BOSTAFIL 20

DOSAGE AND ADMINISTRATION
Dosage
Erectile Dysfunction in Adult Men:

The recommended dose is 10 mg taken prior to anticipated sexual activity.

For patients who do not achieve satisfactory results with the 10 mg dose, the 20 mg dose may be used. It may be taken at least 30 minutes before sexual activity.

The maximum recommended dosing frequency is once per day.

Tadalafil 10 mg and 20 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.

For patients who anticipate frequent use of BOSTAFIL (e.g., at least twice weekly), a once-daily regimen with the lowest dose might be considered, based on patient choice and physician judgment.

In these patients, the recommended dose is 5 mg once daily, taken at the same time each day. The dose may be decreased to 2.5 mg once daily based on individual tolerability.

The appropriateness of continued use of the daily regimen should be reassessed periodically.

Benign Prostatic Hyperplasia in Adult Men (tadalafil 5 mg only):

The recommended dose is 5 mg taken at the same time each day, with or without food. For adult men who are being treated for both benign prostatic hyperplasia and erectile dysfunction, the recommended dose is 5 mg taken at the same time each day. Patients who cannot tolerate the 5 mg dose of tadalafil for the treatment of benign prostatic hyperplasia should consider alternative therapy, as the efficacy of tadalafil 2.5 mg for this condition has not been demonstrated.

Special Populations:

Elderly Men:
No dose adjustment is required for elderly patients.

Men with Renal Impairment:
No dose adjustment is necessary for patients with mild to moderate renal impairment. For patients with severe renal impairment, the maximum recommended dose is 10 mg.

Tadalafil 2.5 mg or 5 mg once daily is not recommended for treating erectile dysfunction or benign prostatic hyperplasia in patients with severe renal impairment (see sections "Warnings and Precautions" and "Pharmacodynamics").

Men with Hepatic Impairment:

For the treatment of erectile dysfunction (on-demand dosing), the recommended dose of BOSTAFIL is 10 mg taken prior to anticipated sexual activity, with or without food. Clinical data on the safety of BOSTAFIL in patients with severe hepatic impairment (Child-Pugh Class C) is limited; if prescribed, the physician must carefully consider the individual benefits/risks.

There is no available data on the use of tadalafil in doses higher than 10 mg in patients with severe hepatic impairment.

The use of once-daily tadalafil for the treatment of erectile dysfunction or benign prostatic hyperplasia in patients with hepatic impairment has not been evaluated; therefore, if prescribed, the physician must carefully consider the individual benefits/risks (see sections "Warnings and Precautions" and "Pharmacodynamics").

Men with Diabetes:
No dose adjustment is required for patients with diabetes.

Pediatrics:
BOSTAFIL is not indicated for the treatment of erectile dysfunction in children.

Administration:
For oral use, with or without food.

4. CONTRAINDICATIONS

Hypersensitivity to tadalafil or any of the excipients.

Concomitant use of nitrates: Tadalafil has been shown to augment the hypotensive effects of nitrates. This is presumed to be due to the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway. Therefore, the use of BOSTAFIL with organic nitrates in any form is contraindicated.

BOSTAFIL should not be used in men with cardiovascular conditions for whom sexual activity is not advised. Physicians should consider the potential cardiac risks of sexual activity in patients with pre-existing cardiovascular disease.

The following groups of patients with cardiovascular disease were not included in clinical trials and, therefore, the use of tadalafil is contraindicated:

Patients who have had a myocardial infarction within the last 90 days.

Patients with unstable angina or angina occurring during sexual intercourse.

Patients with New York Heart Association (NYHA) Class 2 heart failure or greater in the past 6 months.

Patients with uncontrolled arrhythmias, hypotension (< 90/50 mmHg), or uncontrolled hypertension.

Patients who have had a stroke within the last 6 months.

BOSTAFIL is contraindicated in patients with loss of vision in one eye due to non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection with previous PDE5 inhibitor exposure (see "Warnings and Precautions").

Concomitant use with guanylate cyclase stimulators (e.g., riociguat) is contraindicated due to the potential risk of symptomatic hypotension (see "Drug Interactions").

INSTRUCTIONS FOR USE:

DOSAGE AND ADMINISTRATION
Dosage
Erectile Dysfunction in Adult Men:

The recommended dose is 10 mg taken prior to anticipated sexual activity.

For patients who do not achieve satisfactory results with the 10 mg dose, the 20 mg dose may be used. It may be taken at least 30 minutes before sexual activity.

The maximum recommended dosing frequency is once per day.

Tadalafil 10 mg and 20 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.

For patients who anticipate frequent use of BOSTAFIL (e.g., at least twice weekly), a once-daily regimen with the lowest dose might be considered, based on patient choice and physician judgment.

