Unireva Capsule 3 mg (Rivastigmine Tartrate)

Adult dose

Directions for use: Rivastigmine is administered orally twice daily with the morning and evening meals. ○ Adults: 1. Treatment of mild to moderate Alzheimer-type dementia The initial dose is 3 mg/day of rivastigmine. For each patient, increase the dose at intervals of at least 2 weeks to the highest tolerated dose or the maximum recommended dose of 12 mg/day. Because this drug showed greater efficacy in clinical trials at doses of 6 mg/day or higher, a target dose range of 6~12 mg/day is recommended for most patients. Recommended dose titration Administer 1.5 mg per dose twice daily for at least 2 weeks. If well tolerated, the dose may be increased to 3 mg per dose twice daily. Subsequent increases may be made to 4.5 mg per dose twice daily and, if well tolerated for at least 2 weeks, to 6 mg per dose twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or loss of 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 3~12 mg/day in 2 divided doses (1.5~6 mg per dose twice daily). The initial dose is 1.5 mg per dose twice daily. At intervals of at least 4 weeks between dose levels, and according to the patient's tolerability, the dose may be increased successively to 3 mg per dose twice daily, then 4.5 mg per dose twice daily, and subsequently 6 mg per dose twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or loss of appetite), weight gain, or extrapyramidal symptoms (e.g., tremor) occur during treatment, interrupting administration once or several times 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 per dose 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 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 these patients.

Child dose

○ Children: Use in children is not recommended because this drug has not been studied in children.

This drug should not be used in certain patients. For example, patients who are allergic to any component of this drug, those with severely impaired liver function, and those who have experienced skin allergic reactions when using the patch form of this medication should avoid administration. Cautious administration is required for patients with a history of heart disease, gastric ulcers, asthma, urinary retention, seizures, and extrapyramidal disorders. Gastrointestinal side effects such as nausea, vomiting, and diarrhea may commonly occur while taking this drug, especially in female patients. Neurological adverse reactions such as dizziness, headache, drowsiness, and tremors have been reported, so caution is needed while driving or operating machinery. Cardiac side effects such as bradycardia, atrial fibrillation, and heart block may occasionally occur, so patients with heart conditions should take this under a doctor's supervision. This drug may interact when used with other cholinergic or anticholinergic medications, so if there are concomitant medications, consult a physician or pharmacist. Because the safety of this drug during pregnancy or breastfeeding has not been fully established, it is essential to consult a healthcare provider before use. It is not recommended for children due to the lack of appropriate clinical trials in this age group. In case of overdose, symptoms such as nausea, vomiting, bradycardia, and confusion may appear, and in severe cases, professional treatment may be necessary. This medication should be kept out of reach of children, and care should be taken not to transfer it to other containers as this may affect its quality. During treatment, it is important to regularly monitor the patient's weight and adverse reactions, particularly for Parkinson's patients, who should be closely observed for worsening motor symptoms.

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

This drug may be sensitive to air and moisture, so it should be stored in a sealed container. It is recommended to maintain the storage temperature between 1 degree and 30 degrees Celsius to ensure the longevity of its effects.

Appearance

Hard capsule in orange color containing white to pale yellow powder

Package unit

28 capsules/box [(14 capsules/PTP*2)]