Bultium Oral Disintegrating Film 20 Milligrams (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 sufficient effect, 20 mg may be tried. This medicine may be taken at least 30 minutes before sexual activity. The maximum recommended frequency 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 prolonged daily dosing has not been established, and since the effect of this medicine usually lasts for more than one day, continuous daily administration is strongly discouraged. [See Section 1. Warnings and Section 11.1) Pharmacodynamic Properties.] Use in older men No dosage adjustment is required in older patients. Use in men with renal impairment No dosage 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 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. There are no data on administration of doses higher than 10mg to patients with hepatic impairment. [See Section 3. Patients Requiring Caution and Section 11.2) Pharmacokinetic Properties.] Use in men with diabetes No dosage adjustment is required in patients with diabetes.

Child dose

This medicine should not be used in persons under 18 years of age.

This medication is intended to treat erectile dysfunction. Before administration, it is essential to confirm the underlying cause through a doctor's diagnosis and physical examination. Sexual activity can put stress on the heart, so cardiovascular status must be carefully considered. If cardiac-related symptoms occur during sexual activity, it should be stopped immediately and a doctor consulted. If an erection lasts longer than 4 hours while taking this medication, immediate medical attention is required, as untreated it may lead to penile tissue damage and loss of erectile function. Patients taking nitrate compounds or NO donors should inform their doctor, as this medication can dangerously lower blood pressure and should not be used concurrently. Patients with cardiovascular diseases such as myocardial infarction, cardiac arrest, unstable angina, or stroke, or those who have recently experienced them, should not take this medication. Patients with hereditary retinal diseases or those who have experienced vision loss should also avoid using this medication. It is safe not to use this medication with other erectile dysfunction treatments. Patients with severely impaired kidney or liver function should be careful when using this medication, and a discussion with a doctor is necessary as the risk of side effects may increase when used with certain other drugs. Side effects may include headache, dyspepsia, back pain, muscle pain, flushing, limb pain, nasopharyngitis, upper respiratory infections, cough, diarrhea, gastroesophageal reflux disease, abdominal pain, dizziness, facial swelling, itching, anemia, insomnia, drowsiness, vertigo, thrombocytopenia, polycythemia, vomiting, nausea, fatigue, neck stiffness, kidney pain, dry mouth, heartburn, anxiety, sleep disorders, increased blood urea nitrogen, increased SGPT (SGPT), and increased SGOT.

• headache
• dyspepsia
• lumbago
• myalgia
• congestion
• flushing
• limb pain
• nasopharyngitis
• upper respiratory infection
• cough

This medication should be stored in a tightly sealed container to prevent air or moisture from entering, and it is recommended to store it at room temperature between 1 degree and 30 degrees. Proper storage helps maintain the medication's efficacy.

Appearance

Rectangular yellow oral disintegrating film

Package unit

<For domestic use> - 10 sheets/pack [(1 sheet/pouch x 10)], <For export> - 1 sheet/pouch, <For export> - 4 sheets/pack [1 sheet/pouch x 4], <For export> - 10 sheets/pack [1 sheet/pouch x 10]