Remicil ODT 30 mg (Mirtazapine)

Adult dosage

The therapeutic dose of this medicine should be adjusted according to the patient's clinical condition, and the lowest effective dose possible should be administered. Adults The initial dose of mirtazapine is 15 mg per day, and the dose may need to be increased until an adequate clinical effect is achieved. The usual effective daily dose is 15～45 mg of this medicine. Patients with renal impairment Clearance of this medicine may be reduced in patients with moderate to severe renal impairment (creatinine clearance<40 mL/min); use caution when prescribing. Patients with hepatic impairment Clearance of this medicine may be reduced in patients with hepatic impairment; use caution when prescribing. In particular, use caution when prescribing to patients with severe hepatic impairment, as this population has not been studied. Older adults The recommended dose is the same as for adults. When increasing the dose, careful monitoring is necessary to achieve a satisfactory and safe effect. Switching from MAO inhibitors used to treat psychiatric disorders When discontinuing an MAO inhibitor used to treat a psychiatric disorder and starting treatment with this medicine, allow an interval of at least 14 days. Conversely, at least 14 days must elapse after discontinuing this medicine before starting an MAO inhibitor for the treatment of a psychiatric disorder. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with this medicine because of the increased risk of serotonin syndrome. In patients who require treatment for a more urgent psychiatric condition, including hospitalization and other interventions, consider treatment. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient who is already receiving this medicine. If there are no alternative medicines to linezolid or intravenous methylene blue, and the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome in a particular patient, discontinue this medicine immediately and administer linezolid or intravenous methylene blue. Monitor the patient for symptoms of serotonin syndrome for 2 weeks after administration of linezolid or intravenous methylene blue, or until 24 hours after the last dose, whichever comes first. Treatment with this medicine may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risks associated with administration of methylene blue by a non-intravenous route (oral tablets or local injection), or intravenous administration of this medicine at a dose of 1mg/kg or less, are unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses. Because the half-life of this medicine is 20∼40 hours, once-daily administration is sufficient; if possible, take it at a consistent time in the evening before bedtime. The daily dose may also be divided into equal doses taken once in the morning and once in the evening. To allow sufficient time to evaluate the therapeutic response to the dose, do not change the dose at intervals shorter than 1～2 weeks. At an appropriate dose, a therapeutic effect appears within 2～4 weeks. If the effect is insufficient, the dose may be increased up to the maximum dose. Discontinue treatment if there is no effect after continuing treatment for an additional 2～4 weeks. Treatment should continue for at least 4∼6 months until the patient's symptoms have completely resolved. Thereafter, gradual discontinuation is recommended to avoid withdrawal symptoms. Remove this medicine and place it on the tongue. It dissolves quickly on the tongue and can be swallowed without water. To prevent this medicine from breaking, do not press the tablet in its packaging (Figure 1). Each package contains 10 tablets, separated by perforations. As shown in Figures 2 and 3, bend the package along the perforations to separate the tablets, and detach one tablet. As shown in Figures 4 and 5, hold the marked area on the back and carefully peel off the backing in the direction of the arrow. Remove the tablet with dry hands and place it on the tongue.

Children's dosage

Children and adolescents under 18 years of age Do not use this medicine in children and adolescents under 18 years of age because its efficacy was not established in two short-term clinical trials and there are safety concerns. (See 4. Adverse Reactions and 8. Use in Children and Adolescents under Precautions for Use.)

This drug is primarily used as an antidepressant for psychiatric disorders such as depression. During the use of this medication, especially in young adults and adolescents aged 18 to 24, there may be an increased risk of suicidal thoughts or behaviors, so the physician should carefully evaluate the benefits and risks of treatment. Patients and their families should closely monitor for worsening depression symptoms, suicidal thoughts, aggression, or other abnormal behavioral changes during treatment, and consult a doctor immediately if any unusual symptoms appear. This drug can affect bone marrow function, so if there is a decrease in white blood cell count or symptoms of infection appear within 4 to 6 weeks after taking the medication, it should be reported to medical personnel immediately. Patients with impaired liver or kidney function may be affected in drug metabolism and excretion, so caution is necessary while using. Additionally, this drug may cause drowsiness and dizziness, so caution is advised when performing activities that require attention such as driving or operating machinery. Increased appetite and weight gain may commonly occur, so it is advisable to continuously monitor weight changes. Liver function test results may increase, so regular monitoring of liver health is recommended. This drug can interact with other medications, so if you are taking other drugs, you must inform your physician. In particular, it should never be used in combination with MAO inhibitors due to the risk of serious side effects. Women who are pregnant or breastfeeding should consult their doctor before taking this medication, and during pregnancy, it should only be used cautiously if necessary. Safety and efficacy have not been sufficiently proven in children and adolescents, and it is generally not recommended. In case of overdose, severe drowsiness, memory impairment, and heart rhythm abnormalities may occur, and immediate medical attention should be sought. Finally, this medication should be kept out of the reach of children, and discontinuation should not be done arbitrarily but under medical advice.

• Drowsiness
• nausea
• increased appetite
• weight gain
• dizziness
• lethargy
• flu-like syndrome
• back pain
• dry mouth
• constipation

This medication may be sensitive to air or humidity, so it must be stored in a tightly sealed container. It is recommended to maintain storage temperatures between 1 degree and 30 degrees Celsius at room temperature. This helps to preserve the effectiveness of the medication over time.

Appearance

White, round, flat, orally disintegrating tablets with a unique scent on both sides.

Package unit

30 tablets (10 tablets/PTP x 3)