Leaflet BETAHISTINA DICLORHIDRAT AUROBINDO 8mg tablets

Product code:
W66441006
Quantity:
100
Indicated for:
vertigo; vestibular disorders
Route of administration:
oral
Substance:
betahistine (antihistamine)
ATC
N07CA01 — Nervous system | Antivertigo preparations

Precautions:

Driving impairment

This medicine may affect your ability to drive or use machines.

Drowsiness / sedation

This medicine may cause drowsiness or reduced alertness.

Betahistine is a medication primarily used to treat vertigo associated with Ménière's disease and other vestibular disorders. It works by improving blood flow in the inner ear and reducing endolymphatic pressure, which helps alleviate symptoms such as vertigo, tinnitus (ringing in the ears), and temporary hearing loss.

Betahistine is taken orally, usually in tablet form, in divided doses 2-3 times a day, as directed by a doctor. Therapeutic effects may develop gradually, and a few weeks of treatment may be required for full benefit.

The medication is generally well-tolerated but may occasionally cause side effects such as nausea, stomach discomfort, headaches, or skin allergic reactions. Taking it with food can help reduce stomach discomfort.

Betahistine is contraindicated in patients with pheochromocytoma (a tumor of the adrenal gland) and should be used with caution in those with gastric ulcers, bronchial asthma, or low blood pressure. During pregnancy or breastfeeding, its use is recommended only if the benefits outweigh the risks, as advised by a doctor.

General data about BETAHISTINA DICLORHIDRAT AUROBINDO 8mg

Substance:
betahistine
Date of latest medicines list:
01-06-2023
Product code:
W66441006
Concentration:
8mg
Pharmaceutical form:
tablets
Quantity:
100
Product type:
Generic medicine
Prescription status:
P-6L — Medicines dispensed with a medical prescription that is not retained by the pharmacy and may be renewed; the prescription may be used for 6 months from the date of issue.

Marketing authorisation

Manufacturer:
APL SWIFT SERVICES (MALTA) LIMITED - MALTA
Holder:
AUROBINDO PHARMA ROMANIA S.R.L. - ROMANIA
Number:
13599/2020/03
Shelf life:
2 years

Pharmaceutical forms available for betahistine

Concentrations available for betahistine

  • 1.25%
  • 16mg
  • 24mg
  • 8mg
  • 8mg/dose