Urofi

Generic Name: Finesteride 5 mg & Tadalafil 5 mg
Dosage Form: Capsule
TG Name: Urogenital

1. What is Urofi^® Capsule?
Urofi^® is the preparation of Finasteride 5 mg and Tadalafil 5 mg Capsule with HPMC Vegetable capsule shell.

2. How Urofi^® Capsule works in our body?
Urofi^® contains 2 active drugs: finasteride and tadalafil.
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.
Both combinedly treats the signs and symptoms benign prostatic hyperplasia (BPH) along with improving the sexual (erectile) function in men.

3. What is the indication of Urofi^® Capsule?
Urofi^® is indicated to initiate treatment of the signs and symptoms of Benign Prostatic Hyperplasia (BPH) in men with an enlarged prostate.

4. What is the dosage & administration of Urofi^® Capsule?
The recommended dosage of Urofi^® is one capsule once daily at approximately the same time every day for up to 26 weeks. It is advised to take Urofi^® on an empty stomach.

5. What are the contraindications of Urofi^® Capsule?
Urofi^® capsule is contraindicated in case of-

• Concomitant use with any form of organic nitrate, either regularly and/or intermittently. Urofi^® can potentiate the hypotensive effect of nitrates
• Patients with known hypersensitivity to finasteride, tadalafil, or to any of the components of Urofi^®
• Pregnancy & Lactation
• Concomitant use with guanylate cyclase (GC) stimulators

6. What are the adverse effects of Urofi^® Capsule?
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.

7. What would be the storage condition of Urofi^® Capsule?
Do not store above 30^° C. Keep in a dry place. Protect from light and keep out of the reach of children.