Medication info
Reminyl PR Extended-Release Capsule 16mg (Galantamine Bromide)

Reminyl PR Extended-Release Capsule 16mg (Galantamine Bromide)

Prescription medicationHard capsuleOral
Ingredient · strength
Galantamine Hydrobromide›5.13mg / 1 capsule
Manufacturer / importer
Clinigen Korea, LLC.
Appearance
Pink hard capsule containing white to off-white extended-release granules
Packaging
56 capsules/box [7 capsules/PTP × 8]
Approval status
Active

MFDS item code 202104932 · Approved 2021.06.29 · Insurance code 076100100,646902540

Summary

Main use
Treatment of symptoms of mild to moderate Alzheimer's-type dementia
Who takes it
Adults · Children
Adult dose
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). 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). 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.

Ingredients

Importer
Clinigen Korea, LLC.

Efficacy & effects

Treatment of symptoms of mild to moderate Alzheimer's-type dementia

  • Mild dementia symptoms
  • moderate dementia symptoms
View approved original text

This medication is used to treat symptoms of mild to moderate Alzheimer's type dementia. It helps relieve memory decline, cognitive function impairment, and decreased ability to perform daily activities caused by dementia. It is effective in improving patients' cognitive abilities and quality of life.

How to take

Adult dose

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). 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). 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.

Precautions

This medication should not be used in individuals with hypersensitivity to its ingredients or in patients with severe hepatic impairment or severe renal impairment. When taking this medication, side effects such as nausea, vomiting, diarrhea, headache, dizziness, and drowsiness may occur, so caution is advised. Particularly, nausea and vomiting frequently occur during dosage adjustment and typically improve within a week. Rarely, serious side effects such as skin rash, hallucinations, seizures, and hepatitis have been reported, so if any abnormal skin symptoms occur, discontinue use immediately and consult a physician. This medication is approved for use in Alzheimer's dementia patients, and its effectiveness has not been confirmed for other types of dementia or memory disorders. Weight loss may occur during the course of treatment, so it is advisable to monitor your weight regularly. Patients with heart disease or those with a slow heart rate, as well as those with conduction disorders of the heart, should be cautious as heart-related problems may occur while taking this medication. Patients with a history of gastrointestinal ulcers or those recovering from gastrointestinal surgery should consult a physician prior to taking this medication. Patients with asthma or obstructive lung disease should use this medication carefully as respiratory symptoms may worsen. Patients recovering from bladder surgery or those with urination disorders also need to be cautious when using this medication. This medication may enhance muscle relaxant effects during anesthesia, so it must be reported if surgery is planned. Patients with lactose intolerance should avoid this medication due to the lactose it contains. Pregnant women should carefully consider the risks and benefits to the fetus before taking this medication, and breastfeeding women are advised against its use. During the initial week of treatment, dizziness or drowsiness may occur, so caution is advised when driving or operating machinery. In the case of an overdose, serious symptoms such as nausea, vomiting, bradycardia, and seizures may occur, so it is essential to adhere to the prescribed dosage, and immediate medical attention should be sought in case of overdose. Taking this medication with other cholinergic agents may increase side effects, so caution is advised when combining medications, and any other medications being taken should be disclosed as interactions with specific antibiotics or antidepressants may occur. This medication should be kept out of reach of children, and it is safer not to transfer it to other containers.

Side effects

Decreased 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 disturbances, hypersomnia, sensory disturbances, blurred vision, I degree atrioventricular block, palpitations, tachycardia, ventricular ectopic beats, flushing, hypotension, queasiness, hyperhidrosis, muscle weakness, hypersensitivity, hallucinations, visual hallucinations, auditory hallucinations, convulsions, extrapyramidal disorders, tinnitus, complete atrioventricular block, hypertension, hepatitis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, elevated liver enzymes, rash, itching, extrapyramidal syndrome, Parkinson's syndrome, worsening of Parkinson's syndrome, hand paralysis, bradykinesia, pincer syndrome, delirium, sweating, edema, constipation, thirst, gastritis, belching, jaundice, elevated γ-GT, elevated ALT/AST, worsening of chronic renal failure, urinary incontinence, vertigo, thirst, gastric cramps, drooling, tearing, defecation, urination, collapse, Torsades de Pointes, ventricular tachycardia, brief loss of consciousness

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

Storage

This medication should be stored in a sealed container to protect it from air and moisture, and it is advisable to keep it at room temperature between 1°C and 30°C. Proper storage will safely maintain the effectiveness of the medication.

Appearance and packaging

Appearance

Pink hard capsule containing white to off-white extended-release granules

Package unit

56 capsules/box [7 capsules/PTP × 8]

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.

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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.