In these patients, the recommended dose is 5 mg once daily, taken at the same time each day. The dose may be decreased to 2.5 mg once daily based on individual tolerability.

The appropriateness of continued use of the daily regimen should be reassessed periodically.

Benign Prostatic Hyperplasia in Adult Men (tadalafil 5 mg only):

The recommended dose is 5 mg taken at the same time each day, with or without food. For adult men who are being treated for both benign prostatic hyperplasia and erectile dysfunction, the recommended dose is 5 mg taken at the same time each day. Patients who cannot tolerate the 5 mg dose of tadalafil for the treatment of benign prostatic hyperplasia should consider alternative therapy, as the efficacy of tadalafil 2.5 mg for this condition has not been demonstrated.

Special Populations:

Elderly Men:
No dose adjustment is required for elderly patients.

Men with Renal Impairment:
No dose adjustment is necessary for patients with mild to moderate renal impairment. For patients with severe renal impairment, the maximum recommended dose is 10 mg.

Tadalafil 2.5 mg or 5 mg once daily is not recommended for treating erectile dysfunction or benign prostatic hyperplasia in patients with severe renal impairment (see sections "Warnings and Precautions" and "Pharmacodynamics").

Men with Hepatic Impairment:

For the treatment of erectile dysfunction (on-demand dosing), the recommended dose of BOSTAFIL is 10 mg taken prior to anticipated sexual activity, with or without food. Clinical data on the safety of BOSTAFIL in patients with severe hepatic impairment (Child-Pugh Class C) is limited; if prescribed, the physician must carefully consider the individual benefits/risks.

There is no available data on the use of tadalafil in doses higher than 10 mg in patients with severe hepatic impairment.

The use of once-daily tadalafil for the treatment of erectile dysfunction or benign prostatic hyperplasia in patients with hepatic impairment has not been evaluated; therefore, if prescribed, the physician must carefully consider the individual benefits/risks (see sections "Warnings and Precautions" and "Pharmacodynamics").

Men with Diabetes:
No dose adjustment is required for patients with diabetes.

Pediatrics:
BOSTAFIL is not indicated for the treatment of erectile dysfunction in children.

Administration:
For oral use, with or without food.

CONTRAINDICATIONS

Hypersensitivity to tadalafil or any of the excipients.

Concomitant use of nitrates: Tadalafil has been shown to augment the hypotensive effects of nitrates. This is presumed to be due to the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway. Therefore, the use of BOSTAFIL with organic nitrates in any form is contraindicated.

BOSTAFIL should not be used in men with cardiovascular conditions for whom sexual activity is not advised. Physicians should consider the potential cardiac risks of sexual activity in patients with pre-existing cardiovascular disease.

The following groups of patients with cardiovascular disease were not included in clinical trials and, therefore, the use of tadalafil is contraindicated:

Patients who have had a myocardial infarction within the last 90 days.

Patients with unstable angina or angina occurring during sexual intercourse.

Patients with New York Heart Association (NYHA) Class 2 heart failure or greater in the past 6 months.

Patients with uncontrolled arrhythmias, hypotension (< 90/50 mmHg), or uncontrolled hypertension.

Patients who have had a stroke within the last 6 months.

BOSTAFIL is contraindicated in patients with loss of vision in one eye due to non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection with previous PDE5 inhibitor exposure (see "Warnings and Precautions").

Concomitant use with guanylate cyclase stimulators (e.g., riociguat) is contraindicated due to the potential risk of symptomatic hypotension (see "Drug Interactions").

WARNINGS AND PRECAUTIONS

Before Treatment with BOSTAFIL:

A thorough medical history and physical examination should be performed to diagnose erectile dysfunction or benign prostatic hyperplasia and determine potential underlying causes before initiating treatment.

Before initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients since there is a potential cardiac risk associated with sexual activity. Tadalafil has vasodilatory properties, resulting in mild and transient decreases in blood pressure (see "Pharmacodynamics"), and, therefore, augments the hypotensive effects of nitrates (see "Contraindications").

Evaluation of erectile dysfunction should include an assessment of possible underlying causes before considering pharmacological treatment. It is unknown if BOSTAFIL is effective in patients who have undergone pelvic surgery or radical, non-nerve-sparing prostatectomy.

Tadalafil 5 mg – Before initiating treatment with tadalafil for benign prostatic hyperplasia, patients should be evaluated to exclude the presence of prostate cancer and cardiovascular conditions should be carefully evaluated (see "Contraindications").

