Medication info
Fene Tablet 5 mg (Donepezil Hydrochloride Monohydrate)

Fene Tablet 5 mg (Donepezil Hydrochloride Monohydrate)

Prescription medicationTabletOral
Ingredient · strength
Donepezil Hydrochloride Monohydrate›5.215mg / 1 tablet
Manufacturer / importer
IQUR Co., Ltd.
Appearance
Yellow round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201603920 · Approved 2016.06.24 · Insurance code 674401300

Summary

Main use
Treatment of symptoms of Alzheimer-type dementia
Who takes it
Adults · Children
Adult dose
○ Adults: Administer donepezil hydrochloride 5 mg 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 15 days after administration and the incidence of adverse reactions may be affected by the rate of dose escalation, administer the 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 daily, administer with caution for gastrointestinal adverse reactions. When treatment with this medicine is discontinued, its effect gradually diminishes; no rebound effect occurs with abrupt discontinuation. ○ Female patients aged 85 years or older with low body weight: Careful monitoring is necessary because adverse reactions occur more frequently. Elderly women with low body weight should not exceed 5 mg daily.
Child dose
○ Children: There is no experience with use in children.

Ingredients

Manufacturer
IQUR 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 for the treatment of symptoms of Alzheimer's type dementia. It helps improve memory decline and cognitive dysfunction caused by dementia, thus assisting the patient's daily life.

How to take

Adult dose

○ Adults: Administer donepezil hydrochloride 5 mg 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 15 days after administration and the incidence of adverse reactions may be affected by the rate of dose escalation, administer the 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 daily, administer with caution for gastrointestinal adverse reactions. When treatment with this medicine is discontinued, its effect gradually diminishes; no rebound effect occurs with abrupt discontinuation. ○ Female patients aged 85 years or older with low body weight: Careful monitoring is necessary because adverse reactions occur more frequently. Elderly women with low body weight should not exceed 5 mg daily.

Child dose

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

Precautions

This medication contains the ingredient donepezil hydrochloride and is used for treating Alzheimer's type dementia symptoms. First, this medication should not be administered to certain patients. For example, individuals who are allergic to this medication or its components, women who are pregnant or may become pregnant, women who are breastfeeding, and individuals with lactose intolerance or specific genetic metabolic disorders should avoid taking this medication. Furthermore, 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 obstructive lung disease history, patients with extrapyramidal disorders such as Parkinson's disease, and those allergic to certain dyes contained in this medication should use it with caution. Various side effects may occur when taking this medication. Cardiac-related issues may include bradycardia, heart block, myocardial infarction, while gastrointestinal problems may include exacerbation of peptic ulcers, gastrointestinal bleeding, nausea, vomiting, and diarrhea. Neurological cases have reported hallucinations, anxiety, insomnia, seizures, and musculoskeletal issues such as muscle pain or rhabdomyolysis should also be monitored. This medication may affect the cardiovascular system, so patients with a history of heart disease may require regular electrocardiograms. Additionally, it may promote gastric acid secretion, increasing the risk of exacerbating peptic ulcers, thus caution regarding gastric health is advised. It may also impact driving or machinery operation abilities, so care is needed in the initial intake or upon dosage changes. Women who are pregnant or breastfeeding are advised against using this medication unless necessary; in such cases, consultation with a healthcare professional is recommended. This medication may interact with various drugs, so consulting a doctor or pharmacist is crucial if other medications are being taken, especially when taken with medications affecting the heart, antibiotics, antidepressants, or antipsychotics. In cases of overdose, severe symptoms such as nausea, vomiting, bradycardia, or respiratory depression may occur, and immediate medical attention is needed. Lastly, this medication should be kept out of reach of children, and it is advisable to avoid transferring it to another container.

