Medication info
Alzepil Tablets 10mg (Donepezil Hydrochloride Monohydrate)

Alzepil Tablets 10mg (Donepezil Hydrochloride Monohydrate)

Prescription medicationTabletOral
Ingredient · strength
Donepezil Hydrochloride Monohydrate›10mg / 1 tablet
Manufacturer / importer
HuTechs Pharmaceutical Co., Ltd.
Appearance
Yellow round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201405466 · Approved 2014.11.24 · Insurance code 649102530

Summary

Main use
Treatment of symptoms of Alzheimer-type dementia
Who takes it
Adults · Children
Adult dose
○ Adults: Administer 5 mg of donepezil hydrochloride once daily at bedtime. If sleep disturbances such as abnormal dreams, nightmares, or insomnia occur, taking this medicine in the morning may be considered. Since donepezil concentrations reach steady state after 15 days of administration and the incidence of adverse reactions may be affected by the rate of dose escalation, maintain the 5 mg dose for 4~6 weeks. After assessing the clinical response during this period, the dose may be increased to 10 mg. When increasing the dose to 10 mg daily, administer with caution for gastrointestinal adverse reactions. If treatment with this medicine is discontinued, its effects gradually diminish; no rebound effect occurs with abrupt discontinuation. ○ Women aged 85 years and older with low body weight: Adverse reactions occur more frequently, so careful monitoring is required. Older women with low body weight should not exceed 5 mg daily.
Child dose
○ Children: There is no experience with use in children.

Ingredients

Manufacturer
HuTechs Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of symptoms of Alzheimer-type dementia

  • Symptoms of Alzheimer's dementia
View approved original text

This medication is used for the treatment of symptoms of Alzheimer's dementia. It helps alleviate symptoms caused by Alzheimer's disease, such as memory loss, cognitive impairment, and decreased ability to perform daily activities, and improves the overall quality of life of patients.

How to take

Adult dose

○ Adults: Administer 5 mg of donepezil hydrochloride once daily at bedtime. If sleep disturbances such as abnormal dreams, nightmares, or insomnia occur, taking this medicine in the morning may be considered. Since donepezil concentrations reach steady state after 15 days of administration and the incidence of adverse reactions may be affected by the rate of dose escalation, maintain the 5 mg dose for 4~6 weeks. After assessing the clinical response during this period, the dose may be increased to 10 mg. When increasing the dose to 10 mg daily, administer with caution for gastrointestinal adverse reactions. If treatment with this medicine is discontinued, its effects gradually diminish; no rebound effect occurs with abrupt discontinuation. ○ Women aged 85 years and older with low body weight: Adverse reactions occur more frequently, so careful monitoring is required. Older women with low body weight should not exceed 5 mg daily.

Child dose

○ Children: There is no experience with use in children.

Precautions

This medicine contains the ingredient donepezil hydrochloride and is primarily used for the treatment of symptoms of Alzheimer's dementia. First, this medication should not be used in certain patients. For example, individuals with an allergy to this medication or its ingredients, pregnant women or women who may become pregnant, and nursing mothers should not take this medication. Also, patients with genetic lactose metabolism issues should avoid this medication. Patients with heart disease or heart conduction disorders, those with a history of peptic ulcers or who are taking non-steroidal anti-inflammatory drugs, patients with asthma or a history of obstructive pulmonary disease, and patients with extrapyramidal disorders such as Parkinson's disease should exercise caution when using this medication. People allergic to Yellow No. 4 (Tartrazine) included in this medication should also use it cautiously. Possible side effects that can occur while taking this medication include heart-related problems (bradycardia, heart block, myocardial infarction, etc.), gastrointestinal issues (peptic ulcers, gastrointestinal bleeding), liver function abnormalities, brain-related problems (cerebral hemorrhage, seizures), motor function disorders, respiratory distress, acute pancreatitis, acute renal failure, and sudden death. Common side effects include nausea, vomiting, diarrhea, dizziness, insomnia, loss of appetite, and may rarely include serious neurological symptoms. This medication can particularly affect the heart, potentially causing bradycardia or arrhythmias, so patients with heart conditions should have regular electrocardiographic examinations. Additionally, it may burden the gastrointestinal system, so patients with a history of peptic ulcers should carefully monitor their symptoms. Caution is required when driving or operating machinery due to potential side effects such as fatigue, dizziness, and muscle cramps resulting from this medication. This medication may interact with other drugs, so it is essential to consult with a doctor or pharmacist, especially when taken in combination with specific antibiotics, antidepressants, antiarrhythmics, heart-related medications, and other cholinergic drugs. Pregnant or nursing women are advised not to use this medication and should consult a specialist before use if absolutely necessary. Safety for children has not been established, so it should not be used in pediatric patients. In cases of overdose, severe nausea, vomiting, sweating, bradycardia, hypotension, respiratory distress, and seizures may occur, and immediate medical attention should be sought. Finally, this medication should be stored out of reach of children and kept in its original packaging.

