Medication info
Uniphez Tablets 10 mg (Donepezil Hydrochloride Monohydrate)

Uniphez Tablets 10 mg (Donepezil Hydrochloride Monohydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›10mg / 1 tablet
Manufacturer / importer
구주제약(주)
Appearance
Yellow round film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201803011 · Approved 2018.07.20 · Insurance code 669805060

Summary

Main use
Improvement of Alzheimer's dementia symptoms
Who takes it
Adults · Children
Adult dose
Administer 5 mg of Donepezil Hydrochloride once daily before sleep. During the first 4 to 6 weeks, the 5 mg dose should be given, after which clinical response can be evaluated for possible dose escalation to 10 mg. When increasing the dose to 10 mg daily, special attention should be paid to gastrointestinal side effects.
Child dose
There is no experience with the use in children.

Ingredients

Manufacturer
구주제약(주)

Efficacy & effects

Improvement of Alzheimer's dementia symptoms

  • Symptoms of Alzheimer's dementia
View approved original text

This medication is used to treat symptoms of Alzheimer's dementia. It helps improve memory decline, cognitive dysfunction, and difficulties in daily life, thereby enhancing the quality of life for patients.

How to take

Adult dose

Administer 5 mg of Donepezil Hydrochloride once daily before sleep. During the first 4 to 6 weeks, the 5 mg dose should be given, after which clinical response can be evaluated for possible dose escalation to 10 mg. When increasing the dose to 10 mg daily, special attention should be paid to gastrointestinal side effects.

Child dose

There is no experience with the use in children.

Precautions

This medication contains Donepezil Hydrochloride Monohydrate as the main ingredient and is used to treat symptoms of Alzheimer's dementia. It should not be used in certain patients. For example, patients who have had an allergic reaction or hypersensitivity to this medication or Donepezil Hydrochloride, or to piperidine derivatives, pregnant women or those who may become pregnant, and breastfeeding women should not take this medication. Additionally, this medication contains lactose, so it should not be administered to patients with genetic metabolic disorders such as lactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. Patients with heart conditions, such as bradycardia or atrioventricular block, should be cautious as this medication may pose a risk of bradycardia or arrhythmias. Patients currently taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should be cautious with this medication as it can increase gastric acid secretion and gastrointestinal motility, potentially worsening ulcer symptoms. Patients with a history of asthma or obstructive pulmonary diseases should also be careful as this medication may cause bronchoconstriction or increased mucus secretion, worsening symptoms. Patients with extrapyramidal disorders, such as Parkinson's disease, may experience worsened symptoms due to cholinergic stimulation from this medication, thus careful administration is required. This medication contains Tartrazine (Yellow No. 5), and patients with allergies or hypersensitivity to this ingredient should exercise caution. Reported side effects include heart-related issues (syncope, bradycardia, heart block, myocardial infarction, etc.), gastrointestinal issues (peptic ulcers, gastrointestinal bleeding, etc.), liver dysfunction, brain-related issues (seizures, cerebral hemorrhage, etc.), movement disorders, difficulty breathing, pancreatitis, renal failure, and sudden death. Generally common side effects may include nausea, vomiting, diarrhea, loss of appetite, dizziness, insomnia, headache, and fatigue, most of which are mild and temporary. This medication may affect the cardiovascular system, and an electrocardiogram may be necessary in patients with a history of prolonged QT intervals or arrhythmias. Treatment of dementia must be conducted under the diagnosis and supervision of a specialist, and if there is no treatment effect or if side effects are severe, treatment should be discontinued. This medication may affect driving or operating machinery, so caution is required after administration. Pregnant or breastfeeding women should avoid this medication, and if necessary, should make a decision after consulting with a specialist. This medication may interact with several drugs, so if you are taking other medications, it is essential to inform your healthcare provider, particularly when used in conjunction with heart medications, antibiotics, antidepressants, or antipsychotics. In case of overdose, symptoms such as nausea, vomiting, bradycardia, hypotension, respiratory depression, and seizures may occur, and immediate medical attention should be sought. This medication should be stored out of reach of children and should not be transferred to other containers for safety.

Side effects and when to seek care immediately

Serious side effects

Syncope, bradycardia, heart block, QT interval prolongation, myocardial infarction, heart failure, peptic ulcers, perforated duodenal perforation, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, seizures, cerebral hemorrhage, cerebrovascular disorders, extrapyramidal disorders (movement dysfunction, ataxia, dyskinesia, etc.), neuroleptic malignant syndrome, rhabdomyolysis, difficulty breathing, acute pancreatitis, acute renal failure, unexplained sudden death, cardiac arrest, seizures, chest pain

Mild side effects

Nausea, vomiting, diarrhea, loss of appetite, headache, fatigue, dizziness, insomnia, drowsiness, muscle pain, rash, itching, elevated blood pressure, edema, fever, nightmares, hallucinations, agitation, aggressive behavior, anxiety, mania, nervousness, nonsensical speech, delusions, depression, confusion, apathy, hyperactivity, increased libido, talkativeness, decreased concentration, mental dullness, hematologic abnormalities (anemia, leukopenia, thrombocytopenia, etc.), cold, 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. Additionally, it is recommended to store it at room temperature between 1 to 30 degrees Celsius. Proper storage helps maintain the medication's effectiveness and ensures safe use.

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.