In this third trial, tadalafil tablets demonstrated clinically meaningful and statistically significant improvement in erectile function, as measured by the EF domain of the IIEF questionnaire and Questions 2 and 3 of the SEP diary (see Table 18).Table 18: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in a Tadalafil Tablet for Once Daily Use Study in ED Patients with Diabetesa Statistically significantly different from placebo.14.3 Tadalafil Tablet 5 mg for Once Daily Use for Benign Prostatic Hyperplasia (BPH)The efficacy and safety of tadalafil tablet for once daily use for the treatment of the signs and symptoms of BPH was evaluated in 3 randomized, multinational, double-blinded, placebo-controlled, parallel-design, efficacy and safety studies of 12 weeks duration. Two of these studies were in men with BPH and one study was specific to men with both ED and BPH [see Clinical Studies (14.4)]. The first study (Study J) randomized 1058 patients to receive either tadalafil tablet 2.5 mg, 5 mg, 10 mg or 20 mg for once daily use or placebo. The second study (Study K) randomized 325 patients to receive either tadalafil tablet 5 mg for once daily use or placebo. The full study population was 87% White, 2% Black, 11% other races; 15% was of Hispanic ethnicity. Patients with multiple co-morbid conditions such as diabetes mellitus, hypertension, and other cardiovascular disease were included.The primary efficacy endpoint in the two studies that evaluated the effect of tadalafil tablets for the signs and symptoms of BPH was the International Prostate Symptom Score (IPSS), a four week recall questionnaire that was administered at the beginning and end of a placebo run-in period and subsequently at follow-up visits after randomization. The IPSS assesses the severity of irritative (frequency, urgency, nocturia) and obstructive symptoms (incomplete emptying, stopping and starting, weak stream, and pushing or straining), with scores ranging from 0 to 35; higher numeric scores representing greater severity. Maximum urinary flow rate (Qmax), an objective measure of urine flow, was assessed as a secondary efficacy endpoint in Study J and as a safety endpoint in Study K.The results for BPH patients with moderate to severe symptoms and a mean age of 63.2 years (range 44 to 87) who received either tadalafil tablet 5 mg for once daily use or placebo (N=748) in Studies J and K are shown in Table 19 and Figures 5 and 6, respectively.In each of these 2 trials, tadalafil tablet 5 mg for once daily use resulted in statistically significant improvement in the total IPSS compared to placebo. Mean total IPSS showed a decrease starting at the first scheduled observation (4 weeks) in Study K and remained decreased through 12 weeks.Table 19: Mean IPSS Changes in BPH Patients in Two Tadalafil Tablet for Once Daily Use StudiesIn Study J, the effect of tadalafil tablet 5 mg once daily on maximum urinary flow rate (Qmax) was evaluated as a secondary efficacy endpoint. Mean Qmax increased from baseline in both the treatment and placebo groups (tadalafil tablet 5 mg: 1.6 mL/sec, placebo: 1.2 mL/sec); however, these changes were not significantly different between groups.In Study K, the effect of tadalafil tablet 5 mg once daily on Qmax was evaluated as a safety endpoint.

The color yellow helps distinguish Viagra pills from other ED medications.
Some yellow Viagra tablets are designed for extended-release effects.
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Mean Qmax increased from baseline in both the treatment and placebo groups (tadalafil tablet 5 mg: 1.6 mL/sec, placebo: 1.1 mL/sec); however, these changes were not significantly different between groups.Efficacy Results in Patients with BPH initiating Tadalafil Tablets and Finasteride – Tadalafil tablet for once daily use initiated together with finasteride was shown to be effective in treating the signs and symptoms of BPH in men with an enlarged prostate (>30 cc) for up to 26 weeks. This additional double-blinded, parallel-design study of 26 weeks duration randomized 696 men to initiate either tadalafil tablets 5 mg with finasteride 5 mg or placebo with finasteride 5 mg. The study population had a mean age of 64 years (range 46 to 86). Patients with multiple co-morbid conditions such as erectile dysfunction, diabetes mellitus, hypertension, and other cardiovascular disease were included.Tadalafil tablets with finasteride demonstrated statistically significant improvement in the signs and symptoms of BPH compared to placebo with finasteride, as measured by the total IPSS at 12 weeks, the primary study endpoint (see Table 20). Key secondary endpoints demonstrated improvement in total IPSS starting at the first scheduled observation at week 4 (tadalafil tablets -4, placebo -2.3: p<0.001) and the score remained decreased through 26 weeks (tadalafil tablets -5.5, placebo -4.5; p=0.022).

Side Effect	Severity	Common Symptoms	Frequency	Recommended Action
Headache	Mild	Throbbing head	Common	Hydrate, rest
Flushing	Mild	Warm sensation	Common	Cooling measures
Dizziness	Moderate	Lightheadedness	Less common	Sit or lie down
Vision Changes	Mild	Blur or blue tint	Less common	Seek medical help if persistent

Side effects of Tadalafil (Cialis)

However, the magnitude of the treatment difference between placebo/finasteride and tadalafil tablets/finasteride decreased from 1.7 points at Week 4 to 1 point at Week 26, as shown in Table 20 and in Figure 7. The incremental benefit of tadalafil tablets beyond 26 weeks is unknown.Table 20: Mean Total IPSS Changes in BPH Patients in a Tadalafil Tablet for Once Daily Use Study Together with FinasterideaOverall ITT population.bMixed model for repeated measurements.cUnadjusted mean.In the 404 patients who had both ED and BPH at baseline, changes in erectile function were assessed as key secondary endpoints using the EF domain of the IIEF questionnaire. Tadalafil tablets with finasteride (N=203) was compared to placebo with finasteride (N=201). A statistically significant improvement from baseline (tadalafil tablets /finasteride 13.7, placebo/finasteride 15.1) was observed at week 4 (tadalafil tablets/finasteride 3.7, placebo/finasteride -1.1; p<0.001), week 12 (tadalafil tablets/finasteride 4.7, placebo/finasteride 0.6; p<0.001), and week 26 (tadalafil tablets/finasteride 4.7, placebo/finasteride 0; p<0.001).14.4 Tadalafil Tablet 5 mg for Once Daily Use for ED and BPHThe 50mg viagra efficacy and safety of tadalafil tablet for once daily use for the treatment of ED, and the signs and symptoms of BPH, in patients with both conditions was evaluated in one placebo-controlled, multinational, double-blind, parallel-arm study which randomized 606 patients to receive either tadalafil tablet 2.5 mg, 5 mg, for once daily use or placebo. ED severity ranged from mild to severe and BPH severity ranged from moderate to severe.

What is tadalafil used for?

The full study population had a mean age of 63 years (range 45 to 83) and was 93% White, 4% Black, 3% other races; 16% were of Hispanic ethnicity. Patients with multiple co-morbid conditions such as diabetes mellitus, hypertension, and other cardiovascular disease were included.In this study, the co-primary endpoints were total IPSS and the Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF). One of the key secondary endpoints in this study was Question 3 of the Sexual Encounter Profile diary (SEP3). Timing of sexual activity was not restricted relative to when patients took tadalafil tablets.The efficacy results for patients with both ED and BPH, who received either tadalafil tablet 5 mg for once daily use or placebo (N=408) are shown in Tables 21 and 22 and Figure 8.Tadalafil tablet 5 mg for once daily use resulted in statistically significant improvements in the total IPSS and in the EF domain of the IIEF questionnaire. Tadalafil tablet 5 mg for once daily use also resulted in statistically significant improvement in SEP3.

What should I know about tadalafil before using it?

Tadalafil tablets 2.5 mg did not result in statistically significant improvement in the total IPSS.Table 21: Mean IPSS and IIEF EF Domain Changes in the Tadalafil Tablet 5 mg for Once Daily Use Study in Patients with ED and BPHTable 22: Mean SEP Question 3 Changes in the Tadalafil Tablet 5 mg for Once Daily Use Study in Patients with ED and BPHTadalafil tablet for once daily use resulted in improvement in the IPSS total score at the first scheduled observation (week 2) and throughout the 12 weeks of treatment (see Figure 8).In this study, the effect of tadalafil tablet 5 mg once daily on Qmax was evaluated as a safety endpoint. Mean Qmax increased from baseline in both the treatment and placebo groups (tadalafil tablet 5 mg: 1.6 mL/sec, placebo: 1.2 mL/sec); however, these changes were not significantly different between groups. The efficacy and safety of tadalafil in the treatment of erectile dysfunction has been evaluated in 22 clinical trials of up to 24-weeks duration, involving over 4000 patients. Tadalafil tablets, when taken as needed up to once per day, was shown to be effective in improving erectile function in men with erectile dysfunction (ED). Tadalafil tablets were studied in the general ED population in 7 randomized, multicenter, double-blinded, placebo-controlled, parallel-arm design, primary efficacy and safety studies of 12-weeks duration. A statistically significant improvement from baseline (tadalafil tablets /finasteride 13.7, placebo/finasteride 15.1) was observed at week 4 (tadalafil tablets/finasteride 3.7, placebo/finasteride -1.1; p<0.001), week 12 (tadalafil tablets/finasteride 4.7, placebo/finasteride 0.6; p<0.001), and week 26 (tadalafil tablets/finasteride 4.7, placebo/finasteride 0; p<0.001).14.4 Tadalafil Tablet 5 mg for Once Daily Use for ED and BPHThe 50mg viagra efficacy and safety of tadalafil tablet for once daily use for the treatment of ED, and the signs and symptoms of BPH, in patients with both conditions was evaluated in one placebo-controlled, multinational, double-blind, parallel-arm study which randomized 606 patients to receive either tadalafil tablet 2.5 mg, 5 mg, for once daily use or placebo. ED severity ranged from mild to severe and BPH severity ranged from moderate to severe. The full study population had a mean age of 63 years (range 45 to 83) and was 93% White, 4% Black, 3% other races; 16% were of Hispanic ethnicity. Patients with multiple co-morbid conditions such as diabetes mellitus, hypertension, and other cardiovascular disease were included.In this study, the co-primary endpoints were total IPSS and the Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF). One of the key secondary endpoints in this study was Question 3 of the Sexual Encounter Profile diary (SEP3). Timing of sexual activity was not restricted relative to when patients took tadalafil tablets.The efficacy results for patients with both ED and BPH, who received either tadalafil tablet 5 mg for once daily use or placebo (N=408) are shown in Tables 21 and 22 and Figure 8.Tadalafil tablet 5 mg for once daily use resulted in statistically significant improvements in the total IPSS and in the EF domain of the IIEF questionnaire.

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Tadalafil tablet 5 mg for once daily use also resulted in statistically significant improvement in SEP3.

Brand Name	Dosage (mg)	Appearance	Active Ingredient
Viagra Yellow	50	Oval, yellow	Sildenafil Citrate
SuperYellow	100	Round, bright yellow	Sildenafil Citrate
YellowMax	25	Triangular, pale yellow	Sildenafil Citrate
GoldYellow	50	Oval, shiny yellow	Sildenafil Citrate

5.4 Hearing Loss

Additional efficacy and safety studies were performed in ED patients with diabetes mellitus and in patients who developed ED status post bilateral nerve-sparing radical prostatectomy. In these 7 trials, tadalafil tablets were taken as needed, at doses ranging from 2.5 mg to 20 mg, up to once per day. Food and alcohol intake were not restricted. Several assessment tools were used to evaluate the effect of tadalafil tablets on erectile function. SEP Question 2 asks, “Were you able to insert your penis into the partner’s vagina?” SEP Question 3 asks, “Did your erection last long enough for you to have successful intercourse?” The overall percentage of successful attempts to insert the penis into the vagina (SEP2) and to maintain the erection for successful intercourse (SEP3) is derived for each patient.

What should I do if I accidentally use too much tadalafil?

Results in ED Population in US Trials - The 2 primary US efficacy and safety trials included a total of 402 men with erectile dysfunction, with a mean age of 59 years (range 27 to 87 years). The treatment effect of tadalafil tablets did not diminish over time. Table 11: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in the Two Primary US Trials Results in General ED Population in Trials Outside the US - The 5 primary efficacy and safety studies conducted in the general ED population outside the US included 1112 patients, with a mean age of 59 years (range 21 to 82 years).

Does tadalafil interact with other medicines (drug interactions)?

The efficacy and safety of tadalafil in the treatment of erectile dysfunction has been evaluated in 22 clinical trials of up to 24-weeks duration, involving over 4000 patients.

2.4 Tadalafil Tablet for Once Daily Use for Erectile Dysfunction and Benign Prostatic Hyperplasia

What are the serious side effects of tadalafil?

Patients with multiple co-morbid conditions such as diabetes mellitus, hypertension, and other cardiovascular disease were included.The primary efficacy endpoint in the two studies that evaluated the effect of tadalafil tablets for the signs and symptoms of BPH was the International Prostate Symptom Score (IPSS), a four week recall questionnaire that was administered at the beginning and end of a placebo run-in period and subsequently at follow-up visits after randomization. The IPSS assesses the severity of irritative (frequency, urgency, nocturia) and obstructive symptoms (incomplete emptying, stopping and starting, weak stream, and pushing or straining), with scores ranging from 0 to 35; higher numeric scores representing greater severity. Maximum urinary flow rate (Qmax), an objective measure of urine flow, was assessed as a secondary efficacy endpoint in Study J and as a safety endpoint in Study K.The results for BPH patients with moderate to severe symptoms and a mean age of 63.2 years (range 44 to 87) who received either tadalafil tablet 5 mg for once daily use or placebo (N=748) in Studies J and K are shown in Table 19 and Figures 5 and 6, respectively.In each of these 2 trials, tadalafil tablet 5 mg for once daily use resulted in statistically significant improvement in the total IPSS compared to placebo. Mean total IPSS showed a decrease starting at the first scheduled observation (4 weeks) in Study K and remained decreased through 12 weeks.Table 19: Mean IPSS Changes in BPH Patients in Two Tadalafil Tablet for Once Daily Use StudiesIn Study J, the effect of tadalafil tablet 5 mg once daily on maximum urinary flow rate (Qmax) was evaluated as a secondary efficacy endpoint. Mean Qmax increased from baseline in both the treatment and placebo groups (tadalafil tablet 5 mg: 1.6 mL/sec, placebo: 1.2 mL/sec); however, these changes were not significantly different between groups.In Study K, the effect of tadalafil tablet 5 mg once daily on Qmax was evaluated as a safety endpoint.

Recreational use

The yellow Viagra pill may have different branding depending on the manufacturer.
It works by increasing blood flow to the penis during sexual arousal.
Common side effects include headaches, flushing, and nasal congestion.
Do not take the yellow Viagra pill with nitrates or certain heart medications.
The onset of action for Viagra is typically 30 to 60 minutes after ingestion.
It should not be taken more than once per day to avoid overdose.

5.9 Counseling Patients About Sexually Transmitted Diseases

The treatment effect of tadalafil tablets did not diminish over time. Table 11: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in the Two Primary US Trials Results in General ED Population in Trials Outside the US - The 5 primary efficacy and safety studies conducted in the general ED population outside the US included 1112 patients, with a mean age of 59 years (range 21 to 82 years).

Yellow Viagra should be stored out of reach of children and pets.
It is not suitable for use in individuals with severe hypotension or stroke history.
The medication can cause priapism, a prolonged erection that requires medical attention.
Do not take yellow Viagra if you are allergic to sildenafil or other ingredients.
The pill's nutritional compatibility is generally unaffected by diet unless high-fat.
Discontinue use and seek medical help if adverse reactions occur.

T20 Pill: yellow, oval, 13mm