Fortera 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, then take it with water. Safety and efficacy have not been established when administered 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 can cause blood pressure to drop significantly when taken with nitrate preparations that lower blood pressure, so it is essential to inform your doctor if you are taking any nitrate medications before using this drug. Patients with heart conditions should carefully assess their heart status before taking this medication, and individuals with severe cardiovascular diseases should avoid taking this drug as sexual activity itself may be dangerous. This drug can dilate blood vessels and temporarily lower blood pressure, so caution is necessary when taken by patients with cardiovascular diseases or low blood pressure. If an erection persists for more than 4 hours, seek medical attention immediately, as untreated cases can lead to penile tissue damage or loss of erectile function. Patients with specific heart valve diseases or those with impaired blood pressure regulation may be more sensitive to this medication, so it must be used with caution. When combined with other drugs, especially certain antivirals or CYP3A4 inhibitors, the plasma concentration of this medication can increase significantly, necessitating dose adjustments. The artificial sweetener aspartame contained in this medication may be harmful to individuals with phenylketonuria, so they should refrain from using it. This medication should not be used in individuals under 18 years of age and women, nor should it be used by patients with certain cardiovascular diseases, severe hypotension, or significantly impaired liver or kidney function. During treatment, dizziness or visual disturbances may occur, so caution is needed when driving or operating machinery. When taken with alpha-blockers, symptoms of low blood pressure may manifest, necessitating dosage adjustments and adherence to the physician's instructions. In case of overdose, symptoms such as headache, flushing, dizziness, dyspepsia, visual disturbances may worsen, so adherence to the recommended dosage is essential, and in case of overdose, seek medical assistance immediately. This medication should only be used for treating erectile dysfunction and will not prevent sexually transmitted diseases; therefore, it is important to maintain safe sexual practices.

Headache, flushing, rhinitis, hypersensitivity reaction, dizziness, drowsiness, seizures, seizure recurrence, fainting, blurred vision, visual impairment, cyanopsia, eye pain, photophobia, scotoma, chromatic vision, eye hyperemia, brightness in the field of vision, eyelid swelling, eye swelling, dry eyes, eye fatigue, halo effect, yellow vision, red vision, eye disorders, conjunctival hyperemia, eye irritation, abnormal sensation of the eye, eyelid edema, tachycardia, palpitations, facial flushing, flushing, hypotension, nasal congestion, nosebleed, sinus congestion, throat discomfort, dry nose, nasal swelling, nausea, indigestion, gastroesophageal reflux disease, vomiting, upper abdominal pain, dry mouth, oral sensory loss, rash, myalgia, limb pain, priapism, increased erection, feeling hot, irritability, increased heart rate, urinary tract infection, diarrhea, migraine, confusion, weakness, memory impairment, nervousness, insomnia, abnormal dreams, decreased reflex function, sensory decline, 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 loss, tinnitus, ear pain, ocular hemorrhage, cataract, dry eye syndrome, cystitis, nocturia, frequent urination, chest enlargement, urinary incontinence, ejaculation disorder, genital swelling, hyperesthesia, generalized heat sensation, hiccups, redness of lips, gastric ulcer, gastrointestinal disorder, increased non-protein nitrogen, facial edema, chest pain, sensory abnormality, fatigue, migraine, confusion, prolonged erection, hematuria, nosebleed, anxiety disorder, diplopia, transient vision loss, congestion, ocular burning, eye swelling, increased intraocular pressure, retinal vascular disease, bleeding, vitreous detachment, contraction, myelofibrosis edema, anterior ischemic optic neuropathy, myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient angina attack, hypertension, fainting, angina, atrioventricular block, palpitations, orthostatic hypotension, myocardial ischemia, cerebral thrombosis, cardiac arrest, heart failure, electrocardiogram abnormalities, cardiomyopathy, vasodilation, stomatitis, colitis, dysphagia, gastritis, gastroenteritis, esophagitis, stomatitis, liver dysfunction, 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, tension increase, neuralgia, neuropathy, sensory abnormality, tremor, depression, abnormal dreams, insomnia, asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, increased sputum, increased cough, urticaria, herpes simplex, itching, sweating, skin ulcer, contact dermatitis, exfoliative dermatitis, eye pain, conjunctivitis, chromatic vision, photophobia, ocular hyperemia, ocular pain, tinnitus, ocular hemorrhage, cataract, dry eye syndrome, cystitis, nocturia, frequent urination, chest enlargement, urinary incontinence, ejaculation disorder, genital swelling, hyperesthesia, facial flushing, infection, extremity pain, hepatitis, virus, penile dysfunction, painful urination, polyuria, glaucoma, overflow, gastric adenoma, hypersensitivity reaction, weakness, pain, influenza syndrome, increased creatine kinase, increased BUN, increased erythrocytes in urine, fatigue, increased uric acid in urine, decreased sodium levels, increased serum inorganic phosphate levels, increased urinary protein, 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 store it at normal room temperature, avoiding excessively hot or cold areas.

Appearance

Blue or light blue rectangular oral dissolving film

Package unit

10 sheets/pack