Barofezil Tablets 10 mg (Donepezil Hydrochloride Monohydrate)

Adult dose

For Donepezil Hydrochloride, take 5 mg once daily before bed. For 4 to 6 weeks, administer the 5 mg dose, and after evaluating clinical response, it can be increased to 10 mg. When increasing to 10 mg per day, caution should be exercised due to the potential for gastrointestinal side effects. For underweight women over 85 years old, the daily dose should not exceed 5 mg.

Child dose

There is no experience regarding the use in children.

This drug is used to treat symptoms of Alzheimer's type dementia with Donepezil Hydrochloride as the active ingredient. First, this medicine should not be administered to patients allergic to Donepezil Hydrochloride, piperidine derivatives, or any components of this product. Also, it is safe for pregnant women, those who may become pregnant, and breastfeeding women to avoid using this drug. Patients with heart diseases, especially those with sick sinus syndrome or cardiac conduction disorders, should use this drug cautiously as it may slow the heart rate or cause arrhythmias. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should exercise caution as there is a risk of worsening ulcers due to increased gastric acid secretion. Patients with a history of asthma or chronic obstructive pulmonary disease may experience worsening symptoms due to bronchoconstriction and increased mucus secretion; therefore, careful administration is required. Patients with extrapyramidal disorders such as Parkinson's disease should be careful as this drug can worsen symptoms. Serious adverse reactions such as fainting, bradycardia, heart block, gastrointestinal bleeding, liver function abnormalities, seizures, movement disorders, neuroleptic malignant syndrome, rhabdomyolysis, respiratory distress, acute pancreatitis, acute renal failure, and sudden death may occur while taking this drug; if any abnormal symptoms occur, discontinue use immediately and consult a healthcare professional. Common side effects include nausea, vomiting, diarrhea, loss of appetite, dizziness, and insomnia, and most are mild and temporary. Also, this drug may affect the heart rate, so regular ECG monitoring may be needed for patients with heart diseases. As a cholinesterase inhibitor, this drug can stimulate gastric acid secretion and gastrointestinal motility, so patients with a history of peptic ulcers should carefully monitor for symptom worsening. It may affect driving or machinery operation, so caution is needed at the initiation of treatment or during dose changes. This drug is metabolized by CYP3A4 and CYP2D6 enzymes, so when taken with drugs that inhibit or induce these enzymes, efficacy may change, requiring careful monitoring. Additionally, interactions may occur when used with other cholinergic or anticholinergic medications. It is best for pregnant or breastfeeding women to avoid this drug; if it must be used, breastfeeding should be discontinued. Safety for pediatric patients has not been established, and therefore it is not administered to them. In case of overdose, symptoms such as nausea, vomiting, bradycardia, hypotension, respiratory depression, and seizures may occur, necessitating immediate treatment at a medical facility, where antidotes such as atropine may be used. This drug should be stored out of reach of children and transferring to other containers is not advisable for maintaining quality.

Serious side effects

• Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor
• → Severe allergic reaction
• Severe rash with high fever, blisters, peeling skin, pain in mouth/eye mucous membranes
• → Severe skin adverse reaction
• Shortness of breath or difficulty breathing, asthma attacks, cough + fever accompanied by respiratory problems
• → Respiratory issues
• Yellowing of skin or eyes (jaundice), feeling very lethargic
• → Liver abnormalities (jaundice)

Mild side effects

• Nausea
• vomiting
• diarrhea
• loss of appetite
• dizziness
• headache
• fatigue
• insomnia
• drowsiness
• tremor

This drug should be stored in a tightly closed container that is not air-permeable, at a temperature between 1 and 30 degrees Celsius at room temperature. Storing it this way helps maintain the drug's effectiveness over time.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle