Jofluza Tablet 40mg (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 Adults and children aged 12 years and older: 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 Adults and children aged 12 years and older: 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: Children aged 1 year and older but under 12 years, weighing 10 to less than 20kg: 10mg 1. Treatment of influenza A or B virus infection: Children aged 1 year and older but under 12 years, weighing 20kg or more to less than 40kg: 20mg 1. Treatment of influenza A or B virus infection: 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: Children aged 1 year and older but under 12 years, weighing 20kg or more to less than 40kg: 20mg 2. Prevention of influenza A or B virus infection after exposure: Children aged 1 year and older but under 12 years, weighing 40kg or more: 40mg

This medication cannot replace influenza vaccinations, so it is important to receive annual vaccinations for influenza prevention. This medication is only approved for the treatment of influenza A and B virus infections, and safety and efficacy have not been confirmed for the treatment of other infections. Patients who are allergic to this medication or its components should not take it, and individuals with lactose intolerance due to genetic reasons should also avoid taking this medication. While serious side effects have not been reported in most adult and adolescent patients in clinical trials, symptoms such as vomiting, diarrhea, headache, nausea, and nasopharyngitis can occur occasionally. This medication does not prevent influenza complications, so appropriate treatment is necessary if a bacterial infection accompanies the influenza infection. In pediatric and adolescent patients, there have been reported cases of unusual behavior following administration of this medication, so they should be closely monitored for at least 2 days after starting treatment. To be effective, administration should start within 48 hours after symptoms begin, and safety and efficacy have not been confirmed beyond this timeframe. There may be interactions when taken with other medications, so it is advisable not to take it concurrently with medications containing multivalent cations such as certain antacids or iron supplements. The safety of this medication during pregnancy is not guaranteed, and it should only be used when necessary, considering potential risks to the fetus; breastfeeding mothers should consult their physician before taking it. The safety and efficacy have not been confirmed for children under 1 year old, so it should not be used in this age group; for those 1 year and older, it should be administered according to appropriate dosages based on age and weight. Generally, this medication is safe for the elderly, but caution is needed as nausea may occur more frequently. For patients with severely impaired kidney or liver function, the safety and efficacy of this medication have not been thoroughly studied, so it should be used with caution. There is no specific antidote for overdose, and appropriate treatment should be received based on symptoms, so it is important to adhere to the prescribed dosages. This medication should be kept out of the reach of children, and transferring it to other containers can negatively affect its quality, so it should be avoided.

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

This medication should be stored in a sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1°C and 30°C (room temperature).

Appearance

White or yellowish oval film-coated tablet

Package unit

1 tablet/box [1 tablet/PTP x 1], 2 tablets/box [2 tablets/PTP x 1]