Risdal Tablets 0.5 mg (Risperidone)

Adult dose

The therapeutic dose of this medicine should be adjusted according to the patient's clinical condition, and the minimum effective dose should be administered whenever possible. Place this medicine on the tongue and, once it disintegrates within a few seconds, swallow it without water or with water (for orally disintegrating tablets only). 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 as appropriate according to age and symptoms. No additional efficacy has been observed with doses of 10 mg or more per day compared with lower doses, and such doses may increase the risk of extrapyramidal symptoms. Doses of 10 mg or more per day should be administered only when the benefits to the individual patient are judged to outweigh the risks. The safety of doses of 16 mg or more per day has not been established; do not administer such doses. A benzodiazepine may be co-administered if additional sedation is needed. 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 existing antipsychotic medication to this medicine When medically appropriate, start this medicine while gradually reducing the dose of the existing medication. Also, when switching from an existing depot antipsychotic, when medically appropriate, start this medicine in place of the next scheduled depot injection. The need to continue any concomitant antiparkinsonian medication 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, depending on 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 depending on the patient, it may be increased to 1 mg twice daily. Once the patient has reached the optimal dose, once-daily administration may also be considered. As with symptomatic treatment, the justification for continued use of this medicine should be evaluated. Adjunctive treatment of mania 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 up to 1 mg/day at intervals of at least 24 hours. The optimal dose for most patients is within the range of 2～6 mg/day. As with symptomatic treatment, the justification for continued use of this medicine should be evaluated. Renal and hepatic impairment In patients with renal or hepatic impairment, administer half the initial and maintenance doses and make dose adjustments more gradually. Exercise caution when administering this medicine to these patients (see 5. General Precautions).

Child dose

Clinical experience in children and adolescents under 15 years of age is limited. Clinical experience in children and adolescents under 15 years of age is limited. Body weight 50 kg or more The initial dose is 0.5 mg of this medicine once daily. If needed, depending on the patient, the dose may be increased by 0.5 mg/day at intervals of at least 2 days. The optimal dose for most patients is 1 mg once daily. Depending on the patient, 0.5∼1.5 mg may be administered once daily. Body weight less than 50 kg The initial dose is 0.25 mg once daily. If needed, depending on the patient, the dose may be increased by 0.25 mg/day at intervals of at least 2 days. The optimal dose for most patients is 0.5 mg once daily. Depending on the patient, 0.25∼0.75 mg may be administered once daily. Clinical experience in children under 5 years of age is limited.

Caution is required when administering this medication to elderly dementia patients as it may increase the mortality rate. In particular, the risk of death may be higher when used in conjunction with diuretics such as furosemide, so risks and benefits should be carefully considered before combined administration. When using this medication, it is necessary to monitor for the risk of venous thrombosis and take preventive measures. Preparations containing aspartame should be used with caution in patients with phenylketonuria. This medication should not be administered to patients with allergies to this medication or its components, or those in a state of central nervous system depression, coma, those receiving epinephrine, or patients with certain genetic lactose intolerance. Patients with cardiovascular diseases or problems with liver or kidney function, those with a history of seizures, elderly patients, pregnant or nursing women, should use this medication with caution. This medication may cause various neurological symptoms and side effects in the digestive system, cardiovascular system, skin, and other areas, so immediate consultation with medical personnel is necessary if any adverse reactions occur. This medication may enhance central nervous system depression when used with other CNS medications or alcohol, thus caution is required during combined use. Moreover, when used in conjunction with drugs that affect the enzymes that metabolize this medication in the liver, dosage adjustments may be necessary. Women who are pregnant or breastfeeding should consult a physician before using this medication, as it may affect the fetus or newborn. In case of overdose, serious side effects may occur, so dosages should be strictly adhered to and emergency treatment should be sought if any abnormal symptoms occur. This medication should be kept out of reach of children and should be used safely by following the ingredients and storage method.

