Medication info
Donepezil Tablets 5 mg (Donepezil Hydrochloride Monohydrate)

Donepezil Tablets 5 mg (Donepezil Hydrochloride Monohydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›5.22mg / 1 tablet
Manufacturer / importer
맥널티제약(주)
Appearance
Yellow, round, film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201906920 · Approved 2019.09.30 · Insurance code 641502530

Summary

Main use
Improvement of symptoms of Alzheimer's type dementia
Who takes it
Adults · Children
Adult dose
As donepezil hydrochloride, administer 5 mg once daily before bedtime. After administering 5 mg for 4-6 weeks, the dosage can be increased to 10 mg depending on clinical response. When increasing to 10 mg per day, caution should be taken regarding gastrointestinal adverse reactions.
Child dose
There is no dosage available as there is no experience using this medication in children.

Ingredients

Manufacturer
맥널티제약(주)

Efficacy & effects

Improvement of symptoms of Alzheimer's type dementia

  • Symptoms of Alzheimer's type dementia
View approved original text

This medication is used for the treatment of symptoms associated with Alzheimer's type dementia.

How to take

Adult dose

As donepezil hydrochloride, administer 5 mg once daily before bedtime. After administering 5 mg for 4-6 weeks, the dosage can be increased to 10 mg depending on clinical response. When increasing to 10 mg per day, caution should be taken regarding gastrointestinal adverse reactions.

Child dose

There is no dosage available as there is no experience using this medication in children.

Precautions

This medication should not be used by individuals with allergies to specific ingredients or by women who are pregnant or breastfeeding. Additionally, it should not be taken by those with lactose intolerance or certain genetic metabolic disorders. Individuals with heart disease or problems with heart rhythms should use this medication cautiously, as arrhythmias or bradycardia may occur. Those with a history of peptic ulcers or currently taking non-steroidal anti-inflammatory drugs should exercise caution, as gastrointestinal disturbances may worsen. Patients with asthma or obstructive pulmonary diseases should be careful since this medication may lead to bronchoconstriction. Patients with extrapyramidal disorders such as Parkinson’s disease may experience worsening symptoms with this medication. This medication contains specific dyes, so individuals allergic to those ingredients should be cautious. During treatment, various side effects such as dizziness, nausea, vomiting, diarrhea, insomnia, and abnormal heart rhythms may occur, and anyone experiencing symptoms should consult a physician immediately. Serious side effects can include heart attack, liver dysfunction, cerebral hemorrhage, and seizures; if unusual symptoms occur, the medication should be stopped immediately and appropriate treatment sought. This medication is approved only for patients with Alzheimer's type dementia and should not be used for other types of dementia or memory disorders. During treatment, regular evaluations of efficacy and side effects should take place, and discontinuation of the medication may be necessary if required. Caution is needed when driving or operating machinery, especially at the start of treatment or with dosage changes, as fatigue and dizziness may occur. This medication can interact with other medications, so it is essential to inform your physician or pharmacist about any other drugs being taken. Pregnant or breastfeeding women should avoid this medication, and if it must be taken, it should be under the guidance of a healthcare professional. Safety in children has not been established, so it should not be used in pediatric patients. In case of overdose, severe nausea, vomiting, difficulty breathing, and muscle weakness may occur, and immediate emergency treatment is necessary. Store in a tightly closed container to prevent exposure to air or moisture. It should be kept out of reach of children and not transferred to another container.

Side effects and when to seek care immediately

Serious side effects

Severe allergic reactions (urticaria, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor), severe skin reactions (severe rash, blisters, skin peeling, pain in mucous membranes of mouth/eyes combined with high fever), respiratory issues (difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever), liver issues (hepatitis, liver dysfunction, jaundice, yellowing of skin or eyes, systemic lethargy), serious neurological symptoms (sudden and severe symptoms)

Mild side effects

Headache, dizziness, insomnia, anxiety, drowsiness, fatigue, myalgia, loss of appetite, nausea, vomiting, diarrhea, abdominal pain, weight loss, rash, itching, sweating, increased blood pressure, frequent urination, urinary incontinence, urinary retention, dehydration, hyperlipidemia, weight gain, muscle cramps, thrombocytopenia, anemia, leukopenia, urticaria, edema, facial flushing, lethargy, weakness, blood dyscrasias and other common mild symptoms

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. Maintain storage temperature between 1 to 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Yellow, round, film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.