Zofluza Tablet 20 Milligrams (Baloxavir Marboxil)

Adult dose

This medicine may be administered with or without food. Do not take this medicine together with laxatives or antacids containing polyvalent cations, or oral supplements containing iron, zinc, selenium, calcium, or magnesium (see Precautions for Use, 5. Interactions). 1. Treatment of influenza A or B virus infection: Administer this medicine orally as a single dose within 48 hours of symptom onset. Adults and children aged 12 years and older: Body weight 40kg or more to less than 80kg: 40mg Body weight 80kg or more: 80mg 2. Prevention of influenza A or B virus infection after exposure: Administer this medicine orally as a single dose after close contact with a symptomatic person. Adults and children aged 12 years and older: Body weight 40kg or more to less than 80kg: 40mg Body weight 80kg or more: 80mg Patients with hepatic impairment: No dose adjustment is necessary in patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment. This medicine has not been evaluated in patients with severe hepatic impairment.

Child dose

1. Treatment of influenza A or B virus infection: Administer this medicine orally as a single dose within 48 hours of symptom onset. Children aged 1 year and older but under 12 years, weighing 10 to less than 20kg: 10mg Children aged 1 year and older but under 12 years, weighing 20kg or more to less than 40kg: 20mg Children aged 1 year and older but under 12 years, weighing 40kg or more: 40mg 2. Prevention of influenza A or B virus infection after exposure: Administer this medicine orally as a single dose after close contact with a symptomatic person. Children aged 1 year and older but under 12 years, weighing 20kg or more to less than 40kg: 20mg Children aged 1 year and older but under 12 years, weighing 40kg or more: 40mg

This medication cannot replace influenza vaccination, so it should be used in conjunction with vaccination. The safety and efficacy of this medication have not been confirmed for infections other than influenza A and B viruses. It should not be administered to individuals with allergies to this medication or its components. Given that it contains lactose, patients with lactose intolerance or related genetic disorders should not take it. Although most patients experienced few adverse reactions in clinical trials, headaches, nausea, diarrhea, among others, may occur infrequently. Particularly in children and adolescents, abnormal behaviors have been reported, so they should be closely monitored for at least 2 days after administration. It is recommended that administration begin within 48 hours after symptom onset; efficacy and safety have not been established if taken after that period. Interactions may occur with other medications, so it should not be taken with antacids or iron supplements, among others. The safety of this medication during pregnancy is not established, so the risks versus benefits to the fetus should be considered carefully. In breastfeeding cases, there is a possibility that this medication may be excreted in breast milk, so breastfeeding status and administration should be discussed with healthcare professionals. Safety and efficacy have been confirmed for adolescents aged 12 years and older weighing 40 kg and above, and for children aged 1 year and older; however, it is not recommended for children under 1 year. It is also available for use in the elderly, but side effects such as nausea may be somewhat more frequent. The safety of this medication has not been sufficiently verified in patients with severe renal or liver impairment, so caution is required. In the case of overdose, there are no specific antidotes, appropriate treatment should be administered based on symptoms, and it is difficult to remove the drug through dialysis. This medication should be kept out of reach of children and should not be transferred to other containers.

• Diarrhea
• bronchitis
• nausea
• sinusitis
• headache
• nasopharyngitis
• facial swelling
• eyelid swelling
• tongue swelling
• difficulty in speech

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. To maintain its effectiveness, it is best to store it at room temperature between 1 to 30 degrees Celsius.

Appearance

White or yellowish oval film-coated tablets

Package unit

2 tablets/box [2 tablets/PTP X1], 4 tablets/box [4 tablets/PTP X1]