Medication info
Rimacept Tablets 10 mg (Donepezil Hydrochloride Monohydrate)

Rimacept Tablets 10 mg (Donepezil Hydrochloride Monohydrate)

Prescription medicationTabletOral
Ingredient · strength
Donepezil Hydrochloride Monohydrate›10.43mg / 1 tablet
Manufacturer / importer
CTC Bio Co., Ltd.
Appearance
Yellow round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202002049 · Approved 2020.03.24 · Insurance code 669502560

Summary

Main use
Treatment of symptoms of Alzheimer-type dementia
Who takes it
Adults · Children
Adult dose
Adults: Administer 5 mg once daily at bedtime as donepezil hydrochloride. If sleep disturbances such as abnormal dreams, nightmares, or insomnia occur, morning administration of this drug 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 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. If this drug is discontinued, its effects gradually diminish, and no rebound effect occurs following abrupt discontinuation. Women aged 85 years or older with low body weight: Because adverse reactions occur more frequently, careful monitoring is required. Elderly women with low body weight should not exceed 5 mg daily.
Child dose
Pediatric patients: There is no experience with use in pediatric patients.

Ingredients

Manufacturer
CTC Bio Co., Ltd.

Efficacy & effects

Treatment of symptoms of Alzheimer-type dementia

  • Symptoms of Alzheimer-type dementia
View approved original text

This medication is used for the treatment of Alzheimer-type dementia symptoms.

How to take

Adult dose

Adults: Administer 5 mg once daily at bedtime as donepezil hydrochloride. If sleep disturbances such as abnormal dreams, nightmares, or insomnia occur, morning administration of this drug 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 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. If this drug is discontinued, its effects gradually diminish, and no rebound effect occurs following abrupt discontinuation. Women aged 85 years or older with low body weight: Because adverse reactions occur more frequently, careful monitoring is required. Elderly women with low body weight should not exceed 5 mg daily.

Child dose

Pediatric patients: There is no experience with use in pediatric patients.

Precautions

This medication contains the ingredient Donepezil Hydrochloride and is primarily used for the treatment of Alzheimer-type dementia symptoms. This medication should not be administered to certain patients. For example, individuals allergic to this medication or its components, pregnant women or women who may become pregnant, nursing mothers, and individuals with genetic lactose intolerance issues should not take this medication. Patients with heart disease or cardiac conduction disorders, a history of peptic ulcers, asthma or chronic obstructive pulmonary disease, extrapyramidal disorders such as Parkinson's disease, and individuals allergic to Yellow No. 5 contained in this medication should exercise special caution when using this medication. Various adverse reactions may occur while taking this medication. For instance, heart-related issues may lead to fainting or heart block, gastrointestinal problems may cause gastrointestinal bleeding or ulcers, liver dysfunction, and neurological issues may result in seizures or movement disorders. Additionally, severe symptoms such as difficulty breathing, acute pancreatitis, acute renal failure, and sudden death have also been reported. Generally, common symptoms include nausea, vomiting, diarrhea, decreased appetite, dizziness, insomnia, headache, and fatigue, most of which are mild and transient. This medication acts as a cholinesterase inhibitor, potentially slowing heart rate or causing arrhythmias, so patients with heart conditions should be particularly cautious. Moreover, it may increase gastric acid secretion, worsening peptic ulcer symptoms, hence individuals with gastrointestinal health issues need to exercise caution. This medication may affect driving ability or operation of machinery, so caution is necessary during the initial stages of treatment or when the dosage is increased. Women who are pregnant or nursing should avoid taking this medication, and if it must be taken, breastfeeding should be discontinued after consultation with a healthcare professional. This medication may interact with other drugs, so when taken in conjunction, particularly with medications affecting CYP3A4 or CYP2D6 enzymes, drugs influencing cardiac conduction, non-steroidal anti-inflammatory drugs (NSAIDs), consultation with a specialist is required. In the case of overdose, serious symptoms such as nausea, vomiting, bradycardia, and respiratory depression may occur, necessitating immediate medical assistance, and atropine may be used as an antidote. Finally, this medication should be kept out of the reach of children, and transferring it to other containers is not recommended for quality maintenance.

Side effects

Syncope, bradycardia, heart block, QT interval prolongation, myocardial infarction, heart failure, peptic ulcer, perforated duodenal ulcer, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, cerebral seizure, cerebral hemorrhage, cerebrovascular disorder, movement dysfunction, ataxia, movement disorder, dystonia, tremor, involuntary movement, gait disturbance, abnormal posture, speech disorder, akinetic mutism, extreme muscular rigidity, dysphagia, tachycardia, blood pressure fluctuations, sweating, myalgia, malaise, dyspnea, acute pancreatitis, acute renal failure, sudden death, cold, decreased appetite, hallucinations, agitation, aggressive behavior, anxiety disorder, insomnia, drowsiness, increased libido, talkativeness, mania, nightmares, nervousness, nonsensical speech, delusions, depression, confusion, indifference, hyperactivity, hypersexuality, dizziness, tremor, seizures, stupor, chest rigidity, bradycardia, palpitations, sinoatrial block, atrioventricular block, hypertension, hypotension, atrial fibrillation, torsades de pointes ventricular tachycardia, ECG QT interval prolongation, diarrhea, nausea, vomiting, abdominal disorder, gastric-duodenal ulcer, constipation, salivation, fecal incontinence, rash, pruritus, muscle cramps, myalgia, urinary incontinence, frequent urination, urinary retention, headache, fatigue, pain, toothache, facial flushing, lethargy, asthenia, swelling, fever, decreased body temperature, reduced hematocrit, leukopenia, anemia, thrombocytopenia, petechiae, abnormal dreams, decreased appetite, urinary tract infection, increased CPK, dehydration, hyperlipidemia, insomnia, hostility, irritability, drowsiness, depression, confusion, emotional instability, personality disorder, eczema, urinary incontinence, abdominal pain, weakness, fungal infection, influenza-like illness, allergy, soft tissue infection, malaise, sepsis, facial swelling, hernia, hypotension, ECG abnormalities, heart failure, myocardial infarction, angina pectoris, atrial fibrillation, congestive heart failure, peripheral vascular disease, supraventricular ectopic beats, ventricular ectopic beats, cardiac hypertrophy, constipation, gastroenteritis, fecal incontinence, dyspepsia, increased γ-GT, gastritis, dysphagia, periodontitis, gastric ulcer, periodontal abscess, abdominal distension, liver function abnormality, belching, esophagitis, rectal bleeding, diabetes, anemia, leukocytosis, weight loss, peripheral edema, swelling, increased LDH, increased alkaline phosphatase, hypercholesterolemia, hypokalemia, hypoglycemia, weight gain, hyperbilirubinemia, increased BUN, B12 deficiency anemia, cachexia, increased creatinine, gout, hyponatremia, hypoproteinemia, iron deficiency anemia, increased AST, increased ALT, arthritis, arthrosis, bone fracture, arthralgia, leg cramps, osteoporosis, anxiety, restlessness, convulsions, migratory psychosis, gait abnormalities, apathy, delusions, dream abnormalities, cerebrovascular abnormalities, increased salivation, ataxia, euphoria, vasodilation, cerebral hemorrhage, cerebral infarction, cerebral ischemia, dementia, extrapyramidal symptoms, grand mal seizures, hemiplegia, hypertonia, reduced activity, pharyngitis, pneumonia, increased cough, bronchitis, dyspnea, rhinitis, asthma, rash, skin ulcer, itching, psoriasis, skin discoloration, shingles, dry skin, sweating, urticaria, vesicular rash, conjunctivitis, glaucoma, visual disturbances, ear pain, tear abnormalities, urinary tract infection, cystitis, hematuria, diabetes, vaginitis, urination disorder, frequent urination, proteinuria, abdominal pain, anxiety, cholecystitis, confusion, convulsions, hallucinations, heart block, hemolytic anemia, hyponatremia, neuroleptic malignant syndrome, pancreatitis, rash

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture from entering. Additionally, it is best to store the medication at room temperature, which is neither too hot nor too cold, preferably between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.