Medication info

Dorisep Tablet 23 mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›24mg / 1 tablet
Manufacturer / importer
(주)일화
Appearance
Red, biconvex, round film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202102899 · Approved 2021.04.05

Summary

Main use
Treatment of moderate to severe Alzheimer's type dementia symptoms
Who takes it
Adults
Adult dose
This medication should be taken once daily just before bedtime, and it can be administered without regard to meals. The initial recommended dose of Donepezil Hydrochloride is 5 mg once daily. After 15 days, a steady state is reached, and 5 mg should be administered for 4 to 6 weeks. After clinical response evaluation, the dosage may be increased up to 10 mg, and 23 mg may be administered once daily after at least 3 months of 10 mg treatment. Do not split, crush, or chew upon administration.

Ingredients

Manufacturer
(주)일화

Efficacy & effects

Treatment of moderate to severe Alzheimer's type dementia symptoms

  • Moderate Alzheimer's type dementia symptoms
  • severe Alzheimer's type dementia symptoms
View approved original text

This medication is used for the treatment of moderate to severe Alzheimer's type dementia symptoms.

How to take

Adult dose

This medication should be taken once daily just before bedtime, and it can be administered without regard to meals. The initial recommended dose of Donepezil Hydrochloride is 5 mg once daily. After 15 days, a steady state is reached, and 5 mg should be administered for 4 to 6 weeks. After clinical response evaluation, the dosage may be increased up to 10 mg, and 23 mg may be administered once daily after at least 3 months of 10 mg treatment. Do not split, crush, or chew upon administration.

Precautions

This medication contains Donepezil Hydrochloride Hydrate as the active ingredient and is used for the treatment of Alzheimer's type dementia. Firstly, this medication should not be used in individuals who are allergic to Donepezil, piperidine derivatives, or any other components of this medication. Women who are pregnant or may become pregnant, as well as nursing mothers, should not take this medication. Additionally, individuals with lactose intolerance or specific genetic lactose metabolism disorders should also avoid this medication. Those with heart conditions should exercise caution when taking this medication, as it may cause bradycardia or arrhythmias, leading to heart rhythm problems. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should use this medication carefully, as it may exacerbate gastrointestinal issues. Individuals with asthma or obstructive pulmonary disease should be cautious, as symptoms may worsen due to bronchoconstriction and increased mucus production. Patients with extrapyramidal disorders such as Parkinson's disease may also face an increased risk of worsening symptoms. This medication contains Yellow No. 4 (tartrazine), so individuals allergic to this ingredient should exercise caution. Taking this medication can result in severe side effects such as fainting, heart problems, gastrointestinal bleeding, liver dysfunction, seizures, movement disorders, muscle issues, respiratory difficulties, acute pancreatitis, acute renal failure, and sudden death, so immediate medical consultation is required if any unusual symptoms occur. Various other side effects may include nausea, vomiting, diarrhea, loss of appetite, dizziness, insomnia, hallucinations, aggressive behavior, tremors, gait disturbances, involuntary movements, weakened concentration, mental dullness, increased blood pressure, weight loss, muscle pain, urinary incontinence, urinary disorders, fecal incontinence, blood count changes (e.g., leukopenia, anemia, thrombocytopenia), rashes, itching, eczema, sweating, facial flushing, toothache, dehydration, and hives. Special caution is required for patients with heart disease, liver dysfunction, gastrointestinal diseases, or kidney issues, and regular monitoring and examinations by a physician are necessary during treatment. Pregnant and nursing women should avoid this medication, and even in essential cases, a careful decision should be made after consulting with an expert. This medication is not used in children as its safety has not been established. This medication may interact with other drugs, so especially when taken with heart-related medications, antibiotics, antidepressants, anticonvulsants, and anti-inflammatory drugs, consultation with a physician or pharmacist is necessary. In the case of overdose, dangerous symptoms such as nausea, vomiting, decreased heart rate, hypotension, and respiratory depression may occur, requiring immediate treatment at a medical facility, with atropine potentially used as an antidote. Finally, this medication should be kept out of reach of children, and it is advisable to avoid transferring it to other containers.

Side effects and when to seek care immediately

Serious side effects

Fainting, bradycardia, heart block, QT interval prolongation, myocardial infarction, heart failure, peptic ulcers, perforated duodenal ulcer, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, cerebral convulsions, cerebral hemorrhage, cerebrovascular disorders, severe extrapyramidal disorders, neuroleptic malignant syndrome, rhabdomyolysis, respiratory distress, acute pancreatitis, acute renal failure, unexplained sudden death, cardiac arrest, severe allergic reactions (hives, severe swelling

Mild side effects

Nausea, vomiting, diarrhea, loss of appetite, headache, fatigue, lethargy, dizziness, insomnia, drowsiness, anxiety, hallucinations, agitation, aggressive behavior, tremors, gait disturbances, involuntary movements, decreased concentration, mental dullness, elevated blood pressure, weight loss, muscle pain, urinary incontinence, urinary disorders, fecal incontinence, blood count changes (e.g., leukopenia, anemia, thrombocytopenia), rash, itching, eczema, sweating, facial flushing, toothache, dehydration, hives,

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 air and moisture from entering. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius to preserve the efficacy of the medication.

Appearance and packaging

Appearance

Red, biconvex, 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.