Albogen Rivastigmine Capsule 4.5 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 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

Administration to children is not recommended.

This medication may not be used in certain patients. For example, it should not be administered to patients who are allergic to its ingredients or those with severe liver impairment. Also, patients who have previously experienced allergic contact dermatitis after using this medication should be cautious. Patients with heart disease, a history of peptic ulcer, asthma, or obstructive pulmonary disease, urinary retention, or seizure history should use this medication with caution. Taking this medication may often cause gastrointestinal symptoms such as nausea, vomiting, and diarrhea, and female patients might experience these symptoms more than male patients. Neurological symptoms such as dizziness, headaches, and drowsiness may also commonly occur. Moreover, patients with dementia related to Parkinson's disease may show symptoms such as tremors or worsening motor function, so caution is necessary. This medication may have increased efficacy or greater risk of side effects when used in conjunction with other cholinergic drugs, so it is important to discuss any concomitant use with a physician. Pregnant or nursing women must consult a physician before using this medication and it is advisable to avoid its use during breastfeeding. This medication is not recommended for children, and in case of overdose, symptoms such as nausea, vomiting, bradycardia, and confusion may occur, necessitating immediate medical assistance. During the use of this medication, periodic checks of weight changes are recommended, and any abnormal symptoms should be promptly discussed with medical staff. Finally, this medication should be kept out of the reach of children and should not be transferred to other containers for safety.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture. Additionally, it should be kept in a location avoiding extremes of temperature, ideally between 1°C and 30°C, which is considered normal room temperature.

Appearance

Hard capsule containing a white to yellowish powder with a red lower shell

Package unit

28 capsules (14 capsules/PTP×2)