Ocoscept Fast-Dissolving Tablet 10 mg (Donepezil Hydrochloride)

Adult dose

Administer 5 mg once daily before bedtime as donepezil hydrochloride. For 4 to 6 weeks, administer the 5 mg dose. After evaluating the clinical response during this period, the dose may be increased to 10 mg. When increasing to 10 mg per day, caution for gastrointestinal adverse effects should be exercised. This medication is to be administered as a fast-dissolving tablet that can be taken by placing it on the tongue to dissolve or taken without water.

This medication contains aspartame, an artificial sweetener that is metabolized into phenylalanine in the body, and should not be used by patients with phenylketonuria. Patients with allergies to any components of this medication or hypersensitivity to donepezil hydrochloride or piperidine derivatives, pregnant women or those who may become pregnant, and breastfeeding women should not take this medication. Caution should be exercised in patients with heart disease, as this medication may stimulate the vagus nerve, potentially causing bradycardia or arrhythmia. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should be cautious, as increased gastric acid secretion and gastrointestinal motility could exacerbate symptoms. Patients with a history of asthma or obstructive lung disease should be careful, as bronchoconstriction and increased mucus secretion could worsen symptoms. Patients with Parkinson's disease or extrapyramidal disorders may be at risk of exacerbation of symptoms due to stimulation of cholinergic nerves by this medication. This medication contains Yellow No. 4 (Tartrazine), so patients with allergic reactions to this ingredient should use it with caution. During treatment with this medication, symptoms such as syncope, bradycardia, heart block, and myocardial infarction may occur due to cardiovascular-related adverse reactions, so immediate consultation with a physician is required if symptoms arise. There have been reports of gastrointestinal bleeding, peptic ulcers, hepatic dysfunction, cerebral hemorrhage, seizures, extrapyramidal disorder symptoms, neuroleptic malignant syndrome, rhabdomyolysis, respiratory distress, acute pancreatitis, acute renal failure, and unexplained sudden death; caution is required. This medication is used for the treatment of Alzheimer's type dementia, and the therapeutic effect should be evaluated regularly, and discontinuation should be considered if there is no efficacy. Patients with cardiovascular disease or a history of QT interval prolongation may need ECG monitoring due to the risk of cardiac arrhythmias. This medication may affect driving or the ability to operate machinery, so care should be taken during initial doses or dosage adjustments. Pregnant women should not use it unless absolutely necessary, and breastfeeding women are advised to discontinue breastfeeding while taking this medication. This medication is metabolized by the CYP3A4 and CYP2D6 enzymes, so be cautious of drug interactions with medications that inhibit or induce these enzymes. In case of overdose, symptoms such as nausea, vomiting, sweating, bradycardia, hypotension, respiratory depression, and seizures may occur, and antidotes such as atropine may be needed. This medication, when administered as a fast-dissolving tablet, should be placed on the tongue to dissolve and taken with saliva or water, and should be stored out of reach of children and maintained in its packaging to avoid discoloration from light exposure.

Serious side effects

Syncope, bradycardia, heart block, QT interval prolongation, myocardial infarction, heart failure, peptic ulcer, perforated duodenal perforation, gastrointestinal bleeding, hepatitis, hepatic dysfunction, jaundice, cerebral seizures, cerebral hemorrhage, cerebrovascular disorders, extrapyramidal disorders (motor dysfunction, ataxia, abnormal muscle tone, etc.), neuroleptic malignant syndrome, rhabdomyolysis, respiratory distress, acute pancreatitis, acute renal failure, sudden death, cardiac arrest, asthma attack, respiratory distress, severe

Mild side effects

• Headache
• dizziness
• diarrhea
• vomiting
• reduced appetite
• insomnia
• drowsiness
• muscle pain
• rash
• itching

This medication should be stored in a tightly sealed container to prevent air entry, ideally at room temperature between 1°C and 30°C. Proper storage will help maintain efficacy and prevent degradation.

Appearance

Yellow round fast-dissolving tablet

Package unit

30 tablets/PTP [10 tablets/PTP pack x 3]