Libero Capsule 1.5 mg (Rivastigmine Tartrate)

Adult dose

Administration: Rivastigmine is administered orally twice daily with the morning and evening meals. ○ Adults: 1. Treatment of mild to moderate Alzheimer's dementia The initial dose is 3mg of rivastigmine daily. For each patient, increase the dose at intervals of at least 2 weeks to the maximum tolerated dose or the maximum recommended dose of 12mg daily. Since this medicine showed 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. For subsequent increases, administer 4.5mg twice daily; if well tolerated, after at least 2 weeks increase 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 previously well-tolerated dose. 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 was administered at 3~12mg daily 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 each dose, and depending on the patient's tolerability, the dose may be increased sequentially 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, temporarily withholding one or more doses may reduce these symptoms. If adverse reactions persist, temporarily reduce the daily dose to the previously well-tolerated dose or consider discontinuing treatment. 3. Maximum recommended dose Administer 6 mg of this medicine orally twice 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 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

Since this medication has not been tested in children, it is not recommended for pediatric use.

This medication should not be used in certain patients. For example, it should not be given to patients allergic to the active ingredient or components of this drug, patients with severe liver dysfunction, and patients who experienced allergic dermatitis from using the patch form of this drug. Caution is also required when administering this drug to patients with certain conditions, such as those with heart disease, a history of gastric ulcers, asthma or chronic obstructive pulmonary disease, urinary retention or seizure history, and those with extrapyramidal disorders. Gastrointestinal side effects are common with this drug. Nausea, vomiting, and diarrhea often occur during the dose adjustment period, so patient condition should be closely monitored. Moreover, gastrointestinal side effects and weight loss have been reported more frequently in female patients. Neurological symptoms may include agitation, confusion, nightmares, and anxiety, and in rare cases, hallucinations or insomnia may occur. Common central nervous system effects include dizziness, headache, drowsiness, and tremors, with rare reports of convulsions or exacerbation of Parkinson's disease symptoms. Cardiovascular side effects such as bradycardia or heart block may rarely occur, requiring caution. This medication can interact with other drugs, especially when used with anesthetics or other cholinergic drugs. Furthermore, when used with drugs affecting the heart, ECG monitoring may be necessary. For women who are pregnant or breastfeeding, the safety of this medication has not been adequately confirmed, so the decision to administer should be made based on the physician's judgment, and it is advisable to avoid use during breastfeeding. Safety has not been established in children; hence this medication is not recommended for use in pediatric patients. In case of overdose, symptoms may include nausea, vomiting, diarrhea, dizziness, tremors, headache, confusion, bradycardia, etc., and in severe cases, it can be life-threatening, necessitating immediate medical attention. This medication should be stored out of reach of children, and transferring it to another container is not advisable as it may negatively affect its quality. During administration, the patient's weight and occurrence of adverse reactions should be continuously monitored, and dose adjustments or discontinuation should be considered if necessary.

• Nausea
• vomiting
• dizziness
• headache
• drowsiness
• tremor
• fainting
• seizures
• angina
• myocardial infarction

This medication should be stored in a tightly closed container to prevent exposure to air and is best kept at room temperature between 1°C and 30°C. Proper storage helps maintain the effectiveness and safety of the medication.

Appearance

Hard capsule containing white to light yellow powder with a yellowish upper and lower exterior.

Package unit

28 capsules (14 capsules/PTP x 2)