Medication info
Donepezil 5 mg Tablets (Donepezil Hydrochloride Monohydrate)

Donepezil 5 mg Tablets (Donepezil Hydrochloride Monohydrate)

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

MFDS item code 201602671 · Approved 2016.05.16 · Insurance code 649001550

Summary

Main use
Improvement of symptoms associated with Alzheimer's dementia
Who takes it
Adults · Children
Adult dose
As donepezil hydrochloride, administer 5 mg once daily before bedtime. If unusual dreams, nightmares, or sleep disturbances occur, consider morning dosing. Normal state is reached 15 days after administration, so maintain the 5 mg dose for 4–6 weeks. After evaluating the clinical response during this period, the dose can be increased to 10 mg. When increasing to 10 mg daily, be cautious of gastrointestinal adverse reactions.
Child dose
There is no experience in pediatric use.

Ingredients

Manufacturer
풍림무약(주)

Efficacy & effects

Improvement of symptoms associated with Alzheimer's dementia

  • Symptoms of Alzheimer's dementia
View approved original text

This medication is used to slow the progression of symptoms associated with Alzheimer's dementia and to improve memory and cognitive function.

How to take

Adult dose

As donepezil hydrochloride, administer 5 mg once daily before bedtime. If unusual dreams, nightmares, or sleep disturbances occur, consider morning dosing. Normal state is reached 15 days after administration, so maintain the 5 mg dose for 4–6 weeks. After evaluating the clinical response during this period, the dose can be increased to 10 mg. When increasing to 10 mg daily, be cautious of gastrointestinal adverse reactions.

Child dose

There is no experience in pediatric use.

Precautions

This medication contains donepezil hydrochloride monohydrate as its main ingredient and is used to alleviate symptoms of Alzheimer's dementia. First, this medication should not be administered to certain patients. For instance, individuals who are allergic to this medication or any of its components, pregnant women or women who may become pregnant, and lactating women should not take this medication. Additionally, patients with genetic lactose intolerance or specific lactose-degrading enzyme deficiencies should not use this medication. Next, individuals with heart disease should use this medication with caution, as it may slow heart rate or cause arrhythmias. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should also be careful as gastric issues may worsen with this medication. Patients with a history of asthma or obstructive pulmonary disease should exercise caution, as bronchial constriction or increased mucus secretion may exacerbate symptoms. Moreover, patients with extrapyramidal disorders like Parkinson's disease should be cautious, as symptoms may worsen. This medication contains the dye Yellow No. 5, so individuals allergic to this component should also be careful. Possible side effects while taking this medication include syncope, heart abnormalities, gastrointestinal bleeding, liver dysfunction, neurological symptoms, movement disorders, severe muscle issues, respiratory difficulties, pancreatitis, renal failure, etc. Additionally, various neuropsychiatric symptoms such as nausea, vomiting, diarrhea, headache, fatigue, insomnia, dizziness, hallucinations, anxiety, and aggressive behavior have been reported. If severe side effects or unusual symptoms occur, consult a doctor immediately. This medication is not approved for types of dementia or memory disorders other than Alzheimer's dementia, and it must be used under the guidance and supervision of an experienced physician. Therapeutic effects should be regularly evaluated, and if there is no effect, discontinuation of treatment is recommended. Individuals with heart-related conditions or electrolyte imbalances may require an ECG while taking this medication. Those with a history of peptic ulcers or taking analgesics should closely monitor their gastric status. Because this medication can affect driving or machine operation abilities, caution is required when starting treatment or changing dosage. Pregnant or lactating women should avoid taking this medication, and if it is necessary, discontinuation of breastfeeding after consulting a specialist is advised. There is no established safety for pediatric use, so it is not used in children. This medication may interact with other drugs; therefore, it is essential to inform your doctor or pharmacist of any current medications. In particular, caution is needed when taken with heart medications, antibiotics, antidepressants, antipsychotics, and anti-inflammatory analgesics. In case of overdose, symptoms such as severe nausea, vomiting, sweating, bradycardia, hypotension, respiratory depression, and seizures may occur, necessitating an immediate visit to a medical institution for proper treatment. Finally, this medication should be stored out of reach of children, and transferring it to another container is not advisable for maintaining quality.

Side effects and when to seek care immediately

Serious side effects

  • Syncope, bradycardia, heart block, QT interval prolongation, myocardial infarction, heart failure and other cardiovascular adverse reactions
  • Peptic ulcers, perforated duodenal perforation, gastrointestinal bleeding
  • Hepatitis, liver dysfunction, jaundice
  • Cerebral seizure (epilepsy, convulsions, etc.), cerebral hemorrhage, cerebrovascular disorders
  • Extrapyramidal symptoms (motor dysfunction, tremor, gait disturbance, etc.)
  • Neuroleptic malignant syndrome (catatonia, rigidity, fever, etc.)
  • Rhabdomyolysis
  • Dyspnea
  • Acute pancreatitis
  • Acute renal failure

Mild side effects

Nausea, vomiting, diarrhea, loss of appetite, dizziness, insomnia, drowsiness, headache, fatigue, myalgia, rash, itching, increased blood pressure, anxiety, hallucinations, aggressive behavior, tremor, gait disturbance, involuntary movements, decreased concentration, mental dullness, drowsiness, palpitations, lethargy, sweating, thrombocytopenia, and other common adverse reactions have been reported.

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

Storage

This medication should be stored in a tightly sealed container to prevent air exposure, ideally at room temperature between 1 degrees to 30 degrees Celsius. This storage method helps maintain the medication's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

Yellow round film-coated tablets

Package unit

30 tablets, 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

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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.