Newsept Sublingual Tablet 10 mg (Donepezil Hydrochloride Monohydrate)

Adult dosage

Administer 5 mg once daily before bedtime. During the first 4-6 weeks, administer 5 mg. After assessing clinical response during this period, the dose may be increased to 10 mg. When increasing to 10 mg, caution is required for gastrointestinal adverse reactions. This medication is a sublingual tablet that can be placed on the tongue and swallowed with water or taken dry.

This medication contains Donepezil Hydrochloride Monohydrate as its main ingredient and is primarily used for the treatment of symptoms of Alzheimer's-type dementia. This medication should not be administered to certain patients. For example, patients with allergies to this medication or its components, pregnant women or those who may become pregnant, and breastfeeding women should not take this medication. Patients with heart disease, particularly those with bradycardia or heart conduction disorders, should use this medication with caution since it can slow the heart rate or cause arrhythmias. Patients with a history of peptic ulcers or those taking non-steroidal anti-inflammatory drugs should be cautious due to the potential risk of gastrointestinal bleeding or worsening of ulcers. Patients with asthma or chronic obstructive pulmonary disease should also be careful, as respiratory symptoms may worsen upon taking this medication. Patients with extrapyramidal disorders, such as Parkinson's disease, may experience worsening symptoms with this medication, thus should be closely monitored. Severe side effects might occur while taking this medication, such as fainting, cardiac abnormalities, gastrointestinal bleeding, liver dysfunction, seizures, and movement disorders. If any of these symptoms occur, consultation with the healthcare provider is necessary immediately. In addition, this medication can cause relatively common side effects such as drowsiness, dizziness, nausea, vomiting, diarrhea, loss of appetite, headache, fatigue, etc. This medication can induce heart conduction abnormalities; therefore, patients with heart-related conditions or those taking QT interval prolonging medications may require regular electrocardiogram monitoring. It is recommended that pregnant or breastfeeding women avoid this medication, and if absolutely necessary, consult a healthcare professional. The safety of this medication in pediatric patients has not been established, thus it is not used in children. Additionally, this medication may interact with other drugs, so if the patient is taking any other medications, they should inform their doctor or pharmacist. Caution is needed when driving or operating machinery, especially at the beginning of treatment or after a dosage change, as dizziness or drowsiness may occur. In cases of overdose, severe nausea, vomiting, respiratory depression, and convulsions may occur; immediate medical treatment is necessary. When taken as a sublingual tablet, dissolve it under the tongue and store it in individual packaging away from children and protected from light to avoid discoloration.

Serious side effects

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

Mild side effects

• Headache
• dizziness
• insomnia
• drowsiness
• fatigue
• myalgia
• nausea
• vomiting
• diarrhea
• decreased appetite

This medication should be stored in a tightly sealed container to prevent air from entering and should be kept at room temperature, between 1 and 30 degrees Celsius. Storing it this way helps maintain its effectiveness for a longer period.

Appearance

Yellow round orally disintegrating tablet

Package unit

30 tablets (10 tablets/PTP packaging x 3)