Donepezil Tablets 10 mg (Donepezil Hydrochloride Monohydrate)

Adult dose

As donepezil hydrochloride, administer 5 mg once daily before bedtime. In case of unusual dreams, nightmares, or sleep disturbances, morning administration should be considered. Administer 5 mg for 4 to 6 weeks, and after evaluating clinical response, dosage may be increased to 10 mg. When increasing to 10 mg per day, be cautious of gastrointestinal side effects. Underweight females over 85 years of age should not exceed 5 mg per day.

Child dose

There is no experience with pediatric use.

This medication contains donepezil hydrochloride as its main ingredient and is used to treat symptoms of Alzheimer's disease. This medication should not be administered to patients who are allergic to donepezil hydrochloride, piperidine derivatives, or any other components of this medication. Women who are pregnant or may become pregnant and nursing mothers should also not take this medication. Since it contains lactose, patients with hereditary disorders such as lactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medication. Caution should be exercised in patients with heart disease, particularly those with sick sinus syndrome or atrioventricular block, as this medication can stimulate the vagus nerve, potentially causing bradycardia or arrhythmias. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should be cautious due to the risk of increased gastric secretion and gastrointestinal motility, which may exacerbate ulcers. Patients with a history of asthma or obstructive pulmonary disease should be careful, as this medication can contract bronchial smooth muscle and increase mucus secretion, worsening symptoms. Patients with extrapyramidal disorders such as Parkinson's disease should also be cautious, as this medication may worsen their symptoms. Additionally, individuals allergic to the color additive Yellow No. 5 should be administered this medication with caution. While taking this medication, symptoms related to heart abnormalities such as syncope, bradycardia, heart block, QT interval prolongation, myocardial infarction, and heart failure may occur; if these symptoms arise, the medication should be discontinued immediately and medical advice should be sought. Serious side effects such as peptic ulcers, gastrointestinal bleeding, hepatitis, liver dysfunction, cerebral seizures, symptoms of extrapyramidal disorders, neuroleptic malignant syndrome, rhabdomyolysis, respiratory distress, acute pancreatitis, acute renal failure, and sudden death of unknown cause have also been reported, necessitating caution. Commonly, side effects such as diarrhea, nausea, vomiting, dizziness, insomnia, headache, loss of appetite, fatigue, muscle pain, rash, urinary incontinence may occur. These side effects are generally mild and transient; however, if symptoms are severe or persistent, consultation with a physician is advised. This medication is not approved for other forms of dementia or age-related cognitive decline, thus it should only be used in patients diagnosed with Alzheimer's disease. Monitoring by a specialist is required during the initiation and maintenance of therapy, and caregivers should regularly observe the drug administration status. Patients with heart disease or electrolyte abnormalities, as well as those with a history of QT interval prolongation, may require an electrocardiogram during treatment with this medication due to the risk of cardiac arrhythmias. Since this medication may affect driving or operation of machinery, caution is advised if dizziness or fatigue is experienced after taking this medication. This medication may interact with other drugs; therefore, it is essential to discuss with a physician or pharmacist, particularly when taking medications that affect CYP3A4 and CYP2D6 enzymes, muscle relaxants, cholinergic agents, anticholinergic agents, beta-blockers, and NSAIDs. Women who are pregnant or nursing should avoid using this medication and should consult a specialist before use, even when absolutely necessary. Safety for pediatric patients has not been established, so it is not administered to children. In case of overdose, symptoms may include nausea, vomiting, bradycardia, hypotension, respiratory depression, seizures, and immediate medical attention is required, where atropine or other antidotes may be administered. This medication should be stored out of reach of children and not transferred to another container for safety.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headaches, lightning headaches, seizures, altered consciousness, visual disturbances, paralysis, coma

Mild side effects

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

This medication should be stored in a tightly sealed container to prevent air or moisture ingress, and kept at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness for a long time.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle