Medication info
Unipezil Tablets 5 mg (Donepezil Hydrochloride Hydrate)

Unipezil Tablets 5 mg (Donepezil Hydrochloride Hydrate)

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

MFDS item code 201803010 · Approved 2018.07.20 · Insurance code 669805050

Summary

Main use
Improvement of symptoms of Alzheimer's-type dementia
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride, take 5 mg once daily before bedtime. If unusual dreams, nightmares, or insomnia occur, morning dosing may be considered. Administer 5 mg for 4-6 weeks, and after assessing clinical responses during this period, it can be increased up to 10 mg. When increasing the dosage to 10 mg daily, care should be taken regarding gastrointestinal adverse reactions. For underweight women aged 85 and older
Child dose
There is no experience using this medication in children.

Ingredients

Manufacturer
구주제약(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 in the treatment of Alzheimer's-type dementia symptoms and helps improve memory decline and cognitive function impairment. It maintains the function of nerve cells in the brain and slows the progression of symptoms. It supports the patient in maintaining a more independent daily life. It helps alleviate symptoms to enhance the quality of life. It is used in the treatment of symptoms of Alzheimer's-type dementia.

How to take

Adult dose

As Donepezil Hydrochloride, take 5 mg once daily before bedtime. If unusual dreams, nightmares, or insomnia occur, morning dosing may be considered. Administer 5 mg for 4-6 weeks, and after assessing clinical responses during this period, it can be increased up to 10 mg. When increasing the dosage to 10 mg daily, care should be taken regarding gastrointestinal adverse reactions. For underweight women aged 85 and older

Child dose

There is no experience using this medication in children.

Precautions

This medication contains Donepezil Hydrochloride as its active ingredient and is used for treating symptoms of Alzheimer's-type dementia. First, this medication should not be used in individuals who are allergic to Donepezil Hydrochloride or any component of this medication, pregnant women or those who may become pregnant, and nursing mothers. Additionally, it should be avoided by individuals with lactose intolerance or hereditary lactose enzyme deficiency due to its lactose content. Individuals with heart conditions or conduction disturbances may need caution when using this medication as it can increase the likelihood of bradycardia or arrhythmias. Those taking non-steroidal anti-inflammatory drugs or have a history of peptic ulcers must take it carefully due to the risk of gastrointestinal bleeding or ulcer exacerbation. Patients with a history of asthma or chronic obstructive pulmonary disease should be cautious as it may worsen symptoms due to bronchoconstriction or increased mucus secretion. Individuals with extrapyramidal disorders such as Parkinson's disease may also experience exacerbation of symptoms when taking this medication. This medication contains Yellow No. 5, so those with allergies or hypersensitivity to this substance should consult a doctor before taking it. Serious adverse reactions could occur during use, including syncope, heart issues, gastrointestinal bleeding, liver function abnormalities, seizures, and movement disorders, so if any of these symptoms appear, you should immediately stop taking the medication and seek medical attention. Common side effects may include nausea, vomiting, diarrhea, dizziness, insomnia, headache, and fatigue, and most are mild and temporary. This medication carries a risk of heart arrhythmias or QT interval prolongation, so regular ECG checks may be necessary for those with a history of heart disease or taking QT prolonging drugs. Caution is advised when driving or operating machinery, especially during the initial stages of taking the medication or after a dosage change, as dizziness or fatigue may occur. Women who are pregnant or nursing should avoid using this medication unless absolutely necessary and should consult a professional. Safety in children has not been established, so children should not take this medication. This medication may interact with other drugs, so if you are taking drugs that affect CYP3A4 or CYP2D6 enzymes, cardiac drugs, antidepressants, antibiotics, or NSAIDs, you must consult a doctor or pharmacist. In case of overdose, severe nausea, vomiting, bradycardia, and breathing difficulties may occur, requiring immediate emergency treatment, and antidotes like atropine may be used. Finally, this medication should be kept out of the reach of children and not transferred to another container.

Side effects and when to seek care immediately

Serious side effects

Syncope, bradycardia, heart block, QT interval prolongation, Torsades de pointes, myocardial infarction, heart failure, peptic ulcer, perforated duodenal perforation, gastrointestinal bleeding, hepatitis, liver function impairment, jaundice, cerebral seizures, cerebral hemorrhage, cerebrovascular disorders, extrapyramidal disorders (movement dysfunction, ataxia, motor disorders, dystonia, tremors, involuntary movements, gait disturbances, abnormal posture, speech disorders), neuromuscular blockers

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • dizziness
  • insomnia
  • drowsiness
  • anxiety
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  • hallucinations
  • agitation
  • aggressive behavior
  • tremors
  • gait disturbances
  • involuntary movements
  • decreased concentration
  • mental dullness
  • increased libido
  • excessive libido
  • verbosity
  • mania
  • nightmares
  • nonsensical talk
  • delusions
  • depression
  • confusion
  • indifference
  • hyperactivity
  • palpitations
  • hypertension
  • hypotension
  • atrial fibrillation
  • abnormal heart rate
  • abdominal pain
  • constipation
  • fecal incontinence
  • salivation
  • swallowing difficulties

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

Storage

This medication should be stored in a tightly closed container to prevent air or moisture from entering. It is best to store it at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Yellow round film-coated tablets

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

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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.