Reminyl PR Extended Release Capsule 8mg (Galantamine Bromide)

Adult dose

(Adults) Administer once daily in the morning. It is best taken immediately after breakfast. 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: A dose of 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 assessment of clinical benefit and tolerability, the dose may be increased up to a maximum of 24mg daily. - For patients who do not tolerate 24mg daily or have no improvement in response, consider reducing the dose to 16mg daily. - This medicine may be continued for as long as it benefits the patient. Assess the clinical benefit of this medicine regularly and consider discontinuing treatment if it is ineffective. - No rebound phenomenon occurs after discontinuation of treatment (e.g., in preparation for surgery). (Patients with renal or hepatic impairment) Blood concentrations of galantamine may increase in patients with moderate to severe renal or hepatic impairment. For patients with moderate hepatic impairment, based on pharmacokinetic modeling, administer 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 required in patients with mild hepatic impairment. No dose adjustment is required in patients with a 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 or in patients with severe liver or renal impairment. Caution is required as symptoms such as nausea, vomiting, diarrhea, dizziness, and headaches may occur when taking this medication. Particularly, nausea and vomiting are the most commonly occurring symptoms, which typically appear during the dose adjustment period and usually resolve within a week. Serious side effects such as skin rash, hallucinations, convulsions, and cardiac rhythm disturbances have been reported rarely, so immediate consultation with a healthcare professional is necessary if unusual symptoms occur. This medication is used for patients with Alzheimer's-type dementia, and its effectiveness has not been confirmed for other types of dementia or memory disorders. During treatment, periodic monitoring of weight changes is necessary, and patients with heart disease, gastrointestinal disorders, asthma, or bladder problems need special attention. Additionally, this medication should not be taken with other cholinergic agents, and combining it with drugs that lower heart rate may lead to cardiac-related side effects. Women who are pregnant or breastfeeding should consult a doctor before taking this medication, and it is advisable for breastfeeding mothers not to take this medication. Caution should be taken as dizziness or drowsiness may occur after taking this medication when driving or operating machinery. In case of overdose, serious symptoms such as vomiting, bradycardia, and convulsions may occur, so the dosage must be strictly adhered to, and immediate medical attention is required in case of overdose. This medication should be kept out of the reach of children, and it is safer not to transfer it to other containers.

Decreased appetite, depression, dizziness, headache, tremor, fainting, drowsiness, sleepiness, bradycardia, nausea, vomiting, diarrhea, abdominal pain, epigastric pain, dyspepsia, abdominal discomfort, muscle cramps, fatigue, weakness, lethargy, weight loss, falls, laceration, dehydration, taste abnormality, hypersomnia, sensory disturbance, blurred vision, I degree atrioventricular block, palpitations, sinus bradycardia, ventricular extrasystole, flushing, hypotension, nausea, sweating, muscle weakness, hypersensitivity, hallucination, visual hallucination, auditory hallucination, convulsion, extrapyramidal disorder, tinnitus, complete atrioventricular block, hypertension, hepatitis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, increased liver enzymes, rash, itching, extrapyramidal syndrome, Parkinson's syndrome, exacerbation of Parkinson's syndrome, hand paralysis, bradykinesia, Pierre Robin syndrome, delirium, sweating, edema, constipation, thirst, gastritis, belching, jaundice, elevated γ-GT, elevated ALT/AST, exacerbation of chronic kidney failure, urinary incontinence, vertigo, thirst, gastrointestinal spasms, drooling, lacrimation, bowel movement, urination, prostration, Torsades de Pointes, ventricular tachycardia, brief loss of consciousness

This medication should be stored in a tightly sealed container to prevent air and moisture intrusion and kept at a temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness and prevent deterioration.

Appearance

White opaque hard capsules containing white to off-white sustained-release granules

Package unit

56 capsules/box [7 capsules/PTP × 8]