Dorisep Tablets 5 mg (Donepezil Hydrochloride Monohydrate)

Adult dose

Administer 5 mg (as donepezil hydrochloride) once daily before bed. If unusual dreams, nightmares, or sleep disturbances occur, morning administration may be considered. After administering 5 mg for 4-6 weeks, dosage may be increased to 10 mg based on clinical response evaluation. Caution must be taken for gastrointestinal side effects if increasing to 10 mg per day. Female patients over 85 years old who are underweight should not exceed 5 mg per day.

Child dose

There is no experience in using this medication in children.

This medication contains Donepezil Hydrochloride Monohydrate as its main ingredient and is used for the improvement of symptoms of Alzheimer's type dementia. This medication should not be used by individuals allergic to Donepezil Hydrochloride or any components of this medication, by pregnant or breastfeeding women, and by certain genetically lactose intolerant patients. Caution should be exercised in patients with heart conditions or problems with cardiac conduction, patients with a history of peptic ulcers or those taking non-steroidal anti-inflammatory drugs, patients with a history of asthma or obstructive pulmonary disease, and patients with extrapyramidal disorders such as Parkinson's disease. This medication can rarely cause serious side effects such as serious heart problems, gastrointestinal bleeding, liver dysfunction, cerebrovascular issues, movement disorders, neuroleptic malignant syndrome, muscle damage, difficulty breathing, pancreatitis, renal failure, or sudden death, so medical consultation should be sought immediately if symptoms arise. Additionally, common side effects may include nausea, vomiting, diarrhea, dizziness, insomnia, decreased appetite, headache, fatigue, and bradycardia. Patients should inform their healthcare providers if symptoms persist or worsen. This medication is not approved for other types of dementia or memory disorders outside of Alzheimer's type dementia and treatment should occur under the supervision of an experienced physician. Due to potential effects on the heart, patients with heart conditions or electrolyte abnormalities require regular monitoring such as ECG tests. Care should be taken when driving or operating machinery, especially during initial use or dose increases, as dizziness or muscle cramps may occur. This medication may interact with other drugs, particularly those related to CYP3A4 and CYP2D6, neuromuscular blockers, cholinergic drugs, anticholinergic drugs, cardiac medications, and NSAIDs, so caution is warranted when used in combination. Pregnant or breastfeeding women are advised not to use this medication, and if necessary, breastfeeding should be discontinued. Safety in children has not been established, so it is not used in this population. Symptoms of overdose may include nausea, vomiting, sweating, bradycardia, hypotension, respiratory depression, and seizures, and immediate medical attention should be sought.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash accompanied by fever, blisters, peeling skin, pain in oral/ocular mucous membranes, difficulty breathing or shortness of breath, asthma attack, cough with fever indicating respiratory issues, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination problems

Mild side effects

• Loss of appetite
• hallucinations
• excitement
• aggressive behavior
• anxiety
• insomnia
• drowsiness
• increased libido
• talkativeness
• mania

This medication should be stored in a tightly closed container to prevent air exposure, and it is recommended to keep it at room temperature between 1°C to 30°C. Proper storage will maintain the medication's effectiveness and prevent degradation.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle