Medication info

Ocoscept Tablet 5 mg (Donepezil Hydrochloride Monohydrate)

Prescription medicationOrally disintegrating Tablet경구Expired
Ingredient · strength
Donepezil Hydrochloride Hydrate›5.22mg / 1 tablet
Manufacturer / importer
(주)오스코리아제약
Appearance
White round orally disintegrating tablet
Packaging
30 tablets/PTP [10 tablets/PTP packaging x 3]
Approval status
Expired

MFDS item code 202004233 · Approved 2020.06.04

This product's status changed to Expired on 2025.06.04. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of Alzheimer's type dementia symptoms
Who takes it
Adults
Adult dose
As donepezil hydrochloride, administer 5 mg once daily before bedtime. This medication is an orally disintegrating tablet that can be taken by placing it on the tongue to dissolve, with or without water.

Ingredients

Manufacturer
(주)오스코리아제약

Efficacy & effects

Improvement of Alzheimer's type dementia symptoms

  • Alzheimer's type dementia symptoms
View approved original text

This medication is used for improving Alzheimer's type dementia symptoms. It alleviates symptoms such as memory decline, cognitive dysfunction, and decreased ability to perform daily activities, thereby helping to enhance the quality of life for patients.

How to take

Adult dose

As donepezil hydrochloride, administer 5 mg once daily before bedtime. This medication is an orally disintegrating tablet that can be taken by placing it on the tongue to dissolve, with or without water.

Precautions

This medicine contains the artificial sweetener aspartame, which is broken down into phenylalanine in the body. Therefore, patients with the genetic disorder phenylketonuria should not take this medication. Patients allergic to the included donepezil hydrochloride, piperidine derivatives, or any other constituents of this medicine should not use it. Additionally, women who are pregnant or may become pregnant, as well as nursing mothers, should not take this medication. Patients with heart diseases, such as bradycardia or cardiac conduction disorders, should be cautious when using this medication, as it may affect heart rhythms. Patients with a history of peptic ulcers or those taking non-steroidal anti-inflammatory drugs should also be careful, as this medication may exacerbate gastrointestinal symptoms. Patients with a history of asthma or chronic obstructive pulmonary disease should use this medication with caution, as it may lead to bronchoconstriction or increased mucus production, worsening their symptoms. Patients with extrapyramidal disorders, such as Parkinson's disease, may also experience worsening symptoms from this medication. During the course of treatment, patients may experience cardiac-related adverse reactions such as fainting, bradycardia, heart block, or myocardial infarction, and should consult a doctor immediately if any symptoms arise. Additionally, there have been reports of peptic ulcers, liver dysfunction, cerebrovascular disorders, and neurological abnormal symptoms, so caution is warranted. This medication is used for treating dementia, and side effects such as nausea, vomiting, diarrhea, anorexia, dizziness, and insomnia can commonly occur during treatment. Most side effects are mild and transient, but if symptoms become severe, consulting a physician is recommended. This medication may cause arrhythmias or bradycardia in patients with cardiovascular diseases, making regular checks on heart condition necessary. Furthermore, this medication may increase gastric acid secretion, exacerbating peptic ulcers, so patients with a history of gastrointestinal diseases should take precautions. Pregnant women should avoid using this drug due to insufficient safety evidence; nursing mothers are also advised to discontinue breastfeeding due to the possibility of excretion in breast milk. Safety in children has not been established, so it is advisable to avoid use in this population. This medication may interact with other drugs, particularly heart medications, antibiotics, antidepressants, and should be taken with caution and consultation with a doctor. In cases of overdose, serious symptoms such as nausea, vomiting, bradycardia, and respiratory depression may occur, necessitating immediate medical attention. Atropine can be used as an antidote. When taking this medication, place it on your tongue to dissolve slowly, and store it in a place out of the reach of children. It is also advisable to avoid direct sunlight and keep it in its original packaging.

Side effects and when to seek care immediately

Serious side effects

Fainting, bradycardia, heart block, QT interval prolongation, myocardial infarction, heart failure, peptic ulcers, perforated duodenal perforation, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, cerebral seizures, epilepsy, cerebral hemorrhage, cerebrovascular disorders, extrapyramidal disorders (movement dysfunction, ataxia, dystonia, etc.), neuroleptic malignant syndrome, rhabdomyolysis, dyspnea, acute pancreatitis, acute renal failure, unexplained sudden death, cardiac arrest, ventricular fibrillation.

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • anorexia
  • headache
  • fatigue
  • dizziness
  • insomnia
  • anxiety
  • drowsiness
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  • muscle pain
  • rash
  • itching
  • increased blood pressure
  • edema
  • thrombocytopenia
  • anemia
  • urinary incontinence
  • frequent urination
  • urinary retention
  • constipation
  • abdominal pain
  • salivation
  • dysphagia
  • fecal incontinence
  • dehydration
  • hyperlipidemia
  • increased CPK
  • muscle cramps
  • hallucinations
  • agitation
  • aggressive behavior
  • mania
  • nightmares
  • tremors
  • gait disturbance
  • involuntary movements
  • decreased concentration.

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

Storage

This medication should be stored in an airtight container that allows for good ventilation, at a temperature between 1 to 30 degrees Celsius. Proper storage helps maintain the drug's efficacy.

Appearance and packaging

Appearance

White round orally disintegrating tablet

Package unit

30 tablets/PTP [10 tablets/PTP packaging x 3]

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.