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Patients with multiple co-morbid conditions such as erectile dysfunction,

Highlights of Prescribing Information

In Study K, the effect of tadalafil tablets 5 mg once daily on Q maxwas evaluated as a safety endpoint. Mean Q maxincreased from baseline in both the treatment and placebo groups (tadalafil tablets 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 tablets 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 46-86). diabetes mellitus, hypertension, and other cardiovascular disease were included.

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Tadalafil tablets with finasteride demonstrated statistically significant improvement in the signs and symptoms of BPH compared to placebo

• Tadalista Professional can interact with medications for blood pressure and prostate issues.
• Do not combine with recreational drugs, especially nitrates or poppers.
• Pregnant women should avoid handling or taking this medication.
• Men with pre-existing eye conditions should discuss risks with a doctor.
• Use caution if you have kidney or liver impairments.
• Always follow prescribed dosing schedules to prevent complications.

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

How Does Tadalafil 20 mg Work?

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 ( seeTable 18). Table 18: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in a Tadalafil tablets for Once Daily Use Study in ED Patients with Diabetes The efficacy and safety of tadalafil tablets 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 tablets 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 tablets 5 mg for once daily use or placebo.

14.4 Tadalafil tablets 5 mg for Once Daily Use for ED and BPH

The full study population was 87% pink pills for woman White, 2% Black, 11% other races; 15% was of Hicontentic 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 (Q max), an objective measure of urine flow, was assessed as a secondary efficacy endpoint in Study J and as a safety endpoint in Study K. tablets -4.0, placebo -2.3: p<.001) and the score remained decreased through 26 weeks (tadalafil tablets -5.5, placebo -4.5; p=.022).

• Consistent use of Tadalista Professional can lead to improved sexual confidence.
• Combining with therapy or counseling may provide better results for ED.
• Natural remedies and lifestyle changes can complement medication.
• Regular check-ups are recommended to monitor health status.
• The medication doesn’t protect against sexually transmitted infections.
• Use additional protection methods as necessary.

However, the magnitude of the treatment difference between

• Tadalista Professional is part of a class called PDE5 inhibitors.
• It helps relax blood vessels in the penile region for an erection.
• Over-the-counter purchase is illegal; a prescription is mandatory.
• Use of Tadalista can improve sexual confidence and address performance anxiety.
• It is not a cure for ED but a means to manage symptoms.
• Combining it with other ED medications without guidance is unsafe.

placebo/finasteride and tadalafil tablets/finasteride decreased from 1.7 points at

What special precautions should I follow?

The population was 86% White, 3% Black, 0.4% Hicontentic, and 10% of other ethnicities, and included patients with ED of various severities, etiologies (organic, psychogenic, mixed), and with multiple co-morbid conditions, including diabetes mellitus, hypertension, and other cardiovascular disease. Ninety-three percent of patients reported ED of at least 1-year duration. In each of these trials, conducted without regard to the timing of dose and sexual intercourse, tadalafil tablets demonstrated clinically meaningful and statistically significant improvement in erectile function, as measured by the EF domain of the blue pillmen IIEF questionnaire and Questions 2 and 3 of the SEP diary ( seeTable 17). When taken as directed, tadalafil tablets were effective at improving erectile function. In the 6 month double-blind study, the treatment effect of tadalafil tablets did not diminish over time.

1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia

Table 17: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in the Two Tadalafil tablets for Once Daily Use Studies aTwenty-four-week study conducted in the US. bTwelve-week study conducted outside the US. Efficacy Results in ED Patients with Diabetes Mellitus — Tadalafil tablets for once daily use was shown to be effective in treating ED in patients with diabetes mellitus. Patients with diabetes were included in both studies in the general ED population (N=79). A third randomized, multicenter, double-blinded, placebo-controlled, parallel-arm design trial included only ED patients with type 1 or type 2 diabetes (N=298). Week 4 to 1.0 point at Week 26, as shown in Table 20 and in Figure 7.

Mechanism Aspect	Description	Effect
PDE5 Inhibition	Blocks phosphodiesterase type 5 enzyme	Enhances blood flow to the penis
Smooth Muscle Relaxation	Relaxes vascular smooth muscles	Facilitates erection
Nitric Oxide Release	Promotes nitric oxide production	Initiates penile erection

The incremental benefit of tadalafil tablets beyond 26 weeks is unknown.

