This preparation capsule is indicated to initiate treatment of the signs and symptoms of Benign Prostatic Hyperplasia (BPH) in men with an enlarged prostate for up to 26 weeks.

This is the combination of Finasteride, a specific inhibitor of steroid Type II 5α-reductase, and Tadalafil, a selective inhibitor of phosphodiesterase type-5 (PDE5).

Finasteride is a specific inhibitor of steroid Type II 5α-reductase, which is an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). Finasteride lowers the level of DHT hormone (dihydrotestosterone), which is a cause of prostate growth. Lowering DHT leads to shrinkage of the enlarged prostate gland in men.

Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE5). Tadalafil may reduce Benign Prostatic Hyperplasia (BPH) symptoms by inhibiting the action of an enzyme called PDE5 (phosphodiesterase 5), which relaxes the smooth muscles of the prostate that surrounds the urethra, resulting in the release of the restriction to the flow of urine through the urethra.

Adult use: The recommended dosage is one capsule orally once daily at approximately the same time every day for up to 26 weeks. It is advised to take this on an empty stomach. This combination is not recommended for more than 26 weeks because the incremental benefit beyond 26 weeks is unknown.

Pediatric Use: The safety and effectiveness of Finasteride and Tadalafil have not yet been established in patients less than 18 years of age.

Geriatric Use: No overall differences in safety or effectiveness of Finasteride and Tadalafil have been observed between patients 65 years of age and older and younger patients.

Hepatic Impairment: In case of moderately impaired hepatic function, this combination can be given with caution. For severely impaired hepatic function, it is not recommended.

Renal Impairment: Not recommended for patients having creatinine clearance less than 50 mL/min or undergoing hemodialysis.

Nitrates: Administration of this capsule to patients who are using any form of organic nitrate is contraindicated. In clinical pharmacology studies, tadalafil was shown to potentiate the hypotensive effect of nitrates.

Alpha-Blockers: Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. Discontinuation of alpha-blockers is recommended at least one day prior to starting this capsule for once-daily use for the treatment of BPH.

Antihypertensives: PDE5 inhibitors, including tadalafil, are mild systemic vasodilators. Small reductions in blood pressure occurred following coadministration of tadalafil with these agents (amlodipine, angiotensin II receptor blockers, bendrofluazide, enalapril, and metoprolol) compared with placebo.

Concomitant use with any form of organic nitrate, either regularly and/or intermittently. This can potentiate the hypotensive effect of nitrates.

Most common adverse reactions associated with finasteride monotherapy (≥1%) in a 4-year study were impotence, decreased libido, decreased volume of ejaculation, and rash. Most common adverse reactions (≥2%) associated with tadalafil were headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and pain in limb.

This combination is contraindicated in pregnancy and not indicated for use in females. If a pregnant female comes in contact with a crushed or broken capsule, the contact area should be washed immediately with soap and water. This capsule is not indicated for use in lactating mothers.

This combination is not recommended for the following groups of patients:

• Patients who have had a myocardial infarction within the last 90 days.
• Patients with unstable angina.
• Patients classified with heart failure in the last 6 months.
• Patients with uncontrolled arrhythmias, hypotension (<90/50 mm Hg), or uncontrolled hypertension.
• Patients who have had a stroke within the last 6 months.

Hypersensitivity Reactions: It is advised to discontinue immediately if any hypersensitivity reaction occurs.

Prolonged Erection: To be used with caution in patients who have anatomical deformation of the penis. Patients are advised to seek emergency treatment if an erection lasts more than 4 hours.

In cases of overdose, standard supportive measures should be adopted as required.

BPH / Urinary retention / Urinary incontinence

Do not store above 30°C. Keep in a dry place. Protect from light and keep out of the reach of children.