Entiriba Capsule 3.0 mg (Rivastigmine Tartrate)

Adult dose

Directions for use: 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 3 mg of rivastigmine per day. For each patient, increase the dose at intervals of at least 2 weeks up to the highest tolerated dose or the maximum recommended dose of 12 mg per day. Because this medicine showed greater efficacy at doses of 6 mg per day and above in clinical trials, a target dose range of 6~12 mg per day is recommended for most patients. Recommended dose titration schedule Administer 1.5 mg of this medicine twice daily for at least 2 weeks. If well tolerated, the dose may be increased to 3 mg twice daily. Subsequent increases may be made to 4.5 mg twice daily and, if well tolerated for at least 2 weeks, to 6 mg 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 last dose that was well tolerated. 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 3~12 mg per day in two divided doses. (1.5~6 mg per dose twice daily.) The initial dose is 1.5 mg of this medicine twice daily. At intervals of at least 4 weeks between dose levels, the dose may be increased consecutively according to the patient's tolerability, first to 3 mg twice daily, then to 4.5 mg twice daily, and subsequently to 6 mg 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 stopping one or more doses may reduce these symptoms. If adverse reactions persist, temporarily reduce the daily dose to the last well-tolerated dose or consider discontinuing treatment. 3. Maximum recommended dose Administer 6 mg of this medicine orally twice daily. 4. Resumption 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 by individuals allergic to certain ingredients or by patients with severe liver impairment. Patients with heart diseases, peptic ulcers, asthma, urinary retention, seizures, and extrapyramidal disorders should exercise particular caution when using this medicine. Gastrointestinal symptoms such as nausea, vomiting, and diarrhea may frequently occur upon taking this medication, especially during the initial stages of treatment or when increasing the dosage. Neurological adverse reactions such as dizziness, headache, drowsiness, and tremors have also been reported; if symptoms are severe, consult a healthcare provider. Heart rate may decrease, so patients with heart conditions should have regular check-ups. This medication may intensify effects or increase side effects when used in conjunction with other cholinergic drugs, so caution is necessary when combining medications. Pregnant or breastfeeding women should carefully consider the potential effects on the fetus or baby when using this medication. This medication is not recommended for children as its safety and efficacy have not been adequately established in pediatric patients. In case of overdose, severe symptoms such as nausea, vomiting, bradycardia, and seizures may occur, necessitating immediate medical attention. This medication should be stored out of reach of children and not transferred to another container for safety. During treatment, the patient's weight and adverse reactions should be regularly monitored, and any abnormal symptoms should be promptly reported to healthcare personnel.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. Additionally, it is best kept at room temperature between 1°C and 30°C, avoiding excessively hot or cold environments.

Appearance

An orange-colored hard capsule containing a white to yellowish powdered substance.

Package unit

28 capsules/PTP [(14 capsules/PTP × 2)]