Medication info

Green Cross Donepezil Tablets 5 mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Donepezil Hydrochloride Hydrate›5.22mg / 1 tablet
Manufacturer / importer
(주)녹십자
Appearance
Yellow round film-coated tablets
Packaging
For domestic use - 30 tablets/bottle, For domestic use - 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202002433 · Approved 2020.04.07

This product's status changed to Approval withdrawn on 2024.06.10. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of Alzheimer's dementia symptoms
Who takes it
Adults · Children
Adult dose
As Donepezil hydrochloride, administer 5 mg once daily before bedtime. If unusual dreams, nightmares, or insomnia occur, consider morning administration. Administer 5 mg for 4-6 weeks and evaluate clinical response before increasing to 10 mg. When increasing to 10 mg daily, caution for gastrointestinal adverse reactions is required. Underweight women aged 85 and older should not exceed 5 mg daily.
Child dose
There is no experience in pediatric use.

Ingredients

Manufacturer
(주)녹십자

Efficacy & effects

Improvement of Alzheimer's dementia symptoms

  • Symptoms of Alzheimer's dementia
View approved original text

This medication is used to treat symptoms of Alzheimer's dementia. It primarily helps alleviate symptoms related to dementia, such as memory decline and impaired cognitive function, assisting patients in their daily lives. Regular use can contribute to delaying symptom progression and improving quality of life.

How to take

Adult dose

As Donepezil hydrochloride, administer 5 mg once daily before bedtime. If unusual dreams, nightmares, or insomnia occur, consider morning administration. Administer 5 mg for 4-6 weeks and evaluate clinical response before increasing to 10 mg. When increasing to 10 mg daily, caution for gastrointestinal adverse reactions is required. Underweight women aged 85 and older should not exceed 5 mg daily.

Child dose

There is no experience in pediatric use.

Precautions

This medication should not be used by patients who are hypersensitive to specific components or by pregnant or nursing women. It should also not be administered to patients with genetic issues such as lactose intolerance. Patients with a history of heart disease, peptic ulcers, asthma, or chronic obstructive pulmonary disease should use this medication cautiously. This medication can affect heart rate and may increase the risk of bradycardia or arrhythmias. It may irritate the digestive system, exacerbating peptic ulcer symptoms, so monitoring symptoms is important. In addition, this medication can cause bronchoconstriction, so patients with asthma should exercise particular caution. Patients with extrapyramidal disorders, such as Parkinson’s disease, may experience exacerbation of symptoms and should use with caution. Caution should also be exercised if there is an allergy to the dyes included in this drug. During treatment, various side effects such as dizziness, nausea, vomiting, diarrhea, insomnia, and fatigue may occur; consult a healthcare professional immediately if abnormal symptoms occur. In severe cases, serious side effects such as heart problems, liver dysfunction, cerebrovascular disorders, or muscle disorders may arise, requiring caution. This medication is used in the treatment of Alzheimer's dementia, and discontinuation is recommended if there is no therapeutic effect. Patients with heart disease or electrolyte abnormalities should have regular electrocardiograms to monitor heart condition. Caution is needed when driving or operating machinery as dizziness or fatigue may occur. It is recommended that pregnant or nursing women avoid using this medication, and if absolutely necessary, consult with a specialist. This drug may interact with other medications; therefore, it is important to inform about any concurrent medications, especially if combining with heart medications, antibiotics, or antidepressants. Overdosage can lead to severe vomiting, bradycardia, or respiration difficulties, necessitating immediate emergency treatment. This medication should be stored in a safe place out of the reach of children, and transferring to another container should be avoided.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (including facial swelling), chest tightness, difficulty breathing, respiratory distress, cold sweat, pallor → severe allergic reaction. High fever with severe rash, blisters, skin peeling, pain in mouth/eye mucosa → severe skin abnormal reactions. Shortness of breath or difficulty breathing, asthma attacks, coughing along with fever and respiratory issues → respiratory problems. Yellowing of skin or eyes (jaundice), extreme lethargy → liver issues.

Mild side effects

Nausea, vomiting, diarrhea, loss of appetite, headache, fatigue, insomnia, dizziness, drowsiness, tremor, muscle pain, swelling, rash, itching, thrombocytopenia, anxiety, hallucinations, confusion, insomnia, depression, aggressive behavior, reduced attention, mental dullness, increased blood pressure, thrombocytopenia, thrombocytopenia, thrombocytopenia, and other mild to moderate adverse reactions.

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

Storage

This medication should be stored in a tightly sealed container that is airtight, at room temperature between 1°C and 30°C. Proper storage will help maintain the drug's effectiveness for a longer period.

Appearance and packaging

Appearance

Yellow round film-coated tablets

Package unit

For domestic use - 30 tablets/bottle, For domestic use - 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.

Related searches

Search tags

Suggested searches

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.