Medication info
Excel C Capsule 3 Milligrams (Rivastigmine Tartrate)

Excel C Capsule 3 Milligrams (Rivastigmine Tartrate)

Prescription medicationHard capsuleOral
Ingredient · strength
Rivastigmine Tartarate›4.8mg / 1 capsule
Manufacturer / importer
Hanmi Pharmaceutical Co., Ltd.
Appearance
A hard capsule filled with a white to off-white powder, with light brown upper and lower parts.
Packaging
30 capsules (10 capsules/PTP x 3)
Approval status
Active

MFDS item code 201502385 · Approved 2015.04.21 · Insurance code 647303050

Summary

Main use
Treatment of symptoms of mild to moderate dementia (associated with Alzheimer’s disease or Parkinson’s disease)
Who takes it
Adults · Children
Adult dose
Administration: Rivastigmine is administered orally twice daily, with the morning and evening meals. ○ Adults: 1. Treatment of mild to moderate dementia of the Alzheimer type The initial dose is 3 mg of rivastigmine per day. For each patient, increase the dose at intervals of at least 2 weeks to the highest tolerated dose or the maximum recommended dose of 12 mg per day. Because clinical trials showed greater efficacy at doses of 6 mg per day and above, a target dose range of 6~12 mg per day is recommended for most patients. Recommended dose titration schedule Administer 1.5mg per dose twice daily for at least 2 weeks. If well tolerated, the dose may be increased to 3mg twice daily. Subsequent increases may be made to 4.5mg per dose twice daily and, if well tolerated, after at least 2 weeks, to 6mg per dose twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or loss of appetite) or weight loss occurs, one or more doses may be omitted. However, if adverse reactions or weight loss persist, reduce the daily dose to the previously well-tolerated dose. 2. Treatment of mild to moderate dementia associated with Parkinson's disease In controlled clinical trials in patients with dementia associated with Parkinson's disease, rivastigmine was administered at 3~12mg per day in 2 divided doses. (1.5~6mg per dose twice daily.) The initial dose is 1.5mg per dose twice daily. At intervals of at least 4 weeks between doses, subsequent doses may be increased according to the patient's tolerability to 3mg per dose twice daily, then to 4.5mg per dose twice daily, and subsequently to 6mg per dose twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or loss of appetite), weight gain, or extrapyramidal symptoms (e.g., tremor) occur during treatment, omitting one or more doses may reduce these symptoms. If adverse reactions persist, the daily dose may be temporarily reduced to the previously well-tolerated dose, or discontinuation of treatment may be considered. 3. Maximum recommended dose Administer 6 mg per dose orally twice daily. 4. Resumption of treatment The incidence and severity of adverse reactions generally increase at higher doses. If treatment is interrupted for more than 3 days, restart at the lowest daily dose and titrate as described above. ○ Patients with hepatic or renal impairment: 1. Exposure is increased in patients with moderate renal impairment and mild to moderate hepatic impairment, and more adverse reactions may occur. Therefore, take particular care when titrating the dose according to individual tolerability. 2. Do not administer to patients with severe hepatic impairment, as no studies have been conducted in these patients.
Child dose
This medicine has not been studied in children; therefore, its use in children is not recommended.

Ingredients

Manufacturer
Hanmi Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of symptoms of mild to moderate dementia (associated with Alzheimer’s disease or Parkinson’s disease)

  • Alzheimer's-type dementia symptoms
  • dementia symptoms related to Parkinson's disease
View approved original text

This medication is used to treat mild to moderate symptoms of Alzheimer's-type dementia and dementia symptoms related to Parkinson's disease.

How to take

Adult dose

Administration: Rivastigmine is administered orally twice daily, with the morning and evening meals. ○ Adults: 1. Treatment of mild to moderate dementia of the Alzheimer type The initial dose is 3 mg of rivastigmine per day. For each patient, increase the dose at intervals of at least 2 weeks to the highest tolerated dose or the maximum recommended dose of 12 mg per day. Because clinical trials showed greater efficacy at doses of 6 mg per day and above, a target dose range of 6~12 mg per day is recommended for most patients. Recommended dose titration schedule Administer 1.5mg per dose twice daily for at least 2 weeks. If well tolerated, the dose may be increased to 3mg twice daily. Subsequent increases may be made to 4.5mg per dose twice daily and, if well tolerated, after at least 2 weeks, to 6mg per dose twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or loss of appetite) or weight loss occurs, one or more doses may be omitted. However, if adverse reactions or weight loss persist, reduce the daily dose to the previously well-tolerated dose. 2. Treatment of mild to moderate dementia associated with Parkinson's disease In controlled clinical trials in patients with dementia associated with Parkinson's disease, rivastigmine was administered at 3~12mg per day in 2 divided doses. (1.5~6mg per dose twice daily.) The initial dose is 1.5mg per dose twice daily. At intervals of at least 4 weeks between doses, subsequent doses may be increased according to the patient's tolerability to 3mg per dose twice daily, then to 4.5mg per dose twice daily, and subsequently to 6mg per dose twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or loss of appetite), weight gain, or extrapyramidal symptoms (e.g., tremor) occur during treatment, omitting one or more doses may reduce these symptoms. If adverse reactions persist, the daily dose may be temporarily reduced to the previously well-tolerated dose, or discontinuation of treatment may be considered. 3. Maximum recommended dose Administer 6 mg per dose orally twice daily. 4. Resumption of treatment The incidence and severity of adverse reactions generally increase at higher doses. If treatment is interrupted for more than 3 days, restart at the lowest daily dose and titrate as described above. ○ Patients with hepatic or renal impairment: 1. Exposure is increased in patients with moderate renal impairment and mild to moderate hepatic impairment, and more adverse reactions may occur. Therefore, take particular care when titrating the dose according to individual tolerability. 2. Do not administer to patients with severe hepatic impairment, as no studies have been conducted in these patients.

Child dose

This medicine has not been studied in children; therefore, its use in children is not recommended.

Precautions

This medication should not be used in patients with allergies to specific ingredients or severe liver impairment. Caution should be exercised when administering to patients with heart diseases, gastric ulcers, asthma, urinary retention, seizures, or extrapyramidal disorders. While taking this medication, gastrointestinal symptoms such as nausea, vomiting, and diarrhea may occur, particularly during dose adjustments when these symptoms may be more prevalent. There may be neurological adverse reactions such as dizziness, headache, drowsiness, and tremors, so caution is needed. Cardiac issues such as bradycardia or arrhythmias may arise, necessitating careful observation of heart conditions. This medication can worsen symptoms of Parkinson's disease, so patients with Parkinson's disease should exercise particular caution. Weight loss may occur, so it is important to regularly monitor the patient's weight during treatment. Drug interactions may occur when used with other cholinergic or anticholinergic medications, so care should be taken when co-administering. When undergoing anesthesia, this medication should be discontinued for a certain period, and when stopping or resuming the dosage, it should be gradually adjusted to reduce side effects like vomiting. The safety of this medication during pregnancy or breastfeeding has not been adequately established, so it should be used cautiously after consulting a physician. Safety and efficacy in pediatric patients have not been established, so usage is not recommended. In case of overdose, symptoms such as nausea, vomiting, bradycardia, and confusion may occur, and severe cases require immediate medical attention. This medication should be stored out of reach of children and not transferred to another container.

Side effects

  • Nausea
  • vomiting
  • urinary tract infection
  • agitation
  • confusion
  • nightmares
  • anxiety
  • insomnia
  • depression
  • hallucination
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  • dizziness
  • headache
  • drowsiness
  • tremor
  • syncope
  • convulsion
  • extrapyramidal symptoms
  • angina
  • myocardial infarction
  • deep vein thrombosis
  • bradycardia
  • atrioventricular block
  • atrial fibrillation
  • tachycardia
  • hypertension
  • diarrhea
  • loss of appetite
  • abdominal pain
  • dyspepsia
  • gastric ulcer
  • duodenal ulcer
  • gastrointestinal bleeding
  • pancreatitis
  • esophageal rupture
  • increased sweating
  • rash
  • itching
  • fatigue
  • asthenia
  • lethargy
  • falls
  • weight loss
  • abnormal liver function test results
  • mucous membrane syndrome
  • tremor
  • bradykinesia
  • dyskinesia
  • cogwheel rigidity
  • hypokinesia
  • muscle rigidity
  • insomnia
  • gait disturbance
  • urinary incontinence
  • cerebrovascular accident
  • delirium
  • erythema
  • urticaria
  • blisters
  • allergic dermatitis
  • dehydration
  • aggression
  • restlessness
  • dysautonomia
  • hepatitis
  • allergic skin dermatitis
  • decreased appetite
  • salivary secretion
  • saliva production
  • inability to sit still
  • sensory abnormalities
  • confusion
  • somnolence
  • pneumonia
  • sepsis
  • muscle stiffness
  • balance disorders
  • musculoskeletal rigidity
  • rigidity
  • movement disorders
  • hypertension
  • hypotension
  • hallucination
  • lethargy
  • tremor
  • somnolence
  • confused state
  • respiratory depression
  • muscle weakness

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a sealed container. It is advisable to maintain a storage temperature between 1 to 30 degrees Celsius. This will help preserve the medication's efficacy and safety over a long period.

Appearance and packaging

Appearance

A hard capsule filled with a white to off-white powder, with light brown upper and lower parts.

Package unit

30 capsules (10 capsules/PTP x 3)

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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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.