New Sigra 5 mg Tablet (Tadalafil)

Adult dose

Do not crush this drug. Swallow one tablet whole. For oral administration. 1. Erectile dysfunction Use in adult men For patients who are expected 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. The appropriateness of continued daily dosing should be reassessed periodically. 2. Once-daily regimen for benign prostatic hyperplasia The recommended dose of this drug for once-daily administration is 5mg, taken at approximately the same time each day. 3. Once-daily regimen for erectile dysfunction and benign prostatic hyperplasia The recommended dose of this drug for once-daily administration is 5mg, taken at approximately the same time each day, regardless of the timing of sexual activity. 4. Special populations ● Use in older men Dose adjustments are not required in older 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, sections 3.2) and 11.2) Pharmacokinetic Properties]. - 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, sections 3.3) and 11.2) Pharmacokinetic Properties]. ● Use in men with hepatic impairment Once-daily dosing has not been evaluated in patients with hepatic impairment. Therefore, if prescribing, the physician should carefully assess the benefit/risk for each individual. (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 drug should not be used in people under 18 years of age.

This medication is used for the treatment of erectile dysfunction and benign prostatic hyperplasia, and a physician's evaluation is required before use. Patients with heart diseases or a recent history of myocardial infarction, angina, or stroke may be at risk if taking this medication. If cardiovascular symptoms occur while taking this medication, sexual activity should be stopped immediately and a doctor consulted. If an erection lasts more than 4 hours, it is essential to visit a hospital immediately, as untreated, it may lead to penile tissue damage and loss of erectile function. This medication must not be taken simultaneously with nitrates or NO donors as it can cause dangerously low blood pressure. Patients on alpha-blockers or antihypertensives should use caution and consult a doctor due to the risk of blood pressure drop. Additionally, this medication is not administered to patients with certain genetic disorders or hypersensitivity to any component. It is not for use in pregnant women, nursing mothers, women, or children. Side effects such as headaches, dyspepsia, back pain, muscle aches, flushing may occur, and if severe adverse symptoms arise, medical personnel should be informed immediately. Although this medication does not significantly affect driving or operating machinery, dizziness may occur in some individuals. In case of overdose, standard emergency treatment should be provided, as blood dialysis is not effective in removing this medication. Store out of reach of children and maintain in original packaging.

• Headache
• dyspepsia
• low back pain
• myalgia
• nasal congestion
• flushing
• limb pain
• nasopharyngitis
• upper respiratory infection
• cough

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. The storage temperature should be kept at room temperature between 1 degree and 30 degrees Celsius. This will help maintain the medication's efficacy safely for a longer period.

Appearance

Yellow, rounded triangular film-coated tablet

Package unit

30 tablets (10 tablets/PTP packaging x 3)