TDI-cept Tablet 5 mg (Donepezil Hydrochloride Monohydrate)

Adult dose

○ Adults: Administer donepezil hydrochloride 5 mg once daily at bedtime. If sleep disturbances such as abnormal dreams, nightmares, or insomnia occur, taking this medicine in the morning may be considered. Since donepezil concentrations reach steady state 15 days after administration and the frequency of adverse reactions may be affected by the rate of dose increase, 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 treatment with this medicine is discontinued, its effect gradually decreases, and no rebound effect occurs with abrupt discontinuation. ○ Women aged 85 years or older with low body weight: Careful monitoring is necessary because adverse reactions occur more 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 medicine contains donepezil hydrochloride and is primarily used to treat symptoms of Alzheimer's disease. First, this medicine should not be used by certain patients. For example, individuals who are allergic to this medicine or its ingredients, pregnant women or those who may become pregnant, nursing mothers, and individuals with a genetic lactose intolerance should not take this medicine. Additionally, those with heart disease, a history of peptic ulcers, those currently taking non-steroidal anti-inflammatory drugs, individuals with a history of asthma or obstructive pulmonary disease, and those with extrapyramidal disorders such as Parkinson's disease should use this medicine with caution. In particular, this medicine contains a coloring agent known as Tartrazine, and individuals allergic to this component should be cautious. While taking this medicine, various side effects may occur. Commonly experienced symptoms include nausea, vomiting, diarrhea, loss of appetite, dizziness, and insomnia. Rarely, heart-related issues, liver function abnormalities, severe allergic reactions, seizures, and muscle-related symptoms may occur, so immediate consultation with a physician is necessary if severe or unusual symptoms arise. This medicine can affect heart rate, so patients with heart disease or a history of QT interval prolongation should monitor their condition through electrocardiogram tests while using it. Additionally, this medicine increases gastric acid secretion and promotes gastrointestinal motility, so individuals with peptic ulcers or those taking anti-inflammatory medications should periodically check their gastrointestinal health. It may affect driving or operating machinery, so caution is advised during the initial stages of use or when dose changes occur. Pregnant or nursing women should not take this medicine and must consult a healthcare professional if administration is necessary. This medicine can interact with various other medications, so if you are taking other medicines, you must inform your doctor or pharmacist. Caution is especially needed when taking it with heart-affecting drugs, antibiotics, antidepressants, and antipsychotic medications. In case of overdose, severe nausea, vomiting, muscle weakness, and breathing difficulties may occur; thus, immediate medical attention should be sought, and atropine can be used as an antidote. Lastly, this medicine should be stored out of the reach of children, and it is safe not to transfer it to other containers.

• Syncope
• bradycardia
• heart block
• QT interval prolongation
• myocardial infarction
• heart failure
• peptic ulcer
• perforation of the duodenum
• gastrointestinal bleeding
• hepatitis

This medicine should be stored in a tightly sealed container to prevent air or moisture intrusion. The storage temperature should be maintained between 1 and 30 degrees Celsius.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle