Daxas 500 micrograms (Roflumilast)

Adult dose

Adults 18 years of age and older: Take 1 tablet once daily, with or without food.

This drug should not be used in patients who have an allergy to the active ingredient or excipients. It should not be administered to patients with moderate to severe impairment of liver function or severe immunological diseases. This drug is also not suitable for patients with acute severe infections, cancer patients, or those on immunosuppressants. It should not be taken by patients with latent infections or severe heart failure, or those with a history of suicidal thoughts or behaviors. Patients with lactose-related genetic disorders should avoid this drug. Patients with mild liver impairment, low body weight, or a history of mental illness or those taking medications that may cause psychiatric problems should use this drug with caution. Common side effects of this drug include diarrhea, weight loss, nausea, abdominal pain, and headache, which are mostly mild to moderate. These symptoms may appear particularly during the early stages of treatment and often improve over time. Rare psychiatric side effects such as insomnia, anxiety, depression, and suicidal thoughts have been reported, and patients and caregivers should carefully monitor for these changes. This drug should not be used as a relief for acute bronchospasm, and underweight patients should regularly check for weight changes. If psychiatric symptoms occur or there is a history of mental illness, immediate consultation with healthcare professionals is necessary. There may be drug interactions, especially with medications that inhibit or induce specific liver metabolic enzymes. It is safer not to use this drug during pregnancy or breastfeeding, and it should not be administered to children under 18 years of age. In the case of overdose, symptoms such as headache, dizziness, and palpitations may occur; thus, overdose should be avoided, and any unusual symptoms should be reported to healthcare professionals immediately. This drug should be stored out of reach of children and maintained in its original packaging to preserve its quality.

• Diarrhea
• weight loss
• nausea
• abdominal pain
• headache
• hypersensitivity reaction
• angioedema
• gynecomastia
• decreased appetite
• insomnia

This drug should be stored at room temperature between 1°C and 30°C, and it is important to keep it in a tightly closed container to prevent air from entering. This will help maintain the effectiveness of the medication for a longer period.

Appearance

Yellow film-coated tablet shaped like a 'D' with 'D' imprinted on one side

Package unit

30 tablets (10 tablets/PTP x 3)