Albozen Rivastigmine Capsule 6 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 3mg of rivastigmine daily, and the dose 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 daily. Since this medicine demonstrated greater efficacy at doses of 6mg daily and higher in clinical trials, a target dose range of 6~12mg daily is recommended for most patients. Recommended dose titration schedule After administering 1.5mg of this medicine twice daily for at least 2 weeks, the dose may be increased to 3mg twice daily if well tolerated. Subsequent increases may be made by administering 4.5mg twice daily and, if well tolerated, after at least 2 weeks increasing to 6mg 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, reduce the daily dose to the previous dose that was well tolerated. 2. Treatment of mild to moderate dementia associated with Parkinson's disease In a controlled clinical trial in patients with dementia associated with Parkinson's disease, rivastigmine 3~12mg daily was administered 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 doses, the dose may subsequently be increased in sequence 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) are observed during treatment, these symptoms may decrease if one or more doses are withheld. If adverse reactions persist, temporarily reduce the daily dose to the previous well-tolerated dose or consider discontinuing treatment. 3. Maximum recommended dose Administer 6 mg of this medicine orally twice daily. 4. Reinitiation 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, 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; therefore, its use in children is not recommended.

This medication should not be used in patients with allergies to its active ingredient or other components. It should be avoided in patients with severely impaired liver function, as there is no experience administering it to such patients. Patients with a history of allergic contact dermatitis while using this medication should not use it again. It should be used with caution in patients with heart disease or cardiac conduction disorders. Patients with a history of gastric or duodenal ulcers should also use this medication cautiously. Care should be taken when administering this drug to patients with asthma or obstructive pulmonary diseases. Patients with urinary retention or a history of seizures should also use this medication with caution. This medication could worsen symptoms in patients with movement disorders related to Parkinson's disease. Gastrointestinal symptoms such as nausea, vomiting, and diarrhea may occur while taking this medication, so patients should consult a doctor if they experience unusual symptoms. Neurological side effects such as dizziness, headache, and drowsiness may also occur, requiring caution when driving or operating machinery. Rarely, bradycardia or arrhythmia may occur as cardiac adverse reactions, so patients should monitor their heart conditions. This medication may cause weight loss, thus regular weight checks are recommended during treatment. Care is needed when used concurrently with other cholinergic medications, as effects may be amplified, and side effects may increase. This medication should be discontinued in advance as it may enhance the effect of muscle relaxants during anesthesia. This medication may increase gastric acid secretion, so patients with a history of gastric ulcers should be extra cautious. The safety of this medication during pregnancy has not been sufficiently established; therefore, it should only be taken after consulting a doctor during pregnancy. It is recommended that breastfeeding women discontinue breastfeeding while taking this medication. The safety and efficacy in children have not been established; therefore, it is not advisable to use it in children. In the case of overdose, symptoms such as nausea, vomiting, bradycardia, and confusion may appear, so immediate medical attention should be sought if suspected. This medication should be kept out of reach of children and not transferred to other containers.

• nausea
• vomiting
• urinary tract infection
• agitation
• confusion
• nightmares
• anxiety
• insomnia
• depression
• hallucination

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

Appearance

A hard capsule with a red upper part and an orange lower part containing a white to beige powder.

Package unit

28 capsules (14 capsules/PTP×2)