NPSep Tablet 10mg (Donepezil Hydrochloride Monohydrate)

Adult dose

○ Adults: Administer donepezil hydrochloride 5 mg once daily at bedtime. If sleep disturbances such as unusual dreams, nightmares, or insomnia occur, morning administration of this medication may be considered. Since donepezil concentrations reach steady state 15 days after administration and the incidence of adverse reactions may be affected by the rate of dose escalation, administer the 5 mg dose for 4~6 weeks. After evaluating the clinical response during this period, the dose may be increased to 10 mg. When increasing the dose to 10 mg daily, administer with attention to gastrointestinal adverse reactions. If treatment is discontinued, the effects gradually diminish; no rebound effect occurs with abrupt discontinuation. ○ Women aged 85 years or older who are underweight: Adverse reactions occur more frequently, so careful monitoring is required. Older women who are underweight should not receive more than 5 mg daily.

Child dose

○ Children: There is no experience with use in children.

This medication contains the ingredient donepezil hydrochloride, which is primarily used to alleviate symptoms of Alzheimer's type dementia. First, this medication should not be used by those who are allergic to donepezil hydrochloride or piperidine derivatives, or any other component of this medication. Additionally, it should not be taken by women who are pregnant, may become pregnant, or are breastfeeding. This medication contains lactose, so individuals with genetic disorders such as galactose intolerance, lactose deficiency, or glucose-galactose malabsorption should avoid use. Individuals with heart-related conditions should use this medication cautiously, as it may slow the heart rate or cause arrhythmias. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers may be at risk of gastrointestinal bleeding, so caution is advised. Those with a history of asthma or obstructive pulmonary disease should also be careful, as this medication may worsen respiratory symptoms. Patients with extrapyramidal disorders such as Parkinson's disease should use this medication cautiously, as there is a possibility it may exacerbate symptoms. Serious side effects such as syncope, bradycardia, heart block, gastrointestinal bleeding, liver dysfunction, seizures, and muscular abnormalities may occur while taking this medication, so immediate consultation with a physician is necessary if any abnormal symptoms arise. Additionally, various side effects such as fatigue, dizziness, nausea, vomiting, diarrhea, insomnia, headache, myalgia, etc. have been reported, so patients should inform their healthcare providers if they experience any discomfort while taking this medication. This medication is not approved for the treatment of dementia or memory disorders other than Alzheimer's type dementia and must be used only under the diagnosis and supervision of an experienced physician. Caution is advised while driving or operating machinery, especially at the beginning of treatment or when increasing the dosage, as dizziness or fatigue may occur. This medication may interact with certain drugs, so if you are taking other medications, be sure to inform your physician or pharmacist. Special caution is needed when used in conjunction with heart-related medications, antibiotics, antidepressants, and antipsychotics. Pregnant or breastfeeding women are generally advised not to use this medication, and if absolutely necessary, consultation with a professional is required. Safety for pediatric use has not been established, and it is not recommended for use in children. In the case of overdose, symptoms may include nausea, vomiting, bradycardia, hypotension, and respiratory depression, so if these symptoms occur, immediate hospital treatment is necessary, and atropine can be used as an antidote. This medication should be kept out of reach of children and should not be transferred to other containers.

• Syncope
• bradycardia
• heart block
• QT interval prolongation
• myocardial infarction
• heart failure
• peptic ulcer
• perforated duodenal ulcer
• gastrointestinal bleeding
• hepatitis

This medication should be stored in a sealed container to protect it from air and moisture. It is advisable to keep the storage temperature between 1 and 30 degrees Celsius at room temperature. This will help maintain the efficacy of the medication for a longer period.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets