Medication info
Donezin Tablets (Donepezil Hydrochloride Hydrate)

Donezin Tablets (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›5mg / 1 tablet
Manufacturer / importer
(주)하원제약
Appearance
White round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201603159 · Approved 2016.06.01 · Insurance code 651503780

Summary

Main use
Improvement of symptoms associated with Alzheimer's dementia
Who takes it
Adults · Children
Adult dose
For adults: Administer 5 mg of donepezil hydrochloride once daily before bedtime. For 4 to 6 weeks, the dosage of 5 mg should be maintained, and after evaluating the clinical response, it can be increased to 10 mg. When increasing to 10 mg per day, caution should be taken regarding gastrointestinal adverse reactions. Women over 85 years of age with low body weight should not exceed 5 mg daily and require careful monitoring.
Child dose
For pediatric use: There is no experience regarding the use in children.

Ingredients

Manufacturer
(주)하원제약

Efficacy & effects

Improvement of symptoms associated with Alzheimer's dementia

  • Symptoms of Alzheimer's dementia
View approved original text

This medication is used for the treatment of symptoms associated with Alzheimer's dementia.

How to take

Adult dose

For adults: Administer 5 mg of donepezil hydrochloride once daily before bedtime. For 4 to 6 weeks, the dosage of 5 mg should be maintained, and after evaluating the clinical response, it can be increased to 10 mg. When increasing to 10 mg per day, caution should be taken regarding gastrointestinal adverse reactions. Women over 85 years of age with low body weight should not exceed 5 mg daily and require careful monitoring.

Child dose

For pediatric use: There is no experience regarding the use in children.

Precautions

This medication contains donepezil hydrochloride as the active ingredient and is used for the improvement of symptoms associated with Alzheimer's dementia. Individuals who are allergic to donepezil hydrochloride, piperidine derivatives, or any other ingredients of this medication should not take it. Women who are pregnant, may become pregnant, or are breastfeeding should also avoid taking this medication. Since this medication contains lactose, it should not be used in patients with lactose intolerance or congenital lactose metabolism disorders. Patients with heart disease or heart conduction disorders should be cautious as this medication may cause bradycardia or arrhythmia. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should take it with caution due to the possibility of gastrointestinal bleeding or exacerbation of ulcers. Patients with a history of asthma or obstructive pulmonary disease should also be careful as respiratory symptoms may worsen upon taking this medication. Patients with Parkinson's disease or similar extrapyramidal disorders may experience worsening of symptoms, so vigilance is necessary. Serious side effects reported include syncope, heart problems, gastrointestinal bleeding, liver dysfunction, cerebrovascular disorders, muscle abnormalities, respiratory distress, acute pancreatitis, acute renal failure, and sudden death. Milder side effects that may occur include nausea, vomiting, diarrhea, dizziness, insomnia, hallucinations, aggressive behavior, bradycardia, palpitations, rash, muscle pain, urinary incontinence, headache, and fatigue. This medication is not approved for other forms of dementia or memory disorders other than Alzheimer's disease, and it should be administered under the diagnosis and supervision of a specialist. During treatment, the patient's condition should be regularly evaluated, and if there is no effect, discontinuation should be considered. This medication can affect the heart, so patients with heart disease require monitoring, including an electrocardiogram. Patients with gastrointestinal diseases should carefully observe for worsening gastrointestinal symptoms. As it may affect driving or operating machinery, caution is needed during the initial dosing or when the dosage is changed. This medication is metabolized by CYP3A4 and CYP2D6 enzymes, so care should be taken regarding drug interactions when taken with medications that inhibit or induce these enzymes. Caution is also required when combined with other neuromuscular blockers or cholinergic drugs. Pregnant women are advised not to take this medication, and breastfeeding women should also avoid it. If it is essential, breastfeeding should be discontinued. Safety in children has not been established, so use is not recommended. In the event of overdose, symptoms such as nausea, vomiting, bradycardia, hypotension, respiratory depression, and seizures may occur, and immediate medical attention is required. In case of overdose, antidotes like atropine may be used. This medication should be kept out of the reach of children, and transferring it to another container is not recommended to maintain quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, peeling skin, pain in mouth/eyes mucosa, shortness of breath or difficulty breathing, asthma attacks, coughing with fever accompanied by respiratory abnormalities, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, lightning headaches, seizures, altered consciousness, visual disturbances, paralysis, urination problems

Mild side effects

Loss of appetite, hallucinations, agitation, aggressive behavior, anxiety, insomnia, drowsiness, increased libido, talkativeness, mania, nightmares, nervousness, mumbling, delusions, depression, confusion, apathy, hyperactivity, increased libido, excessive libido, dizziness, tremor, mental confusion, palpitations, hypertension, hypotension, atrial fibrillation, diarrhea, nausea, vomiting, abdominal disturbances (including abdominal pain), constipation, salivation, swallowing difficulties, fecal incontinence

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 and moisture infiltration. The storage temperature should be maintained between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness.

Appearance and packaging

Appearance

White 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.

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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.