Teva Donepezil Oral Disintegrating Tablet 10 mg (Donepezil Hydrochloride Hydrate)

Adult dose

○ Adults : Administer 5 mg of donepezil hydrochloride once daily at bedtime. If sleep disturbances such as unusual dreams, nightmares, or insomnia occur, taking this medicine in the morning may be considered. Since donepezil reaches steady state 15 days after administration and the frequency of adverse reactions may be affected by the rate of dose escalation, administer the 5 mg dose for 4~6 weeks. After evaluating the clinical response during this period, the dose may be increased to 10 mg. When increasing the dose to 10 mg daily, administer with caution for gastrointestinal adverse reactions. When this medicine is discontinued, its effect gradually decreases, and no rebound effect occurs following abrupt discontinuation. This medicine is an orally disintegrating tablet. Place it on the tongue and allow it to dissolve; it may be taken with or without water. ○ Women aged 85 years or older with low body weight : Careful monitoring is required because adverse reactions occur frequently. Elderly women with low body weight should not exceed 5 mg daily.

Child dose

○ Children : There is no experience with use in children.

This medication is used to treat symptoms of Alzheimer's type dementia, with Donepezil Hydrochloride as its active ingredient. This medication should not be administered to patients who are allergic to Donepezil Hydrochloride or any components of this drug, women who are pregnant or may become pregnant, and nursing women. Patients with heart diseases or issues such as bradycardia and heart block should exercise caution when using this medication, and regular examinations of cardiac function are necessary. Patients taking non-steroidal anti-inflammatory drugs or those with a history of peptic ulcers should use this medication cautiously to prevent gastrointestinal bleeding or exacerbation of ulcers. Patients with asthma or obstructive pulmonary diseases should also be cautious, as this medication may worsen symptoms due to bronchoconstriction or increased mucus secretion. Patients with extrapyramidal disorders such as Parkinson's disease should administer this medication carefully, as it may exacerbate symptoms. Severe side effects such as fainting, arrhythmias, gastrointestinal bleeding, liver dysfunction, seizures, extrapyramidal disorder symptoms, neuroleptic malignant syndrome, rhabdomyolysis, respiratory distress, acute pancreatitis, acute renal failure, and sudden death have been reported. If these symptoms occur, the medication should be discontinued immediately and a healthcare provider should be consulted. Additionally, side effects such as nausea, vomiting, diarrhea, dizziness, insomnia, headache, fatigue, and loss of appetite may frequently occur, so symptoms should be closely monitored. This medication may affect liver and kidney function; therefore, regular blood tests and liver function tests may be necessary. Symptoms such as dizziness or drowsiness may occur while driving or operating machinery, so caution is advised. There may be interactions with other medications, especially those affecting the CYP3A4 or CYP2D6 enzymes, cardiac medications, anticholinergic drugs, and NSAIDs. Therefore, it is essential to inform healthcare providers about any other medications being taken. Pregnant or nursing women should avoid using this medication, and if necessary, should consult with a specialist before making a decision. Safety in children has not been established, so it should not be used in children. In cases of overdose, serious symptoms such as nausea, vomiting, bradycardia, hypotension, and respiratory depression may occur, requiring immediate emergency treatment. Atropine may be used as an antidote. This medication is taken as an oral disintegrating tablet, placed on the tongue to dissolve and then swallowed, and should be stored out of reach of children. It may discolor due to light exposure, so it is best to store it in its unopened packaging.

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

This medication should be stored in a tightly sealed container to protect it from air or moisture. Additionally, it is important to store it at room temperature, between 1 to 30 degrees Celsius, to maintain the medication's effectiveness.

Appearance

White to pale yellow round oral disintegrating tablet

Package unit

30 tablets (10 tablets/PTP X 3)