Prolis 5mg Tablets (Tadalafil)

Adult dose

Do not crush this medicine. Swallow one tablet whole. For oral administration. 1. Erectile dysfunction Use in adult men For patients who anticipate frequent use of tadalafil (at least 2 times per week), the recommended dose is up to 5mg once daily, taken at approximately the same time each day. The suitability of continuous daily dosing should be reassessed periodically. 2. Once-daily use for benign prostatic hyperplasia The recommended dose of this medicine for once-daily use is 5mg, taken at approximately the same time each day. 3. Once-daily use 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 each day, regardless of the timing of sexual activity. 4. Special populations ● Use in elderly men Dose adjustment is not required in elderly patients. ● Use in men with renal impairment - Erectile dysfunction Dose adjustment is not required in patients with mild to moderate renal impairment. Once-daily tadalafil is not recommended in patients with severe renal impairment.[See sections 3.2) and 11.2) Pharmacokinetic properties of Precautions for use]. - Benign prostatic hyperplasia Dose adjustment is not required in patients with mild renal impairment. Once-daily tadalafil is not recommended in patients with severe renal impairment. [See sections 3.3) and 11.2) Pharmacokinetic properties of Precautions for use]. ● Use in men with hepatic impairment Once-daily dosing 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 11. <Special populations>) ● Use in men with diabetes Dose adjustment is not required in patients with diabetes.

Child dose

● Use in children and adolescents This medicine should not be used in people under 18 years of age.

This medication is used for treating erectile dysfunction and benign prostatic hyperplasia, and professional medical evaluation is necessary before use. Particularly, patients with heart disease or unstable cardiovascular conditions should consult a doctor, considering the cardiac burden during sexual activity. Rarely, an erection lasting more than 4 hours may occur after taking this medication, and immediate medical assistance must be sought; if left untreated, it could result in penile tissue damage or loss of potency. Additionally, co-administration with nitrates or NO donors can result in dangerously low blood pressure, so patients taking these medications should not use this drug. Patients with recent severe cardiovascular conditions such as myocardial infarction, unstable angina, heart failure, or stroke should also refrain from using this medication. Patients with penile deformities or blood disorders, or those with severely impaired kidney or liver function should use this drug cautiously, and should discuss potential risks of blood pressure reduction with a doctor when combined with alpha-blockers or antihypertensives. This drug is not for use in women, children, or infants, and its safety during pregnancy has not been established. During treatment, if sudden vision loss, hearing reduction, severe headache, dizziness, chest pain, or other symptoms occur, a doctor should be consulted immediately. This medication may cause side effects such as headache, dyspepsia, back pain, muscle pain, flushing, congestion, and is generally mild or transient. In case of overdose, standard emergency treatment is needed, and dialysis is not effective. When storing, keep it out of reach of children, and it's advisable to maintain it in its original packaging. Prior to and following administration, interactions with other medications must be checked, particularly caution is advised against using strong CYP3A4 inhibitors or nitrates together. It does not significantly affect driving or operating machinery, but individual responses may vary, and caution is advised in case of symptoms like dizziness.

• Headache
• dyspepsia
• lower back pain
• muscle pain
• 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. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius to safely retain its effectiveness for a longer period.

Appearance

Yellow oval film-coated tablet

Package unit

30 tablets (10 tablets/PTP × 3)