Tadalafil Orally Disintegrating Film 5 mg

Adult dose

1. Erectile dysfunction Use in adult men For patients who expect to use tadalafil frequently (at least 2 times per week), the recommended dose is up to 5mg once daily, taken at approximately the same time each day. Immediately after removing this medicine from its individual package, place it on the tongue and allow it to dissolve; take without water. The appropriateness of continuous daily dosing should be reassessed periodically. 2. Once-daily dosing for benign prostatic hyperplasia The recommended dose of this medicine for once-daily use is 5mg, taken at approximately the same time every day. 3. Once-daily dosing for erectile dysfunction and benign prostatic hyperplasia The recommended dose of this medicine for once-daily use is 5mg, taken at approximately the same time every day, regardless of the timing of sexual activity. 4. Special populations ● Use in elderly men Dose adjustments are not required in elderly patients. ● Use in men with renal impairment - Erectile dysfunction No dose adjustment is required in patients with mild to moderate renal impairment. Once-daily tadalafil is not recommended for patients with severe renal impairment. [See Precautions for Use 3.2) and Pharmacokinetic Properties 12.2)]. - Benign prostatic hyperplasia No dose adjustment is required in patients with mild renal impairment. Once-daily tadalafil is not recommended for patients with severe renal impairment. [See Precautions for Use 3.3) and Pharmacokinetic Properties 12.2)]. ● Use in men with hepatic impairment The once-daily dose has not been evaluated in patients with hepatic impairment. Therefore, if prescribing this medicine, the physician should carefully assess the individual benefit/risk. (See section 12. <Special Populations>.) ● Use in men with diabetes No dose adjustment is required in patients with diabetes.

Child dose

Do not use in persons under 18 years of age.

This medication is used for the treatment of erectile dysfunction and benign prostatic hyperplasia, and prior to taking it, a consultation with a healthcare provider is necessary to evaluate overall health status, including cardiovascular condition. Sexual activity can put strain on the heart, so patients with cardiovascular disease should exercise particular caution, and if heart-related symptoms appear during sexual activity, they should immediately stop and seek medical attention. This medication can rarely cause an erection lasting more than 4 hours (priapism), so if an erection lasts longer than 4 hours, immediate medical assistance should be sought, as delayed treatment can result in penile tissue damage and permanent erectile dysfunction. Patients taking nitrate medications or other antihypertensive drugs must not take this medication as it can lead to dangerously low blood pressure; they must inform their healthcare provider of any medication they are taking. Patients who have recently experienced severe cardiovascular diseases such as myocardial infarction, angina, heart failure, or stroke should not take this medication, and must discuss their medical history with their healthcare provider. This medication is contraindicated in patients with certain hereditary retinal diseases or those allergic to any component of this medication. Combining it with other erectile dysfunction treatments is not recommended as safety and efficacy have not been established. Patients with severely impaired kidney or liver function should carefully consider taking this medication, and patients on alpha-blockers or antihypertensives should consult their doctor due to the risk of low blood pressure. While using this medication, symptoms such as headache, dyspepsia, back pain, muscle pain, nasal congestion, flushing, limb pain, facial flushing, itching, abnormal sensations, dizziness, drowsiness, lightheadedness, diarrhea, cough, upper respiratory infection, nasopharyngitis, gastrointestinal reflux disease, abdominal pain, joint pain, sore throat, decreased hemoglobin, anxiety, sleep disorders, dry mouth, swallowing difficulties, nausea, vomiting, abdominal cramps, heartburn, sweating, rash, itchy skin, thrombocytopenia, and leukocytosis may occur, most of which are mild or temporary. This medication is not to be used by children or women, and its safety in pregnant women has not been established. It does not have a significant impact on driving or operating machinery, but caution is advised due to potential dizziness after taking the medication. In case of overdose, immediate medical assistance is required, and dialysis is not very effective in removing this medication. This medication should be stored out of the reach of children and should be kept in its original packaging.

Headache, dyspepsia, low back pain, muscle pain, congestion, flushing, limb pain, nasopharyngitis, upper respiratory infection, cough, diarrhea, urinary tract infection, gastroesophageal reflux disease, abdominal pain, hypertension, dizziness, priapism, increased blood urea nitrogen, tachycardia, palpitations, conjunctival injection, increased SGPT, chest pressure, vomiting, nausea, increased alkaline phosphatase, fatigue, neck stiffness, urethral pain, renal pain, dry mouth, heartburn, gastrointestinal disease, drowsiness, leukocytosis, thrombocytopenia, anxiety, sleep disorder, hypochromia, eye pain, chest pain, joint pain, hyperventilation, eye hemorrhage, eyelid swelling, conjunctival hemorrhage, dry eyes, abdominal cramps, increased bilirubin, ejaculation disorder, pain in the external genitalia, erythema, itching, penile dysfunction, myocardial infarction, tinnitus, nasal bleeding, dry nose, increased serum creatinine, hiccups, weakness, abdominal discomfort, abdominal pain, allergic reaction, facial edema, fever, increased SGOT, increased hemoglobin, urticaria, Stevens-Johnson syndrome, exfoliative dermatitis, migraine, seizure, transient global amnesia, visual field defect, retinal vein occlusion, retinal artery occlusion, permanent vision loss, non-arteritic anterior ischemic optic neuropathy, sudden hearing loss, hearing loss, tinnitus, angioedema, myasthenia, facial swelling, fatigue, pain, peripheral edema, angina, chest pain, hypotension, orthostatic hypotension, syncope, palpitations, tachycardia, renal impairment, dyspnea, nasal bleeding, pharyngitis, itching, rash, sweating, blurred vision, color vision deficiency, conjunctivitis, eye pain, increased tear secretion, eyelid swelling, increased erection, spontaneous penile erection

This medication should be stored in a sealed container to protect it from air and moisture, ideally at temperatures between 1°C and 30°C.

Appearance

White rectangular orally disintegrating film

Package unit

30 sheets/case (1 sheet x 25 mg)