Jungwoo Donepezil Suppository 5 mg (Donepezil Hydrochloride Monohydrate)

Adult dose

○ Adults : Administer donepezil hydrochloride 5 mg once daily at bedtime. If sleep disturbances such as abnormal dreams, nightmares, or insomnia occur, taking this medicine in the morning may be considered. Since donepezil concentrations reach steady state 15 days after administration and the incidence of adverse reactions may be affected by the rate of dose escalation, administer the 5 mg dose for 4~6 weeks. After assessing the clinical response during this period, the dose may be increased to 10 mg. When increasing the dose to 10 mg once daily, administer with caution for gastrointestinal adverse reactions. If treatment with this medicine is discontinued, its effects gradually decrease; no rebound effect occurs with abrupt discontinuation. This medicine is an orally disintegrating tablet. Place it on the tongue and allow it to dissolve, then take it with water or without water. ○ Female patients aged 85 years or older who are underweight : Since adverse reactions occur more frequently, careful monitoring is required. Elderly underweight women should not receive more than 5 mg once daily.

Child dose

○ Children : There is no experience with use in children.

This medication contains donepezil hydrochloride as its active ingredient and is used to treat symptoms of Alzheimer-type dementia. This medication should not be used in certain patient populations. For example, individuals who are allergic to this medication or its ingredients, pregnant women or those who may become pregnant, and breastfeeding women should not take this medication. Patients with heart diseases or conduction abnormalities should use this medication with caution. It may lower heart rate and carry a risk of causing heart problems such as bradycardia or arrhythmias. Additionally, patients with a history of peptic ulcers or those taking non-steroidal anti-inflammatory drugs should be cautious of gastrointestinal bleeding or worsening of ulcers when taking this medication. Patients with asthma or obstructive pulmonary disease should also be cautious as this medication may cause bronchospasm and worsen symptoms. Patients with extrapyramidal disorders such as Parkinson's disease should use this medication carefully, as it may exacerbate symptoms. This medication can cause various side effects. In severe cases, fainting, heart problems, gastrointestinal bleeding, liver function abnormalities, seizures, movement disorders, respiratory distress, acute pancreatitis, acute renal failure, and sudden death have been reported. Common side effects such as nausea, vomiting, diarrhea, appetite loss, dizziness, insomnia, headache, fatigue, palpitations, and rash may also occur. During treatment, the patient's condition should be regularly assessed to check for the effectiveness and side effects of the medication, and any abnormal symptoms should be immediately discussed with healthcare professionals. This medication may affect liver and kidney functions, so patients with liver or kidney diseases should consult a doctor before use. Caution is required when driving or operating machinery, particularly when starting treatment or changing the dosage, as dizziness or fatigue may occur. This medication may interact with other drugs, so patients should inform their healthcare providers about any other medications they are currently taking. Pregnant or breastfeeding women are advised to avoid this medication, but if it is necessary to take it, one should consult with a specialist to make a decision. In cases of overdose, symptoms such as nausea, vomiting, bradycardia, hypotension, respiratory depression, and seizures may occur, requiring immediate emergency treatment. These oral disintegrating tablets should be taken by placing them on the tongue, and they should be stored out of reach of children. To prevent discoloration by light, it is best to store the product in its unopened packaging.

Syncope, bradycardia, heart block, QT interval prolongation, myocardial infarction, heart failure, peptic ulcer, perforated duodenal perforation, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, cerebral seizures, cerebral hemorrhage, cerebrovascular disorders, movement dysfunction, ataxia, motor disabilities, dystonia, tremor, involuntary movements, gait disturbances, abnormal posture, speech disorders, akinetic mutism, extreme muscle rigidity, dysphagia, tachycardia, blood pressure fluctuations, sweating, myalgia, malaise, dyspnea, acute pancreatitis, acute renal failure, sudden death, cold, loss of appetite, hallucinations, excitement, aggressive behavior, anxiety disorders, insomnia, drowsiness, increased libido, talkativeness, mania, nightmares, hyperexcitability, delirium, delusions, depression, confusion, apathy, hyperactivity, increased libido, hypersexuality, dizziness, tremor, seizures, stupor, thoracic rigidity, bradycardia, palpitations, sinoatrial block, atrioventricular block, hypertension, hypotension, atrial fibrillation, torsades de pointes, electrocardiogram QT interval prolongation, diarrhea, nausea, vomiting, abdominal disorders, gastrointestinal bleeding, gastric and duodenal ulcers, constipation, salivation, dysphagia, fecal incontinence, rash, pruritus, muscle spasm, myalgia, urinary incontinence, polyuria, urinary retention, headache, fatigue, pain, toothache, facial flushing, lethargy, asthenia, edema, fever, decreased body temperature, decreased hematocrit, leukopenia, anemia, thrombocytopenia, petechiae, abnormal dreams, thought disturbances, back pain, chest pain, bleeding, increased CPK, dehydration, hyperlipidemia, hostility, irritability, eczema, urinary incontinence, abdominal pain, weakness, fungal infection, influenza-like syndrome, allergy, soft tissue infection, lethargy, sepsis, facial edema, hernia, hypotension, ECG abnormalities, heart failure, myocardial infarction, angina pectoris, atrial fibrillation, congestive heart failure, peripheral vascular disease, supraventricular extrasystole, ventricular extrasystole, cardiac hypertrophy, constipation, gastroenteritis, fecal incontinence, dyspepsia, increased γ-GT, gastritis, periodontitis, gastric ulcer, periodontal abscess, abdominal bloating, liver function abnormalities, belching, esophagitis, anal bleeding, diabetes, anemia, leukocytosis, weight loss, peripheral edema, edema, increased LDH, increased alkaline phosphatase, hypercholesterolemia, hypokalemia, hypoglycemia, weight gain, hyperbilirubinemia, increased BUN, B12 deficiency anemia, cachexia, increased creatinine, gout, hyponatremia, hypoalbuminemia, iron deficiency anemia, elevated AST, elevated ALT, arthritis, arthrosis, bone fracture, arthralgia, leg cramps, osteoporosis, agitation, anxiety, spasms, transient psychotic disorder, gait abnormalities, apathy, delusions, dream disorders, cerebrovascular abnormalities, increased salivation, ataxia, dysphoria, vasodilation, cerebral hemorrhage, cerebral infarction, cerebral ischemia, dementia, generalized tonic-clonic seizures, hemiplegia, hypertonia, decreased motor activity, pharyngitis, pneumonia, increased cough, bronchitis, rhinitis, asthma, skin ulcer, psoriasis, skin discoloration, shingles, dry skin, urticaria, vesicular rash, conjunctivitis, glaucoma, visual disturbances, ear pain, tear abnormalities, urinary tract infection, cystitis, hematuria, vaginitis, urination disorders, proteinuria, agitation, cholecystitis, hemolytic anemia, hyponatremia

This medication should be stored in a tightly sealed container to protect it from air and moisture. The appropriate storage temperature is room temperature between 1 to 30 degrees Celsius, and it is advisable to avoid extremely hot or cold places.

Appearance

White round orally disintegrating tablet.

Package unit

30 tablets (6 tablets/PTP x 5)