Medication info

TaoPhilm Oral Dispersible Film 50 mg (Sildenafil)

Prescription medicationOral
Ingredient · strength
Sildenafil›50mg / 1 sheet
Manufacturer / importer
Kolon Pharmaceutical Co., Ltd.
Appearance
Rectangular oral dispersible film in blue or light blue color
Packaging
10 pieces/box [1 piece/pack * 10]
Approval status
Active

MFDS item code 202402295 · Approved 2024.09.23

Summary

Main use
Treatment of erectile dysfunction
Who takes it
Adults
Adult dose
For sildenafil, the recommended dose is 25 ∼ 50 mg taken orally once daily approximately 1 hour before sexual activity. Depending on the circumstances, it may be taken from 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: - Patients aged 65 years or older (AUC increased by 40 %) - Patients with hepatic impairment (cirrhosis: 80 %) - Patients with severe renal impairment (creatinine clearance of 30 mL/min or less: 100 %) - Concomitant use with CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, erythromycin (182 %), or 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 a maximum single dose over 48 hours.

Ingredients

Manufacturer
Kolon Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of erectile dysfunction

  • Erectile dysfunction
View approved original text

This drug is used for the treatment of erectile dysfunction. Erectile dysfunction is a type of sexual dysfunction, and this drug helps restore sexual function and maintain a healthy sex life.

How to take

Adult dose

For sildenafil, the recommended dose is 25 ∼ 50 mg taken orally once daily approximately 1 hour before sexual activity. Depending on the circumstances, it may be taken from 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: - Patients aged 65 years or older (AUC increased by 40 %) - Patients with hepatic impairment (cirrhosis: 80 %) - Patients with severe renal impairment (creatinine clearance of 30 mL/min or less: 100 %) - Concomitant use with CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, erythromycin (182 %), or 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 a maximum single dose over 48 hours.

Precautions

This drug dilates blood vessels and may lower blood pressure; thus, if used with nitrate compounds or NO donors, blood pressure may drop to dangerous levels. Patients with cardiovascular diseases should consult with a doctor sufficiently before using this drug, and it should not be used if sexual activity is not recommended based on cardiac condition. Patients with very low or very high blood pressure, serious heart diseases, or certain eye conditions should be cautious as using this drug may not be safe. If an erection lasts longer than 4 hours after taking this drug, medical attention should be sought immediately, as untreated can lead to penile tissue damage or loss of erection capability. This drug can significantly increase blood concentration when taken with certain antiviral agents, necessitating dose adjustment. If sudden vision loss or hearing loss occurs while taking this drug, it should be stopped immediately, and medical advice should be consulted. Elderly patients or those with impaired liver or kidney function should start with a lower dose and follow a doctor’s instructions. This drug should not be used for purposes other than treating erectile dysfunction, and it is not recommended to take it with other erectile dysfunction treatments. Caution is required when driving or operating machinery, as dizziness or visual disturbances may occur. In case of overdose, symptomatic treatment is needed, and immediate medical attention should be sought as renal dialysis may not adequately remove the drug. This drug is not to be used by children and women, and pregnant women should also refrain from taking it. Before taking this drug, patients should inform their doctor about any other diseases or medications they are taking and be aware of drug interactions. This drug does not have preventive effects against sexually transmitted diseases, so safe sexual practices should be maintained.

Side effects

Headache, flushing, rhinitis, hypersensitivity reaction, dizziness, drowsiness, seizures, recurrent seizures, syncope, blurred vision, visual impairment, cyanopsia, eye pain, photophobia, scotoma, color vision changes, eye congestion, increased brightness in vision, eye swelling, eye edema, dry eyes, eye fatigue, halo vision, xanthopsia, erythropsia, eye disorders, conjunctival hyperemia, eye irritation, eye sensory abnormalities, eyelid edema, tachycardia, palpitations, facial flushing, flushing, hypotension, nasal congestion, epistaxis, sinusal congestion, throat tightness, nasal dryness, nasal edema, nausea, dyspepsia, gastroesophageal reflux disease, vomiting, upper abdominal pain, dry mouth, oral sensory reduction, rash, myalgia, limb pain, persistent erection, increased erection, feeling hot, irritability, increased heart rate, urinary tract infection, diarrhea, migraine, confusion, weakness, pain, chills, accidental falls, abdominal pain, allergic reaction, chest pain, accidental trauma, angina, atrioventricular block, palpitations, postural hypotension, myocardial ischemia, cerebral thrombosis, cardiac arrest, heart failure, electrocardiogram abnormalities, cardiomyopathy, vasodilation, glossitis, 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, hypertonia, neuralgia, neuropathy, paresthesia, tremor, depression, insomnia, abnormal dreams, reduced reflex function, sensory decline, asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, increased sputum, increased cough, urticaria, herpes simplex, pruritus, sweating, skin ulcer, contact dermatitis, exfoliative dermatitis, sudden hearing loss, hearing loss, mydriasis, conjunctivitis, tinnitus, eye pain, ocular hemorrhage, cataract, dry eye syndrome, cystitis, nocturia, frequency of urination, enlarged chest, incontinence, ejaculation disorder, genital edema, hyperesthesia, migraine, hypertonia, confusion, anxiety, hematuria, epistaxis, hypersensitivity reaction, diplopia, transient vision loss, retinal vascular disease, hemorrhage, vitreous detachment, contraction, macular edema, non-arteritic anterior ischemic optic neuropathy, facial flushing, infection, distal pain, hepatitis, virus, penile dysfunction, painful urination, polyuria, glaucoma, overflow, gastric cancer, seborrhea, myocardial infarction, hypotension, syncope, vasodilation, hypertension, palpitations, arrhythmia, incomplete right bundle branch block, headache, confusion, weakness, drowsiness, memory impairment, neuroirritability, insomnia, nausea, abdominal pain, vomiting, diarrhea, dyspepsia, abdominal discomfort, abdominal distension, constipation, dry mouth, tongue discoloration, prolonged erection, urinary tract infection, prostate abnormalities, penile pain, reflex erection, morning erection, ejaculation disorder, nasal congestion, nasal bleeding, rhinitis, pharyngitis, respiratory infection, sinusitis, respiratory distress, arthralgia, abdominal pain, myalgia, rash, pruritus, skin dryness, decreased red blood cell volume, decreased white blood cell count, eosinophilia, lymphocytosis, decreased red blood cell count, increased red blood cell count, decreased hemoglobin, increased red blood cell volume, decreased lymphocytes, eye pain, congestion, conjunctivitis, color vision changes, scotoma, ocular congestion, hypersensitivity reaction, weakness, pain, influenza syndrome, increased creatine kinase, increased BUN, increased red blood cells in urine, fatigue, increased uric acid in urine, decreased sodium levels, increased serum inorganic phosphorus levels, increased protein in urine, increased blood sugar in urine, increased urobilinogen.

Not everyone experiences these, and they can vary from person to person.

Storage

This drug should be stored in a tightly closed container to prevent air or moisture from entering, preferably at room temperature between 1°C and 30°C. Proper storage will help maintain the drug's effectiveness for a long time.

Appearance and packaging

Appearance

Rectangular oral dispersible film in blue or light blue color

Package unit

10 pieces/box [1 piece/pack * 10]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.