Samsung Donepezil Tablet 5 mg (Donepezil Hydrochloride Monohydrate)

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. For 4-6 weeks, administer the 5 mg dose; thereafter, the dose can be increased to 10 mg based on clinical response. When increasing to 10 mg per day, take caution regarding gastrointestinal adverse reactions. In underweight female patients aged 85 and over, the dosage must not exceed 5 mg per day and requires careful monitoring.

Child dose

No experience in children.

This medication contains Donepezil Hydrochloride as its active ingredient and is used for the treatment of Alzheimer's disease symptoms. First, this medication should not be administered to patients allergic to Donepezil Hydrochloride or any components of this medication, to pregnant women or those who might become pregnant, and to nursing women. In patients with heart-related diseases, such as sick sinus syndrome or cardiac conduction disorders, this medication may stimulate the vagus nerve, causing bradycardia or arrhythmias; therefore, it should be administered with caution. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should be cautious as this medication may increase gastric acid secretion and gastrointestinal motility, potentially worsening ulcer symptoms. Patients with a history of asthma or obstructive pulmonary disease should be careful as this medication may increase bronchial smooth muscle contraction and mucus secretion, worsening symptoms. Additionally, patients with extrapyramidal disorders, such as Parkinson's disease, should use this medication cautiously, as it may stimulate cholinergic nerves, potentially worsening symptoms. This medication contains Yellow No. 5 dye, so caution is advised in patients with allergies or hypersensitivity to this substance. During the use of this medication, serious adverse reactions such as syncope, bradycardia, heart block, gastrointestinal bleeding, liver dysfunction, seizures, movement disorders, neuroleptic malignant syndrome, rhabdomyolysis, respiratory distress, acute pancreatitis, acute renal failure, and unexplained sudden death may occur; therefore, if any symptoms appear, consult a doctor immediately. Additionally, various mild adverse reactions such as nausea, vomiting, diarrhea, dizziness, insomnia, hallucinations, anxiety, myalgia, rash, etc., have also been reported, so these symptoms should be monitored closely. This medication is only approved for use in Alzheimer's disease and should not be used for other forms of dementia or memory disorders. Patients with a history of heart disease or prolonged QT interval may need an ECG due to the risk of cardiac arrhythmias. This medication is primarily metabolized by the liver, so patients with impaired liver function should be cautious, and any medications being taken should be disclosed, as there may be interactions with other drugs. In particular, caution should be taken as the effects of this medication may increase or decrease when combined with drugs affecting CYP3A4 and CYP2D6 enzymes. Pregnant or nursing women are advised to avoid this medication; if necessary, nursing may be discontinued under a doctor's direction. Safety in children is not established, and it is advisable not to use it in this population. In cases of overdose, symptoms such as nausea, vomiting, bradycardia, hypotension, respiratory depression, and seizures can occur, and immediate medical attention should be sought. This medication should be stored out of reach of children, and transferring it to other containers may lead to quality degradation or accidents; therefore, care should be taken.

Serious side effects

• Syncope
• bradycardia
• heart block
• QT interval prolongation
• myocardial infarction
• heart failure
• peptic ulcer
• perforated duodenal ulcer
• gastrointestinal bleeding
• hepatitis

Mild side effects

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

This medication should be stored in a tightly closed container to prevent air or moisture from entering. It is advisable to maintain the storage temperature between 1 and 30 degrees Celsius.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle