Teva Donepezil Orally Disintegrating Tablets 5 mg (Donepezil Hydrochloride Monohydrate)

Adult dose

○ Adults : Administer 5 mg of donepezil hydrochloride once daily at bedtime. If sleep disturbances such as unusual dreams, nightmares, or insomnia occur, taking this medicine in the morning may be considered. Since donepezil reaches steady state 15 days after administration and the frequency of adverse reactions may be affected by the rate of dose escalation, administer the 5 mg dose for 4~6 weeks. After evaluating the clinical response during this period, the dose may be increased to 10 mg. When increasing the dose to 10 mg daily, administer with caution for gastrointestinal adverse reactions. When this medicine is discontinued, its effect gradually decreases, and no rebound effect occurs following abrupt discontinuation. This medicine is an orally disintegrating tablet. Place it on the tongue and allow it to dissolve; it may be taken with or without water. ○ Women aged 85 years or older with low body weight : Careful monitoring is required because adverse reactions occur frequently. Elderly women with low body weight should not exceed 5 mg daily.

Child dose

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

This medication contains Donepezil Hydrochloride and is used to treat symptoms of Alzheimer's dementia. You should not take this medication if you have allergies to Donepezil Hydrochloride or other components of this medication. Also, it is safer for women who are pregnant or may become pregnant, as well as those who are breastfeeding, to avoid using this medication. Patients with heart conditions or heart conduction disorders should take this medication cautiously, as it may slow heart rate or induce arrhythmia. Patients with a history of peptic ulcers or those currently taking non-steroidal anti-inflammatory drugs should be careful due to the increased risk of gastrointestinal bleeding. Patients with asthma or obstructive pulmonary disease may experience worsened symptoms as this medication can constrict the bronchi or increase mucus secretion. Those with extrapyramidal disorders such as Parkinson's disease should be cautious, as this medication may worsen their symptoms. This medication can cause various adverse reactions, and in severe cases, symptoms such as fainting, heart problems, gastrointestinal bleeding, liver dysfunction, seizures, and muscle-related symptoms may occur. If such symptoms arise, consult a doctor immediately. Additionally, this medication may affect driving or machine operation capabilities, so particular caution is needed during the initial dosing period. This medication can interact with other drugs, so be sure to inform healthcare professionals of any medications you are currently taking, especially when combined with heart-related drugs, antibiotics, antidepressants, and antipsychotics. Pregnant or breastfeeding women should avoid using this medication; if necessary, usage should be discussed with a healthcare professional. Safety in pediatric populations has not been established; therefore, it is not recommended for use in children. In cases of overdose, symptoms such as nausea, vomiting, bradycardia, hypotension, respiratory depression, and seizures may occur, and emergency treatment should be sought immediately. Atropine can be used as an antidote. This medication is in a orally disintegrating format, so it is important to completely dissolve it in the mouth before swallowing. When storing, keep it out of reach of children and store in a tightly sealed container away from direct sunlight.

Syncope, bradycardia, heart block, QT interval prolongation, myocardial infarction, heart failure, peptic ulcer, perforated duodenal perforation, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, encephalopathy, cerebral hemorrhage, cerebrovascular disorders, motor function disorders, ataxia, movement disorders, dystonia, tremor, involuntary movements, gait disturbances, abnormal posture, speech disorders, akinetic mute, extreme muscle rigidity, dysphagia, tachycardia, blood pressure fluctuations, sweating, myalgia, general weakness, dyspnea, acute pancreatitis, acute renal failure, sudden death of unknown cause, cold, anorexia, hallucinations, agitation, aggressive behavior, anxiety disorders, insomnia, drowsiness, increased libido, talkativeness, mania, nightmares, neuroticism, nonsense, delusions, depression, confusion, apathy, hyperactivity, increased libido, hypersexuality, dizziness, tremor, seizures, stupor, chest rigidity, palpitations, sinoatrial block, atrioventricular block, hypertension, hypotension, atrial fibrillation, ventricular tachycardia due to torsades de pointes, ECG QT interval prolongation, diarrhea, nausea, vomiting, abdominal disorders, gastric and duodenal ulcers, constipation, salivation, fecal incontinence, liver disorders, rash, itching, muscle cramps, urinary incontinence, frequent urination, urine retention, headache, fatigue, pain, toothache, facial flushing, lethargy, weakness, edema, fever, decreased body temperature, decreased hematocrit, leukopenia, anemia, thrombocytopenia, petechiae, abnormal dreams, decreased appetite, urinary tract infections, increased CPK, dehydration, hyperlipidemia, eczema, back pain, chest pain, hypotension, abnormal ECG, heart failure, constipation, gastroenteritis, fecal incontinence, dyspepsia, increased γ-GT, gastritis, periodontal disease, gastric ulcers, periodontal abscess, abdominal distension, abnormal liver function, belching, esophagitis, rectal 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, increased AST, increased ALT, arthritis, arthrosis, bone fractures, arthralgia, leg cramps, osteoporosis, myalgia, agitation, anxiety, seizures, migratory mental disturbances, abnormal gait, apathy, delusions, dream abnormalities, cerebrovascular anomalies, increased salivation, ataxia, abnormal euphoria, vasodilation, cerebral hemorrhage, cerebral infarction, cerebral ischemia, dementia, grand mal seizures, hemiplegia, hypertonia, reduced mobility, pharyngitis, pneumonia, increased cough, bronchitis, rhinitis, asthma, skin ulcers, psoriasis, skin discoloration, shingles, dry skin, urticaria, vesicular rash, conjunctivitis, glaucoma, visual disturbances, ear pain, tear abnormalities, urinary tract infections, cystitis, hematuria, vaginitis, urinary disorders, proteinuria, agitation, cholecystitis, hemolytic anemia, hyponatremia

This medication must be stored in a tightly sealed container to protect it from air and moisture. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature. Proper storage will help maintain the effectiveness of the medication for a longer period.

Appearance

White round orally disintegrating tablet

Package unit

30 tablets (10 tablets/PTP x 3)