Mahapegil Oral Disintegrating Tablet 5 mg (Donepezil Hydrochloride Monohydrate)

Adult dose

As Donepezil Hydrochloride, 5 mg is administered once daily before bedtime. After administering the 5 mg dose for 4 to 6 weeks, clinical response will be assessed and the dose may be increased to 10 mg. This drug may be taken by placing it on the tongue, allowing it to dissolve, and swallowing it with water, or it may be taken without water.

Child dose

There is no experience with the use of this drug in children.

This drug should not be used in patients who are allergic to specific ingredients, or in pregnant or breastfeeding women. Patients with heart disease or conduction disorders should use this drug with caution, as side effects related to the heart, such as bradycardia or arrhythmia, may occur. Patients with a history of peptic ulcers or taking non-steroidal anti-inflammatory drugs should be cautious when using this drug due to the potential risk of gastrointestinal bleeding or aggravation of ulcers. Patients with asthma or obstructive pulmonary disease may experience worsening of symptoms due to bronchoconstriction or increased mucus secretion, so caution is required when using this drug. Patients with extrapyramidal disorders such as Parkinson's disease are at risk of exacerbation, so caution is needed. This drug has been reported to cause serious adverse reactions such as syncope, bradycardia, heart block, gastrointestinal bleeding, liver dysfunction, cerebrovascular issues, extrapyramidal disorders, neuroleptic malignant syndrome, rhabdomyolysis, acute pancreatitis, acute renal failure, and sudden death, so any abnormal symptoms should be reported to a medical professional immediately. Common side effects such as nausea, vomiting, diarrhea, dizziness, insomnia, headache, and fatigue may occur, and if these symptoms worsen or persist, healthcare providers should be notified. This drug is only approved for patients with Alzheimer's-type dementia and is not approved for other types of dementia or memory impairment, so it should be used under the supervision of a healthcare professional following an accurate diagnosis. Patients with cardiovascular disease may require an electrocardiogram due to the potential for this drug to cause bradycardia or conduction abnormalities. Caution is needed when driving or operating machinery, especially at the beginning of treatment or when increasing the dose, as dizziness or muscle cramps may occur. This drug is metabolized by specific enzymes, so there may be interactions with other medications, particularly when taken with antibiotics, antidepressants, and antiarrhythmics. Pregnant or breastfeeding women are advised not to use this drug unless absolutely necessary, and should consult a specialist before making any decisions. Safety in children has not been established, so its use is not recommended. In case of overdose, serious side effects may occur, such as nausea, vomiting, irregular heartbeat, and respiratory depression, and immediate medical attention should be sought. This drug dissolves in the mouth but is not absorbed through the mucosa, so it should be placed on the tongue to dissolve and then swallowed with saliva or water. When storing, keep this drug out of reach of children, and as it may discolor when exposed to light, it is best to store it in its individual packaging.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in oral/ocular mucosa, difficulty or shortness of breath, asthma attack, respiratory distress accompanied by cough and fever, yellowing of the skin or eyes (jaundice), systemic lethargy, sudden and severe headache, lightning headache, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

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

This drug should be stored in a well-closed container that is airtight and kept at a temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain the drug’s effectiveness without altering its components.

Appearance

White, round oral disintegrating tablet

Package unit

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