Newcellon Capsule 1.5 mg (Rivastigmine Tartrate)

Adult dose

Administration: Rivastigmine should be administered orally twice daily with the morning and evening meals. ○ Adults: 1. Treatment of mild to moderate Alzheimer-type dementia The initial dose is rivastigmine 3mg per day, and should be increased at intervals of at least 2 weeks for each patient 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 After administering 1.5mg per dose twice daily for at least 2 weeks, the dose may be increased to 3mg per dose twice daily if well tolerated. Subsequent increases may be made to 4.5mg per dose twice daily and, if well tolerated, after at least 2 weeks to 6mg per dose twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or decreased appetite) or weight loss are observed, one or more doses may be omitted. However, if adverse reactions or weight loss persist, the daily dose should be reduced to the previously well-tolerated dose. 2. Treatment of mild to moderate dementia associated with Parkinson's disease In controlled clinical trials in patients with dementia associated with Parkinson's disease, rivastigmine 3~12mg per day was administered twice daily (1.5~6mg per dose twice daily). The initial dose is 1.5mg per dose twice daily. Depending on the patient's tolerability, subsequent doses may be increased consecutively at intervals of at least 4 weeks to 3mg per dose twice daily, then 4.5mg per dose twice daily, and then 6mg per dose twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or decreased appetite), weight gain, or extrapyramidal symptoms (e.g., tremor) are observed during treatment, these symptoms may decrease if one or more doses are withheld. If adverse reactions persist, temporarily reducing the daily dose to the previously well-tolerated dose or discontinuing treatment may be considered. 3. Maximum recommended dose Administer 6 mg per dose orally twice daily. 4. Reinitiation 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, and more adverse reactions may occur. Therefore, take particular care when titrating the dose according to individual tolerability. 2. Do not administer to patients with severe hepatic impairment, as no studies have been conducted in these patients.

Child dose

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

This medication should not be administered to certain patients. For instance, patients with an allergy to this drug's components, severe liver impairment, or those who have previously experienced allergic skin reactions to this medication's patch dosage form should not use it. Patients with heart disease, gastric ulcers, duodenal ulcers, asthma, obstructive pulmonary disease, urinary retention, seizures, or extrapyramidal disorders should use this medication cautiously. Common gastrointestinal side effects such as nausea, vomiting, and diarrhea may occur, especially during the initial dosage adjustment period. If these symptoms are severe, it is necessary to consult a doctor to adjust the dosage or discontinue use. This medication can affect the heart, thus patients with syndromes affecting cardiac function or abnormal electrocardiograms should exercise caution, as heart rate may slow. It may increase gastric acid secretion, so patients with a history of gastric ulcers should exercise caution. Asthma or obstructive pulmonary disease patients should absolutely consult a doctor before using this drug. This drug can worsen urinary retention or seizures, therefore patients with these conditions should use it cautiously. It is important to start treatment at a low dose and gradually adjust the dose, and in the case of re-administering after a long pause in treatment, it should also begin at a low dose. This drug may have increased effects when used in combination with other cholinergic medications, so extra care is necessary when administered concurrently. Women who are pregnant or nursing should carefully consider the potential impact on the fetus or newborn when using this medication, and it is advisable to avoid use during breastfeeding. Safety and efficacy in children have not been established, hence it is not recommended for pediatric use. In case of overdose, symptoms such as nausea, vomiting, diarrhea, dizziness, bradycardia, etc., may occur and severe cases might require emergency treatment. Store this medication out of reach of children, and it is advisable not to transfer it to other containers. Finally, during the course of treatment with this medication, regularly observe the patient's condition and consult medical personnel immediately if any adverse reactions occur.

• Nausea
• vomiting
• urinary tract infection
• agitation
• confusion
• nightmares
• anxiety
• insomnia
• depression
• hallucinations

This medication can be sensitive to air or humidity, so it should be stored in a tightly sealed container. The storage temperature should be maintained between 1 and 30 degrees Celsius at room temperature. This helps in retaining the drug's effectiveness and preventing deterioration.

Appearance

Hard capsule with yellow-colored upper and lower parts containing white powder

Package unit

30 capsules/bottle, 100 capsules/bottle