Cardiovascular Considerations:

Serious cardiovascular events, including myocardial infarction, sudden cardiac death, unstable angina, ventricular arrhythmias, stroke, transient ischemic attack, chest pain, palpitations, and tachycardia, have been reported post-marketing and/or during clinical trials. Most of these events occurred in patients with pre-existing cardiovascular risk factors. It is impossible to determine definitively whether these events are directly related to these risk factors, tadalafil, sexual activity, or a combination of these factors.

Tadalafil 2.5 mg and 5 mg – In patients receiving concomitant antihypertensive therapy, tadalafil may induce blood pressure decreases. Appropriate clinical considerations should be taken when initiating daily tadalafil therapy to allow dose adjustments of the antihypertensive therapy.

Patients taking alpha-blockers: Caution is advised when BOSTAFIL is co-administered with alpha-blockers as symptomatic hypotension may occur in some patients (see "Drug Interactions"). Therefore, concomitant use of tadalafil and doxazosin is not recommended.

Vision:

Visual impairment and cases of non-arteritic anterior ischemic optic neuropathy (NAION) have been reported with the use of BOSTAFIL and other PDE5 inhibitors. Observational data suggest an increased risk of acute NAION following tadalafil or other PDE5 inhibitor use in men with erectile dysfunction. In the event of sudden visual impairment, patients should stop taking the medication and consult a physician immediately (see "Contraindications").

Sudden Hearing Loss:

Sudden hearing loss has been reported after the use of tadalafil. Although other risk factors (e.g., age, diabetes, hypertension, and pre-existing hearing loss) were present in some cases, patients should stop taking tadalafil and seek immediate medical attention in the event of sudden hearing impairment.

Renal and Hepatic Impairment (Tadalafil 2.5 mg and 5 mg):

Due to increased exposure (AUC) of tadalafil, limited clinical experience, and the inability to remove the drug by dialysis, BOSTAFIL once-daily dosing is not recommended in patients with severe renal impairment.

Clinical safety data on the use of BOSTAFIL in single doses in patients with severe hepatic impairment (Child-Pugh Class C) is limited. The once-daily regimen has not been evaluated in patients with hepatic impairment. If BOSTAFIL is prescribed, the physician should carefully consider the individual benefits/risks.

Hepatic Impairment (Tadalafil 10 mg and 20 mg):

Clinical safety data on the use of BOSTAFIL in single doses in patients with severe hepatic impairment (Child-Pugh Class C) is limited. If prescribing for these patients, the physician should weigh the benefits and risks carefully.

Penile Erection and Anatomical Deformity of the Penis

Patients experiencing an erection lasting 4 hours or longer should be instructed to seek immediate medical assistance. If priapism is not treated promptly, it can result in penile tissue damage and permanent loss of erectile function.

Caution should be exercised when prescribing BOSTAFIL to patients with anatomical deformities of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease) or to those with conditions that may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia).

Use with CYP3A4 Inhibitors

Caution is advised when prescribing BOSTAFIL to patients taking strong CYP3A4 inhibitors (such as ritonavir, saquinavir, ketoconazole, itraconazole, and erythromycin), as the area under the curve (AUC) of tadalafil is increased when co-administered with these drugs (see section on Drug Interactions).

BOSTAFIL and Other Erectile Dysfunction Treatments

The safety and efficacy of combining BOSTAFIL with other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied. Therefore, the concomitant use of BOSTAFIL with these medications is not recommended.

Precaution with Excipients
BOSTAFIL contains lactose monohydrate. It should not be used in patients with hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.

USE IN PREGNANT AND BREASTFEEDING WOMEN 

BOSTAFIL is not indicated for use in women.

Pregnant Women Limited data are available on the use of tadalafil in pregnant women. Animal studies have shown no direct or indirect harmful effects on pregnancy, embryonal/fetal development, parturition, or postnatal development. As a precaution, BOSTAFIL should be avoided during pregnancy.

Breastfeeding Women 

Available pharmacodynamic and toxicological data in animals suggest the excretion of tadalafil in breast milk. A risk to the breastfeeding child cannot be excluded. BOSTAFIL should not be used during breastfeeding.

Fertility 

Observed effects in dogs may suggest impaired fertility. Subsequent clinical studies indicate that these effects are unlikely in humans, although a reduction in sperm concentration has been observed in some men.

EFFECTS ON ABILITY TO DRIVE AND OPERATE MACHINERY 

BOSTAFIL has negligible influence on the ability to drive and use machines. Although the incidence of dizziness reported in clinical trials was similar between the placebo and tadalafil groups, patients should be aware of how they react to BOSTAFIL before driving or operating machinery.

SHELF LIFE
36 months (from the date of manufacture), do not use the product beyond the expiration date.

STORAGE CONDITIONS
Store in a dry place, below 30°C, and protect from light.

 

Al/Al blister, box of 01 blister x 02 film-coated tablets with a package insert.