Donepezil Hydrochloride 5 mg Tablets

Adult dose

As Donepezil Hydrochloride, it is administered at a dose of 5 mg once daily before bedtime. For the first 4 to 6 weeks, maintain the 5 mg dose, and thereafter, the dosage may be increased up to 10 mg based on clinical response. When increasing to a daily dose of 10 mg, care should be taken regarding gastrointestinal adverse reactions. Women over 85 years old with low body weight should not exceed 5 mg daily and require careful monitoring.

Child dose

There is no experience with the use in pediatrics.

This medication is used to improve symptoms of Alzheimer-type dementia and contains Donepezil Hydrochloride. Firstly, this medication should not be used by individuals allergic to Donepezil Hydrochloride or any components of this medication, pregnant women or those who may become pregnant, breastfeeding women, and those with lactose intolerance or specific inherited metabolic disorders. Individuals with heart disease or heart conduction disorders should be cautious as this medication may cause bradycardia or arrhythmias during use. Caution is advised for those taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers due to the possibility of gastrointestinal bleeding or exacerbation of ulcers. Individuals with a history of asthma or obstructive pulmonary disease may experience worsening of their symptoms due to bronchoconstriction or increased mucus secretion, thus should be administered carefully. Individuals with extrapyramidal disorders such as Parkinson's disease should be cautious as their symptoms might worsen. Serious adverse reactions such as fainting, heart problems, gastrointestinal bleeding, liver dysfunction, central nervous system symptoms, muscle disorders, and respiratory distress may appear while taking this medication, so consult a physician immediately if any unusual symptoms occur. Additionally, various side effects such as nausea, vomiting, diarrhea, dizziness, insomnia, hallucinations, and anxiety may occur. Most of these symptoms are mild or temporary; however, if they persist or worsen, one should inform the healthcare staff. This medication may affect the cardiovascular system; thus, periodic heart monitoring, including ECG tests, may be necessary for patients with heart disease. Treatment of dementia should be under the diagnosis and supervision of a specialist; if the treatment shows no effect or causes severe side effects, discontinuation of the medication should be considered. This medication may affect driving or operating machinery; caution should be observed, particularly at the start of treatment or when increasing the dosage. Pregnant or breastfeeding women should avoid using this medication due to insufficient safety confirmation; consultation with professionals is advised. Safety in children has not been established; hence, it is advisable not to use this medication in pediatrics. This medication may influence certain clinical test results such as liver function tests or muscle enzyme tests, so consideration should be given when interpreting test results. In case of overdose, severe nausea, vomiting, bradycardia, respiratory depression, and convulsions may occur, requiring immediate emergency treatment, with agents like atropine potentially used as an antidote. Finally, this medication should be stored out of reach of children, and transferring to another container should be avoided as it may adversely affect quality and safety.

Serious side effects

Urticaria, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor (severe allergic reaction), severe rash with high fever, blisters, skin peeling, pain in mouth/eye mucosa (severe skin adverse reactions), shortness of breath or difficulty breathing, asthma attack, respiratory issues accompanied by cough and fever (respiratory problems), yellowing of the skin or eyes (jaundice), profound lethargy (liver abnormalities), sudden and severe

Mild side effects

Nausea, vomiting, diarrhea, loss of appetite, headache, fatigue, dizziness, insomnia, sweating, anxiety, drowsiness, muscle pain, tremors, aggressive behavior, hallucinations, confusion, urination disorders, edema, thrombocytopenia, blood pressure changes (hypertension, hypotension), palpitations, petechiae, weight loss, dehydration, arthralgia, common cold, influenza-like illness, urticaria, rash, itching, flushing, hematologic abnormalities (anemia, leukopenia, hematocrit changes)

This medication should be stored in an airtight container and kept at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness.

Appearance

Yellow, round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle