Entiriva Capsule 1.5 mg (Rivastigmine Tartrate)

Adult dose

Method of administration: Rivastigmine is administered orally twice daily with breakfast and dinner. ○ Adults: 1. Treatment of mild to moderate Alzheimer-type dementia The initial dose is 3 mg of rivastigmine daily. 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 daily. Since this medication demonstrated greater efficacy in clinical trials at doses of 6 mg daily and higher, a target dose range of 6~12 mg daily is recommended for most patients. Recommended dose titration schedule Administer 1.5 mg of this medication twice daily for at least 2 weeks. If well tolerated, the dose may be increased to 3 mg twice daily. Further dose increases may be made to 4.5 mg twice daily, and, if well tolerated, after at least 2 weeks, to 6 mg 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 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 daily in 2 divided doses. (1.5~6 mg per dose, twice daily.) The initial dose is 1.5 mg of this medication twice daily. Depending on the patient's tolerability, subsequent consecutive dose increases may be made at intervals of at least 4 weeks to 3 mg twice daily, then 4.5 mg twice daily, and then 6 mg twice daily. If adverse reactions (for example, nausea, vomiting, abdominal pain, or decreased appetite), weight gain, or extrapyramidal symptoms (for example, tremor) are observed during treatment, omitting 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 medication twice daily by mouth. 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 treatment 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 this population.

Child dose

○ Children: This medication has not been studied in children; therefore, its use in children is not recommended.

This medication contains the ingredient rivastigmine and should not be used in certain patients. For example, it should not be taken by individuals who are allergic to its components or those with severe liver impairment. Additionally, patients with a history of heart disease, peptic ulcer, asthma, urinary retention, seizures, or extrapyramidal disorders should use this drug with caution, as it may exacerbate these conditions. Taking this medication may lead to various side effects such as nausea, vomiting, diarrhea, dizziness, and headaches. Such symptoms may occur more frequently during the initial period of dose adjustment, so caution is advised. For patients with dementia related to Parkinson's disease, this drug may worsen Parkinson's symptoms, and it should be administered carefully according to the physician's instructions. Moreover, this medication can interact with other drugs, so it is essential to consult with a doctor or pharmacist, particularly when taking anesthetics, other cholinergic medications, anticholinergics, or beta-blockers. Women who are pregnant or breastfeeding should determine whether to take this medication after consulting with their doctor, as its safety has not been sufficiently established. The use of this medication is not recommended for children. In case of overdose, severe side effects may occur, so if overdose is suspected, contact a medical institution immediately for appropriate treatment. Finally, this medication should be kept out of reach of children and should not be transferred to other containers.

• Nausea
• vomiting
• dizziness
• headache
• drowsiness
• tremor
• syncope
• convulsions
• extrapyramidal symptoms
• angina

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. It is recommended to maintain a storage temperature of between 1 and 30 degrees Celsius. Proper storage will ensure the safety and efficacy of the medication.

Appearance

A yellow hard capsule containing a white to light yellow powder.

Package unit

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