Composition: Each tablet contains:
Betahistine dihydrochloride . . . . . . . . . . . .16 mg
2 blisters of 20 tablets in a carton box.
Treatment of Ménière’s syndrome with three basic symptoms:
– Vertigo (accompanied by nausea, vomiting).
– Impaired hearing.
Treatment of symptoms of vertigo due to vestibular dysfunction.
|Dosage and administration||
Hypersensitivity to betahistine or any component of the product.
|Warnings and precautions for use||
Agihistine® 16 tablets induce histamine-like effects; therefore, caution should be taken in the following cases:
|Recommendation for pregnancy and breastfeeding||
The safety of betahistine in human pregnancy has not been completely established. This medicine should be used during pregnancy or lactation only if the expected therapeutic benefit is thought to outweigh any possible risk.
|Effects on ability to drive and use machines||
There is no information on the effect of betahistine on driving and using machinery.
|Interactions, incompatibilities of medicine||
There are no proven cases of hazardous interactions.
|Undesirable effects (ADRs)||
Agihistine® 16 is well tolerated, so it can be used for a long time. Relatively few side effects have been reported.
|Overdose and management||
Symptoms of overdose: Nausea, vomiting, dyspepsia; ataxia and seizures at higher doses.
After oral administration, betahistine dihydrochloride is rapidly and completely absorbed from the gastrointestinal tract. The drug is rapidly metabolised to one major metabolite 2-pyridylacetic acid and excreted in the urine.
|Storage conditions, shelf-life, quality specification of the medicine||
Storage conditions: Protect from humidity and light, below 30 degrees C.