Tadalafil Oral Dissolving Film 20mg (Tadalafil)

Adult dose

Use in adult men The recommended dose of this medication is 10mg, taken with or without food before anticipated sexual activity. For patients in whom tadalafil (tadalafil) 10mg does not provide an adequate effect, 20 mg may be tried. This medication may be taken at least 30 minutes before sexual activity. The maximum recommended dosing frequency is once daily. Immediately after removing this medication from its individual package, place it on the tongue and allow it to dissolve; take without water. Long-term safety following extended daily dosing has not been established, and because the effect of this medication usually lasts more than one day, continuous daily administration of this medication is strongly discouraged. [See section 1. Warnings and section 11.1) Pharmacodynamic properties] Use in older men No dosage adjustments are required in older 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 is 10mg, taken with or without food before anticipated sexual activity. Since clinical data on the safety of this medication in patients with severe hepatic impairment (Child-Pugh Class C) are limited, the physician should carefully evaluate 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. Use with caution in the following patients and section 11.2) Pharmacokinetic properties]. Use in men with diabetes No dose adjustment is required in patients with diabetes.

Child dose

Do not use in people under 18 years of age.

This medication is for the treatment of erectile dysfunction, and a doctor's diagnosis and physical examination must be performed prior to use. Patients with heart diseases must use it cautiously, considering the cardiovascular stress caused by sexual activity. If an erection persists for more than 4 hours after taking this medication, seek medical assistance immediately, as untreated prolonged erection can lead to penile tissue damage or permanent loss of erectile function. Patients taking nitrate-containing drugs or nitric oxide donors must not use this medication, as it can cause dangerously low blood pressure. Patients who have recently experienced a myocardial infarction, angina, heart failure, or stroke, or who have poorly controlled blood pressure should not use this medication. This medication is contraindicated for patients with certain hereditary retinal diseases or those allergic to any of its components. Additionally, combining it with other erectile dysfunction treatments is not recommended due to lack of safety data. Care should be taken with patients who have penile deformities or certain blood disorders, as well as those with severely impaired kidney or liver function. Patients taking alpha-blockers or strong CYP3A4 inhibitors need dose adjustments and monitoring. In clinical trials and post-marketing studies, common side effects may include headache, dyspepsia, back pain, muscle pain, flushing, limb pain, dizziness, diarrhea, nasopharyngitis, upper respiratory tract infections, cough, gastroesophageal reflux disease, abdominal pain, facial flushing, itching, facial swelling, dysesthesia, visual impairment, palpitations, drowsiness, vertigo, dry mouth, dysphagia, esophagitis, gastritis, loose stools, nausea, upper abdominal pain, vomiting, hemorrhoidal bleeding, rectal bleeding, joint pain, throat pain, sensory loss, and insomnia. If sudden vision loss or hearing decrease occurs during use of this medication, stop immediately and consult a doctor. Caution is advised when taking this medication with alcohol, as it may increase blood pressure lowering or dizziness. In case of overdose, standard treatment should be administered; blood dialysis is not effective. Keep out of reach of children, and it is safest to maintain its original packaging. It does not significantly affect driving or operation of machinery, but it is advisable to check individual reactions.

• Headache
• indigestion
• low back pain
• muscle pain
• nasal congestion
• flushing
• limb pain
• nasopharyngitis
• upper respiratory infection
• cough

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The recommended storage temperature is room temperature between 1 to 30 degrees Celsius.

Appearance

White rectangular oral dissolving film

Package unit

10 sheets/case