Side effects

  • Syncope
  • bradycardia
  • heart block
  • QT interval prolongation
  • myocardial infarction
  • heart failure
  • peptic ulcer
  • perforated duodenal perforation
  • gastrointestinal bleeding
  • hepatitis
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  • liver dysfunction
  • jaundice
  • cerebral convulsions
  • cerebral hemorrhage
  • cerebrovascular disorders
  • motor function disorders
  • ataxia
  • movement disorders
  • muscle tone disorders
  • tremors
  • involuntary movements
  • gait disturbances
  • abnormal posture
  • speech disorders
  • catatonic mutism
  • extreme muscle rigidity
  • dysphagia
  • tachycardia
  • blood pressure fluctuation
  • sweating
  • rhabdomyolysis
  • myalgia
  • weakness
  • dyspnea
  • acute pancreatitis
  • acute kidney failure
  • unexplained sudden death
  • cold
  • decreased appetite
  • hallucinations
  • agitation
  • aggressive behavior
  • anxiety disorder
  • insomnia
  • drowsiness
  • increased libido
  • excessive talking
  • mania
  • nightmares
  • neuroticism
  • nonsense
  • delusions
  • depression
  • confusion
  • apathy
  • hyperactivity
  • increased libido
  • hypersexuality
  • dizziness
  • tremors
  • convulsions
  • stupor
  • chest rigidity
  • bradycardia
  • palpitations
  • sinoatrial block
  • atrioventricular block
  • hypertension
  • hypotension
  • atrial fibrillation
  • torsades de pointes
  • ECG QT interval prolongation
  • diarrhea
  • nausea
  • vomiting
  • abdominal disorders
  • gastrointestinal bleeding
  • gastric and duodenal ulcers
  • constipation
  • salivation
  • dysphagia
  • fecal incontinence
  • rash
  • pruritus
  • muscle cramps
  • myalgia
  • urinary incontinence
  • frequent urination
  • urinary retention
  • headache
  • fatigue
  • pain
  • toothache
  • facial flushing
  • malaise
  • lethargy
  • edema
  • fever
  • decreased body temperature
  • decreased hematocrit
  • leukopenia
  • anemia
  • thrombocytopenia
  • petechiae
  • abnormal dreams
  • thinking
  • headache
  • pain
  • back pain
  • fever
  • chest pain
  • hypertension
  • bleeding
  • syncope
  • constipation
  • gastroenteritis
  • fecal incontinence
  • dyspepsia
  • increased γ-GT
  • gastritis
  • dysphagia
  • periodontitis
  • gastric ulcer
  • periodontal abscess
  • abdominal bloating
  • liver dysfunction
  • belching
  • esophagitis
  • rectal bleeding
  • diabetes
  • anemia
  • leukocytosis
  • weight loss
  • peripheral edema
  • edema
  • increased LDH
  • increased alkaline phosphatase
  • hypercholesterolemia
  • hypokalemia
  • hypoglycemia
  • weight gain
  • hyperbilirubinemia
  • increased BUN
  • B12 deficiency anemia
  • cachexia
  • increased creatinine
  • gout
  • hyponatremia
  • hypoalbuminemia
  • iron deficiency anemia
  • increased AST
  • increased ALT
  • arthritis
  • arthropathy
  • bone fracture
  • arthralgia
  • leg cramps
  • osteoporosis
  • myalgia
  • restlessness
  • anxiety
  • tremors
  • convulsions
  • transient mental disturbance
  • gait abnormality
  • flat affect
  • dizziness
  • delusions
  • dream anomalies
  • cerebrovascular abnormalities
  • increased salivation
  • ataxia
  • euphoric states
  • vasodilation
  • cerebral hemorrhage
  • cerebral infarction
  • cerebral ischemia
  • dementia
  • extrapyramidal symptoms
  • grand mal seizures
  • hemiplegia
  • hypertonicity
  • hypokinesia
  • pharyngitis
  • pneumonia
  • increased cough
  • bronchitis
  • respiratory distress
  • rhinitis
  • asthma
  • rash
  • skin ulcers
  • itching
  • psoriasis
  • skin discoloration
  • herpes zoster
  • dry skin
  • sweating
  • urticaria
  • vesicular rash
  • conjunctivitis
  • glaucoma
  • visual disturbances
  • ear pain
  • tear abnormalities
  • urinary tract infection
  • cystitis
  • hematuria
  • diabetes
  • vaginitis
  • urination disorders
  • frequent urination
  • proteinuria
  • abdominal pain
  • restlessness
  • cholecystitis
  • confusion
  • convulsions
  • hallucinations
  • heart block
  • hemolytic anemia
  • hyponatremia
  • neuroleptic malignant syndrome
  • pancreatitis
  • 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 protect it from air and moisture, and it is safe to store at room temperature between 1°C and 30°C. Storing it this way helps maintain the efficacy of the medication and prevents deterioration.

Appearance and packaging

Appearance

Yellow round film-coated tablets

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.