Remeron Soltab 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 used. 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. 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. 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 primarily an antidepressant used for the treatment of depression. During treatment, the risk of suicidal thoughts or behaviors may increase, particularly in children, adolescents, and young adults, so patients and caregivers should closely monitor for any symptoms during the initial period of treatment or when changing dosages. This drug can rarely cause agranulocytosis, a rapid decrease in the number of white blood cells in the blood; immediate consultation with a doctor is necessary if fever, sore throat, or symptoms of infection occur. Patients with impaired liver or kidney function may be affected in terms of the metabolism and excretion of this medication, thus caution is advised during use. This medication can cause drowsiness and dizziness, so caution should be taken when performing hazardous activities such as driving or operating machinery. Increased appetite and weight gain may occur during treatment, so it is important to monitor for changes in weight. Liver function test results may be elevated, so patients with liver disorders need regular testing. This medication may interact with other drugs, so patients should inform their doctor or pharmacist about any other medications they are taking. It should not be taken with MAO inhibitors due to the risk of serious adverse effects. Pregnant or breastfeeding women must consult a physician before taking this medication. Safety and efficacy in children and adolescents have not been established, so it is generally not used in this population. Elderly patients may be more sensitive to medications, requiring dosage adjustments and careful monitoring of side effects. Severe side effects may occur in the event of overdose, so the prescribed dosage must be adhered to, and emergency treatment should be sought immediately in case of overdose. This medication should be stored out of the reach of children, and it is preferable not to transfer it to another container.

drowsiness, nausea, increased appetite, weight gain, dizziness, lethargy, flu-like syndrome, low back pain, dry mouth, constipation, peripheral edema, myalgia, abnormal dreams, abnormal behavior, tremors, confusion, dyspnea, frequent urination, fatigue, abdominal pain, acute abdominal syndrome, chills, fever, facial edema, ulcers, photosensitivity reaction, neck stiffness, neck pain, abdominal distension, soft tissue inflammation, chest pain below the sternum, hypertension, vasodilation, angina, myocardial infarction, bradycardia, ventricular extrasystole, syncope, migraine, hypotension, atrial arrhythmia, ectopic heartbeat, vascular headache, pulmonary embolism, cerebral ischemia, cardiomegaly, phlebitis, left heart failure, vomiting, loss of appetite, belching, glossitis, cholecystitis, gum bleeding, stomatitis, colitis, abnormal liver function tests, tongue depigmentation, ulcerative stomatitis, salivary gland enlargement, hypersalivation, intestinal obstruction, pancreatitis, aphthous stomatitis, liver cirrhosis, gastritis, gastroenteritis, oral candidiasis, tongue swelling, goiter, hypothyroidism, lymphadenopathy, leukopenia, petechiae, anemia, thrombocytopenia, lymphocytosis, pancytopenia, thirst, dehydration, weight loss, gout, elevated AST, abnormal healing, increased acid phosphatase enzyme, elevated ALT, diabetes, hyponatremia, myasthenia, arthralgia, arthritis, tendinitis, pathological fractures, osteoporotic fractures, bone pain, myositis, tendon rupture, arthrosis, bursitis, sensory impairment, apathy, depression, reduced motor function, dizziness, single contraction, restlessness, anxiety, amnesia, hyperactivity, sensory disturbances, ataxia, delirium, hallucination, loss of self, dyskinesia, extrapyramidal syndrome, increased libido, abnormal cooperation, stuttering, hallucinations, manic reaction, neurosis, muscle tension abnormality, hostility, hyperreflexia, emotional instability, relief, paranoid reaction, aphasia, nystagmus, inability to sit still, confusion, dementia, diplopia, drug dependence, paralysis, grand mal seizure, decreased muscle tone, metabolic muscle spasms, psychotic depression, withdrawal syndrome, serotonin syndrome, increased coughing, sinusitis, nosebleed, bronchitis, asthma, pneumonia, asphyxia, laryngitis, pneumothorax, hiccups, itching, rash, acne, desquamative dermatitis, dry skin, herpes simplex, hair loss, urticaria, shingles, skin hypertrophy, seborrhea, skin ulcer, ocular pain, abnormal eye accommodation, conjunctivitis, hearing loss, keratoconjunctivitis, overflow incontinence, glaucoma, auditory hyperreaction, ear pain, ocular inflammation, temporary partial hearing loss, otitis media, loss of taste, abnormal smell, urinary tract infection, kidney stones, cystitis, dysuria, urinary incontinence, urinary retention, vaginitis, hematuria, breast pain, amenorrhea, dysmenorrhea, white discharge, erectile dysfunction, polyuria, urethritis, uterine bleeding, menorrhagia, abnormal ejaculation, breast engorgement, breast enlargement, urgency, excessive sedation, forgetfulness, facial tremor, fatigue, tinnitus, skin mucosal syndrome, vesicular dermatitis, erythema multiforme, toxic epidermal necrolysis, eosinophilia, drug reactions with systemic eosinophilia, increased serum creatine kinase, rhabdomyolysis, oral sensory impairment, lip edema, bone marrow suppression, eosinophilia, restless legs syndrome, oral sensory abnormalities, aggressiveness, hyperprolactinemia, sleepwalking, priapism, insomnia, agitation, impulsivity, inability to sit still, mania, panic disorder, anxiety, panic disorder, insomnia, agitation, hostility, aggressiveness, impulsivity, inability to sit still, mania, seizures, hyponatremia, serotonin syndrome, suicidal tendencies, suicidal impulses, suicidal behavior

This medication should be stored in a tightly closed container to protect it from air and moisture. Additionally, it is important to keep it in a cool place below 30 degrees Celsius to maintain its effectiveness.

Appearance

White round oral dispersible tablet

Package unit

30 tablets (6 tablets/PTP x 5 PTP)