Remeron SolTab 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 used. 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, this medicine has not been studied in patients with severe hepatic impairment, so use caution when prescribing. Elderly patients: The recommended dose is the same as for adults. When increasing the dose, careful monitoring is required 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, when starting an MAO inhibitor to treat a psychiatric disorder, at least 14 days must have elapsed since discontinuing this medicine. Other MAO inhibitors, such as linezolid or methylene blue: Patients receiving linezolid or intravenous methylene blue should not start this medicine because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization or other interventions, 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, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, discontinue this medicine immediately and administer linezolid or intravenous methylene blue. Monitor the patient for symptoms of serotonin syndrome for 2 weeks after starting linezolid or intravenous methylene blue, or for 24 hours after the last dose, whichever occurs 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 with 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. 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 going to bed. The daily dose 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, do not change the dose at intervals of less 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. If there is no effect after continuing treatment for another 2～4 weeks, discontinue treatment. 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 rapidly on the tongue and can be swallowed without water. To prevent this medicine from breaking, do not press the tablets through the packaging (Figure 1). Each pack contains 6 tablets, separated by perforations. As shown in Figures 2 and 3, bend the pack 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: Do not use this medicine in children or adolescents under 18 years of age because its efficacy has not been demonstrated in two short-term clinical trials and there are safety concerns (see sections 4. Adverse Reactions and 8. Use in Children and Adolescents under Precautions for Use).

This medication is used for the treatment of depression, and particularly in younger age groups, the risk of suicidal thoughts and behaviors may increase, so caution is necessary during use. It is not approved for use in children and adolescents, and if sore throat, fever, or symptoms of infection occur during use, consult a doctor immediately. This medication can cause drowsiness and dizziness, so care should be taken when driving or operating machinery, and alcohol consumption should be avoided. Also, appetite and weight may increase, making it important to monitor weight changes regularly. Patients with impaired liver or kidney function should consult a doctor before taking this medication, and treatment should be stopped if signs of liver dysfunction appear. This medication may interact with other drugs; therefore, inform your doctor of any medications you are taking. In particular, serious side effects can occur if taken with certain psychiatric medications, so caution is required. Women who are pregnant or nursing should consult a doctor before taking this medication, and the use during pregnancy is carefully decided only when necessary. In cases of overdose, severe drowsiness, memory impairment, and cardiac arrhythmia may occur, so it is crucial to strictly adhere to the prescribed dosage. If thoughts of suicide, aggression, anxiety, or other changes in mental state occur during the use of this medication, consult healthcare professionals immediately.

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

This medication should be stored in a tightly sealed container to prevent air or moisture from entering, and kept in a cool place below 30 degrees Celsius to maintain effectiveness and safety.

Appearance

White, round orally disintegrating tablet

Package unit

30 tablets (6 tablets/PTP x 5 PTP)