Increased mortality, stroke, transient ischemic attack, venous thromboembolism, nasopharyngitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity, insomnia, anxiety, irritability, Parkinson's syndrome, akathisia, drowsiness, dizziness, sedation, tremor, muscle rigidity, somnolence, orthostatic dizziness, dyskinesia, syncope, blurred vision, ear pain, orthostatic hypotension, tachycardia, hypotension, nasal congestion, dyspnea, epistaxis, sinus congestion, nausea, constipation, dyspepsia, vomiting, diarrhea, hypersalivation, 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, appetite loss, confusion, transient ischemic attack, decreased consciousness, drooling, cerebrovascular accident, conjunctivitis, hypotension, cough, runny nose, dysphagia, fecal impaction, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, dependent edema, elevated body temperature, upper respiratory infection, rhinitis, influenza, increased appetite, middle insomnia, fatigue, headache, stuttering, attention disorder, balance disorder, excessive sleep, palpitations, pharyngeal and laryngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, frequent urination, hyperprolactinemia, emotional disturbance, apathy, chest discomfort, restlessness, blunted affect, sleep disturbance, decreased libido, anorgasmia, depression, nightmares, unresponsiveness to stimuli, abnormal cooperation, loss of consciousness, speech disorder, sensory loss, movement disorder, generalized dyskinesia, cerebral ischemia, cerebrovascular accident disorder, neuroleptic malignant syndrome, diabetic coma, head tremor, convulsions, psychomotor hyperactivity, delayed dyskinesia, cerebrovascular disorder, sensory disturbances, conjunctival injection, eye discharge, eye movement, eyelid swelling, photophobia, crusting of eyelid margin, dry eyes, increased tearing, glare, glaucoma, decreased vision, tinnitus, dizziness, bradycardia, sinus rhythm, tachycardia, I-degree atrioventricular block, left bundle branch block, right bundle branch block, complete heart block, flushing, conduction disorder, abnormal electrocardiogram, QT interval prolongation on electrocardiogram, inferior vena cava, bradycardia, wheezing, aspiration pneumonia, speech disorder, moist cough, airway congestion, rales, respiratory distress, nasal swelling, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, salivary deficiency, bloating, gastroenteritis, tongue swelling, toothache, skin discoloration, skin lesions, skin disorders, erythematous rash, papular rash, generalized rash, papulopustular rash, eczema, musculoskeletal chest pain, joint stiffness, muscle weakness, rhabdomyolysis, urinary disturbances, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculation disorders, menstrual disorders, breast engorgement, sexual dysfunction, retrograde ejaculation, breast discharge, thirst, influenza-like syndrome, swelling, malaise, facial edema, discomfort, generalized edema, chills, peripheral coldness, drug withdrawal syndrome, drug adverse reactions, decreased body temperature, procedure-related pain, weight gain, elevated blood prolactin, agranulocytosis, thrombocytopenia, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes, hypoglycemia, water intoxication, mania, taste disturbances, intraoperative iris tension decrease syndrome, atrial fibrillation, deep vein thrombosis, pulmonary embolism, sleep apnea syndrome, intestinal obstruction, pancreatitis, jaundice, vascular edema, hair loss, neonatal drug withdrawal syndrome, urinary retention, prolonged erection, hypothermia, QT interval prolongation on electrocardiogram, chest pain, abnormal liver function, hepatitis, thirst, dry mouth, urinary retention, polyuria, pain, hiccups, increased sweating, urinary disturbances, leukopenia, arrhythmia, epistaxis, anemia, diarrhea, hangover, ocular motor seizures, acne, dysphagia, enuresis, tic disorder, respiratory distress, suicidal ideation, abnormal thoughts, delusions, hallucinations, exacerbation of auditory hallucinations, falls, hematological abnormalities, drug hypersensitivity, hyperglycemia, hyperuricemia, hyperinsulinemia, depression, initial insomnia, delusion, persecutory delusion, suicidal ideation, increased libido, decreased libido, anorgasmia, sensory disturbances, seizures, tremors of the hands and feet, psychomotor agitation, immobility, paresthesia, head discomfort, eyelid spasms, ocular movement disorders, dizziness, bradycardia, ventricular ectopy, arrhythmia, thromboembolism, postural orthostatic tachycardia syndrome, toothache, tongue spasm, hyperlactation, hemorrhoids, eczema, hyperhidrosis, drug rash, urticaria, buttock pain, delayed menstruation, delayed ejaculation, infrequent menstruation, breast discomfort, breast engorgement, breast hypertrophy, urination difficulties, anaphylactic reaction, pain, sclerosis, weight loss, elevated γ-GT, elevated liver enzymes, glucosuria, falls

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance

Oblong reddish-brown film-coated tablet

Package unit

For domestic use - 30 tablets/bottle, For domestic use - 200 tablets/bottle