M-Stein Oral Disintegrating 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 drug can excessively lower blood pressure if taken with nitrate medications or NO donors, so it is essential that a doctor confirms this before use. Patients with cardiovascular diseases need to carefully evaluate their heart condition before taking this medication, and those at high cardiovascular risk should not engage in sexual activity. This drug may temporarily lower blood pressure by dilating blood vessels, so patients with cardiovascular conditions must exercise particular caution. Patients with heart rhythm problems, heart failure, unstable angina, and those with very low or very high blood pressure should not take this medication. If an erection lasts longer than 4 hours or is accompanied by pain, medical consultation should be sought immediately, as untreated cases may lead to penile tissue damage and permanent erectile dysfunction. This medication may act sensitively in patients with specific heart diseases or severely impaired blood pressure regulation, requiring caution. Taking this medication with certain antiviral drugs can significantly increase its plasma concentration, necessitating dose adjustment. Contains aspartame, so patients with phenylketonuria should not take it. Patients with hypersensitivity to this drug, those regularly taking nitrate medications, patients with severe cardiovascular conditions, severe liver or kidney failure, children under 18, and women should not take it. Patients with penile deformities, bleeding disorders, elderly patients, and those with weakened liver or kidney functions should take it cautiously after consulting with a physician. During the use of this medication, side effects such as headaches, flushing, dyspepsia, nasal congestion, dizziness, vision disturbances (sensitivity to light, color vision changes, blurred vision), drowsiness, nausea, vomiting, diarrhea, muscle pain, limb pain, urinary tract infection, dry eyes, eye fatigue, facial swelling, hematuria, anxiety, insomnia, memory impairment, enhanced brightness of vision, eye congestion, ocular pain, hives, itching, skin rash, skin dryness, sweating, generalized warm sensation, chest pain, vasodilation, and hypotension may occur, and severe symptoms should be discussed with a physician. Caution should be exercised when driving or operating machinery, as visual disturbances or dizziness may occur. The risk of side effects may increase when taking this medication with other erectile dysfunction treatments or certain blood pressure medications, so consultation with a physician is necessary beforehand. Pregnant and nursing women should not use this medication, and it should also not be used by children or women. Overdose can lead to severe side effects, so the prescribed dosage must be adhered to, and medical contact should be made immediately in case of overdose. Keep out of the reach of children and avoid transferring it to other containers.

Headache, flushing, rhinitis, hypersensitivity reaction, dizziness, drowsiness, seizures, seizure recurrence, syncope, blurred vision, visual impairment, cyanopsia, eye pain, photophobia, phosphenes, chromatopsia, eye congestion, enhanced brightness, eyelid swelling, eye edema, dry eyes, eye fatigue, halo vision, yellow vision, red vision, visual disturbances, conjunctival hyperemia, eye irritation, abnormal sensations in the eyes, eyelid edema, tachycardia, palpitations, facial flushing, flushing, hypotension, nasal congestion, epistaxis, sinus congestion, throat fullness, dry nose, nasal edema, nausea, dyspepsia, gastroesophageal reflux disease, vomiting, upper abdominal pain, dry mouth, oral sensory disturbance, rash, myalgia, limb pain, priapism, increased erection, warm sensation, irritability, increased heart rate, urinary tract infection, diarrhea, migraine, confusion, weakness, memory impairment, nervous hyperreactivity, insomnia, abnormal dreams, reduced reflex function, sensory impairment, asthma, shortness of breath, laryngitis, pharyngitis, sinusitis, bronchitis, increased sputum, increased cough, urticaria, herpes simplex, itching, sweating, skin ulcer, contact dermatitis, exfoliative dermatitis, sudden hearing loss, hearing loss, dilation of pupils, conjunctivitis, tinnitus, eye pain, ear pain, ocular hemorrhage, cataract, dry eye syndrome, cystitis, nocturia, frequent urination, breast enlargement, urinary incontinence, ejaculation disorder, genital edema, hyperesthesia of the genitals, generalized heat sensation, hiccups, reddening of the lips, gastric ulcer, gastroesophageal reflux, gastrointestinal disorders, increased non-protein nitrogen, facial edema, chest pain, sensory abnormalities, fatigue, migraine, confusion, prolonged erection, hematuria, epistaxis, anxiety disorder, diplopia, temporary vision loss, congestion, eye burning, eye swelling, increased intraocular pressure, retinal vascular disease, bleeding, vitreous detachment, contraction, muscular retinal macular edema, non-arteritic anterior ischemic optic neuropathy, myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient angina attack, hypertension, syncope, angina, atrioventricular block, palpitations, orthostatic hypotension, myocardial ischemia, cerebral venous thrombosis, cardiac arrest, heart failure, ECG abnormalities, cardiomyopathy, vasodilation, glossitis, colitis, dysphagia, gastritis, gastroenteritis, esophagitis, stomatitis, abnormal liver function, rectal bleeding, gingivitis, anemia, leukopenia, thirst, edema, gout, unstable diabetes, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemia, hypernatremia, arthritis, arthrosis, tendon rupture, tenosynovitis, bone pain, myasthenia, synovitis, ataxia, hypertonia, neuralgia, neuropathy, sensory abnormality, tremor, depression, insomnia, abnormal dreams, reduced reflex function, sensory impairment, rhinitis, nasal congestion, shortness of breath, upper respiratory tract infection, elevated AST, elevated ALT, anxiety, insomnia, sleepiness, penile disorder, painful urination, polyuria, glaucoma, overflow incontinence, gastric adenocarcinoma, seborrhea, increased creatine kinase, increased BUN, increased erythrocytes in urine, fatigue, increased uric acid in urine, decreased sodium levels, increased serum inorganic phosphate levels, increased protein in urine, increased blood glucose in urine, increased urobilinogen

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, it is advisable to keep it at room temperature that is neither too hot nor too cold.

Appearance

Blue or light blue rectangular oral disintegrating film

Package unit

10 sheets (1 sheet/pack) x 10