Aroset Tablets 5 mg (Donepezil Hydrochloride Monohydrate)

Adult dose

As donepezil hydrochloride, administer 5 mg once daily before bedtime. If unusual dreams, nightmares, or insomnia occur, morning dosing can be considered. Normal levels are reached 15 days after administration, so maintain the 5 mg dose for 4 to 6 weeks. After assessing clinical responses during this period, the dose may be increased up to 10 mg. If increasing the dosage to 10 mg daily, careful monitoring for gastrointestinal adverse reactions is necessary.

Child dose

There is no experience of use in pediatric patients.

This drug contains donepezil hydrochloride as its main ingredient and is used to treat symptoms of Alzheimer’s dementia. This drug should not be administered to certain patients. For example, individuals allergic to this medication or its components, women who are pregnant or may become pregnant, and patients with a genetic inability to digest lactose should not take this drug. Patients with heart disease or issues with cardiac conduction should use this drug cautiously as it may present heart-related side effects such as bradycardia or arrhythmia. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcer disease should be closely monitored for symptoms since gastrointestinal bleeding or ulcer aggravation may occur while taking this drug. Patients with a history of asthma or obstructive lung disease should be cautious as respiratory symptoms may worsen with this medication. Patients with extrapyramidal disorders like Parkinson's disease should also use this medication cautiously as its cholinergic effect may worsen symptoms. This drug contains a dye called Yellow No. 5, so patients allergic to it should take careful precautions. This medication can produce various adverse reactions, including cardiac issues (syncope, bradycardia, heart block), gastrointestinal bleeding, liver dysfunction, intracerebral hemorrhage, seizures, muscle symptoms, dyspnea, acute pancreatitis, acute kidney failure, and sudden death. Common side effects may include nausea, vomiting, diarrhea, dizziness, insomnia, loss of appetite, hallucinations, agitation, aggressive behavior, anxiety, somnolence, increased libido, hyperactivity, nightmares, irritability, delirium, delusions, depression, confusion, apathy, excessive motor activity, increased sexual desire (libido), hypersexuality, dizziness, insomnia, tremors, delirium, palpitations, hypertension, hypotension, atrial fibrillation, diarrhea, nausea, vomiting, abdominal disturbance, constipation, salivation, dysphagia, fecal incontinence, rash, itching, muscle pain. This medication is only approved for use in Alzheimer’s dementia and should not be used for other forms of dementia or memory disorders. Treatment should be conducted under the supervision and diagnosis of a specialist, and changes in medication and their effects should be regularly evaluated. Patients with heart disease or a history of QT interval prolongation may require an electrocardiogram. This drug may affect driving or operating machinery, so caution is needed when initiating therapy or adjusting dosages. It is recommended that women who are pregnant or breastfeeding avoid using this medication. If absolutely necessary, they should consult with a healthcare professional. This drug can interact with other medications, particularly those affecting the CYP3A4 or CYP2D6 enzymes, so caution should be exercised when used in combination. In case of overdose, symptoms such as nausea, vomiting, bradycardia, hypotension, and seizures may occur, and atropine can be used as an antidote. This medication's safety has not been established for children, so it should not be used in pediatric patients. When storing this medication, keep it in a sealed container to prevent air or moisture ingress, and it is best to store at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the medication's efficacy over time.

Serious side effects

Syncope, bradycardia, heart block, QT interval prolongation, myocardial infarction, heart failure, peptic ulcer, perforating duodenal perforation, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, cerebral seizures, intracerebral hemorrhage, cerebrovascular disorders, extrapyramidal disorders, neuroleptic malignant syndrome, rhabdomyolysis, dyspnea, acute pancreatitis, acute kidney failure, sudden death of unknown cause, severe allergic reactions (urticaria, severe swelling (edema), chest tightness).

Mild side effects

• Loss of appetite
• hallucinations
• agitation
• aggressive behavior
• anxiety
• insomnia
• drowsiness
• increased libido
• hyperactivity
• nightmares

This drug should be stored in a sealed container to protect it from air and moisture, and it's best to keep it at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the medication's efficacy for a longer period.

Appearance

Yellow, round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle