Medication info
Alzpil Tablets 5mg (Donepezil Hydrochloride Monohydrate)

Alzpil Tablets 5mg (Donepezil Hydrochloride Monohydrate)

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

MFDS item code 200709250 · Notified 2007.08.08

Summary

Main use
Improvement of Alzheimer's disease symptoms
Who takes it
Adults · Children
Adult dose
Adults: Administer 5 mg of Donepezil Hydrochloride once daily before bedtime. If unusual dreams, nightmares, or sleep disturbances occur, consider morning dosing of this medication. The concentration of Donepezil reaches a normal state 15 days post-initiation and the frequency of adverse reactions may be affected by dose titration speed; therefore, a dose of 5 mg should be maintained for 4-6 weeks. Clinical responses during this period will be evaluated for possible dose escalation up to 10 mg. Care should be taken with gastrointestinal adverse reactions when titrating to 10 mg daily. Gradual cessation of this medication may reduce its effects, but abrupt discontinuation does not typically cause rebound effects. For underweight women over 85 years of age: Close monitoring is required due to a higher incidence of adverse reactions. Underweight elderly women should not exceed a dose of 5 mg per day.
Child dose
Children: There is no experience in using this medication in children.

Ingredients

Manufacturer
(주)셀트리온제약

Efficacy & effects

Improvement of Alzheimer's disease symptoms

  • Symptoms of Alzheimer's disease
View approved original text

The medication used for the treatment of Alzheimer's disease symptoms helps to alleviate memory decline and cognitive function deterioration, improving the patient's ability to perform daily activities. These medications help delay the progression of symptoms by regulating neurotransmitters in the brain and assist in maintaining overall cognitive function. Patients can expect to see symptom relief when taken consistently, so it is recommended to follow the prescribed directions. This medication is used to treat symptoms of Alzheimer's disease.

How to take

Adult dose

Adults: Administer 5 mg of Donepezil Hydrochloride once daily before bedtime. If unusual dreams, nightmares, or sleep disturbances occur, consider morning dosing of this medication. The concentration of Donepezil reaches a normal state 15 days post-initiation and the frequency of adverse reactions may be affected by dose titration speed; therefore, a dose of 5 mg should be maintained for 4-6 weeks. Clinical responses during this period will be evaluated for possible dose escalation up to 10 mg. Care should be taken with gastrointestinal adverse reactions when titrating to 10 mg daily. Gradual cessation of this medication may reduce its effects, but abrupt discontinuation does not typically cause rebound effects. For underweight women over 85 years of age: Close monitoring is required due to a higher incidence of adverse reactions. Underweight elderly women should not exceed a dose of 5 mg per day.

Child dose

Children: There is no experience in using this medication in children.

Precautions

This medication is used to alleviate symptoms of Alzheimer's disease, containing Donepezil Hydrochloride Monohydrate as the main ingredient. This medication should not be used by individuals who have allergies to certain ingredients, pregnant or breastfeeding women, and individuals with genetic lactose intolerance. Patients with heart disease or problems with heart rhythm, a history of peptic ulcers or currently taking non-steroidal anti-inflammatory drugs, and those with asthma or obstructive pulmonary disease should use this medication with caution. This medication can slow heart rate or cause arrhythmias, so careful monitoring of heart health is required. It may affect the gastrointestinal tract, potentially causing nausea, vomiting, diarrhea, and gastric ulcers; symptoms should be reported to healthcare professionals immediately. This medication can affect the central nervous system, potentially causing hallucinations, anxiety, insomnia, dizziness, seizures, and symptoms should be discussed with a professional if they occur. This medication may impact driving or machine operation abilities, so caution is necessary at the beginning of treatment or when changing doses. Interactions with other medications, particularly antibiotics, antidepressants, heart-related medications, and analgesics should be discussed with a doctor or pharmacist. It is generally advised not to take this medication during pregnancy or breastfeeding unless absolutely necessary, and under the guidance of a professional. Safety in children has not been confirmed, so it should not be used in pediatric patients. In the event of an overdose, symptoms may include nausea, vomiting, severe muscle weakness, and difficulty breathing; immediate medical assistance should be sought.

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, peeling skin, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory distress with cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • drowsiness
  • dizziness
  • insomnia
  • anxiety
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  • depression
  • hallucinations
  • excitement
  • aggressive behavior
  • tremors
  • gait disturbances
  • involuntary movements
  • decreased concentration
  • mental dullness
  • increased libido
  • hypersexuality
  • delusion
  • confusion
  • apathy
  • cough
  • pharyngitis
  • rhinitis
  • asthma
  • rash
  • itching
  • skin rashes
  • hives
  • facial flushing
  • fever
  • sweating
  • muscle pain
  • muscle cramps
  • urinary incontinence
  • frequent urination
  • urination disorders

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 and moisture exposure, preferably at room temperature between 1 to 30 degrees Celsius. Proper storage will maintain the medication's efficacy over time.

Appearance and packaging

Appearance

White round film-coated tablet

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

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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.