Ajuceylon Capsule 3 mg (Rivastigmine Tartrate)

Adult dose

Administration: Rivastigmine should be taken orally 2 times daily with the morning and evening meals. ○ Adults: 1. Treatment of mild to moderate Alzheimer's dementia The initial dose is 3mg of rivastigmine per day. For each patient, increase the dose at intervals of at least 2 weeks 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 above, a target dose range of 6~12mg per day is recommended for most patients. Recommended dose titration schedule Administer 1.5mg of this medicine per dose 2 times daily for at least 2 weeks. If well tolerated, the dose may be increased to 3mg per dose 2 times daily. Subsequent increases may be made to 4.5mg per dose 2 times daily, and, if well tolerated for at least 2 weeks, to 6mg per dose 2 times daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or decreased appetite) or weight loss occurs, one or more doses may be omitted. However, if adverse reactions or weight loss persist, reduce the daily dose 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 was administered at 3~12mg per day in 2 divided doses (1.5~6mg per dose 2 times daily). The initial dose is 1.5mg of this medicine per dose 2 times daily. At intervals of at least 4 weeks between dose levels, the dose may subsequently be increased according to the patient's tolerability, first to 3mg per dose 2 times daily, then to 4.5mg per dose 2 times daily, and then to 6mg per dose 2 times daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or decreased appetite), weight gain, or extrapyramidal symptoms (e.g., tremor) occur during treatment, discontinuing one or more doses may reduce these symptoms. If adverse reactions persist, the daily dose may be temporarily reduced to the previously well-tolerated dose, or discontinuation of treatment may be considered. 3. Maximum recommended dose Administer 6 mg of this medicine per dose orally 2 times daily. 4. Restarting treatment The frequency 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 or 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

This medicine has not been studied in children and is not recommended for use in children.

This drug should not be used in patients who are allergic to certain ingredients or have severe liver impairment. Additionally, patients who have previously experienced skin allergic reactions from this drug in patch form should not be given this medication. Patients with heart disease, gastric ulcers, asthma, urinary retention, seizures, or extrapyramidal symptoms should use this drug cautiously. Gastrointestinal symptoms such as nausea, vomiting, and diarrhea may commonly occur when taking this drug, and these symptoms may occur more frequently in female patients. Dizziness, headache, drowsiness, agitation, and anxiety were also reported, so caution is advised. This drug may worsen the symptoms of Parkinson's disease, so consult a doctor immediately if such symptoms occur. Weight loss may occur during treatment, so regular weight checks are essential. This drug may enhance effects or increase side effects when used with other cholinergic drugs, thus caution is needed when combining. In particular, it is important to discontinue this drug for a certain period before undergoing anesthesia, and patients with heart rhythm abnormalities should also use it with caution. Women who are pregnant or breastfeeding should consult a doctor before using this drug and it is advisable to avoid taking it while breastfeeding. It is not recommended for children as safety and efficacy have not been established. Overdose may cause symptoms such as nausea, vomiting, bradycardia, and confusion, so the prescribed dosage must be strictly followed, and if any abnormal symptoms occur, notify healthcare professionals immediately. This drug should be kept out of reach of children and should not be transferred to another container. Lastly, caution is needed as dizziness or drowsiness may occur while driving or operating machinery during the course of taking this drug.

• nausea
• vomiting
• urinary tract infection
• restlessness
• confusion
• nightmares
• anxiety
• insomnia
• depression
• hallucinations

This medicine should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain storage temperatures between 1 degree and 30 degrees Celsius to ensure the drug's effectiveness.

Appearance

White powder inside an orange hard capsule

Package unit

28 capsules (14 capsules/PTP packaging x 2)