Risdal Tablet 3 mg (Risperidone)

Adult dose

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. Schizophrenia - Adults Initial dose: Administer 1 mg of risperidone orally twice daily and increase the dose gradually. Maintenance dose: Administer 1∼3 mg twice daily. Adjust the dose appropriately according to age and symptoms. At doses of 10 mg or more per day, no additional effects were observed compared with lower doses, and the risk of extrapyramidal symptoms may increase. Doses of 10 mg or more per day should be administered only when the benefits are judged to outweigh the risks for the individual patient. The safety of doses of 16 mg or more per day has not been established; do not administer these doses. A benzodiazepine may be co-administered if additional sedation is needed. Schizophrenia - Elderly patients and patients predisposed to hypotension The initial dose is 0.5 mg twice daily. Depending on the patient's condition, increase the dose by 0.5 mg twice daily until a dose of 1～2 mg twice daily is reached. In general, increases to doses of 1.5 mg or more twice daily should be made at intervals of at least 1 week. Switching from another antipsychotic medicine to this medicine When medically appropriate, start treatment with this medicine while gradually reducing the dose of the previous medicine. Also, when medically appropriate, when switching from an existing depot antipsychotic, start treatment with this medicine in place of the next scheduled depot injection. The need to continue concomitant antiparkinsonian medicines should be reassessed regularly. Agitation, aggression, or psychotic symptoms in patients with dementia of the Alzheimer type The initial dose is 0.25 mg of this medicine twice daily. If needed for the patient, the dose may be increased by 0.25 mg twice daily at intervals of at least 2 days. The optimal dose for most patients is 0.5 mg twice daily, but the dose may be increased to 1 mg twice daily depending on the patient. Once the patient has reached the optimal dose, once-daily administration may also be considered. As with symptomatic treatment, the rationale for continued use of this medicine should be evaluated. Adjunctive therapy for manic episodes in bipolar disorder The recommended initial dose is 2 mg of this medicine once daily. Depending on the patient, the dose may be increased by 1 mg per day at intervals of at least 24 hours. The optimal dose for most patients is within the range of 2∼6 mg per day. As with symptomatic treatment, the rationale for continued use of this medicine should be evaluated. Renal and hepatic impairment For patients with renal or hepatic impairment, administer half the initial and maintenance doses and adjust the dose more gradually. Use this medicine with caution in these patients (see 5. General Precautions).

Child dose

Schizophrenia - Clinical experience in children and adolescents under 15 years of age is limited. Adjunctive treatment of manic episodes in bipolar disorder - Clinical experience in children and adolescents under 15 years of age is limited. Conduct disorder and other disruptive behavior disorders - Body weight 50 kg or more: The initial dose is 0.5 mg of this medicine once daily. If necessary, the dose may be increased by 0.5 mg per day at intervals of at least 2 days. For most patients, the optimal dose is 1 mg once daily. Depending on the patient, 0.5∼1.5 mg may be administered once daily. Conduct disorder and other disruptive behavior disorders - Body weight under 50 kg: The initial dose is 0.25 mg once daily. If necessary, the dose may be increased by 0.25 mg per day at intervals of at least 2 days. For most patients, the optimal dose is 0.5 mg once daily. Depending on the patient, 0.25∼0.75 mg may be administered once daily. Conduct disorder and other disruptive behavior disorders - Clinical experience in children under 5 years of age is limited.

This medication may increase mortality when used in elderly dementia patients, thus caution is advised, particularly. When combined with certain diuretics like furosemide, the risk of mortality may further increase, hence careful decision on combination is required. Thromboembolic events may occur, thus thrombotic risk factors should be checked before and during the use of this medication and preventive measures should be taken if necessary. Patients with allergies to this medication or its components, patients with reduced central nervous system function due to alcohol and central nervous system depressants, comatose patients, patients receiving epinephrine, and those with lactose intolerance should not take this medication. Patients with cardiovascular diseases (heart failure, myocardial infarction, conduction abnormalities, hypotension, etc.), patients at risk of arrhythmias or QT interval prolongation, patients with a history of seizures, those with impaired liver or kidney function, patients at risk of suicide, patients with Parkinson's disease or Lewy body dementia, diabetic patients, the elderly, pregnant women, and nursing mothers should use this medication with caution. This medication can cause various side effects such as drowsiness, dizziness, hypotension, insomnia, anxiety, agitation, Parkinsonism, muscular rigidity, weight gain, gastrointestinal disorders, etc., therefore if any abnormal symptoms occur, immediate consultation with a doctor is necessary. When taken with other central nervous system depressants or alcohol, the central nervous system depressant effect may be enhanced, thus caution should be exercised, and interactions with certain antihypertensives, antidepressants, antifungals, and antiepileptic drugs should be disclosed. During pregnancy, the effects on the fetus are unclear, hence it should be administered only if necessary, and while breastfeeding, as this medication may be transferred into breast milk, cessation of breastfeeding is recommended. When administering this medication to children or the elderly, careful dose adjustments and side effect monitoring are necessary, and in case of overdose, emergency care should be sought immediately. This medication should be stored in a tightly closed container to prevent air or moisture ingress, and stored at room temperature between 1 to 30 degrees Celsius, avoiding extreme temperatures.

