ZEDRAFIL 20mg (Tadalafil)

Adult dose

Use in adult men The recommended dose of this medicine is 10mg, taken with or without food before anticipated sexual activity. For patients in whom tadalafil 10mg does not provide an adequate effect, 20 mg may be tried. This medicine may be administered at least 30 minutes before sexual activity. The maximum recommended frequency of use is once daily. Long-term safety after extended daily administration has not been established, and because the effect of this medicine usually lasts longer than one day, continuous daily administration of this medicine is strongly discouraged. [See sections 1. Warnings and 11.1) Pharmacodynamic properties] Use in elderly men No dose adjustment is required in elderly patients. Use in men with renal impairment No dose adjustment is required in patients with mild to moderate renal impairment. The maximum recommended dose in patients with severe renal impairment is 10mg. [See section 11.2) Pharmacokinetic properties]. Use in men with hepatic impairment The recommended dose of this product is 10mg, taken with or without food before anticipated sexual activity. Since clinical data on the safety of this product in patients with severe hepatic impairment (Child-Pugh Class C) are limited, the physician should carefully assess the individual benefit/risk when prescribing it. There are no data on administering doses higher than 10mg to patients with hepatic impairment. [See sections 3. Administration with caution in the following patients and 11.2) Pharmacokinetic properties]. Use in men with diabetes No dose adjustment is required in patients with diabetes.

Child dose

Under 18 years of age: This product should not be used.

This medication is a drug for the treatment of erectile dysfunction and will only have effects when there is sexual stimulation. Before taking this medication, a physician must accurately diagnose the cause of erectile dysfunction through the patient's medical history and physical examination. Patients with heart disease may experience a burden on the heart due to sexual activity, and cardiovascular status must be evaluated before taking this medication. If cardiovascular symptoms occur during sexual activity, sexual activity should be stopped immediately and the physician should be consulted. This medication may rarely cause a prolonged erection (priapism) lasting more than 4 hours, in which case immediate medical attention should be sought. If priapism is not treated, it can lead to penile tissue damage and permanent loss of erectile function. Patients taking nitrate drugs or NO donors should not take this medication, as it may cause dangerously low blood pressure. Recent patients with cardiovascular diseases such as myocardial infarction, cardiac arrest, unstable angina pectoris, ventricular arrhythmias, or stroke should not use this medication. Patients with hereditary retinal diseases are also not recommended to take this medication. Patients with hypersensitivity to this drug or those taking other erectile dysfunction medications should avoid it. Patients with severely impaired kidney or liver function should be cautious when taking this medication and dosage adjustments may be necessary. When combined with some antihypertensive drugs such as alpha-blockers, hypotension symptoms may occur, so caution is advised. Common side effects of this medication include headache, dyspepsia, back pain, myalgia, congestion, flushing, limb pain, nasopharyngitis, upper respiratory infection, cough, diarrhea, gastroesophageal reflux disease, abdominal pain, dizziness, gastroenteritis, itching, fatigue, reduced hemoglobin, drowsiness, insomnia, abnormal sensation, sensory impairment, thrombocytopenia, increased blood urea nitrogen, elevated alkaline phosphatase, heartburn, vomiting, nausea, persistent thrombocytopenia, reduced hemoglobin, increased hemoglobin, facial flushing, and facial edema. Most of these are mild or moderate. Though rare, serious cardiovascular adverse reactions or vision and hearing loss have been reported, so if abnormal symptoms occur, consult a physician immediately. This medication should not be used in women, children, or infants, and its safety in pregnant women has not been established. Caution should be taken when consuming alcohol during treatment, as it may cause blood pressure drop or dizziness. In case of overdose, standard emergency treatment should be administered, as blood dialysis is not effective in removing this medication. When storing, keep it out of reach of children and maintain the original packaging.

Priapism, headache, dyspepsia, lower back pain, muscle pain, congestion, flushing, limb pain, nasopharyngitis, upper respiratory tract infection, cough, diarrhea, gastroesophageal reflux disease, abdominal pain, dizziness, urinary tract infection, gastroenteritis, hypertension, adverse reactions related to benign prostatic hyperplasia, dizziness, sensory loss, insomnia, paresthesia, drowsiness, vertigo, renal impairment, shortness of breath, epistaxis, pharyngitis, itching, rash, sweating, blurred vision, color vision abnormalities, conjunctivitis, eye pain, increased tear secretion, eyelid edema, sudden hearing decrease or loss, tinnitus, increased erection, spontaneous penile erection, urticaria, Stevens-Johnson syndrome, exfoliative dermatitis, migraine, seizures, transient global amnesia, visual field loss, retinal vein occlusion, retinal artery occlusion, permanent vision loss, angioedema, myocardial infarction, sudden cardiac death, stroke, chest pain, palpitations, ventricular arrhythmia, tachycardia, increased blood urea nitrogen, chest tightness, vomiting, nausea, increased alkaline phosphatase, fatigue, neck stiffness, urethral pain, kidney pain, dry mouth, heartburn, gastrointestinal disease, drowsiness, leukocytosis, thrombocytopenia, anxiety, sleep disorders, decreased hemoglobin, eye pain, chest pain, joint pain, hyperventilation, eye hemorrhage, eyelid swelling, conjunctival hemorrhage, dry eye syndrome, abdominal cramps, increased bilirubin, ejaculatory dysfunction, pain in external genitalia, erythema, itching, penile disorders, myocardial infarction, tinnitus, epistaxis, nasal dryness, increased serum creatinine, hiccups, asthenia, abdominal discomfort, allergic reactions, facial edema, fever, increased SGOT, increased hemoglobin, chills, skeletal pain

This medication should be stored in a tightly closed container to prevent air or moisture ingress. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to keep the efficacy and safety of the medication for an extended period.

Appearance

Film-coated tablet in yellow color, rounded triangular shape with a dividing line

Package unit

8 tablets (8 tablets/PTP x 1)