Medication info
Dimensol 5 mg (Donepezil Hydrochloride Monohydrate)

Dimensol 5 mg (Donepezil Hydrochloride Monohydrate)

Prescription medicationTabletOral
Ingredient · strength
Donepezil Hydrochloride Monohydrate›5mg / 1 tablet
Manufacturer / importer
Dong Sung Pharmaceutical Co., Ltd.
Appearance
Yellow round film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201600584 · Approved 2016.01.28 · Insurance code 643202810

Summary

Main use
Treatment of symptoms of Alzheimer-type dementia
Who takes it
Adults · Children
Adult dose
○ Adults: Administer donepezil hydrochloride 5 mg once a day at bedtime. If sleep disturbances such as unusual dreams, nightmares, or insomnia occur, consider taking this medicine in the morning. Donepezil reaches steady state 15 days after administration, and the frequency of adverse reactions may be affected by the rate of dose escalation; therefore, administer a 5 mg dose for 4~6 weeks. After evaluating the clinical response during this period, the dose may be increased to 10 mg. When increasing the dose to 10 mg per day, administer with caution for gastrointestinal adverse reactions. After discontinuation of this medicine, the effect gradually decreases, and no rebound effect occurs following 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 per day.
Child dose
○ Children: There is no experience with use in children.

Ingredients

Manufacturer
Dong Sung Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of symptoms of Alzheimer-type dementia

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

This medication is used to improve memory decline and cognitive function in patients with Alzheimer's type dementia. It helps to maintain the patient's daily living abilities and slow the progression of symptoms.

How to take

Adult dose

○ Adults: Administer donepezil hydrochloride 5 mg once a day at bedtime. If sleep disturbances such as unusual dreams, nightmares, or insomnia occur, consider taking this medicine in the morning. Donepezil reaches steady state 15 days after administration, and the frequency of adverse reactions may be affected by the rate of dose escalation; therefore, administer a 5 mg dose for 4~6 weeks. After evaluating the clinical response during this period, the dose may be increased to 10 mg. When increasing the dose to 10 mg per day, administer with caution for gastrointestinal adverse reactions. After discontinuation of this medicine, the effect gradually decreases, and no rebound effect occurs following 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 per day.

Child dose

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

Precautions

This medication is used to relieve symptoms of Alzheimer's type dementia with the active ingredient Donepezil Hydrochloride. It should not be used in certain patients. For example, it should not be administered to individuals who are allergic to this medication or its ingredients, pregnant women or women of childbearing potential, breastfeeding women, and patients with lactose intolerance or genetic lactose metabolism disorders. Patients with heart disease or conduction disorders of the heart should be cautious, as bradycardia or arrhythmias may occur when using this medication. Additionally, patients with a history of peptic ulcer disease or those taking non-steroidal anti-inflammatory drugs should use it cautiously due to the risk of gastrointestinal issues worsening. Patients with a history of asthma or chronic obstructive pulmonary disease should also be careful as symptoms may worsen due to bronchoconstriction or increased mucus secretion. Patients with extrapyramidal diseases such as Parkinson's disease may be at risk for worsening symptoms. This medication contains the dye Yellow No. 5, so caution is advised in case of hypersensitivity to this dye. Serious side effects such as fainting, irregular heartbeat, gastrointestinal bleeding, liver dysfunction, cerebrovascular issues, movement disorders, neuroleptic malignant syndrome, muscle damage, respiratory distress, acute pancreatitis, acute renal failure, and unexplained sudden death may occur, so it is important to consult a doctor immediately if symptoms arise. Various mild side effects such as nausea, vomiting, diarrhea, decreased appetite, dizziness, insomnia, hallucinations, anxiety, depression, aggressive behavior, urinary disorders, rash, itching, muscle pain, incontinence, fever, swelling, thrombocytopenia, anemia, dehydration, hypertension, hypotension, palpitations, hyperlipidemia, weight loss, weight gain, dental pain, pain, blood disorders, psychiatric symptoms, movement disorders, and digestive system symptoms may also occur. Regular evaluation of therapeutic effects and side effects is necessary while taking this medication, and if there is no effect or severe side effects, discontinuation may be considered. Patients with a history of heart disease or arrhythmias should have regular ECG tests to monitor heart condition. Since this medication is metabolized in the liver, caution is necessary in patients with impaired liver function, and interactions with other drugs may occur, so it is important to inform healthcare providers about any medications being taken. It is advisable to avoid using this medication during pregnancy or breastfeeding, unless necessary, and in such cases, consultation with a healthcare professional should be conducted. Safety in children has not been established, so it should not be used in pediatric patients. In case of overdose, symptoms such as nausea, vomiting, severe muscle weakness, and respiratory distress may occur, and appropriate medical treatment should be sought immediately. This medication should be kept out of reach of children and not transferred to other containers.

Side effects

  • Syncope
  • bradycardia
  • heart block
  • QT interval prolongation
  • myocardial infarction
  • heart failure
  • peptic ulcer
  • perforated duodenal ulcer
  • gastrointestinal bleeding
  • hepatitis
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  • liver function impairment
  • jaundice
  • cerebral seizures
  • cerebral hemorrhage
  • cerebrovascular disorders
  • motor function disorders
  • ataxia
  • movement disorders
  • dystonia
  • tremors
  • involuntary movements
  • gait disturbances
  • abnormal posture
  • speech disorders
  • akinetic mutism
  • severe muscle rigidity
  • dysphagia
  • tachycardia
  • blood pressure fluctuations
  • sweating
  • myalgia
  • weakness
  • dyspnea
  • acute pancreatitis
  • acute renal failure
  • unexplained sudden death
  • cold
  • loss of appetite
  • hallucinations
  • agitation
  • aggressive behavior
  • anxiety
  • insomnia
  • drowsiness
  • increased libido
  • talkativeness
  • mania
  • nightmares
  • nervousness
  • nonsense
  • delusions
  • depression
  • confusion
  • apathy
  • hyperactivity
  • increased sexual desire (libido)
  • hypersexuality
  • dizziness
  • tremors
  • seizures
  • coma
  • chest wall rigidity
  • palpitations
  • sinoatrial block
  • atrioventricular block
  • hypertension
  • hypotension
  • atrial fibrillation
  • torsades de pointes
  • QT interval prolongation on ECG
  • diarrhea
  • nausea
  • vomiting
  • abdominal disturbances
  • gastric and duodenal ulcer
  • constipation
  • saliva secretion
  • fecal incontinence
  • liver disorders including hepatitis
  • rash
  • itching
  • muscle cramps
  • urinary incontinence
  • polyuria
  • urinary retention
  • headache
  • fatigue
  • pain
  • toothache
  • facial flushing
  • lethargy
  • asthenia
  • edema
  • fever
  • hypothermia
  • decreased hematocrit
  • leukopenia
  • anemia
  • thrombocytopenia
  • petechiae
  • abnormal dreams
  • decreased appetite
  • urinary tract infection
  • increased CPK
  • dehydration
  • hyperlipidemia
  • insomnia
  • hostility
  • irritability
  • drowsiness
  • depression
  • confusion
  • emotional instability
  • personality disorders
  • eczema
  • urinary incontinence
  • abdominal pain
  • weakness
  • fungal infections
  • influenza-like illness
  • allergies
  • soft tissue infections
  • lethargy
  • sepsis
  • facial swelling
  • hernia
  • hypotension
  • bradycardia
  • abnormal ECG
  • heart failure
  • myocardial infarction
  • angina pectoris
  • atrial fibrillation
  • congestive heart failure
  • peripheral vascular disease
  • supraventricular extrasystoles
  • ventricular extrasystoles
  • cardiac hypertrophy
  • constipation
  • gastroenteritis
  • fecal incontinence
  • dyspepsia
  • increased γ-GT
  • gastritis
  • dysphagia
  • periodontitis
  • gastric ulcer
  • periodontal abscess
  • abdominal bloating
  • abnormal liver function
  • belching
  • esophagitis
  • anal bleeding
  • diabetes
  • anemia
  • leukocytosis
  • weight loss
  • peripheral edema
  • edema
  • increased LDH
  • increased alkaline phosphatase
  • hypercholesterolemia
  • hypokalemia
  • hypoglycemia
  • weight gain
  • hyperbilirubinemia
  • increased BUN
  • vitamin B12 deficiency anemia
  • cachexia
  • increased creatinine
  • gout
  • hyponatremia
  • hypoalbuminemia
  • iron deficiency anemia
  • increased AST
  • increased ALT
  • arthritis
  • arthrosis
  • bone fracture
  • arthralgia
  • leg cramps
  • osteoporosis
  • myalgia
  • agitation
  • anxiety
  • convulsions
  • psychosis
  • gait abnormalities
  • emotional flatness
  • delusions
  • dream disturbances
  • cerebrovascular abnormalities
  • increased salivation
  • ataxia
  • abnormal euphoria
  • vasodilation
  • cerebral hemorrhage
  • cerebral infarction
  • cerebral ischemia
  • dementia
  • extrapyramidal symptoms
  • generalized tonic-clonic seizures
  • hemiplegia
  • hypertonia
  • decreased physical activity
  • pharyngitis
  • pneumonia
  • increased cough
  • bronchitis
  • dyspnea
  • rhinitis
  • asthma
  • rash
  • skin ulcer
  • itching
  • psoriasis
  • skin discoloration
  • shingles
  • dry skin
  • sweating
  • urticaria
  • vesicular rash
  • conjunctivitis
  • glaucoma
  • visual disturbances
  • ear pain
  • tear abnormalities
  • urinary tract infection
  • cystitis
  • hematuria
  • diabetes
  • vaginitis
  • urinary disorders
  • polyuria
  • proteinuria
  • abdominal pain
  • agitation
  • cholecystitis
  • confusion
  • convulsions
  • hallucinations
  • heart block
  • hemolytic anemia
  • hepatitis
  • 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 that is airtight, at a temperature between 1 to 30 degrees Celsius. Storing it this way will help to maintain the effectiveness of the medication for a long time.

Appearance and packaging

Appearance

Yellow round film-coated tablets

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.