Sandoz Olanzapine Tablet 5 mg

Adult dose

The therapeutic dose of this medicine should be adjusted according to the patient's clinical condition. Any increase above the usual recommended daily dose of 10 mg is recommended only after an appropriate clinical evaluation. Schizophrenia — The recommended initial dose is 5∼10 mg of olanzapine once daily. Schizophrenia — Maintenance treatment: Its efficacy was demonstrated in a placebo-controlled study in which patients with schizophrenia whose symptoms had stabilized after taking this medicine for approximately 8 weeks received maintenance treatment at doses of 10∼20 mg daily for 8 months. The need for maintenance treatment at an appropriate dose should be assessed periodically. Treatment of manic and mixed episodes associated with bipolar I disorder — The initial dose is 15 mg of this medicine once daily as monotherapy, or 10 mg once daily as adjunctive therapy to lithium or valproate. Prevention of recurrence in bipolar disorder — The recommended initial dose is 10 mg once daily. In patients who have received this medicine to treat mania, continue the same dose to prevent recurrence. Treatment of schizophrenia and manic and mixed episodes associated with bipolar I disorder, and prevention of recurrence in bipolar disorder — The daily dose may be adjusted within the range of 5 mg to 20 mg daily according to the clinical condition. Increases above the recommended initial dose are advised only after an appropriate clinical evaluation and should generally be made at intervals of at least 24 hours. If treatment with this medicine is discontinued, the dose should be gradually reduced with care. Acute treatment of depressive episodes associated with bipolar I disorder — Start treatment with 5mg of olanzapine once daily, then increase to 10mg once daily. Administer this medicine at bedtime and adjust the dose as appropriate according to age and symptoms, but do not exceed a daily dose of 20mg. Elderly patients — Starting at a dose of 5 mg or less daily may be considered when supported by sufficient clinical factors. Patients with renal or hepatic impairment — A low initial dose (5 mg) should be considered. In moderate hepatic impairment (cirrhosis, Child-Pugh class A or B), the initial dose is 5 mg and should be increased with caution. A low starting dose may also be used in patients with a combination of factors that delay the metabolism of this medicine (female sex, advanced age, and nonsmoking status).

This medication can cause a serious and life-threatening side effect known as Neuroleptic Malignant Syndrome, so if abnormal high fever, muscle rigidity, or changes in mental state occur, the use should be stopped immediately. It is not approved for the treatment of dementia-related psychosis or behavioral disorders, and caution is advised as it may increase mortality and the risk of cerebrovascular disorders. Long-term use may result in a movement disorder called tardive dyskinesia, so dose adjustments or discontinuation should be considered if symptoms occur. New diabetes or worsening of hyperglycemia may occur, so blood glucose and weight should be monitored regularly, and if symptoms appear, immediate consultation with a doctor is necessary. Abrupt discontinuation of this medication may result in symptoms such as sweating, insomnia, tremors, anxiety, and nausea, so the dosage should be reduced gradually. Pregnant or breastfeeding women should consult a doctor before administration as it may affect the fetus or newborn. This medication can cause drowsiness and dizziness, so caution is needed when driving or operating dangerous machinery. Patients with impaired liver function or a history of seizures should be administered carefully, and regular liver function tests and symptom monitoring are necessary. There may be drug interactions, so if you are currently taking other medications, it is essential to inform the healthcare provider, especially as concomitant use with epinephrine is prohibited. In case of overdose, serious side effects may occur, so the dosage must be strictly adhered to, and if abnormal symptoms arise, immediate medical attention should be sought.

High fever, muscle rigidity, changes in mental state, irregular pulse, changes in blood pressure, tachycardia, sweating, cardiac arrhythmia, elevated creatine phosphokinase, myoglobinuria, acute renal failure, increased mortality, stroke, transient ischemic attack, tardive dyskinesia, drowsiness, weight gain, eosinophilia, elevated prolactin, elevated cholesterol, elevated blood sugar, increased triglycerides, diabetes, increased appetite, inability to sit still, Parkinson's disease, leukopenia, neutropenia, movement disorders, orthostatic hypotension, anticholinergic effects, elevated liver transaminases, rash, weakness, fatigue, fever, joint pain, increased alkaline phosphatase, elevated gamma-glutamyl transferase, elevated uric acid, elevated creatine phosphokinase, edema, blood sugar over 160, blood sugar over 200, increased triglycerides, petechiae, anemia, cyanosis, leukocytosis, lymphadenopathy, neutropenia, hypersensitivity, acidosis, increased alkaline phosphatase, hyperbilirubinemia, dehydration, hypercholesterolemia, hyperglycemia, hyperlipidemia, hyperuricemia, hypoglycemia, hypokalemia, hyponatremia, peripheral edema, upper limb edema, hyperkalemia, ketoacidosis, coma, gout, hypernatremia, hypoproteinemia, ketosis, water intoxication, hypothermia, dizziness, abnormal gait in Alzheimer’s disease, insomnia, depression, vertigo, inability to sit still, all extrapyramidal symptoms, personality disorders, tremors, hypertonia, speech disorders, sensory disturbances, apathy, confusion, euphoria, cooperative movement disorders, abnormal dreams, delusions, emotional instability, manic reactions, schizophrenia responses, akinesia, alcohol abuse, antisocial reactions, inability to perform coordinated movements, CNS stimulation, cogwheel rigidity, nonsensical speech, dementia, depersonalization, stuttering, facial paralysis, sensory loss, reduced mobility, decreased muscle tone, reduced libido, increased libido, obsessive symptoms, phobias, somatization, stimulant abuse, stupor, tardive dyskinesia, vertigo, withdrawal syndrome, suicide attempts, amnesia, seizures, dyskinesia, restless legs syndrome, peri-oral paralysis, coma, encephalopathy, neuropathy, nystagmus, paralysis, subarachnoid hemorrhage, tobacco abuse, neuroleptic malignant syndrome, withdrawal symptoms, orthostatic hypotension, tachycardia, hypertension, bradycardia, atrial fibrillation, cerebrovascular accidents, congestive heart failure, cardiac arrest, hemorrhage, migraine, pallor, palpitations, vasodilation, ventricular ectopic contractions, prolonged QTc, thromboembolism, arteritis, heart failure, pulmonary embolism, ventricular fibrillation, sudden death, diabetes, diabetic ketoacidosis, goiter, constipation, thirst, dyspepsia, vomiting, increased salivation, dysphagia, esophagitis, fecal incontinence, gastritis, gastroenteritis, gingivitis, melena, oral ulcers, nausea, oral candidiasis, periodontal abscess, rectal bleeding, stomatitis, tongue swelling, dental caries, diarrhea, abdominal distension, excessive salivation, apnea, asthma, epistaxis, hemoptysis, hyperventilation, hypoxia, laryngitis, change in voice, atelectasis, hiccups, respiratory depression, pulmonary edema, stridor, hepatic steatosis, hepatitis, jaundice, sweating, photosensitivity reactions, acne, dry skin, alopecia, contact dermatitis, eczema, papular rash, itching, seborrhea, skin discoloration, skin ulcer, urticaria, vesicular rash, hirsutism, pustular rash, drug reactions, low back pain, chest pain, toothache, influenza-like syndrome, injection site pain, abdominal enlargement, chills, facial swelling, deliberate self-harm, lethargy, candidiasis, neck pain, neck stiffness, pelvic pain, hangover, sudden death, joint stiffness, single contraction, arthritis, arthrosis, leg cramps, myasthenia, arthralgia, bone pain, bursitis, myopathy, osteoporosis, rheumatoid arthritis, rhabdomyolysis, amblyopia, visual disturbances, conjunctivitis, abnormal accommodation, blepharitis, cataract, hearing loss, diplopia, dry eyes, ear pain, ocular hemorrhage, ocular inflammation, eye pain, ocular muscle abnormalities, taste disturbances, tinnitus, corneal lesions, glaucoma, keratoconjunctivitis, decreased macular pigmentation, miosis, mydriasis, lens pigmentation, urinary incontinence, urinary tract infection, dysmenorrhea, vaginitis, abnormal ejaculation, amenorrhea, mastalgia, cystitis, decreased menstruation, urination disorders, female galactorrhea, gynecomastia, hematuria, erectile dysfunction, increased menstruation, menorrhagia, uterine bleeding, polyuria, premenstrual syndrome, pyuria, frequent urination, urinary retention, oliguria, uterine fibroid hypertrophy, vaginal bleeding, urinary delay, albuminuria, breast enlargement, mastitis, oliguria, male erectile dysfunction, benign decreased libido, female amenorrhea, galactorrhea, breast enlargement, persistent erection, elevated plasma prolactin levels, increased alkaline phosphatase, elevated creatine phosphokinase, elevated gamma-glutamyl transferase, elevated uric acid, increased total bilirubin, neonatal withdrawal symptoms, ocular movement seizures, confusion, hypertrophic muscle spasms, ocular motor nerve paralysis, headache, abdominal pain, pain, weight loss, bloody stools, convulsions, hypomania, sexual discomfort, neurogenic responses, auditory hallucinations, hepatic failure, loss of appetite, urinary retention, pyelonephritis, electrocardiography abnormalities, pupillary nonreactivity, torticollis, weight gain, drowsiness, increased appetite, sedation, hypersomnia

This medication should be stored in a tightly sealed container that is well-ventilated and kept at room temperature, ideally between 15 degrees Celsius and 30 degrees Celsius. Proper storage ensures that the effectiveness of the medication is maintained over time and prevents degradation.

Appearance

White round film-coated tablet

Package unit

30 tablets per bottle