Side effects

  • Syncope
  • bradycardia
  • heart block
  • prolonged QT interval
  • myocardial infarction
  • heart failure
  • peptic ulcer
  • perforated duodenal perforation
  • gastrointestinal bleeding
  • hepatitis
Show 261 more
  • hepatic dysfunction
  • jaundice
  • cerebral seizure
  • epilepsy
  • convulsions
  • cerebral hemorrhage
  • cerebrovascular disorders
  • motor function impairment
  • ataxia
  • movement disorders
  • dystonia
  • tremor
  • involuntary movements
  • gait disturbance
  • abnormal posture
  • speech disorder
  • akinetic mutism
  • extreme muscle rigidity
  • dysphagia
  • tachycardia
  • blood pressure fluctuations
  • sweating
  • myoglobinuria
  • renal dysfunction
  • rhabdomyolysis
  • myalgia
  • weakness
  • increased CK in blood and urine
  • dyspnea
  • acute pancreatitis
  • acute renal failure
  • sudden death
  • cold
  • loss of appetite
  • hallucination
  • agitation
  • aggressive behavior
  • anxiety disorder
  • insomnia
  • drowsiness
  • increased libido
  • talkativeness
  • mania
  • nightmares
  • hypersensitivity
  • delirium
  • delusion
  • depression
  • confusion
  • apathy
  • hyperactivity
  • increased sexual desire
  • hypersexuality
  • dizziness
  • tremor
  • seizure
  • stupor
  • thoracic rigidity
  • bradycardia
  • palpitations
  • sinoatrial block
  • atrioventricular block
  • hypertension
  • hypotension
  • atrial fibrillation
  • torsades de pointes
  • prolonged QT interval in ECG
  • diarrhea
  • nausea
  • vomiting
  • abdominal disorder
  • gastrointestinal bleeding
  • gastric and duodenal ulcer
  • constipation
  • salivation
  • fecal incontinence
  • liver dysfunction including hepatitis
  • rash
  • itching
  • 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
  • accidents
  • back pain
  • chest pain
  • bleeding
  • 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
  • malaise
  • sepsis
  • facial edema
  • hernia
  • hypotension
  • abnormal ECG
  • heart failure
  • myocardial infarction
  • angina pectoris
  • atrial fibrillation
  • congestive heart failure
  • peripheral vascular disease
  • supraventricular ectopic beats
  • ventricular ectopic beats
  • cardiac hypertrophy
  • constipation
  • gastroenteritis
  • fecal incontinence
  • dyspepsia
  • increased γ-GT
  • gastritis
  • dysphagia
  • periodontitis
  • gastric ulcer
  • periodontal abscess
  • abdominal distension
  • 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
  • B12 deficiency anemia
  • cachexia
  • increased creatinine
  • gout
  • hyponatremia
  • hypoproteinemia
  • iron deficiency anemia
  • increased AST
  • increased ALT
  • arthritis
  • arthrosis
  • bone fracture
  • arthralgia
  • leg cramps
  • osteoporosis
  • myalgia
  • restlessness
  • anxiety
  • convulsions
  • transient psychosis
  • gait abnormalities
  • apathy
  • delusion
  • dream abnormalities
  • cerebrovascular abnormalities
  • increased salivation
  • ataxic syndrome
  • euphoric state
  • vasodilation
  • cerebral hemorrhage
  • cerebral infarction
  • cerebral ischemia
  • dementia
  • extrapyramidal symptoms
  • generalized tonic-clonic seizures
  • hemiplegia
  • excessive tension
  • reduced movement
  • pharyngitis
  • pneumonia
  • increased cough
  • bronchitis
  • dyspnea
  • rhinitis
  • asthma
  • rash
  • skin ulcer
  • itching
  • psoriasis
  • skin discoloration
  • herpes zoster
  • dry skin
  • sweating
  • urticaria
  • vesicular rash
  • conjunctivitis
  • glaucoma
  • visual disturbances
  • ear pain
  • tear abnormalities
  • urinary tract infections
  • cystitis
  • hematuria
  • diabetes
  • vaginitis
  • urination disorders
  • frequent urination
  • proteinuria
  • abdominal pain
  • restlessness
  • cholecystitis
  • confusion
  • convulsions
  • hallucination
  • heart block
  • hemolytic anemia
  • hepatitis
  • hyponatremia
  • neuroleptic malignant syndrome
  • pancreatitis
  • rash
  • nausea
  • vomiting
  • excessive salivation
  • sweating
  • hypotension
  • respiratory depression
  • weakness
  • convulsions
  • muscle weakness symptoms
  • respiratory muscle relaxation
  • miosis
  • fibrous fasciculation
  • decreased body surface temperature

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

Storage

This medication should be stored in a tightly closed container to prevent air or moisture ingress and should be kept at a temperature between 1°C and 30°C (33.8°F to 86°F). Storing it this way helps maintain the medication’s efficacy and prevent 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.