Dutasteride Soft Capsules 0.5 mg (Dutasteride)

Adult dose

The recommended dose of this drug is 1 capsule (0.5mg) once daily. Because exposure to the capsule contents may cause irritation of the oropharyngeal mucosa, swallow this drug whole without chewing or opening the capsule. This drug may be taken with or without food. No dose adjustment is required in patients with renal impairment or elderly patients. Since there are no data on administration of this drug to patients with hepatic impairment, a recommended dose for these patients has not been established.

This medication is absorbed through the skin; therefore, women who are pregnant or may become pregnant should not handle or come into contact with this medication. If the capsule is broken and the medication comes into contact with the skin, wash it off immediately with soap and water. This medication should not be used in children under 18 years of age, and care should be taken to prevent contact with children. Women, children under 18, and individuals allergic to this medication or similar components should not take this medication. Men planning to conceive should consult with their doctor before using this medication, as it may affect reproductive ability. Patients with difficulty in urinary drainage or severe reduction in urinary flow need to be careful when taking this medication and should closely monitor for symptoms of urinary retention. Patients with liver dysfunction should also be cautious when taking this medication. Taking this medication in conjunction with strong CYP3A4 inhibitors may alter drug concentration, so caution is necessary. During the course of this medication, side effects related to sexual function such as erectile dysfunction, reduced libido, and ejaculation disorders may occur, and some patients may experience breast tenderness or breast enlargement. Most side effects are mild to moderate and often resolve after discontinuation of the medication. While taking this medication, there may be a decrease in prostate-specific antigen (PSA) levels in blood tests, so caution should be taken when interpreting PSA levels. Long-term use of this medication may increase the risk of high-grade prostate cancer, thus regular prostate cancer screenings are recommended. Avoid blood donation while taking this medication, and at least 6 months should pass after the last dose before donating blood. There is no specific antidote for overdose, and appropriate supportive treatment may be required depending on the symptoms. Store out of reach of children, and keep in the original container to prevent misuse or degradation in quality. This medication is not known to affect the ability to drive or operate machinery.

• Erectile dysfunction
• decreased libido
• ejaculation disorder
• gynecomastia
• headache
• gastrointestinal discomfort and pain
• sexual dysfunction
• breast disorders
• dizziness
• rash

This medication should be stored in a tightly closed container to prevent air from entering, and it is best to maintain a temperature below 30 degrees Celsius. This will help keep the medication effective and prevent degradation.

Appearance

A translucent yellow oval soft capsule containing a colorless transparent substance.

Package unit

30 capsules (15 capsules/PTP × 2)