Donepezil Fast Disintegrating Tablets 5 mg (Donepezil Hydrochloride Monohydrate)

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily at bedtime. For 4 to 6 weeks, maintain the dosage at 5 mg. After evaluating the clinical response during this period, increase to 10 mg if necessary. When increasing to 10 mg, administer cautiously, being aware of gastrointestinal adverse reactions. This medication is available as an orally disintegrating tablet and can be placed on the tongue to dissolve and swallowed with water or taken without water.

Child dose

There is no experience in use for pediatric patients.

This medicine contains aspartame, an artificial sweetener, and should not be used by patients with phenylketonuria, a genetic disorder. The intake of aspartame included in this medicine should be kept below the recommended limit set by WHO, and care should be taken not to exceed 2.4 g per day for a 60 kg adult. Patients with an allergy to this medicine or hypersensitivity to its components, pregnant women or those who may be pregnant, and breastfeeding women should not take this medicine. Patients with heart disease or conduction disorders, those with a history of peptic ulcers, patients taking non-steroidal anti-inflammatory drugs, those with a history of asthma or obstructive pulmonary diseases, and patients with extrapyramidal disorders like Parkinson’s disease should use this medication with caution. This medicine can slow down the heart rate or cause arrhythmia, so patients with heart conditions may require regular ECG monitoring. It can increase gastric acid secretion and promote gastrointestinal motility, potentially worsening symptoms of peptic ulcers; therefore, patients with a history of gastrointestinal diseases should monitor their symptoms carefully. It may contract bronchial smooth muscles and increase mucus secretion, worsening symptoms in patients with asthma or lung diseases, so respiratory conditions should be closely monitored during the use of this medication. Patients with extrapyramidal disorders may experience worsening of symptoms due to this medicine, so changes in symptoms should be observed closely. This medication can cause a variety of adverse reactions, and in severe cases can lead to serious side effects such as syncope, heart block, liver dysfunction, cerebral hemorrhage, muscle abnormalities, acute renal failure, and sudden death. If side effects are suspected, patients should immediately discontinue the medication and consult a healthcare professional. This medication may affect the ability to drive or operate machinery, so caution is needed during the initial dosing or when changing dosage. This medication can interact with other drugs; therefore, patients currently taking medication should inform their healthcare provider. Pregnant or breastfeeding women are advised not to use this medication unless absolutely necessary, in which case they should consult a professional. Safety in children has not been established, so children should not take this medication. In case of overdose, symptoms such as nausea, vomiting, bradycardia, and respiratory depression may occur, requiring immediate medical treatment. This medication dissolves in the mouth and should be stored out of reach of children and protected from direct sunlight.

Serious side effects

• Severe allergic reactions include hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, and pallor.
• Severe skin adverse reactions such as a rash with high fever, blisters, skin peeling, and pain in oral/ocular mucosa.
• Respiratory issues such as shortness of breath or difficulty breathing, asthma attacks, and cough accompanied by fever.
• Liver abnormalities like jaundice (yellowing of the skin or eyes) and extreme lethargy throughout the body.
• Sudden and severe headaches.

Mild side effects

• Common adverse reactions include headache, dizziness, nausea, vomiting, diarrhea, insomnia, loss of appetite, fatigue, muscle pain, rash, itching, drowsiness, elevated blood pressure, swelling, urinary incontinence, urinary disturbances, and changes in blood test results.
• Neurological symptoms include hallucinations, agitation, aggressive behavior, anxiety, depression, confusion, movement disorders, tremors, gait disturbances, and involuntary movements.
• Cardiovascular symptoms include palpitations, hypertension, and hypotension.
• Gastrointestinal symptoms include abdominal pain, gastrointestinal bleeding, and gastric ulcer.

This medication should be stored in a sealed container that allows for good air circulation, ideally at room temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain its effectiveness.

Appearance

White round orally disintegrating tablets

Package unit

30 tablets (10 tablets/PTP packaging x 3)