Please Oral Dissolving Film 50 mg (Sildenafil)

Adult dose

As sildenafil, the recommended dose of 25 ∼ 50 mg is administered orally once daily approximately 1 hour before sexual activity; in some cases, it may be administered 4 hours to 30 minutes before sexual activity. The dose may be increased or decreased according to efficacy and tolerability. Immediately after removing this medicine from its individual package, place it on the tongue and allow it to dissolve. It may be taken with or without water. The initial dose should be adjusted to 25 mg in the following patients, as sildenafil plasma concentrations may be increased: - Age 65 years or older (AUC increased by 40 %) - Hepatic impairment (cirrhosis: 80 %) - Severe renal impairment (creatinine clearance of 30 mL/min or less: 100 %) - Concomitant use with CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, erythromycin (182 %), and saquinavir (210 %)); increased blood concentrations may increase efficacy and the incidence of adverse reactions. - In patients receiving concomitant ritonavir, do not exceed 25 mg as the maximum single dose within 48 hours.

This medication lowers blood pressure, so taking it with nitrate preparations or NO donors can risk excessive blood pressure drop. You must inform your doctor about any other medications you are taking before taking this drug. Patients with cardiovascular diseases should undergo a thorough evaluation of their heart condition before using this medication, as it is not recommended for patients at risk for cardiovascular diseases to engage in sexual activity, thus their use of this medication is restricted. This medication has a vasodilating effect and can temporarily decrease blood pressure when lying down, so patients with cardiovascular diseases should take particular caution. Patients with a history of serious arrhythmias, heart failure, unstable angina, hypotension, or hypertension within the last 6 months, patients with pigmentary retinopathy should not take this drug. If an erection lasts more than 4 hours or is accompanied by pain, seek medical attention immediately, as untreated cases can lead to penile tissue damage and permanent erectile dysfunction. Patients with left ventricular outflow obstruction or severely impaired blood pressure regulation may respond sensitively to this drug, so caution is advised. Patients taking certain antiviral medications, such as Ritonavir, may experience significantly increased blood concentrations of this medication, requiring dosage adjustments. Patients who are hypersensitive to this medication or are taking nitrate preparations, patients for whom sexual activity is not recommended due to cardiovascular diseases, patients with severe liver failure, patients with hypotension or uncontrolled hypertension, patients with recent cardiovascular disease history, pigmentary retinopathy patients, patients taking other erectile dysfunction medications, children under 18 years, and women should not be administered this medication. Use this medication with caution in patients with penile deformities or hemorrhagic disorders, in elderly patients, in patients with severe renal or liver failure, or when used in combination with specific medications. Common side effects of this medication may include headache, flushing, dyspepsia, nasal congestion, visual disturbances (color vision changes, increased photosensitivity, blurred vision), nausea, vomiting, diarrhea, rash, myalgia, limb pain, dry eyes, conjunctival injection, eye pain, eye swelling, eye edema, facial flushing, vasodilation, hypotension, epistaxis, rhinitis, throat tightness, dry mouth, hematuria, anxiety, fatigue, muscle pain, pain, chills, phototoxic reactions, and allergies. Sexual activity can put stress on the heart, so cardiovascular status should be confirmed before taking this medication, and caution is advised when driving or operating machinery as visual disturbances or dizziness may occur. Many drugs can interact with this medication, so inform your healthcare provider of all medications taken, especially when used in combination with CYP3A4 inhibitors or certain antiviral medications, as dosage adjustments may be necessary. This medication is not for use in women or children under 18 years, and safety during pregnancy and breastfeeding has not been established. In case of overdose, seek immediate medical assistance as symptoms such as hypotension may appear.

• Headache
• flushing
• rhinitis
• hypersensitivity reactions
• dizziness
• drowsiness
• seizures
• seizure recurrence
• syncope
• blurriness

Store this medication in a tightly closed container to keep air and moisture out, and it is recommended to store it at room temperature between 1 and 30 degrees Celsius. This way, the effectiveness of the medication can be well maintained.

Appearance

Blue or light blue rectangular oral dissolving film.

Package unit

For domestic use - 1 film/pack; For domestic use - 10 films/box [1 film/pack x 10]; For export - 1 film/pack; For export - 2 films/box [1 film/pack x 2]; For export - 4 films/box [1 film/pack x 4]; For export - 5 films/box [1 film/pack x 5]; For export - 6 films/box [1 film/pack x 6]; For export - 10 films/box [1 film/pack x 10]; For export - 20 films/box [1 film/pack x 20]; For export - 25 films/box [1 film/pack x 25]