Dutalac Soft Capsule 0.5 mg (Dutasteride)

Adult dose

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

This medication can be absorbed through the skin, so women who are pregnant or may become pregnant should not touch or handle this medication directly. If the capsule is broken or if the contents come into contact with the skin, it must be washed off immediately with soap and water. Children under 18 years old should also avoid contact with this medication, and immediate washing is necessary in case of contact. This medication is not intended for use in women and children under 18 years old, and should not be administered to those with allergies to its components. Adult men planning to conceive should use this medication cautiously under medical supervision as it may affect reproductive capability. Patients with urinary obstruction or severe urination difficulties should be careful when using this medication, as well as those with impaired liver function. Additionally, patients taking strong CYP3A4 inhibitors for prolonged periods need to be cautious when using this medication in combination. During the course of this medication, erectile dysfunction, decreased libido, ejaculatory disorders, and other sexual dysfunctions may occur, and these symptoms may persist even after stopping the drug. Some patients may experience breast-related adverse reactions such as gynecomastia or breast tenderness. This medication can lower prostate-specific antigen (PSA) levels, so when interpreting PSA test results, a new baseline obtained 3-6 months after starting treatment should be used. It is important to regularly check for prostate cancer while taking this medication. Long-term use of this medication may increase the risk of high-grade prostate cancer, necessitating periodic evaluation. Blood donation during treatment is prohibited, and at least 6 months must pass after the last dose before donating blood. There is no specific antidote for overdose, so appropriate treatment should be administered according to symptoms, and caution is necessary due to the long half-life of this medication. Store out of reach of children and in the original container to prevent misuse or degradation of quality. This medication is known not to affect the ability to drive or operate machinery. Pregnant women must not use or handle this medication, and nursing women should also avoid using it. There may be potential interactions with other medications, so if taking other medications, consultation with a physician or pharmacist is essential. In patients with heart failure, the risk of heart failure may increase when this medication is used in combination with other agents, requiring caution.

• 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 sealed container to prevent air ingress, and kept in a cool place below 30 degrees Celsius to maintain its effectiveness.

Appearance

A transparent, light yellow oval soft capsule containing a colorless transparent substance.

Package unit

30 capsules (15 capsules/PTP*2)