Remicil ODT 15 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. The initial dose of mirtazapine is 15 mg once daily, and the dose may need to be increased until an adequate clinical response is achieved. The usual effective daily dose is 15～45 mg of this medicine. Because the clearance of this medicine may be reduced in patients with moderate to severe renal impairment (creatinine clearance<40 mL/min), use caution when prescribing it. Because the clearance of this medicine may be reduced in patients with hepatic impairment, use caution when prescribing it. In particular, this medicine has not been studied in patients with severe hepatic impairment; therefore, use caution when prescribing it. The recommended dose is the same as for adults. When increasing the dose, careful monitoring is required to achieve a satisfactory and safe response. When discontinuing treatment with an MAO inhibitor used to treat a psychiatric disorder and starting treatment with this medicine, an interval of at least 14 days must be allowed. Conversely, when starting an MAO inhibitor to treat a psychiatric disorder, at least 14 days must have elapsed after discontinuing this medicine. Patients receiving linezolid or intravenous methylene blue should not start treatment with this medicine because of the increased risk of serotonin syndrome. For patients requiring treatment for a more urgent psychiatric condition, including hospitalization or other interventional procedures, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine. If there is no alternative 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, this medicine may be discontinued immediately and linezolid or intravenous methylene blue administered. Patients should be monitored 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 restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk 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 is unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses. As 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 of this medicine may also be divided into equal doses taken once each in the morning and evening. To allow sufficient time to evaluate the therapeutic response to the dose of this medicine, do not change the dose at intervals of less than 1～2 weeks. With treatment at an appropriate dose, a therapeutic effect appears within 2～4 weeks; if the therapeutic effect is insufficient, the dose may be increased up to the maximum dose. If there is no effect after continuing treatment for a further 2～4 weeks, discontinue treatment. Treatment should be continued 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 through the packaging (Figure 1). Each package contains 10 tablets, separated by perforations. As shown in Figures 2 and 3, bend the package along the perforation to separate one tablet, and remove it. 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. With dry hands, remove the tablet and place it on the tongue.

Children's dosage

Do not use this medicine in children or adolescents under 18 years of age.

This drug is an antidepressant used to treat symptoms associated with depression. During the use of this medication, there may be an increase in suicidal thoughts or suicidal behavior, so young adults and adolescents, especially those aged 18 to 24, should be monitored closely. There is a rare possibility of agranulocytosis, which is a rapid decrease in white blood cell count, so if symptoms of infection such as sore throat or fever occur, consult a doctor immediately. This medicine should be administered cautiously to patients with liver or kidney impairment, as the blood concentration of this medication may increase in cases of liver or kidney issues. Drowsiness or dizziness is common during the initial phase of treatment, so caution is advised while driving or operating dangerous machinery. This medication may increase appetite and lead to weight gain, so it is advisable to regularly monitor weight changes. Liver function test values may increase, so periodic tests are necessary for patients with liver disease. Mental changes such as anxiety, agitation, aggression, or impulsive behavior may appear during the use of this medication, so family members or caregivers should closely monitor the patient's condition. Severe side effects may occur if this drug is taken with other antidepressants, especially MAO inhibitors, hence it is essential to consult a doctor. Alcohol consumption may exacerbate side effects such as drowsiness, so it is recommended to avoid drinking during the course of treatment. If pregnant or nursing, it is crucial to consult with a doctor regarding the use of this medication. This medication is not recommended for children and adolescents under 18, and if administered, careful observation of any suicidal tendencies or behavioral changes is necessary. In case of overdose, symptoms like heart abnormalities, severe drowsiness, and coma may occur, so immediate medical attention is required. This drug should be kept out of reach of children and it is advisable to avoid transferring it to another container.

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

This medication should be stored in a closed container, as it may be sensitive to air or moisture. It's best to maintain storage temperatures between 1 to 30 degrees Celsius at room temperature. Storing it this way helps retain the medication's effectiveness and safety for a longer time.

Appearance

Flat white round orally disintegrating tablets with a unique aroma on both sides.

Package unit

30 tablets (10 tablets/PTP x 3)