Increased mortality, cerebrovascular adverse reactions, venous thrombosis, rhinitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity reactions, insomnia, anxiety, nervousness, Parkinsonism, akathisia, drowsiness, dizziness, sedation, tremor, muscle rigidity, hypersomnia, orthostatic dizziness, dyskinesia, syncope, blurred vision, earache, orthostatic hypotension, tachycardia, hypotension, nasal congestion, dyspnea, epistaxis, sinus congestion, nausea, constipation, dyspepsia, vomiting, diarrhea, excessive salivation, dry mouth, abdominal discomfort, abdominal pain, gastrointestinal discomfort, epigastric pain, rash, dry skin, dandruff, seborrheic dermatitis, hyperkeratosis, back pain, arthralgia, limb pain, urinary incontinence, ejaculatory dysfunction, fatigue, asthenia, fever, chest pain, elevated blood creatinine phosphokinase, increased heart rate, pneumonia, soft tissue infection, decreased appetite, confusion, transient ischemic attack, decreased consciousness, drooling, cerebrovascular accident, conjunctivitis, cough, runny nose, dysphagia, fecal impaction, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, dependent edema, elevated body temperature, rhinitis, influenza, increased appetite, moderate insomnia, malaise, headache, stuttering, attention deficit, balance disorder, excessive sleep, palpitations, oropharyngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, frequent urination, galactorrhea, emotional disturbances, lethargy, chest discomfort, elevated blood prolactin, agitation, blunted affect, sleep disorders, decreased libido, sexual dysfunction, depression, nightmares, unresponsiveness to stimuli, disturbance of cooperation, loss of consciousness, speech disorders, sensory impairment, movement disorders, generalized dyskinesia, cerebral ischemia, cerebrovascular accident disorders, neuroleptic malignant syndrome, diabetic coma, head tremor, convulsions, psychomotor hyperactivity, delayed movement disorders, cerebrovascular disorders, sensory disturbances, conjunctival hyperemia, ocular discharge, eye movements, eyelid edema, photophobia, eyelid crusting, dry eyes, increased tear production, glare, glaucoma, decreased vision, tinnitus, vertigo, bradycardia, torpid pulse, palpitations, I degree atrioventricular block, left bundle branch block, right bundle branch block, atrioventricular block, flushing, conduction disorders, electrocardiogram abnormalities, prolonged QT interval on ECG, right-sided venous dilation, bradycardia, wheezing, aspiration pneumonia, voice disorders, moist cough, airway congestion, crackles, respiratory distress, nasal cavity swelling, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, salivary deficiency, distension, gastroenteritis, tongue swelling, toothache, skin pigmentation, skin lesions, skin disorders, erythematous rash, papular rash, generalized rash, papulopustular rash, eczema, musculoskeletal chest pain, joint rigidity, muscle weakness, rhabdomyolysis, urination disorders, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculation disorders, menstrual disorders, breast swelling, sexual dysfunction, retrograde ejaculation, breast discharge, thirst, influenza-like syndrome, edema, fatigue, facial swelling, discomfort, generalized edema, chills, peripheral coldness, drug withdrawal syndrome, drug adverse reactions, decreased body temperature, procedure-related pain, increased ALT, electrocardiogram abnormalities, eosinophilia, increased AST, leukopenia, increased blood glucose, decreased hemoglobin, decreased hematocrit, decreased body temperature, hypotension, increased transaminases, increased gamma-glutamyl transferase, increased liver enzymes, agranulocytosis, thrombocytopenia, antidiuretic hormone secretion abnormalities, diabetic ketoacidosis, diabetes mellitus, hypoglycemia, water intoxication, mania, dysgeusia, intraoperative iris tension decrease syndrome, atrial fibrillation, deep vein thrombosis, pulmonary embolism, sleep apnea syndrome, intestinal obstruction, pancreatitis, jaundice, angioedema, alopecia, neonatal drug withdrawal syndrome, urinary retention, priapism, hypothermia, prolonged QT interval on ECG, chest pain, liver dysfunction, hepatitis, thirst, dry mouth, urinary retention, polyuria, pain, hiccups, increased sweating, urination disorders, leukopenia, arrhythmia, epistaxis, anemia, diarrhea, hangover, ocular movement seizures, acne, dysphagia, enuresis, tic disorder, respiratory distress, Rabbit syndrome, suicidal ideation, accident abnormalities, delusions, hallucinations, symptom exacerbation, falls, priapism, thromboembolism, postural orthostatic tachycardia syndrome

This medication should be stored in a tightly closed container to prevent air or moisture ingress. Additionally, it is recommended to store the medication at room temperature, between 1 to 30 degrees Celsius, avoiding excessively hot or cold conditions.

Appearance

Yellow, oval-shaped film-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle