Medication info
Hydone 5 mg Tablet (Donepezil Hydrochloride Monohydrate)

Hydone 5 mg Tablet (Donepezil Hydrochloride Monohydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›5mg / 1 tablet
Manufacturer / importer
(주)테라젠이텍스
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201507715 · Approved 2015.11.13 · Insurance code 698503280

Summary

Main use
Improvement of symptoms in Alzheimer's disease
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. Administer 5 mg for 4-6 weeks, after which dosage may be increased to 10 mg based on clinical response evaluation. Caution should be taken for gastrointestinal adverse reactions when increasing to 10 mg per day. Underweight females aged 85 years or older should not exceed 5 mg per day and require careful monitoring.
Child dose
There is no experience in using it in pediatric patients.

Ingredients

Manufacturer
(주)테라젠이텍스

Efficacy & effects

Improvement of symptoms in Alzheimer's disease

  • Symptoms of Alzheimer's disease
View approved original text

Used for the treatment of symptoms of Alzheimer's disease.

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. Administer 5 mg for 4-6 weeks, after which dosage may be increased to 10 mg based on clinical response evaluation. Caution should be taken for gastrointestinal adverse reactions when increasing to 10 mg per day. Underweight females aged 85 years or older should not exceed 5 mg per day and require careful monitoring.

Child dose

There is no experience in using it in pediatric patients.

Precautions

This medication contains Donepezil Hydrochloride Monohydrate as the active ingredient and is used for the treatment of Alzheimer's disease. First, this medication should not be administered to certain patients. For instance, it should not be used in individuals who are allergic to this medication or its components, pregnant women or those who may become pregnant, nursing mothers, and patients with genetic lactose intolerance. Moreover, patients with heart disease or heart conduction disorders, those with a history of peptic ulcer or taking non-steroidal anti-inflammatory drugs, those with a history of asthma or obstructive lung disease, as well as patients with extrapyramidal disorders such as Parkinson's disease should use this medication with caution. This medication can slow the heart rate or cause arrhythmias, lead to gastrointestinal bleeding or worsening of symptoms, and may exacerbate asthma symptoms. Various adverse reactions may occur during the administration of this medication. Common symptoms include nausea, vomiting, diarrhea, dizziness, insomnia, headache, and fatigue, while rare but serious reactions can include severe heart problems, liver dysfunction, cerebrovascular disorders, and muscle abnormalities, necessitating immediate consultation with a physician if severe symptoms arise. This medication should only be used in patients with Alzheimer's disease and is not approved for other types of dementia or cognitive decline. Treatment should be conducted under the supervision of an experienced physician, with regular evaluations of the patient's condition to discontinue treatment if no effect is observed. Caution is needed as it may affect the cardiovascular system, especially in individuals with heart disease or ECG abnormalities, where ECG monitoring may be required. Additionally, caution should be exercised as this medication may impair driving or operating machinery, particularly during the initial dosing or dose escalation, where dizziness or muscle cramps may occur. It is advisable for pregnant or nursing women to avoid using this medication, and it is essential to consult a specialist if necessary. Safety in children has not been established, and therefore it should not be used in pediatric patients. This medication may affect liver and kidney function; thus, regular clinical examinations to monitor status are important. In the event of an overdose, severe symptoms such as severe nausea, vomiting, bradycardia, respiratory depression may occur, requiring immediate emergency treatment, where atropine can be used as an antidote. Finally, this medication may interact with other drugs; thus, caution is necessary, especially when used in conjunction with cardiac medications, antidepressants, antibiotics, and anticholinergic medications, and consultation with a physician or pharmacist is imperative.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with coughing and fever, yellowing of the skin or eyes (jaundice), profound lethargy, sudden and severe headaches, lightning-like headaches, seizures, confusion of consciousness, visual disturbances, paralysis, urinary abnormalities.

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • insomnia
  • dizziness
  • tremors
  • muscle pain
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  • rash
  • itching
  • elevated blood pressure
  • urinary disorders
  • drowsiness
  • confusion
  • anxiety
  • hallucinations
  • aggressive behavior
  • delusions
  • involuntary movements
  • gait disturbances
  • decreased concentration
  • mental sluggishness
  • sweating
  • weight loss
  • dehydration
  • hypotension
  • hypertension
  • palpitations
  • atrial fibrillation
  • petechial hemorrhages
  • urinary incontinence
  • frequent urination
  • fecal incontinence
  • back pain
  • pain
  • toothache
  • facial flushing
  • and etc.

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

Storage

This medication should be stored in a sealed container to prevent air exposure, ideally at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's efficacy for a longer period.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 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.