Overall, approximately 0.5% of all subjects treated with TADALISTA for on demand use discontinued treatment as a consequence of back pain/myalgia. In general, pain was reported as mild or moderate in severity and resolved without medical treatment, but severe back pain was reported with a low frequency (<5% of all reports). The back pain/myalgia associated with Tadalista treatment was characterized by diffuse bilateral lower lumbar , gluteal , thigh, or thoracolumbar muscular discomfort and was exacerbated by recumbency.

Back pain or myalgia was reported at incidence rates described in Tables 1 through 4. In Tadalista clinical pharmacology trials, back pain or myalgia generally occurred 12 to 24 hours after dosing and typically resolved within 48 hours. Adverse reactions leading to discontinuation reported by at least 2 patients treated with Tadalista included headache, upper abdominal pain, and myalgia. In three placebo-controlled clinical trials of 12 weeks duration, two in patients with BPH and one in patients with ED and BPH, the mean age was 63 years (range 44 to 93) and the discontinuation rate due to adverse events in patients treated with Tadalista was 3.6% compared to 1.6% in placebo-treated patients.

TADALISTA For Once Daily Use For BPH And For ED And BPH. In three placebo-controlled clinical trials of 12 or 24 weeks duration, mean age was 58 years (range 21 to 82) and the discontinuation rate due to adverse events in patients treated with Tadalista was 4.1%, compared to 2.8% in placebotreated patients. TADALISTA For Once Daily Use For ED.

In eight primary placebo-controlled clinical studies of 12 weeks duration, mean age was 59 years (range 22 to 88) and the discontinuation rate due to adverse events in patients treated with Tadalista 10 or 20 mg was 3.1%, compared to 1.4% in placebo treated patients. In trials of TADALISTA for once daily use, a total of 1434, 905, and 115 were treated for at least 6 months, 1 year, and 2 years, respectively. TADALISTA (Tadalista) is supplied as follows:

Mild or moderate (Child Pugh Class A or B): The dose should not exceed 10 mg once per day. Benign Prostatic Hyperplasia and Erectile Dysfunction/Benign Prostatic Hyperplasia. Creatinine clearance less than 30 mL/min or on hemodialysis: TADALISTA for once daily use is not recommended see WARNINGS AND PRECAUTIONS and Use In Specific Populations.

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 and Use In Specific Populations. TADALISTA For Once Daily Use For Benign Prostatic Hyperplasia. Therefore, when advising patients on optimal use of TADALISTA, this should be taken into consideration.

The maximum recommended dosing frequency is once per day in most patients. Do not split TADALISTA tablets; entire dose should be taken. If TADALISTA is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of TADALISTA decreases from 4 weeks until 26 weeks, and the incremental benefit of TADALISTA beyond 26 weeks is unknown see Clinical Studies.
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm
http://www.webmd.com/erectile-dysfunction/guide/drugs-linked-erectile-dysfunction
http://time.com/money/4462919/prescription-drug-prices-too-high/
http://www.everydayhealth.com/pictures/lifestyle-changes-natural-treatments-erectile-dysfunction/
http://tadalista.fr/tadalista-40-mg.html