Entafi

• Benign Prostatic Hyperplasia (BPH): Used to initiate treatment of signs and symptoms of 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 5a-reductase and Tadalafil, a selective inhibitor of phosphodiesterase type-5 (PDE5). Finasteride lowers DHT hormone levels, which is a cause of prostate growth. Tadalafil inhibits PDE5 to relax smooth muscles of the prostate, resulting in release of restriction to urine flow through the urethra.

Adult Dose:

• One capsule orally once daily at approximately the same time every day for up to 26 weeks.
• Recommended to take on an empty stomach.

Common Side Effects (>=1%):

• Impotence
• Decreased libido
• Decreased volume of ejaculation
• Rash

Tadalafil-associated Side Effects (>=2%):

• Headache
• Dyspepsia
• Back pain
• Myalgia
• Nasal congestion
• Flushing
• Pain in limb

Use in Pregnancy: Contraindicated; not indicated for females; if a pregnant female comes in contact with crushed or broken capsule, wash with soap and water.

Precautions:

• Nitrates: Contraindicated in patients using any form of organic nitrate (potentiates hypotensive effect).
• Alpha-Blockers: Caution when co-administered; discontinue alpha-blockers at least one day prior to starting this capsule.
• Antihypertensives: Small reductions in blood pressure may occur.
• Hypersensitivity Reactions: Discontinue immediately if occurs.
• Prolonged Erection: Caution in patients with anatomical deformation of the penis; seek emergency treatment if erection lasts more than 4 hours.

Overdose: In cases of overdose, standard supportive measures should be adopted.

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