Beasept Oral Disintegrating Film 10 mg (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, taking this medicine in the morning may be considered. Since donepezil reaches steady-state concentration 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 caution for gastrointestinal adverse reactions. When treatment with this medicine is discontinued, its effects gradually diminish; no rebound effect occurs with abrupt discontinuation. This medicine is an orally disintegrating film that can be placed on the tongue and allowed to dissolve, and taken without water. Female patients aged 85 years or older who are underweight: Careful monitoring is required because adverse reactions occur more frequently. Underweight elderly women should not exceed 5 mg daily.

Child dose

Children: There is no experience with use in children.

This medication contains donepezil hydrochloride and is used to treat symptoms of Alzheimer's dementia. Firstly, this medication should not be used in patients with allergies to this ingredient or other components, pregnant women or those who may become pregnant, and nursing women. Patients with heart-related diseases, such as sick sinus syndrome or heart conduction disorders, should exercise extreme caution when using this medication as it may slow down the heart rate or cause arrhythmias. Additionally, patients with a history of peptic ulcers or those taking non-steroidal anti-inflammatory drugs (NSAIDs) should be cautious since this medication may increase gastric acid secretion and enhance gastrointestinal motility, potentially worsening ulcer symptoms. Patients with asthma or obstructive pulmonary diseases should use this medication carefully as it may cause bronchial smooth muscle contraction and increase mucus secretion, exacerbating symptoms. Patients with extrapyramidal disorders such as Parkinson's disease should also be cautious as the cholinergic effects of this medication could exacerbate symptoms. Severe side effects such as fainting, heart rhythm irregularities, gastrointestinal bleeding, liver dysfunction, seizures, movement disorders, difficulty breathing, acute pancreatitis, and renal failure may occur while taking this medication; if any of these symptoms appear, medical consultation should be sought immediately. Common side effects may include nausea, vomiting, diarrhea, dizziness, insomnia, headache, and decreased appetite. Since this medication can affect heart rhythms, patients with heart disease or a history of QT interval prolongation should be monitored through electrocardiograms. Moreover, because this medication is metabolized in the liver, patients with impaired liver function should be cautious, and regular liver function tests are recommended. Dizziness or drowsiness may occur while driving or operating machinery, so caution is advised. This medication may interact with other drugs, particularly those affecting CYP3A4 and CYP2D6 enzymes, heart-related medications, anticholinergic drugs, and NSAIDs, so consultation with a professional is necessary when taken together. It is generally recommended that pregnant or nursing women do not use this medication, and if necessary, careful consideration should be made after consulting a specialist. Safety in children has not been established, so it is not used in pediatric patients. In case of overdose, symptoms such as nausea, vomiting, bradycardia, hypotension, respiratory depression, muscle weakness may occur, requiring immediate hospital treatment. When taking the medication, it should be placed on the tongue to dissolve in the mouth without water; keep it away from children's reach, and after opening the package, avoid exposure to light to prevent discoloration.

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

This medication should be stored in a tightly sealed container to prevent air and moisture from entering and should be kept away from direct sunlight. The storage temperature should be maintained at room temperature between 1 degree and 30 degrees Celsius.

Appearance

Rectangular yellow to pale yellow oral disintegrating film

Package unit

30 pieces/box