Pharmacist tips for Tadalafil (Cialis)

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 tablets 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 tablets 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 tablets for Once Daily Use Studies Figure 5: Mean IPSS Changes in BPH Patients by Visit in Study J Figure 6: Mean IPSS Changes in BPH Patients by Visit in Study K In Study J, the effect of tadalafil tablets 5 mg once daily on maximum urinary flow rate (Q max) was evaluated as a secondary efficacy endpoint. Mean Q maxincreased from baseline in both the treatment and placebo groups (tadalafil tablets 5 mg: 1.6 mL/sec, placebo: 1.2 mL/sec); however, these changes were not significantly different between groups. Table 20: Mean Total IPSS Changes in BPH Patients in a Tadalafil tablets for Once Daily Use Study

Storage Condition	Details	Shelf Life
Temperature	Store at room temperature (20-25°C)	Usually 2-3 years
Light & Moisture	Keep in a dry, cool place, away from light	Protect from humidity
Outdated medication	Do not use	Dispose properly

Together with Finasteride Figure 7: Mean Total IPSS Changes By Visit in BPH Patients Taking Tadalafil tablets for

• Tadalista Professional helps improve confidence by providing reliable erections.
• It does not cause spontaneous erections; sexual stimulation is still required.
• The medication is often preferred for its quick onset and long duration.
• It is not suitable for individuals with severe heart or liver problems.
• Possible drug interactions include nitrates and certain antihypertensives.
• Always follow your healthcare provider’s instructions for use and dosage.

Once Daily Use Together With Finasteride In the 404 patients who had both ED and BPH at baseline,

Available strengths and packaging for Tadalista Professional 20 mg Sublingual Tablet generic

The results demonstrated a difference between the placebo group and the tadalafil tablets group at each of the pre-specified timepoints. At the 24-hour timepoint, (more specifically, 22 to 26 hours), 53/144 (37%) patients reported at least 1 successful intercourse in the placebo group versus 84/138 (61%) in the tadalafil tablets 20-mg group. At the 36-hour timepoint (more specifically, 33 to 39 hours), 49/133 (37%) of patients reported at least 1 successful intercourse in the placebo group versus 88/137 (64%) in the tadalafil tablets 20-mg group. In the second of these studies, a total of 483 patients were evenly randomized to 1 of 6 groups: 3 different dosing groups (placebo, tadalafil tablets 10, or 20 mg) that were instructed to attempt intercourse at 2 different times (24 and 36 hours post-dosing). Patients were encouraged to make 4 separate attempts at their assigned dose and assigned timepoint.

Available Strengths

In this study, the results demonstrated a statistically significant difference between the placebo group and the tadalafil tablets groups at each of the pre-specified timepoints. At the 24-hour timepoint, the mean, per patient percentage of attempts resulting in successful intercourse were 42, 56, and 67% for the placebo, tadalafil tablets 10-, and 20-mg groups, respectively. At the 36-hour timepoint, the mean, per-patient percentage of attempts resulting in successful intercourse were 33, 56, and 62% for placebo, tadalafil tablets 10-, and 20-mg groups, respectively. The efficacy and safety of tadalafil tablets for once daily use in the treatment of erectile dysfunction has been evaluated in 2 clinical trials of 12-weeks duration and 1 clinical trial of 24-weeks duration, involving a total of 853 patients. Tadalafil tablets, when taken once daily, was shown to be effective in improving erectile function in men with erectile dysfunction (ED). changes in erectile function were assessed as key secondary endpoints using the EF domain of the IIEF questionnaire.

What other information should I know?

Tadalafil tablets were studied in the general ED population in 2 randomized, multicenter, double-blinded, placebo-controlled, parallel-arm design, primary efficacy and safety studies of 12- and 24-weeks duration, respectively. One of these studies was conducted in the United States and one was conducted in centers outside the US. An additional efficacy and safety study was performed in ED patients with diabetes mellitus. Tadalafil tablets were taken once daily at doses ranging from 2.5 to 10 mg. Food and alcohol intake were not restricted.

Frequently Asked Questions about Tadalista Professional

Timing of sexual activity was not restricted relative to when patients took tadalafil tablets. Results in General ED Population — The primary US efficacy and safety trial included a total of 287 patients, with a mean age of 59 years (range 25 to 82 years). The population was 86% White, 6% Black, 6% Hicontentic, and 2% of other ethnicities, and included patients with ED of various severities, etiologies (organic, psychogenic, mixed), and with multiple co-morbid conditions, including diabetes mellitus, hypertension, and other cardiovascular disease. Most (>96%) patients reported ED of at least 1-year duration. The primary efficacy and safety study conducted outside the US included 268 patients, with a mean age of 56 years (range 21 to 78 years).

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