Scored, white tablets, for oral administration containing 24 mg
Excipients : microcrystalline cellulose, mannitol, citric acid
monohydrate, colloidal anhydrous silica and talc.
Meniere's Syndrom as defined by the following trias of core symptoms:
– vertigo ( with nausea/vomiting )
– hearing loss ( hardness of hearing )
Symptomatic treatment of vestibular vertigo.
Dosage and administration
The dosage for adults is 1 tablet 2 times/day. The dosage should be individually
adapted according to the response. Improvement can sometimes only be observed
after a couple of weeks of treatment. The best results are sometimes obtained
after a few months. There are indications that treatment from the onset of the
disease prevents the progression of the disease and/or the loss of hearing in
later phases of the disease.
Hypersensitivity to any component of the product.
Warnings and special precautions for use
Patients suffering from phaeochromocytoma and patients with bronchial asthma
need to be carefully monitored during the therapy. Caution should be taken in
the treatment of patients with a history of peptic ulcer.
No interactions are known.
Pregnancy and lactation
There is insufficient data on the use of this drug during pregnancy to evaluate
possible harmful effects. There are no indications for harmful effects in animal
Effect on ability to drive and use machines
Research has shown that betahistine does not influence the ability to drive and
to use machines.
In some cases mild gastric complaints have been observed. These can normally be
dealt with by taking the dose during meals or by lowering the dose. In very rare
cases skin hypersensitivity reactions have been reported, in particular rash,
pruritus and urticaria.
A few cases of overdose ( up to 728 mg ) with mild to moderate symptoms have
been reported. At a dose of 728 mg a convulsion was reported.
In all cases recovery was complete. Treatment of overdose should include
standard supportive measures.
The mechanism of action of betahistine is not known. Pharmacological testing in
animals has shown that the blood circulation in the inner ear improves, probably
by means of a relaxation of the precapillary sphincters. In pharmacological
studies, betahistine was found to have weak H1 receptor agonistic and
considerate H3 antagonistic properties in the CNS and autonomic
nervous system. Betahistine was also found to have a dose dependent inhibiting
effect on spike generation of neurons in lateral and medial vestibular nuclei.
The importance of this observation in the action against Meniere's syndrome or
vestibular vertigo, however, remains unclear.
Betahistine dihydrochloride is completely absorbed after oral administration.
Only one metabolite, 2-pyridylacetic acid which is excreted in the urine, is
Shelf life and storage conditions
5 years at temperatures not exceeding 25°C and
3 years at temperatures not exceeding 30°C.