Prometax Capsule 1.5 Milligrams (Rivastigmine Tartrate)

Adult dosage

Directions for use: Rivastigmine is administered orally twice daily with breakfast and dinner. ○ Adults: 1. Treatment of mild to moderate Alzheimer-type dementia The initial dose is 3mg of rivastigmine daily. Increase the dose for each patient at intervals of at least 2 weeks to the maximum tolerated dose or the maximum recommended dose of 12mg daily. Since this medicine showed greater efficacy at doses of 6mg daily and higher in clinical trials, a target dose range of 6~12mg daily is recommended for most patients. Recommended dose titration After administering 1.5mg of this medicine twice daily for at least 2 weeks, the dose may be increased to 3mg twice daily if well tolerated. Subsequent increases may be made to 4.5mg twice daily, and, if well tolerated, after at least 2 weeks to 6mg twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or decreased appetite) or weight loss are observed, 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 3~12mg daily was administered in 2 divided doses. (1.5~6mg per dose was administered twice daily.). The initial dose is 1.5mg of this medicine twice daily. At intervals of at least 4 weeks between dose levels, the dose may then be increased sequentially according to patient tolerability to 3mg twice daily, then 4.5mg twice daily, and then 6mg twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or decreased appetite), weight gain, or extrapyramidal symptoms (e.g., tremor) are observed during treatment, omitting one or more doses may reduce these symptoms. If adverse reactions persist, consider temporarily reducing the daily dose to the previously well-tolerated dose or discontinuing treatment. 3. Maximum recommended dose Administer 6 mg of this medicine orally twice daily. 4. Resumption of treatment The incidence and severity of adverse reactions generally increase at higher doses. If treatment is interrupted for 3 days or longer, 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, so more adverse reactions may occur. Therefore, use particular caution 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.

Children's dosage

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

This medication should not be administered to patients with allergies to the active ingredient or other components. Patients with severe liver impairment have not been proven to be safe, so it should be avoided. Patients who have had skin reactions with a transdermal patch of this medication are advised not to use it. Patients with a history of heart disease, gastric ulcers, asthma, urinary retention, or seizures should use this medication with caution. Gastrointestinal side effects such as nausea, vomiting, and diarrhea may occur during treatment, and if symptoms are severe, consulting a doctor is necessary. Symptoms of dizziness, drowsiness, and tremors have also been reported, so caution is required when driving or operating machinery. In patients with Parkinson's disease, symptoms may worsen, so it is important to report any abnormal symptoms immediately. Women who are pregnant or breastfeeding should carefully consider the effects of this medication on their fetus or baby before use. Safety and efficacy in pediatric patients have not been established, so it is not recommended. Interactions may occur when combined with other cholinergic drugs, anesthetics, or specific heart medications, so healthcare providers must be informed. In case of overdose, severe symptoms such as nausea, vomiting, bradycardia, and confusion may occur, so immediate emergency treatment is required. This medication should be stored out of reach of children and should not be transferred to a different container.

• Nausea
• vomiting
• diarrhea
• loss of appetite
• abdominal pain
• indigestion
• gastric ulcer
• duodenal ulcer
• gastrointestinal bleeding
• pancreatitis

This medication should be stored in a tightly closed container to prevent exposure to air or light and is best kept at room temperature. Avoid storing in areas that are excessively hot or cold and place it in a cool place away from direct sunlight to help maintain its efficacy.

Appearance

A hard yellow capsule containing a white to light yellow powder.

Package unit

28 capsules (14 capsules in PTP packaging x 2)