Medication info
Alsept 5mg (Donepezil Hydrochloride Monohydrate)

Alsept 5mg (Donepezil Hydrochloride Monohydrate)

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

MFDS item code 200706330 · Notified 2007.06.01 · Insurance code 656001240

Summary

Main use
Improvement of symptoms associated with Alzheimer's-type dementia
Who takes it
Adults · Children
Adult dose
Donepezil hydrochloride should be administered at a dose of 5 mg once daily before bedtime. If disturbing dreams, nightmares, or insomnia occur, morning administration should be considered. After administering 5 mg for 4-6 weeks and evaluating the clinical response, the dosage may be increased up to 10 mg. When increasing to 10 mg, caution should be exercised for gastrointestinal adverse reactions. Women aged 85 and over with low body weight should not exceed a daily dose of 5 mg.
Child dose
There is no experience of use in pediatric patients.

Ingredients

Manufacturer
알리코제약(주)

Efficacy & effects

Improvement of symptoms associated with Alzheimer's-type dementia

  • Symptoms of Alzheimer's-type dementia
View approved original text

This medication is used to treat symptoms of Alzheimer's-type dementia. It helps alleviate dementia-related symptoms such as memory decline and cognitive function impairment, allowing the affected individuals to carry out daily activities more smoothly.

How to take

Adult dose

Donepezil hydrochloride should be administered at a dose of 5 mg once daily before bedtime. If disturbing dreams, nightmares, or insomnia occur, morning administration should be considered. After administering 5 mg for 4-6 weeks and evaluating the clinical response, the dosage may be increased up to 10 mg. When increasing to 10 mg, caution should be exercised for gastrointestinal adverse reactions. Women aged 85 and over with low body weight should not exceed a daily dose of 5 mg.

Child dose

There is no experience of use in pediatric patients.

Precautions

This medication should not be used by patients who are allergic to specific ingredients or have a hypersensitivity to donepezil hydrochloride or piperidine derivatives. Women who are pregnant, may become pregnant, or are breastfeeding should not take this medication. Additionally, this medication contains lactose; therefore, patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take it. Patients with heart disease or those with sick sinus syndrome, atrial and ventricular conduction disorders should be cautious, as bradycardia or arrhythmias may occur when using this medication. Patients taking non-steroidal anti-inflammatory analgesics or those with a history of peptic ulcers should use this drug carefully, as it may increase gastric acid secretion and gastrointestinal motility, worsening symptoms. Patients with a history of asthma or obstructive lung disease should take care since bronchoconstriction and increased mucus secretion may aggravate their condition. Patients with extrapyramidal disorders such as Parkinson's disease should also be cautious due to the possibility of worsening symptoms, and patients allergic to Yellow No. 5 should exercise caution. This medication may cause various serious side effects such as cardiac arrhythmias, peptic ulcers, liver dysfunction, cerebrovascular issues, and movement disorders. If you experience any unusual symptoms, discontinue use and consult a physician immediately. Common side effects such as nausea, vomiting, diarrhea, dizziness, insomnia, hallucinations, bradycardia, rash, and others have also been reported, so observe closely for any symptom occurrences. This medication is used to treat Alzheimer's-type dementia and is not approved for use in other forms of dementia or memory disorders. Treatment should begin under the supervision of an experienced physician, with regular evaluations to assess efficacy. If no apparent effect is observed, discontinuation should be considered. Patients with heart disease may require an ECG as this medication can potentially induce bradycardia or heart block. Patients with gastrointestinal diseases should monitor for possible exacerbation of peptic ulcers and should check urination status due to possible bladder dysfunction. Asthma patients and those with lung diseases should also exercise caution due to the potential for exacerbation of symptoms. This medication may affect driving or operating machinery, so be careful during the initial stages of use or when changing dosages. Pregnant or breastfeeding women should avoid this medication unless absolutely necessary, in which case discontinuation of breastfeeding is recommended. Safety in children has not been established, so it is best not to use it in pediatric patients. This medication may interact with enzymes involved in liver metabolism, so caution is required when taken with certain antibiotics, antidepressants, or antiarrhythmics, and discuss with a physician or pharmacist when combining with other medications. In case of overdose, severe nausea, vomiting, bradycardia, hypotension, convulsions, and respiratory distress may occur; thus, immediate medical attention should be sought for appropriate treatment. This medication should be stored out of the reach of children, and transferring it to another container should be avoided as it may degrade quality or pose an accident risk.

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, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, etc.

Mild side effects

  • Headache
  • dizziness
  • nausea
  • vomiting
  • diarrhea
  • insomnia
  • fatigue
  • loss of appetite
  • rash
  • itching
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  • myalgia
  • urinary incontinence
  • frequent urination
  • edema
  • drowsiness
  • elevated blood pressure
  • weight loss
  • anxiety
  • hallucinations
  • aggressive behavior
  • tremors
  • gait disturbances
  • involuntary movements
  • decreased concentration
  • mental dullness
  • lethargy
  • sweating
  • skin rash
  • talkativeness
  • increased libido
  • mania
  • delusions
  • depression
  • confusion
  • disorientation
  • fatigue
  • pain
  • dental pain
  • facial pain.

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 and 30 degrees Celsius. Storing the medication this way helps maintain its efficacy and safety.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

30 tablets per 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.