Medication info
Niseon Tablets 10 mg (Nisergoline)

Niseon Tablets 10 mg (Nisergoline)

Prescription medicationTabletOral
Ingredient · strength
Nicergoline›10mg / 1 tablet
Manufacturer / importer
Hwanin Pharmaceutical Co., Ltd.
Appearance
White, round, film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202401478 · Approved 2024.06.19 · Insurance code 657204190

Summary

Main use
Improvement of decreased motivation after cerebral infarction, relief of atherosclerotic headaches in older adults, and adjunctive treatment of hypertension
Who takes it
Adults
Adult dose
* 5 mg, 10 mg Adults: Administer 5 ∼ 10 mg of nicergoline orally 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, the dose may be increased to 60 mg. The dose may be reduced after symptoms improve. For patients with renal impairment (serum creatinine >175 µmol/L) (2 mg/dL), administer a reduced dose.

Ingredients

Manufacturer
Hwanin Pharmaceutical Co., Ltd.

Efficacy & effects

Improvement of decreased motivation after cerebral infarction, relief of atherosclerotic headaches in older adults, and adjunctive treatment of hypertension

  • Apathy due to chronic cerebral circulatory disorder
  • elderly arteriosclerotic headache
  • memory impairment
  • concentration disorder
  • judgment disorder
  • lack of initiative
View approved original text

The 5 mg and 10 mg dosages improve apathy arising from chronic cerebral circulatory disorders following cerebral infarction and assist in the treatment of senile arteriosclerotic headaches. It is also used as an adjunct therapy for hypertension. The 30 mg dosage is effective in treating the major symptoms of primary degenerative vascular dementia and composite dementia such as memory, concentration, judgment disorders, and lack of initiative. Thus, this medication is used to improve both cerebrovascular-related symptoms and dementia symptoms.

How to take

Adult dose

* 5 mg, 10 mg Adults: Administer 5 ∼ 10 mg of nicergoline orally 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, the dose may be increased to 60 mg. The dose may be reduced after symptoms improve. For patients with renal impairment (serum creatinine >175 µmol/L) (2 mg/dL), administer a reduced dose.

Precautions

This medication should not be used in certain patients. Individuals allergic to this drug or to ergot alkaloids should not take it. Patients with acute myocardial infarction or acute bleeding should also avoid this medication. Those taking sympathomimetic drugs, patients with significantly low heart rates (under 50 beats per minute), patients who have not completed hemostasis after intracranial hemorrhage, and individuals with orthostatic dysregulation should refrain from using this drug. Caution is required for patients with mild bradycardia or renal function issues when taking this medication. Rarely, symptoms such as dyspepsia, diarrhea, constipation, nausea, vomiting, abdominal pain, dry mouth may occur. Liver function tests may show elevated levels, so liver health should be monitored. Cardiovascular symptoms like dizziness, blood pressure changes, and orthostatic hypotension can also occur rarely. Neurological symptoms such as drowsiness, headache, fatigue, and insomnia have also been reported. Allergic reactions may manifest as rashes, hives, itching, facial flushing, and warmth, necessitating immediate notification of any unusual symptoms. When taken with other antihypertensive medications, blood pressure may decrease excessively, so blood pressure should be routinely monitored. It may affect uric acid levels, so patients with a history of gout should use caution. Be careful when driving or operating machinery after taking this medication. This drug is metabolized in the liver by a specific enzyme (CYP450 2D6), and interactions may occur with other medications using this enzyme. Women who are pregnant or may become pregnant should carefully assess the risks and benefits of using this drug, and breastfeeding women should avoid taking it if possible or stop breastfeeding. The elderly may need to adjust the dosage due to decreased bodily functions. Safety for pediatric use has not yet been established, so it is advisable to avoid its use. In cases of overdose, blood pressure may temporarily decrease, so changes in blood pressure should be closely monitored, and appropriate measures should be taken when necessary. This medication should be stored out of the reach of children and kept sealed in its original container.

Side effects

  • Loss of appetite
  • diarrhea
  • constipation
  • nausea
  • vomiting
  • acute upper abdominal pain or cramping
  • dry mouth
  • ALT elevation
  • AST elevation
  • dizziness
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  • orthostatic hypotension
  • hypertension
  • elevated blood uric acid
  • blood pressure reduction
  • drowsiness
  • fatigue
  • headache
  • tinnitus
  • tiredness
  • insomnia
  • rash
  • urticaria
  • itchiness
  • flushing
  • heat sensation
  • nightmares
  • mood disturbances
  • indigestion

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

Storage

This drug should be stored in a tightly closed container to prevent air and moisture from entering, and it is recommended to keep it at room temperature between 1 and 30 degrees. Proper storage will help maintain the drug's efficacy over time.

Appearance and packaging

Appearance

White, round, film-coated tablet

Package unit

30 tablets/bottle, 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.