China's Simenafil(盐酸司美那非片):Pictures,Uses,Dosage,Side Effects,Warnings-SEAGULL HEALTH

Introduction of Simenafil

Simenafil features a prominent safety profile, with no safety signals detected following single-dose administration of 5–30mg in Phase I clinical trials.

Indications

Simenafil is indicated for the treatment of erectile dysfunction, and it can improve the erectile function status of the penis during the medication period.

Overview

Generic Name

Simenafil Hydrochloride Tablets,盐酸司美那非片

Brand Name

昂伟达

Drug Type

Rx Drug

Approval No.

10mg:国药准字H20250050;5mg:国药准字H20250049;2.5mg:国药准字H20250048

Active Ingredient

Simenafil

Dosage Form

2.5mg*2tablets;5mg*1tablets;10mg*1tablets

Specification

Tablets

Description

Simenafil Hydrochloride Tablets is a film-coated tablet. When the coating is removed, the tablet core appears white or almost white.

Expiry Date

24 months

Manufacturer

Vigonvita Life Sciences Co., Ltd.;Suzhou Thery Pharmaceutical Co., Ltd.

Storage

Store in a sealed container at a temperature not exceeding 30℃. Keep this product out of the reach of children.

Dosage and Administration

For most patients, the recommended starting dose of Simenafil for on-demand use is 5mg, administered orally 0.5–4hours before sexual activity. The dose may be increased to 10mg (maximum dose) or decreased to 2.5mg (minimum dose) based on individual efficacy and tolerability. The recommended maximum dosing frequency is once daily. This product requires sexual stimulation to exert its therapeutic effect, and can be taken with or without food.

For patients concomitantly taking strong CYP3A4 inhibitors (e.g., itraconazole), the recommended starting dose of this product is 2.5mg.

For patients with mild to moderate hepatic impairment, the dose is recommended to be reduced by half. For patients with severe hepatic impairment (Child-Pugh Classification C), the pharmacokinetics of Simenafil Hydrochloride have not been studied.

For patients who are on a stable regimen of α-blockers, this product should be initiated at the lowest dose (2.5mg).

Post-administration Precautions

This product is indicated only for the treatment of male erectile dysfunction to improve penile erectile function. It does not act on the central nervous system, and thus has no addiction, dependence, or aphrodisiac effect. It needs sexual stimulation to exert its efficacy.

Do not use this product if its physical properties have changed.

Keep this product out of the reach of children.

Contraindications

This product is contraindicated in patients with hypersensitivity to any component of the product, as well as in pregnant and lactating women and pediatric patients.

Patients whose cardiovascular status is not suitable for sexual activity should generally not use any drugs for the treatment of erectile dysfunction, including this product.

Adverse Reactions

During the medication period, common adverse reactions of this product include: hyperlipidemia, hyperuricemia, dizziness, headache, flushing, dry mouth, nasal congestion, fever, increased alanine aminotransferase, elevated serum triglycerides, positive urine occult blood, increased aspartate aminotransferase, etc.

Use in Special Populations

Geriatric Patients

For patients aged ≥ 65 years, dose adjustment is generally not required.

Patients with Hepatic Impairment

For patients with mild or moderate hepatic impairment (Child-Pugh Class A or B), the dose should be reduced by half.

Situations Requiring Immediate Discontinuation of Medication

If sudden loss of vision occurs in one or both eyes, the use of all phosphodiesterase type 5 (PDE5) inhibitors, including this product, should be immediately discontinued, and medical advice should be sought promptly.

If sudden hearing impairment or loss occurs, the use of PDE5 inhibitors (including this product) should be discontinued, and medical attention should be obtained as soon as possible.

If an erection persists for more than 4 hours, the patient must seek immediate medical care. Failure to promptly manage priapism may result in penile tissue damage and permanent loss of erectile function.

For more detailed drug information, please consult the official package leaflet.