AgiSept Tablets 10 mg (Donepezil Hydrochloride Monohydrate)

Adult dose

Donepezil Hydrochloride should be administered at a dose of 5 mg once daily before bedtime. If strange dreams, nightmares, or sleep disturbances occur, morning administration of this medication may be considered. Normal levels of donepezil concentration are reached 15 days after administration, hence a 5 mg dose should be given for 4 to 6 weeks. After evaluating clinical responses during this period, the dose may be increased to 10 mg. When increasing the dose to 10 mg daily, gastrointestinal side effects should be monitored.

Child dose

There is no experience regarding use in pediatric patients.

This medication contains Donepezil Hydrochloride Monohydrate as its main ingredient and is used to improve symptoms of Alzheimer's type dementia. First, this medication should not be administered to certain patients. Patients who are allergic to Donepezil Hydrochloride or any of this drug's components, pregnant women or those who may become pregnant, and women who are breastfeeding should not take this medication. Additionally, patients with genetic issues such as lactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption should not use this medication. Next, patients with heart disease, especially those with bradycardia, atrioventricular block, or conduction disorders, should be cautious as this medication can slow heart rate or induce arrhythmia. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should be careful as increased gastric acid secretion or enhanced gastrointestinal motility may worsen symptoms. Patients with a history of asthma or obstructive pulmonary disease should be cautious as bronchoconstriction and increased mucus secretion may exacerbate symptoms. Patients with extrapyramidal disorders such as Parkinson's disease should also be careful as this medication may worsen symptoms. Moreover, patients allergic to Yellow 5 should use this medication with caution. While taking this medication, various adverse reactions may occur. Serious cardiac-related adverse reactions may include syncope, bradycardia, heart block, QT interval prolongation, myocardial infarction, and heart failure. Gastrointestinal issues such as peptic ulcers, perforation, gastrointestinal bleeding may also occur, along with liver dysfunction, jaundice, seizures, cerebral hemorrhage, and motor dysfunction. Rarely, malignant neuroleptic syndrome, rhabdomyolysis, respiratory distress, acute pancreatitis, acute kidney failure, and unexplained sudden death may occur. Commonly observed side effects generally include nausea, vomiting, diarrhea, dizziness, insomnia, decreased appetite, headache, and fatigue. This medication may also cause psychiatric symptoms such as hallucinations, agitation, aggressive behavior, depression, confusion, and delusions, thus requiring caution. This medication is not approved for use in other forms of dementia or memory disorders other than Alzheimer's type dementia, and treatment should be conducted under the supervision of an experienced physician. Consideration should be given to discontinuation if treatment effects are not observed, and the patient's condition should be regularly evaluated. Patients with cardiovascular disease may experience bradycardia, heart block, or arrhythmia while taking this medication, and an electrocardiogram may be required. Patients with a history of peptic ulcers should be monitored for symptom exacerbation due to increased gastric acid. Caution is also needed for neurological symptoms or potential seizures, and respiratory symptoms may worsen in patients with asthma or chronic obstructive pulmonary disease. This medication may affect driving and machine operation abilities, so caution is necessary during initial use or when increasing dosage. Pregnant or breastfeeding women are advised not to take this medication, and if it must be taken, breastfeeding should be discontinued. This medication can interact with various drugs, so if you are taking other medications, be sure to inform your doctor or pharmacist. Particularly, caution is needed when taken alongside drugs affecting CYP3A4 and CYP2D6 enzymes, neuromuscular blockers, cholinergic drugs, anticholinergic drugs, beta-blockers, NSAIDs, and medications that prolong the QT interval. In cases of overdose, symptoms may include nausea, vomiting, excessive salivation, bradycardia, hypotension, respiratory depression, muscle weakness, and seizures, requiring immediate medical treatment. Atropine sulfate may be used as an antidote. Finally, this medication should be stored out of reach of children, and transferring it to another container should be avoided as it may not maintain quality.

Serious side effects

Syncope, bradycardia, heart block, QT interval prolongation, myocardial infarction, heart failure, peptic ulcers, perforated duodenal ulcers, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, seizures, epilepsy, convulsions, cerebral hemorrhage, cerebrovascular disorders, extrapyramidal symptoms (motor dysfunction, ataxia, movement disorders, dystonia, tremors, involuntary movements, gait abnormalities, abnormal posture, speech disorders), malignant neuroleptic syndrome, rhabdomyolysis, respiratory distress,

Mild side effects

• Nausea
• vomiting
• diarrhea
• decreased appetite
• headache
• fatigue
• dizziness
• insomnia
• drowsiness
• itching

Store this medication in a tightly closed container to prevent air or moisture from entering, and it is best to keep it at room temperature between 1 degree and 30 degrees Celsius. Proper storage will maintain the medication's effectiveness for a longer period.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle