Mshtein Oral Dissolving Film 100 mg (Sildenafil)

Adult dose

Administer sildenafil orally once daily at the recommended dose of 25 ∼ 50 mg approximately 1 hour before sexual activity. In some cases, it may be taken 4 hours to 30 minutes before sexual activity. The dose may be increased or decreased according to efficacy and tolerability. Immediately after removing this product 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 (ketoconazole, itraconazole, erythromycin (182 %), etc., and saquinavir (210 %)); increased blood concentrations may increase efficacy and the incidence of adverse reactions. - In patients taking ritonavir concomitantly, do not exceed 25 mg as the maximum single dose over 48 hours.

This drug has the effect of dilating blood vessels and may lower blood pressure, so taking it with nitrates or NO donors could lead to a dangerous drop in blood pressure. Patients with heart or vascular problems should consult their doctor before using this drug, and it is safer not to use it if there are severe cardiovascular diseases. As sexual activity itself may put stress on the heart, it is not recommended for patients with poor cardiovascular health to take this drug or engage in sexual activity. This drug can temporarily lower blood pressure, thus caution is needed for patients with unstable blood pressure or hypotension. Patients who have had serious heart problems or strokes within the last 6 months, those with severely impaired liver or kidney function, and those with specific retinal diseases should not use this drug. If an erection lasts longer than 4 hours, seek immediate medical attention, as untreated cases can lead to permanent damage. This drug may interact with certain medications, so dosage adjustment is necessary, especially for those taking medications like ritonavir. Patients allergic to this drug or those regularly taking nitrates, as well as children under 18 years and women, should not take this drug. Elderly patients or those with reduced liver or kidney function should start at a lower dose and should be closely monitored to reduce the chance of adverse reactions. This drug may have side effects like headaches, flushing, indigestion, dizziness, visual disturbances, etc., so if symptoms are severe during use, consult a doctor. Visual disturbances or dizziness may occur when driving or operating machinery, therefore caution is advised, and it's important to carefully observe one’s reactions during the first dose. This drug should only be used for the treatment of erectile dysfunction and does not provide protection against sexually transmitted diseases. Overdosing may lead to more severe side effects, so adhere to the prescribed dosage and seek immediate medical attention if an overdose occurs. Keep out of reach of children and do not transfer to other containers.

Headache, flushing, rhinitis, hypersensitivity reactions, dizziness, drowsiness, seizures, seizure recurrence, syncope, blurred vision, visual impairment, cyanopsia, eye pain, photophobia, phosphenes, chromatopsia, conjunctival injection, increased brightness of vision, eyelid edema, eyelid swelling, dry eyes, eye fatigue, halo vision, xanthopsia, erythropsia, eye disorders, conjunctival hyperemia, eye irritation, altered eye sensation, 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 paresthesia, rash, myalgia, limb pain, priapism, increased erection, feeling warm, stimulus hypersensitivity, increased heart rate, urinary tract infection, diarrhea, migraine, confusion, asthenia, pain, chills, accidental falls, allergic reactions, chest pain, incidental trauma, angina pectoris, atrioventricular block, palpitations, orthostatic hypotension, 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, edema, gout, unstable diabetes, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemia, hypernatremia, arthritis, arthropathy, tendon rupture, tenosynovitis, bone pain, myasthenia, synovitis, ataxia, tension increase, neuralgia, neuropathy, sensory disturbance, tremor, depression, insomnia, abnormal dreams, decreased reflex function, sensory dullness, asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, increased sputum, increased cough, urticaria, herpes simplex, itching, sweating, skin ulcer, contact dermatitis, exfoliative dermatitis, sudden hearing loss, hearing impairment, mydriasis, conjunctivitis, tinnitus, eye pain, ear pain, ocular hemorrhage, cataract, dry eye syndrome, cystitis, nocturia, increased urination, chest enlargement, urinary incontinence, ejaculation disorder, genital edema, sexual hyperesthesia, migraine, confusion, anxiety disorder, hematuria, epistaxis, hypersensitivity reactions, diplopia, transient vision loss, vision impairment, ocular burning sensation, ocular swelling, increased intraocular pressure, retinal vascular diseases, bleeding, vitreous detachment, contraction, macular edema, non-arteritic anterior ischemic optic neuropathy, systemic warmth, hiccups, erythema, reddening of lips, gastric ulcer, gastroesophageal reflux, gastrointestinal disorders, increased non-protein nitrogen, migraine, confusion, asthenia, pain, chills, accidental falls, allergic reactions, chest pain, incidental trauma, myocardial infarction, sudden cardiac death, ventricular arrhythmias, cerebrovascular hemorrhage, transient angina attacks, hypertension, syncope, vasodilation, edema, hepatitis, virus, penile disorders, painful urination, polyuria, glaucoma, overflow incontinence, gastric adenocarcinoma, seborrhea, increased creatine kinase, increased AST, increased ALT, increased serum LDH, increased γ-GTP, decreased total protein, decreased albumin, elevated total bilirubin, increased serum amylase, increased serum phospholipids, increased BUN, increased urinary red blood cells, fatigue, increased urinary uric acid, decreased sodium levels, increased serum inorganic phosphate, increased urinary protein, increased urinary glucose, increased urobilinogen

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. This will help maintain the drug's efficacy and safety for a long time.

Appearance

Rectangular oral dissolving film in blue or light blue color

Package unit

10 sheets/box [1 sheet/pack X10]