Donepezil Orodispersible Tablets 10 mg (Donepezil Hydrochloride Monohydrate)

Adult dose

Administer Donepezil Hydrochloride 5 mg once daily before bedtime. For the first 4 to 6 weeks, the dose should be 5 mg, and after evaluating the clinical response during this period, it may be increased to 10 mg. When increasing the dose to 10 mg per day, caution should be exercised regarding gastrointestinal adverse reactions. This medication is an orodispersible tablet that can be taken by placing it on the tongue and dissolving it with water, or it can be taken without water.

This medication contains the artificial sweetener aspartame and should not be given to patients with phenylketonuria, a hereditary disorder. Care must be taken not to exceed the maximum allowable daily dose of aspartame. Patients who are allergic to or have hypersensitivity to any components in this drug, pregnant women or women of childbearing potential, and nursing mothers should not take this medication. Patients with heart disease or conduction disorder of the heart should use this drug cautiously, as it may affect heart rate. Patients taking nonsteroidal anti-inflammatory drugs or with a history of peptic ulcer should be cautious as gastrointestinal problems may worsen. Patients with asthma or obstructive lung disease should be careful as symptoms may worsen due to bronchoconstriction and increased mucus secretion. Patients with extrapyramidal disorders such as Parkinson's disease should consult their doctor as this medication may worsen symptoms. This medication contains Yellow No. 4 dye, so those allergic to this component should be cautious. This drug can cause serious side effects, such as cardiac-related adverse reactions, gastrointestinal bleeding, liver dysfunction, and cerebrovascular disorders, so patients should inform their doctor immediately if symptoms occur. During treatment, various side effects such as dizziness, nausea, diarrhea, insomnia, and muscle pain may occur, so it is essential to monitor the patient's condition closely. Patients with cardiovascular disease may experience heart-related side effects such as bradycardia, heart block, and QT interval prolongation, necessitating regular electrocardiographic monitoring. This drug, as a cholinesterase inhibitor, increases gastric acid secretion and promotes gastrointestinal motility, which may worsen peptic ulcers; therefore, caution is needed if there is a history of gastrointestinal disease. It may affect the ability to drive or operate machinery, so caution should be exercised when starting treatment or changing dosages. Pregnant women or nursing mothers should avoid use unless safety has been established, in which case they should consult their doctor. Safety in children has not been confirmed; therefore, it should not be used in pediatric patients. There may be interactions with other medications, so it is important to inform the doctor if taking any medications especially related to CYP3A4, CYP2D6, heart medications, anticholinergic medications, or NSAIDs. In the case of overdose, symptoms such as severe nausea, vomiting, bradycardia, and respiratory depression may occur, requiring immediate emergency treatment. This medication should be consumed by placing it on the tongue, and it should be stored out of reach of children. It may discolor due to light, so it is best to store it in the original, unopened packaging.

Serious side effects

• Hives
• severe swelling (edema)
• difficulty breathing
• jaundice
• hepatitis
• impaired liver function
• seizures (epilepsy, convulsions)
• cerebral hemorrhage
• cerebrovascular disorders
• neuroleptic malignant syndrome

Mild side effects

Loss of appetite, hallucinations, excitement, aggressive behavior, anxiety, insomnia, drowsiness, increased libido, talking too much, mania, nightmares, nervousness, nonsensical speech, delusions, depression, confusion, indifference, hyperactivity, increased libido, dizziness, insomnia, tremors, disorientation, palpitations, hypertension, hypotension, atrial fibrillation, diarrhea, nausea, vomiting, abdominal discomfort (including abdominal pain), constipation, salivation, difficulty swallowing, fecal incontinence, rash, itching, muscle cramps, muscle.

This medication should be stored in a tightly closed container to prevent air or moisture from entering. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature to preserve the drug's effectiveness for a longer duration.

Appearance

Yellow round orally disintegrating tablet

Package unit

30 tablets (10 tablets/ PTP packaging x 3)