WIPS Oral Dissolving Film 20 mg (Tadalafil)

Adult dose

Use in adult men The recommended dose of this medicine is 10mg, taken regardless of meals before anticipated sexual activity. For patients in whom tadalafil 10mg does not provide a sufficient effect, 20 mg may be tried. This medicine may be taken at least 30 minutes before sexual activity. The maximum recommended frequency of use is once daily. Immediately after removing this medicine from its individual package, place it on the tongue and allow it to dissolve; take it without water. Long-term safety following extended daily dosing has not been established, and because the effect of this medicine usually lasts for more than one day, continuous daily administration is strongly not recommended. [See section 1. Warnings and section 11.1) Pharmacodynamic properties] Use in elderly men No dosage adjustments are necessary in elderly patients. Use in men with renal impairment No dosage adjustment is necessary 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 is 10mg, taken regardless of meals before anticipated sexual activity. Since clinical data on the safety of this medicine 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 section 3. Cautions for use in the following patients and section 11.2) Pharmacokinetic properties]. Use in men with diabetes No dosage adjustment is necessary in patients with diabetes.

Child dose

Should not be used in people under 18 years of age.

This medicine is used for the treatment of erectile dysfunction; before use, a doctor's diagnosis and physical examination to identify the underlying cause are essential. Sexual activity may put stress on the heart; therefore, patients with cardiovascular diseases should take special care, and if heart-related symptoms appear during or after sexual activity, they should immediately cease sexual activity and consult a physician. If an erection lasts more than 4 hours or if an erection accompanied by pain lasts more than 6 hours, medical attention should be sought immediately, as untreated cases may result in penile tissue damage and loss of erectile function. Taking this medicine with nitrate preparations may cause blood pressure to drop severely, so patients currently taking nitrate preparations must not use this medication. Patients who have experienced serious cardiovascular illnesses, such as myocardial infarction, stroke, or unstable angina, recently should not use this medicine. This medicine may rarely affect sperm count and concentration; therefore, consultation regarding reproductive function with a physician is recommended for long-term use. Patients with penile deformities, blood disorders, or severe kidney or liver dysfunction should use this medicine with caution, and special care is needed when used with other specific medications. While taking this medicine, side effects such as headache, dyspepsia, back pain, muscle pain, flushing, limb pain, pharyngitis, upper respiratory infections, cough, diarrhea, gastroesophageal reflux disease, abdominal pain, dizziness, generalized weakness, facial swelling, fatigue, pain, peripheral edema, angina, chest pain, hypotension, orthostatic hypotension, palpitations, fainting, tachycardia, dry mouth, dysphagia, esophagitis, gastritis, increased GGTP, loose stools, nausea, upper abdominal pain, vomiting, and hemorrhoids may occur; if symptoms are severe or persistent, consult a physician. If sudden vision loss or hearing reduction occurs, discontinue use immediately and inform healthcare personnel. Caution should be exercised as co-administration with alcohol may lead to low blood pressure and dizziness. This medicine is not for use in women or children, and its safety has not been confirmed in pregnant women. When driving or operating machinery, one should act cautiously after confirming individual responses to the medication. In case of overdose, immediate medical attention is required, and blood dialysis is ineffective for the removal of this medicine. This medicine should be kept out of the reach of children and stored in its original packaging.

Headache, indigestion, low back pain, muscle pain, congestion, flushing, limb pain, nasopharyngitis, upper respiratory infection, cough, diarrhea, gastroesophageal reflux disease, abdominal pain, hypertension, dizziness, priapism, increased blood urea nitrogen, tachycardia, palpitations, conjunctival injection, increased SGPT, chest pressure sensation, vomiting, nausea, increased alkaline phosphatase, fatigue, neck stiffness, urethral pain, kidney pain, dry mouth, heartburn, gastrointestinal disorders, drowsiness, leukocytosis, thrombocytopenia, decreased hemoglobin, eye pain, chest pain, joint pain, hyperventilation, eye hemorrhage, eyelid swelling, conjunctival hemorrhage, dry eye syndrome, abdominal cramps, increased bilirubin, ejaculation disorder, pain in external genitalia, erythema, itching, penile disorders, post-ictal state, myocardial infarction, tinnitus, epistaxis, dry nose, increased serum creatinine, hiccups, weakness, abdominal discomfort, allergic reaction, facial swelling, fever, increased SGOT, increased hemoglobin, urticaria, Stevens-Johnson syndrome, exfoliative dermatitis, migraine, seizure, transient global amnesia, visual field loss, retinal vein occlusion, retinal artery occlusion, permanent vision loss, non-arteritic anterior ischemic optic neuropathy, sudden hearing loss, hearing loss, tinnitus, angioedema, priapism

This medicine should be stored in a tightly sealed container to protect it from air and moisture. Avoid storing in excessively hot or cold places, and it is recommended to store it at room temperature between 1°C and 30°C.

Appearance

White rectangular oral dissolving film

Package unit

10 sheets/box