Libero Capsule 3.0 mg (Rivastigmine Tartrate)

Adult dose

Dosage and administration: Rivastigmine is administered orally twice daily, in the morning and evening, with meals. ○ Adults: 1. Treatment of symptoms of mild to moderate Alzheimer-type dementia The initial dose is 3mg of rivastigmine per day, 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 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 twice daily for at least 2 weeks; if well tolerated, the dose may be increased to 3mg twice daily. Subsequent increases may be made to 4.5mg twice daily and, if well tolerated, after at least 2 weeks, 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 symptoms 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 per day in two 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 dose levels, the dose may be increased successively according to the patient's tolerability to 3mg twice daily, then 4.5mg twice daily, and subsequently 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, withholding 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 6mg 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 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 this population.

Child dose

This medication has not been tested in children, so it is not recommended for pediatric use.

This medication should not be administered to certain patients. For example, individuals who are allergic to this medication's components, those with severe liver dysfunction, and those who have experienced skin allergic reactions to the patch form of this medication should not use it. Patients with heart disease, stomach ulcers, duodenal ulcers, asthma, obstructive pulmonary disease, urinary retention, seizures, and extrapyramidal disorders should use this medication cautiously. Gastrointestinal disturbances such as nausea, vomiting, and diarrhea may occur while taking this medication, and these symptoms are particularly common at the beginning of treatment or when increasing the dose. Dizziness or drowsiness may occur, so caution should be exercised when driving or operating machinery, and patients’ weight and cardiac status should be monitored regularly during treatment. The effects of this medication may be enhanced when taken with other cholinergic drugs, so it is essential to consult a healthcare professional before combining it with other medications. Women who are pregnant or breastfeeding should consult their physician before taking this medication, and especially while breastfeeding, it is advisable to avoid this medication. In cases of overdose, severe nausea, vomiting, bradycardia, confusion, and other symptoms may occur, so the dosage should be strictly followed, and any unusual symptoms should be reported to a healthcare professional immediately. Lastly, this medication is not recommended for children, and it should be stored in a safe place out of reach of children.

• Nausea
• vomiting
• dizziness
• restlessness
• confusion
• nightmares
• anxiety
• insomnia
• depression
• hallucinations

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained between 1°C and 30°C to preserve its effectiveness.

Appearance

White to pale yellow powder in an orange hard capsule

Package unit

28 capsules (14 capsules/PTP × 2)