Beacept Oral Dissolving Film 5 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 is used for the treatment of Alzheimer's dementia with the active ingredient donepezil hydrochloride. Firstly, this medication should not be administered to individuals allergic to donepezil hydrochloride or any components of the medication, to women who are pregnant or may become pregnant, or to breastfeeding women. Patients with cardiovascular diseases or cardiac conduction disorders should use this medication with caution, as it may slow down heart rate or induce arrhythmia. Those with a history of peptic ulcers or who are taking non-steroidal anti-inflammatory drugs (NSAIDs) should also exercise caution, as this drug can increase gastric acid secretion and promote gastrointestinal motility, potentially exacerbating ulcer symptoms. Patients with asthma or obstructive pulmonary disease should be careful due to the risk of bronchoconstriction and increased mucus secretion worsening their symptoms. Patients with extrapyramidal disorders such as Parkinson's disease may experience worsened symptoms due to the drug stimulating cholinergic nerves. While using this medication, severe adverse reactions such as syncope, heart problems, gastrointestinal bleeding, liver dysfunction, cerebrovascular issues, muscle abnormalities, and respiratory difficulties may occur; hence symptoms should prompt immediate consultation with healthcare professionals. Additionally, side effects such as nausea, vomiting, diarrhea, reduced appetite, dizziness, insomnia, hallucinations, and anxiety may frequently occur. This medication may increase the risk of serious side effects when taken with other drugs that affect cardiac conduction, so it is essential to inform your healthcare provider of any medications you are currently taking. Pregnant or breastfeeding women should preferably avoid using this medication, and if necessary, should consult a healthcare professional to discontinue breastfeeding after consultation. Safety in children has not been established; therefore, it should not be administered to children. Dizziness or drowsiness may occur while driving or operating machinery, so caution is advisable. In cases of overdose, severe nausea, vomiting, bradycardia, hypotension, respiratory difficulties, or convulsions may present, necessitating immediate emergency treatment. This medication should be dissolved in the mouth and is to be taken without water. Store in a sealed container to protect from air and moisture. It is also important to keep away from direct sunlight and to store at room temperature between 1 to 30 degrees Celsius.

• Fainting
• 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 tightly sealed container to prevent exposure to air and moisture. It should also be kept away from direct sunlight and at room temperature between 1 to 30 degrees Celsius.

Appearance

Rectangular yellow to pale yellow oral dissolving film

Package unit

30 sheets/box