Medication info
Niserol Tablet 30mg (Nisergoline)

Niserol Tablet 30mg (Nisergoline)

Prescription medicationTabletOral
Ingredient · strength
Nicergoline›30mg / 1 tablet
Manufacturer / importer
Aprogen Pharmaceuticals Co., Ltd.
Appearance
Yellow, round film-coated tablet
Packaging
Bottle packaging - 30 tablets/bottle, Bottle packaging - 100 tablets/bottle
Approval status
Active

MFDS item code 202400379 · Approved 2024.02.22 · Insurance code 645210880

Summary

Main use
Treatment of dementia syndrome (memory impairment, difficulty concentrating, etc.)
Who takes it
Adults
Adult dose
* 5, 10 mg Adults: Administer 5 ~ 10 mg of nicergoline orally per dose, 2 ~ 3 times daily before meals. Adjust the dose as appropriate according to symptoms. * 30 mg Adults: Administer 30 mg of nicergoline orally once daily before a meal. If the desired effect is not achieved at this dose, it may be increased to 60 mg. The dose may be reduced after symptoms improve. In patients with impaired renal function (serum creatinine > 175 µmol/L) (2 mg/dL), administer a reduced dose.

Ingredients

Manufacturer
Aprogen Pharmaceuticals Co., Ltd.

Efficacy & effects

Treatment of dementia syndrome (memory impairment, difficulty concentrating, etc.)

  • Apathy due to chronic cerebral circulation disorders
  • atherosclerotic headaches in the elderly
  • memory impairment
  • concentration disorders
  • judgment impairment
  • lack of initiative
View approved original text

This medication helps improve chronic cerebral circulation disorders and apathy due to sequelae of cerebral infarction. It is also used to relieve atherosclerotic headaches commonly occurring in the elderly and is utilized as an adjunct therapy for hypertension. The 30mg dosage is effective in treating primary degenerative vascular dementia and complex dementia symptoms, improving various symptoms of dementia syndrome, such as memory impairment, concentration disorders, decreased judgment, and lack of initiative. Overall, this medication is used for the improvement of symptoms related to the central nervous system and dementia symptoms.

How to take

Adult dose

* 5, 10 mg Adults: Administer 5 ~ 10 mg of nicergoline orally per dose, 2 ~ 3 times daily before meals. Adjust the dose as appropriate according to symptoms. * 30 mg Adults: Administer 30 mg of nicergoline orally once daily before a meal. If the desired effect is not achieved at this dose, it may be increased to 60 mg. The dose may be reduced after symptoms improve. In patients with impaired renal function (serum creatinine > 175 µmol/L) (2 mg/dL), administer a reduced dose.

Precautions

This medication should not be used in certain patients. Individuals who are allergic to this medication or ergot alkaloids should not take it. Patients with acute cardiac issues or acute hemorrhage should also avoid this medication. Patients taking sympathomimetic drugs should not use this medication concurrently. Patients with very slow heart rates and those who have not completed hemostasis after intracranial hemorrhage should avoid this medication as well. Additionally, it is not recommended for patients with orthostatic hypotension. Patients with mild bradycardia or renal function issues should take caution when using this medication. This medication may occasionally cause symptoms such as dyspepsia, diarrhea, constipation, nausea, vomiting, and dry mouth. It may also lead to increased liver function tests. Rarely, dizziness, changes in blood pressure, fatigue, drowsiness, headaches, and insomnia may occur. Allergic reactions such as skin rash or itching may occur as well. Reported adverse reactions after use include nightmares or mood changes, and dyspepsia. When used with antihypertensive agents, blood pressure may drop too low, so blood pressure should be checked regularly. It may affect uric acid levels, so gout patients or those with hyperuricemia should exercise caution. Caution is advised when driving or operating machinery after taking this medication. Since this medication is metabolized by the liver, it may interact with other drugs. Particularly, when used with antihypertensive medications, the antihypertensive effect may be enhanced. Women who are pregnant or may become pregnant should carefully consider the risks and benefits of taking this medication. Animal studies have shown potential harm to the fetus, so pregnant women should avoid it if possible. If breastfeeding, this medication may be excreted in breast milk, so it should be avoided or breastfeeding should be stopped if possible. Elderly individuals may have reduced bodily functions, so a reduced dosage or caution is required when taking this medication. Safety in pediatric patients has not been confirmed, so it is best not to use this medication in children. In case of overdose, blood pressure may temporarily decrease, so blood pressure changes should be closely monitored, and necessary measures should be taken. This medication should be kept out of the reach of children and stored securely in its original container.

Side effects

  • Loss of appetite
  • diarrhea
  • constipation
  • nausea
  • vomiting
  • localized upper abdominal pain or cramps
  • thirst
  • ALT increase
  • AST increase
  • dizziness
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  • orthostatic hypotension
  • hypertension
  • elevated blood uric acid
  • blood pressure reduction
  • drowsiness
  • lethargy
  • headache
  • tinnitus
  • fatigue
  • insomnia
  • rash
  • hives
  • itching
  • flushing
  • heat sensation
  • nightmares
  • mood disturbances
  • dyspepsia

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

Storage

Store this medication in a tightly closed container protected from light, preferably at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's efficacy.

Appearance and packaging

Appearance

Yellow, round film-coated tablet

Package unit

Bottle packaging - 30 tablets/bottle, Bottle packaging - 100 tablets/bottle

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.