Medication info

Entibeta Tablet 24 mg (Betahistine Hydrochloride)

Prescription medicationApproval withdrawn
Ingredient · strength
Betahistine Hydrochloride›Strength being verified
Manufacturer / importer
Korea Sintax Pharmaceuticals Co., Ltd.
Appearance
Blue oblong tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201905504 · Notified 2019.08.05

This product's status changed to Approval withdrawn on 2023.04.04. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of symptoms of Ménière's disease (such as dizziness and tinnitus)
Who uses it
Adults
Adult dosage
Adults: The initial dose is betahistine hydrochloride 16 mg per dose, administered orally three times daily with meals. The usual maintenance dose is betahistine hydrochloride 24 ~ 48 mg per day.

Ingredients

Manufacturer
Korea Sintax Pharmaceuticals Co., Ltd.

Efficacy & effects

Relief of symptoms of Ménière's disease (such as dizziness and tinnitus)

  • Dizziness
  • tinnitus
  • hearing loss
View approved original text

Used for dizziness, tinnitus, and hearing loss caused by Meniere's disease.

Dosage and Administration

Adult dosage

Adults: The initial dose is betahistine hydrochloride 16 mg per dose, administered orally three times daily with meals. The usual maintenance dose is betahistine hydrochloride 24 ~ 48 mg per day.

Precautions

This medication should not be used in patients with certain types of tumors such as adrenal tumors or pheochromocytoma. Patients with known allergic reactions to any of the ingredients should also avoid this medication. Caution is advised in patients with a history of peptic ulcers, current active ulcers, asthma, and those taking antihistamines. Gastrointestinal symptoms such as indigestion, diarrhea, loss of appetite, abdominal bloating, nausea, vomiting, and stomach pain may occur after taking this medication. Additionally, symptoms like headache, itching, skin rash, hives, rapid heartbeat, agitation, chest pain, excessive sweating, and transient skin flushing may also be observed. The effectiveness of this medication may diminish when taken alongside antihistamines, so caution is advised when used together. Women who are pregnant or may become pregnant should use this medication only when the benefits of treatment outweigh the risks. Caution is necessary as the safety of this medication in children has not been adequately confirmed. In elderly patients, care should be taken to reduce the dose as physical functions may be impaired. Overdosing may lead to symptoms such as dry mouth, abdominal pain, drowsiness, and nausea; in severe cases, seizures may occur. It is important to seek prompt emergency care in case of overdose. This medication should be stored in a secure place out of the reach of children and should be protected from direct sunlight and moisture. Additionally, transferring the medication to another container is not recommended as it may lead to accidents or degradation of the medication's quality.

Side effects

  • Dyspepsia
  • diarrhea
  • loss of appetite
  • abdominal bloating
  • nausea
  • vomiting
  • stomach pain
  • headache
  • itching
  • skin rash
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  • urticaria
  • palpitations
  • agitation
  • chest pain
  • sweating
  • transient erythematous rash
  • dry mouth
  • abdominal pain
  • drowsiness
  • cramps

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

Storage

This medication is sensitive to light and should be stored in a tightly sealed container that blocks light. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. Proper storage will help preserve the effectiveness and safety of the medication for a longer period.

Appearance and packaging

Appearance

Blue oblong tablet

Package unit

30 tablets/bottle, 300 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.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.