Tadalista was administered to over 9000 men during clinical trials worldwide. 5.14 Consideration of Other Urological Conditions Prior to Initiating Treatment for BPH. 5.13 Counseling Patients About Sexually Transmitted Diseases.

TADALISTA has not been administered to patients with bleeding disorders or significant active peptic ulceration. When administered in combination with aspirin, Tadalista 20 mg did not prolong bleeding time, relative to aspirin alone. Because of insufficient information in patients with severe hepatic impairment, use of TADALISTA in this group is not recommended see Use in Specific Populations ( 8.6 ).

Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor. Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers. 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 ).

Neither the rare postmarketing reports, nor the association of PDE5 inhibitor use and NAION in the observational studies, substantiate a causal relationship between PDE5 inhibitor use and NAION see Adverse Reactions ( 6.2 ). A similar study reported a consistent result, with a risk estimate of 2.27 (95% CI 0.99, 5.20). TADALISTA should be used with caution in patients who have conditions that might predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia), or in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie’s disease).

5.2 Potential for Drug Interactions When Taking TADALISTA for Once Daily Use. Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis see Adverse Reactions ( 6.2 ). Mild or moderate (Child Pugh Class A or B): The dose should not exceed 10 mg once per day.

Creatinine clearance less than 30 mL/min or on hemodialysis: TADALISTA for once daily use is not recommended see Warnings and Precautions ( 5.7 ) and Use in Specific Populations ( 8.7 ). Creatinine clearance less than 30 mL/min or on hemodialysis: The maximum dose is 5 mg not more than once in every 72 hours see Warnings and Precautions ( 5.7 ) and Use in Specific Populations ( 8.7 ). 2.3 TADALISTA for Once Daily Use for Benign Prostatic Hyperplasia.

1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia. TADALISTA for use as needed: no more than 10 mg every 72 hours. TADALISTA can potentiate the hypotensive effects of nitrates, alpha-blockers, antihypertensives or alcohol ( 7.1 ).

Patients should stop TADALISTA and seek prompt medical attention in the event of sudden decrease or loss of hearing ( 5.5 ). TADALISTA should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION.