Donete Tablet 10 mg (Donepezil Hydrochloride Monohydrate)

Adult dose

Adults: Donepezil hydrochloride is administered at a dose of 5 mg once daily before bedtime. For the first 4-6 weeks, 5 mg will be administered, and after assessing the clinical response, it may be increased to 10 mg. When increasing to 10 mg daily, caution should be taken regarding gastrointestinal adverse reactions. Women over 85 years of age who are underweight should not exceed 5 mg daily and require careful monitoring.

Child dose

Pediatric: There is no experience regarding the use in children.

This medication contains Donepezil Hydrochloride and is used for the treatment of symptoms of Alzheimer-type dementia. First, this medication should not be used in individuals allergic to donepezil hydrochloride, piperidine derivatives, or any of its components. Pregnant women, women who are likely to become pregnant, and nursing mothers should also avoid taking this medication. Moreover, patients with genetic metabolic issues such as lactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medication. Patients with cardiovascular diseases or cardiac conduction disorders should use this medication with caution, as it may cause bradycardia or arrhythmias. Caution is also needed for patients who are taking non-steroidal anti-inflammatory drugs (NSAIDs) or have a history of peptic ulcers, as this may worsen symptoms due to increased gastric acid secretion. Patients with a history of asthma or obstructive pulmonary disease should use this medication cautiously, as it may lead to bronchoconstriction and increased mucus secretion. Patients with extrapyramidal disorders such as Parkinson's disease should also be cautious, as symptoms may worsen. Additionally, caution is required if allergic to Tartrazine, an ingredient in this medication. While taking this medication, various side effects may occur. For example, cardiac-related adverse reactions such as syncope, bradycardia, heart block, myocardial infarction, and heart failure have been reported, as well as peptic ulcers, gastrointestinal bleeding, liver dysfunction, intracerebral hemorrhage, seizures, extrapyramidal symptoms, neuroleptic malignant syndrome, rhabdomyolysis, dyspnea, acute pancreatitis, acute renal failure, and unexplained sudden death. Common side effects may include loss of appetite, nausea, vomiting, diarrhea, dizziness, insomnia, headache, fatigue, rash, and psychiatric symptoms such as hallucinations, agitation, aggressive behavior, anxiety, and confusion. This medication is approved only for patients with Alzheimer-type dementia and is not to be used for other forms of dementia or memory disorders. Treatment must be conducted under the supervision and diagnosis of an experienced physician, and if no therapeutic effects are observed, discontinuation should be considered. This medication may slow the heart rate and cause arrhythmias, so patients with cardiovascular disease or electrolyte abnormalities should use caution and be monitored with electrocardiograms if necessary. Additionally, since this medication increases gastric acid secretion and can accelerate gastrointestinal motility, patients with a history of peptic ulcers should monitor their condition closely. It may affect the ability to drive or operate machinery, especially at the start of treatment or when increasing the dosage. Pregnant or nursing women are advised not to take this medication, and if necessary, breastfeeding should be discontinued. The safety of this medication in children has not been established, thus it is not used in this population. There may be drug interactions, especially with medications that inhibit or induce CYP3A4 or CYP2D6, neuromuscular blockers, anticholinergic drugs, medications affecting cardiac conduction, and NSAIDs, so caution is warranted. In case of overdose, symptoms such as nausea, vomiting, sweating, bradycardia, hypotension, respiratory depression, and seizures may occur, and immediate medical attention is required. Atropine may be used as an antidote. This medication should be kept out of the reach of children and should not be transferred to another container.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with a high fever, blistering, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory symptoms accompanied by coughing and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, lightning headaches, seizures, altered consciousness, vision changes, paralysis, urination.

Mild side effects

• Loss of appetite
• insomnia
• drowsiness
• dizziness
• diarrhea
• nausea
• vomiting
• headache
• fatigue
• pain

This medication should be stored in a tightly sealed container to prevent air or moisture exposure and kept at room temperature between 1 to 30 degrees Celsius. Therefore, it is advisable to avoid direct sunlight and do not place it in excessively hot or cold locations.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle