Donepezil Sublingual Tablet 10mg (Donepezil Hydrochloride Hydrate)

Adult dose

Administer donepezil hydrochloride as 5 mg once daily before bedtime. After administering 5 mg for 4-6 weeks, clinical response should be evaluated, and the dose may be increased to 10 mg. When increasing to a daily dose of 10 mg, caution should be exercised regarding gastrointestinal adverse reactions. The sublingual tablet can be placed on the tongue and dissolved without water.

This medication should not be administered to patients with phenylketonuria, a genetic disorder, as aspartame, the artificial sweetener contained in this medication, is metabolized to phenylalanine in the body. Daily intake of aspartame should be limited to less than 40mg/kg as recommended by WHO, and only the minimum amount necessary should be used. For example, for a 60kg adult, the maximum daily dosage is 2.4g. Patients with allergic reactions to the ingredients of this medication, or hypersensitivity to donepezil hydrochloride or piperidine derivatives, should not take this medication. Furthermore, pregnant women, women of childbearing potential, and nursing mothers should avoid using this medication unless strictly necessary. Caution should be taken when administering this medication to patients with heart diseases, especially those with bradycardia syndrome or cardiac conduction disorders, as it may stimulate the vagus nerve, leading to bradycardia or arrhythmias. Patients taking non-steroidal anti-inflammatory drugs or those with a history of peptic ulcers should be cautious as this medication may increase gastric acid secretion, potentially exacerbating symptoms. Patients with asthma or a history of obstructive pulmonary disease should be careful since this medication may cause bronchial smooth muscle contraction and increase mucus secretion, worsening symptoms. Patients with Parkinson’s disease or extrapyramidal disorders may find that this medication exacerbates symptoms by stimulating cholinergic nerves. This medication contains Yellow No. 4 (Tartrazine), and patients with allergies or hypersensitivity to this ingredient should use it cautiously. While taking this medication, there may be serious side effects such as cardiac-related abnormal symptoms (fainting, bradycardia, cardiac blockage, etc.), gastrointestinal bleeding, liver function abnormalities, cerebrovascular issues, extrapyramidal disorders, neuroleptic malignant syndrome, rhabdomyolysis, shortness of breath, acute pancreatitis, acute renal failure, and unexplained sudden death; therefore, any unusual symptoms should promptly be discussed with a doctor. Additionally, this medication may cause various side effects such as diarrhea, nausea, vomiting, loss of appetite, dizziness, insomnia, headache, fatigue, and muscle pain, so symptoms should be carefully monitored during use. This medication is approved solely for the treatment of Alzheimer’s type dementia and should not be used for other forms of dementia or memory disorders. Treatment should be conducted under the supervision of an experienced physician, and the treatment's effectiveness should be regularly evaluated. Patients with heart diseases or electrolyte abnormalities may require cardiac monitoring when taking this medication. As dizziness or fatigue may occur while driving or operating machinery, caution is advised. It is generally recommended that women who are pregnant or breastfeeding avoid using this medication, and if necessary, they should consult a specialist. This medication may interact with various drugs; therefore, it is crucial to inform a doctor or pharmacist if taking other medications. In case of overdose, symptoms such as nausea, vomiting, sweating, bradycardia, respiratory depression, and seizures may occur, necessitating immediate medical attention. This medication is taken orally in dissolvable tablet form, and it should be completely dissolved on the tongue before swallowing with saliva or water. For storage, keep it in a tightly closed container to prevent air ingress and store it at room temperature between 1°C and 30°C. Proper storage will help to maintain the effectiveness of the medication.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rashes with high fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances, paralysis, changes in urine output.

Mild side effects

• Diarrhea
• nausea
• vomiting
• loss of appetite
• headache
• fatigue
• dizziness
• insomnia
• drowsiness
• sweating

This medication should be stored in a tightly closed container to prevent air ingress and at a temperature between 1°C and 30°C. Proper storage will help maintain the medication's effectiveness.

Appearance

Yellow round sublingual tablet

Package unit

30 tablets/PTP [(10 tablets/PTP packaging x 3)]