Aroset Tablet 10 mg (Donepezil Hydrochloride Monohydrate)

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. If strange dreams, nightmares, or sleep disturbances occur, morning dosing may be considered. Donepezil concentrations reach a steady state 15 days after administration, so maintain the 5 mg dose for 4 to 6 weeks. Clinical response should be evaluated during this period, and the dosage may be increased to 10 mg thereafter. When increasing to 10 mg daily, precautions for gastrointestinal adverse reactions should be taken.

Child dose

There is no experience of use in children.

This medication contains Donepezil Hydrochloride Monohydrate as the active ingredient and is mainly used to treat symptoms of Alzheimer's type dementia. This medication should not be used in patients allergic to Donepezil Hydrochloride or piperidine derivatives, or any component of the drug. Additionally, pregnant women or women who may become pregnant, as well as lactating women, should not take this medication. This medication contains lactose, so it should not be administered to patients with genetic metabolic disorders such as lactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. Patients with heart diseases, particularly those with bradycardia or atrioventricular conduction disturbances, should be cautious because this medication may cause bradycardia or arrhythmias through vagal stimulation. Patients taking non-steroidal anti-inflammatory drugs or those with a history of peptic ulcers should use this medication cautiously as it may exacerbate symptoms due to increased gastric acid secretion and gastrointestinal motility. Patients with a history of asthma or obstructive pulmonary disease may experience worsened symptoms due to bronchoconstriction and increased mucus secretion, requiring caution. Moreover, patients with Parkinson's disease or similar extrapyramidal disorders may have exacerbated symptoms, as this medication stimulates cholinergic neurons. This medication contains Yellow No. 5 dye, so patients with hypersensitivity or allergic history to this component should be careful. During treatment, cardiovascular adverse reactions such as syncope, bradycardia, heart block, myocardial infarction, heart failure, and severe adverse reactions like peptic ulcers, gastrointestinal bleeding, hepatitis, cerebral seizures, extrapyramidal disorders, neuroleptic malignant syndrome, rhabdomyolysis, respiratory distress, acute pancreatitis, acute renal failure, and sudden death may occur. If symptoms arise, consult a healthcare professional immediately. Common side effects that may occur include nausea, vomiting, diarrhea, loss of appetite, dizziness, insomnia, headache, and fatigue. This medication is not approved for other types of dementia or memory disorders aside from Alzheimer's type dementia and should only be used under the diagnosis and supervision of an experienced physician. Patients with cardiovascular diseases or a history of QT interval prolongation may require ECG monitoring while taking this medication. As a cholinesterase inhibitor, this medication may enhance the effect of succinylcholine-type muscle relaxants during anesthesia, so it is crucial to inform healthcare providers before anesthesia. This medication is primarily metabolized in the liver and may show increased or decreased efficacy when taken with certain drugs, so inform healthcare providers of any concurrent medications. Pregnant or lactating women are advised against taking this medication, and if it is necessary, discontinuing breastfeeding is recommended. Safety in pediatric patients has not been established; thus, it is not used in children. In case of overdose, symptoms such as nausea, vomiting, sweating, bradycardia, hypotension, respiratory depression, and seizures may occur; in such cases, seek emergency treatment immediately, and atropine may be used as an antidote. This medication should be kept out of reach of children, and transferring it to another container should be avoided due to the risk of accidental ingestion and degradation of quality.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, paleness, severe rash with fever, blisters, skin peeling, pain in oral or ocular mucosa, difficulty or shortness of breath, asthma attack, respiratory distress with cough and fever, yellowing of skin or eyes (jaundice), profound lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination.

Mild side effects

• Nausea
• vomiting
• diarrhea
• loss of appetite
• headache
• fatigue
• fever
• insomnia
• dizziness
• drowsiness

This medication should be stored in a tightly closed container that is air-tight, at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain efficacy and prevent deterioration.

Appearance

Yellow, round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle