Medication info
Ocoscept 10mg (Donepezil Hydrochloride Monohydrate)

Ocoscept 10mg (Donepezil Hydrochloride Monohydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›10mg / 1 tablet
Manufacturer / importer
(주)오스코리아제약
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201502704 · Approved 2015.04.30 · Insurance code 629700530

Summary

Main use
Improvement of Alzheimer's dementia symptoms
Who takes it
Adults · Children
Adult dose
Adults: Administer donepezil hydrochloride at a dose of 5 mg once daily before bedtime. For the first 4 to 6 weeks, administer 5 mg. After evaluating clinical response during this period, it can be increased to 10 mg. When increasing the dose to 10 mg once daily, be cautious of gastrointestinal adverse reactions. Women aged 85 and older who are underweight should not exceed 5 mg per day.
Child dose
Pediatric use: There is no experience with pediatric patients.

Ingredients

Manufacturer
(주)오스코리아제약

Efficacy & effects

Improvement of Alzheimer's dementia symptoms

  • Alzheimer's dementia symptoms
View approved original text

This medication is used for the treatment of symptoms associated with Alzheimer's dementia. It alleviates symptoms such as memory decline and cognitive dysfunction, helping patients maintain daily activities more smoothly. It is effective in slowing the progression of dementia symptoms and improving cognitive abilities, thereby contributing to an improved quality of life for patients and their families.

How to take

Adult dose

Adults: Administer donepezil hydrochloride at a dose of 5 mg once daily before bedtime. For the first 4 to 6 weeks, administer 5 mg. After evaluating clinical response during this period, it can be increased to 10 mg. When increasing the dose to 10 mg once daily, be cautious of gastrointestinal adverse reactions. Women aged 85 and older who are underweight should not exceed 5 mg per day.

Child dose

Pediatric use: There is no experience with pediatric patients.

Precautions

This medication contains Donepezil Hydrochloride Monohydrate as the main ingredient and is used in the treatment of Alzheimer's dementia symptoms. Before taking this medication, individuals who are allergic to Donepezil Hydrochloride, piperidine derivatives, or any other components of this medication should not take it. Pregnant women, women who may become pregnant, and breastfeeding women should also preferably avoid using this medication. Additionally, patients with certain genetic conditions such as lactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should avoid taking it. Patients with heart disease or cardiac conduction disorders should be cautious as this medication may stimulate the vagus nerve, potentially causing bradycardia or arrhythmias. Patients currently on non-steroidal anti-inflammatory medications or those with a history of peptic ulcers should use this medication with caution due to possible increased gastric acid secretion worsening symptoms. Patients with asthma or chronic obstructive pulmonary disease may experience worsened symptoms due to bronchoconstriction and increased mucus secretion. Patients with extrapyramidal disorders such as Parkinson’s disease are at risk of exacerbated symptoms. Additionally, this medication contains Yellow No. 5 dye, which should be used with caution in individuals with allergies to it. If any serious adverse symptoms such as fainting, heart problems, gastrointestinal bleeding, liver dysfunction, seizures, movement disorders, or difficulty breathing occur while taking this medication, discontinue its use immediately and consult a healthcare professional. Generally, mild side effects like nausea, vomiting, diarrhea, dizziness, insomnia, and loss of appetite may occur, most of which are transient. This medication is not approved for the treatment of other forms of dementia aside from Alzheimer's disease, so it should be taken under the management of a qualified physician after a precise diagnosis. Patients with heart disease or electrolyte abnormalities may require an electrocardiogram due to the risk of arrhythmias. Caution is advised when driving or operating machinery, especially at the beginning of treatment or after a dosage change, as fatigue, dizziness, and muscle cramps may occur. Since this medication is primarily metabolized in the liver, patients with reduced liver function should also be cautious, and potential drug interactions should be disclosed to the healthcare provider. Pregnant or breastfeeding women should avoid using this medication unless absolutely necessary, in which case breastfeeding should be discontinued. Safety in pediatric patients has not been established, thus it should not be used in this population. Overdose may lead to symptoms such as nausea, vomiting, bradycardia, respiratory depression, and seizures, necessitating immediate medical attention, with atropine as an antidote. This medication should be stored out of the reach of children, and it is safest not to transfer it to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, pain in the oral/eye mucous membranes, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough + fever, jaundice (yellowing of skin or eyes), profound lethargy, sudden and severe headaches, thunderclap headaches, seizures, disorientation, visual disturbances, paralysis, urination

Mild side effects

  • Headache
  • dizziness
  • fatigue
  • drowsiness
  • insomnia
  • loss of appetite
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
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  • fever
  • muscle pain
  • muscle cramps
  • elevated blood pressure
  • sweating
  • skin rash
  • itching
  • abnormal dreams
  • anxiety
  • aggressive behavior
  • hallucinations
  • delirium
  • delusions
  • depression
  • confusion
  • lethargy
  • drowsiness
  • increased libido
  • urinary incontinence
  • frequent urination
  • urination difficulties
  • thrombocytopenia
  • anemia
  • leukopenia
  • thrombocytopenia
  • petechial bleeding
  • dehydration
  • muscle 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 exposure to air or moisture. Additionally, it is recommended to keep it at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow 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

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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.