Pristine Oral Dissolving Film 50 Milligrams (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 should not be taken with nitrate preparations or NO donors, as it can cause dangerously low blood pressure; patients taking these medications should consult their doctor. Patients with heart or vascular issues should check their cardiovascular status before using this medication, and those with severe cardiovascular disease should avoid sexual intercourse and should not use this medication. This medication can temporarily lower blood pressure when lying down due to its vasodilatory effects, so caution is warranted in patients with cardiovascular disease. Patients who have had serious cardiac arrhythmias, heart failure, unstable angina, hypotension, uncontrolled hypertension, or pigmentary retinopathy within the last six months should not use this medication. If an erection lasts longer than 4 hours, immediate medical attention is needed, as untreated cases can lead to penile tissue damage and permanent erectile dysfunction. The plasma concentration of this medication can be significantly increased when used in combination with certain medications, especially protease inhibitors like ritonavir, thus requiring dose adjustments. This medication contains the artificial sweetener aspartame, which means patients with phenylketonuria should not take it. Patients who have hypersensitivity to this medication, regularly take nitrate preparations, are advised against sexual activity due to cardiovascular disease, have severe liver failure, or are children under 18 years of age or women should not use this medication. Patients with anatomical penile deformities, hemorrhagic disorders, elderly patients, those with renal or liver failure, or patients with diabetic retinopathy should use this medication with caution, as there may be a higher risk of adverse reactions and dose adjustments may be necessary. While taking this medication, side effects such as headaches, flushing, dyspepsia, visual disturbances, dizziness, drowsiness, rashes, dry mouth, visual abnormalities (mild and temporary color vision disorders, increased photophobia, blurred vision), dry eyes, eye fatigue, eye redness, eye pain, eye swelling, conjunctival hyperemia, itching, myalgia, limb pain, anxiety, hematuria, vasodilation, tachycardia, palpitation, orthostatic hypotension, vomiting, glossitis, colitis, dysphagia, gastritis, and gastroenteritis may occur, and if these adverse reactions are severe or persistent, consultation with a doctor is necessary. Caution is needed when driving or operating machinery as this medication may cause visual disturbances or dizziness. This medication should not be used in conjunction with other erectile dysfunction treatments, and it may interact with certain antihypertensive drugs, antibiotics, and antiviral drugs, so patients should definitely inform their doctor about any medications they are taking. Women who are pregnant or breastfeeding should not use this medication, nor should children or adolescents under 18 years of age. In case of an overdose, appropriate treatment is needed based on symptoms, and this medication cannot be removed by renal dialysis. Keep this medication out of reach of children and do not transfer it to other containers.

headache, flushing, rhinitis, hypersensitivity reaction, dizziness, drowsiness, seizures, recurrence of seizures, syncope, blurred vision, visual impairment, cyanopsia, eye pain, glare, photopsia, chromatopsia, eye congestion, increased brightness in the field of vision, eyelid edema, eye swelling, dry eyes, eye fatigue, halo vision, xanthopsia, erythropsia, eye disorders, conjunctival hyperemia, eye irritation, sensory abnormality of the eye, eyelid swelling, tachycardia, palpitations, facial flushing, flushing, hypotension, nasal congestion, epistaxis, sinus congestion, throat discomfort, nasal dryness, nasal swelling, nausea, dyspepsia, gastroesophageal reflux disease, vomiting, upper abdominal pain, dry mouth, oral sensory decrease, rash, myalgia, limb pain, priapism, increased erections, feeling hot, hypersensitivity, increased heart rate, urinary tract infection, diarrhea, migraine, confusion, weakness, memory impairment, neuroticism, insomnia, abnormal dreams, decreased reflex function, perceptual decline, 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, tinnitus, eye pain, ear pain, ocular hemorrhage, cataract, dry eye syndrome, cystitis, nocturia, frequent urination, breast enlargement, urinary incontinence, ejaculation disorder, genital swelling, sexual hyperesthesia, migraine, confusion, nausea, hiccups, dry throat, abdominal pain, dysphagia, gastric ulcer, gastrointestinal disorders, abdominal bloating, visual disturbances, diplopia, dry eye syndrome, tachycardia, vasodilation, hypotension, rhinitis, nasal congestion, shortness of breath, upper respiratory tract infection, elevated AST, elevated ALT, anxiety, insomnia, daytime sedation, persistent erection, genital pain, reddened lips, swelling, generalized warmth, facial edema, chest pain, weakness, sensory abnormalities, fatigue, increased non-protein nitrogen, sweating, erythema, itching, myalgia, facial edema, photosensitivity reaction, shock, pain, chills, accidental falls, allergic reaction, chest pain, accidental trauma, angina, atrioventricular block, myocardial ischemia, cerebral thrombosis, cardiac arrest, heart failure, abnormal electrocardiogram, cardiomyopathy, vasodilation, glossitis, colitis, dysphagia, gastritis, gastroenteritis, esophagitis, stomatitis, liver function abnormalities, rectal bleeding, gingivitis, anemia, leukopenia, thirst, swelling, gout, unstable diabetes, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemia, hypernatremia, arthritis, arthropathy, tendon rupture, tenosynovitis, bone pain, myasthenia, synovitis, ataxia, heightened tension, neuralgia, neuropathy, sensory abnormalities, tremors, depression, abnormal dreams, decreased reflex function, perceptual decline, 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, mydriasis, conjunctivitis, glare, tinnitus, eye pain, ear pain, ocular hemorrhage, cataract, dry eye syndrome, cystitis, nocturia, frequent urination, breast enlargement, urinary incontinence, ejaculation disorder, genital swelling, sexual hyperesthesia, anxiety disorder, hematuria, epistaxis, hypersensitivity reaction, diplopia, transient vision loss, retinal vascular disease, hemorrhage, palpebral edema, prolonged erection, glaucoma, overflow, gastric adenoma, seborrhea, myocardial infarction, hypotension, syncope, tachycardia, vasodilation, heightened tension, headache, confusion, dizziness, weakness, drowsiness, memory impairment, neuroticism, insomnia, nausea, vomiting, dry mouth, myalgia

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is advisable to maintain storage temperatures between 1 and 30 degrees Celsius. This will help preserve the medication's efficacy for longer.

Appearance

Blue or light blue rectangular oral dissolving film

Package unit

Package - 10 pieces/box [(1 piece/package x 10)]