs include painful erections lasting over 4 hours.
• Seek immediate medical attention if overdose is suspected.
• Follow dosage directions strictly to avoid complications.