Umaphne Capsule 3mg (Rivastigmine Tartrate)

Adult dose

○ Adults: 1. Treatment of mild to moderate symptoms of Alzheimer's-type dementia The initial dose is 3mg of rivastigmine per day. Increase the dose for each patient at intervals of at least 2 weeks, up to the highest tolerated dose or the maximum recommended dose of 12mg per day. Since this medicine showed greater efficacy in clinical trials at doses of 6mg per day and higher, a target dose range of 6~12mg per day is recommended for most patients. Recommended dose titration schedule Administer 1.5mg of this medicine twice daily for at least 2 weeks. If well tolerated, the dose may be increased to 3mg twice daily. Subsequent increases may be made to 4.5mg twice daily and, if well tolerated for at least 2 weeks, to 6mg twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or decreased appetite) or weight loss occur, one or more doses may be omitted. However, if adverse reactions or weight loss persist, reduce the daily dose to the previous dose that was well tolerated. 2. Treatment of mild to moderate symptoms of dementia associated with Parkinson's disease In controlled clinical trials in patients with dementia associated with Parkinson's disease, rivastigmine was administered at 3~12mg per day in 2 divided doses. (1.5~6mg per dose twice daily.) The initial dose is 1.5mg of this medicine twice daily. At intervals of at least 4 weeks between dose levels, the dose may be increased consecutively according to the patient's tolerability to 3mg twice daily, then 4.5mg twice daily, and then 6mg twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or decreased appetite), weight gain, or extrapyramidal symptoms (e.g., tremor) occur during treatment, withholding one or more doses may reduce these symptoms. If adverse reactions persist, the daily dose may be temporarily reduced to the previous well-tolerated dose or discontinuation of treatment may be considered. 3. Maximum recommended dose Administer 6mg of this medicine orally twice daily. 4. Resumption of treatment The incidence and severity of adverse reactions generally increase at higher doses. If treatment is interrupted for more than 3 days, restart at the lowest daily dose and titrate as described above. ○ Patients with hepatic or renal impairment: 1. Exposure is increased in patients with moderate renal impairment and mild to moderate hepatic impairment, which may result in more adverse reactions. Therefore, take particular care when titrating the dose according to individual tolerability. 2. No studies have been conducted in patients with severe hepatic impairment; do not administer.

Child dose

○ Children: This medicine has not been studied in children; therefore, its use in children is not recommended.

This drug should not be used in patients with hypersensitivity to the main ingredient or other components. Its safety has not been confirmed in patients with severe liver disease, so administration should be avoided. It is also advisable for patients who previously experienced allergic contact dermatitis from the patch formulation of this drug not to use this drug. Patients with cardiovascular disease or conditions such as gastrointestinal ulcers, asthma, obstructive pulmonary disease, urinary retention, seizures, or extrapyramidal disorders should use this drug with caution. Gastrointestinal side effects such as nausea, vomiting, and diarrhea can occur frequently, especially in female patients. Neurological side effects such as dizziness, headache, drowsiness, and tremors have also been reported, necessitating caution. Rare cardiovascular adverse reactions may include bradycardia, angina pectoris, and myocardial infarction. Caution is advised as the effect may increase when this drug is used in combination with other cholinergic medications, and it is recommended to discontinue use for a certain period before anesthesia. Patients at risk of gastrointestinal ulcers or those taking NSAIDs should carefully observe their gastrointestinal status when using this drug. The use of this drug is not recommended for asthma or obstructive pulmonary disease patients, and it should also be administered cautiously to patients with urinary retention and seizures. Dementia patients may experience weight loss and deterioration of motor functions, so regular monitoring is necessary. Pregnant or nursing women should consider the potential risks to the fetus or newborn as the safety of this drug has not been established. There are no appropriate clinical trials for pediatric patients, so its use is not recommended. In case of overdose, symptoms such as nausea, vomiting, diarrhea, dizziness, bradycardia, and confusion may occur, and in severe cases, medical treatment is necessary. This drug should be stored out of reach of children, and it is safest not to transfer it to other containers.

Area, vomiting, urinary tract infection, restlessness, confusion, nightmares, anxiety, insomnia, depression, hallucinations, dizziness, headache, drowsiness, tremor, syncope, convulsion, extrapyramidal symptoms, angina, myocardial infarction, deep vein thrombosis, hypertension, diarrhea, loss of appetite, abdominal pain, indigestion, gastric ulcer, duodenal ulcer, gastrointestinal bleeding, pancreatitis, esophageal rupture, increased sweating, rash, itching, fatigue, weakness, lethargy, falling, weight loss, abnormal liver function test results, Stevens-Johnson syndrome, tremor, somnolence, bradykinesia, worsening of Parkinson's disease, dyskinesia, cogwheeling, akinesia, bradycardia, atrial fibrillation, heart block, decreased appetite, dehydration, increased perspiration, gait disorder, urinary incontinence, cerebrovascular accident, delirium, erythema, urticaria, blister, allergic dermatitis, tremor, hypersomnolence, state of confusion, sialorrhea, hypotension, respiratory depression, muscle weakness, syncope, lethargy, aggression, restlessness, dysfunction of gastrointestinal motility syndrome, hepatitis, allergic skin dermatitis, inability to remain seated, sensory disturbance, delirium, stupor, pneumonia, sepsis, muscle rigidity, inability to remain seated, personality disorder

This drug should be stored in a tightly sealed container to prevent exposure to air or moisture, and it is recommended to keep it at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the drug's efficacy and prevent deterioration.

Appearance

Orange hard capsule containing white powder

Package unit

28 capsules (14 capsules/PTP packaging x 2)