Medication info
Beyacept Sublingual Tablet 5 mg (Donepezil Hydrochloride Monohydrate)

Beyacept Sublingual Tablet 5 mg (Donepezil Hydrochloride Monohydrate)

Prescription medicationOrally disintegrating Tablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›5.22mg / 1 tablet
Manufacturer / importer
대웅바이오(주)
Appearance
White circular orodispersible tablet
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Active

MFDS item code 201604538 · Approved 2016.07.22 · Insurance code 694001280

Summary

Main use
Improvement of symptoms of Alzheimer's type dementia
Who takes it
Adults
Adult dose
Administer 5 mg of donepezil hydrochloride once daily before bedtime. After maintaining the 5 mg dosage for 4 to 6 weeks, it may be increased to 10 mg based on clinical response. Caution should be exercised regarding gastrointestinal adverse reactions when increasing to 10 mg. The medication is an orodispersible tablet that can be placed on the tongue and swallowed with water or taken without water.

Ingredients

Manufacturer
대웅바이오(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 to alleviate the symptoms of Alzheimer's type dementia. It helps improve key symptoms such as memory decline and cognitive dysfunction, thereby enhancing the quality of daily life. It is also expected to assist patients' cognitive abilities and slow the progression of dementia. Overall, it is used to manage symptoms of Alzheimer's type dementia and maintain quality of life.

How to take

Adult dose

Administer 5 mg of donepezil hydrochloride once daily before bedtime. After maintaining the 5 mg dosage for 4 to 6 weeks, it may be increased to 10 mg based on clinical response. Caution should be exercised regarding gastrointestinal adverse reactions when increasing to 10 mg. The medication is an orodispersible tablet that can be placed on the tongue and swallowed with water or taken without water.

Precautions

This medication should not be administered to patients with a genetic disorder known as phenylketonuria. This is because it contains an artificial sweetener called aspartame, which is broken down into phenylalanine in the body. Patients with allergic reactions to any of the components in this medication or hypersensitivity to donepezil hydrochloride or piperidine derivatives should not use this medication. Pregnant or potentially pregnant women and nursing mothers should also avoid taking this medication. Patients with heart disease or cardiac conduction disorders should use this medication with caution, as it may slow the heart rate or cause arrhythmias. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should be cautious, as gastrointestinal symptoms may worsen with this medication. Individuals with asthma or obstructive lung disease should be careful, as there is a risk of bronchoconstriction and increased mucus secretion exacerbating symptoms. Patients with extrapyramidal disorders like Parkinson's disease should use this medication with caution, as it may worsen symptoms. Serious side effects such as arrhythmias, gastrointestinal bleeding, liver dysfunction, seizures, muscle abnormalities, respiratory distress, acute pancreatitis, acute renal failure, and sudden death may occur; any unusual symptoms should prompt immediate consultation with a doctor. Generally, this medication may have side effects like fatigue, dizziness, nausea, vomiting, diarrhea, insomnia, headache, and myalgia. Use in other forms of memory disturbances aside from dementia is not approved, and it should only be used under the supervision of a specialist for patients with Alzheimer's dementia. This medication may affect the heart, so patients with heart disease should have careful monitoring with an electrocardiogram. It may also affect driving or operating machinery, thus caution is needed when starting treatment or changing the dosage. Pregnant or nursing women are advised against using this medication unless absolutely necessary and should consult a specialist if required. The safety for pediatric use has not been established, thus it should generally not be used in children. This medication may interact with other drugs, so patients should inform their doctor or pharmacist of any medications they are currently taking. In case of overdose, severe nausea, vomiting, bradycardia, respiratory suppression, and seizures may occur, requiring immediate medical treatment. This medication should be placed on the tongue to dissolve and can be swallowed with saliva or water, keeping it out of reach of children. It is advised to store it unopened to prevent discoloration from light.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, high fever with severe rash, blisters, exfoliative dermatitis, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory distress accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urinary issues

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • insomnia
  • dizziness
  • drowsiness
  • myalgia
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  • urinary incontinence
  • rash
  • itching
  • thrombocytopenia
  • anxiety
  • aggressive behavior
  • tremors
  • gait disturbances
  • involuntary movements
  • decreased concentration
  • mental dullness
  • sweating
  • weight loss
  • dehydration
  • hyperlipidemia
  • hypotension
  • hypokalemia
  • hyponatremia
  • hematologic abnormalities
  • arthralgia
  • arthritis
  • muscle cramps
  • psoriasis
  • skin discoloration
  • urticaria
  • vesicular rash

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 and moisture, at room temperature between 1 and 30 degrees Celsius. By doing so, the efficacy of the medication can be maintained for a longer period.

Appearance and packaging

Appearance

White circular orodispersible tablet

Package unit

30 tablets (10 tablets/PTP 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.