Myeongin Galantamine Extended-Release Capsule 8 mg (Galantamine Bromide)

Adult dose

(Adults) Administer once daily in the morning. Administration immediately after breakfast is preferred. Swallow this medicine whole with an adequate amount of water; do not chew or crush it. Ensure adequate fluid intake while taking this medicine. Initial dose: 8mg once daily is recommended for the first 4 weeks. Maintenance dose: - After the initial dose, administer 16mg once daily for at least 4 weeks. - Thereafter, based on evaluation of clinical benefit and tolerability, the dose may be increased to a maximum of 24mg daily. - For patients who do not tolerate 24mg daily or whose response does not improve, consider reducing the dose to 16mg daily. - This medicine may be continued for as long as it benefits the patient. Regularly evaluate the clinical benefit of this medicine and consider discontinuing treatment if there is no therapeutic effect. - No rebound effects occur after treatment is discontinued (e.g., in preparation for surgery). (Patients with renal or hepatic impairment) Galantamine blood concentrations may increase in patients with moderate to severe renal or hepatic impairment. Based on pharmacokinetic modeling, patients with moderate hepatic impairment should receive 8mg every other day for at least 1 week, preferably in the morning. Thereafter, administer 8mg once daily for at least 4 weeks. Do not exceed 16mg daily. This medicine is contraindicated in patients with severe hepatic impairment (Child-Pugh score >9). No dose adjustment is necessary in patients with mild hepatic impairment. No dose adjustment is necessary in patients with creatinine clearance of 9mL/min or higher. This medicine is contraindicated in patients with severe renal impairment (creatinine clearance < 9mL/min). (Concomitant therapy) Consider reducing the dose of this medicine in patients receiving CYP 2D6 or CYP 3A4 inhibitors (e.g., ketoconazole).

Child dose

Use in children is not recommended.

This medication should not be used in patients with allergies to its ingredients, those with severely impaired liver function, and those with severely compromised kidney function. While taking this medication, caution is required as various side effects such as nausea, vomiting, dizziness, headache, and fatigue may occur. Nausea and vomiting, in particular, frequently occur when adjusting the dosage and usually subside within a week. Patients with heart diseases or gastrointestinal disorders should consult a doctor due to potential slow heart rate or digestive system issues. This medication is used for patients with mild to moderate Alzheimer's-type dementia and is not proven effective for other forms of dementia or memory disorders. If rash or severe skin reactions occur, discontinue the medication immediately and consult a physician. It is important to regularly monitor weight changes during treatment. As this medication can affect heart rate, caution is especially required for patients with heart disease or bradycardia. Patients with asthma or lung conditions need to use this medication cautiously, as symptoms may worsen upon intake. It is not recommended for patients with bladder problems or urinary retention issues. Women who are pregnant or breastfeeding should always consult their doctor before taking this medication, and it is advised not to take this medication while breastfeeding. This medication may cause drowsiness or dizziness, so caution is needed when driving or operating machinery. In case of overdose, severe symptoms such as nausea, vomiting, reduced heart rate, and seizures may occur, requiring immediate medical attention. Co-administration with other cholinergic medications may increase side effects, so it must be discussed with healthcare providers. Taking this medication with food can reduce gastrointestinal discomfort, so it is advisable to take it during or after meals. If taking other medications that affect drug metabolism, dosage adjustments may be necessary, so inform your doctor. This medication should be kept out of reach of children, and it should not be transferred to other containers.

Loss of appetite, depression, dizziness, headache, tremors, fainting, drowsiness, sleepiness, bradycardia, nausea, vomiting, diarrhea, abdominal pain, upper abdominal pain, indigestion, abdominal discomfort, muscle cramps, fatigue, weakness, lethargy, weight loss, falls, lacerations, dehydration, taste disorders, hypersomnia, sensory disturbances, blurred vision, I degree atrioventricular block, palpitations, sinus bradycardia, ventricular premature contractions, flushing, hypotension, nausea, sweating, muscle weakness, hypersensitivity, hallucinations, visual hallucinations, auditory hallucinations, seizures, tinnitus, complete heart block, hypertension, hepatitis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, elevated liver enzymes, dizziness, rash, pruritus, extrapyramidal syndrome, Parkinson's syndrome, worsening of Parkinson's syndrome, hand paralysis, bradykinesia, Pisa syndrome, delirium, sweating, edema, constipation, thirst, gastritis, belching, jaundice, elevated γ-GT, elevated ALT/AST, exacerbation of chronic renal failure, urinary incontinence, drowsiness, severe nausea, gastrointestinal cramps, drooling, tearing, defecation, urination, prostration, hypersecretion of the airways, bronchospasm, Torsades de Pointes, QT prolongation, ventricular tachycardia, brief loss of consciousness

This medication should be stored in a sealed container to prevent air exposure, preferably at a temperature between 1 to 30 degrees Celsius at room temperature. Proper storage helps maintain the drug's efficacy and prevent deterioration.

Appearance

Opaque white or nearly white hard capsule containing extended-release pellets.

Package unit

30 capsules/bottle, 100 capsules/bottle