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Microser

Microser contains betahistine, a histamine-like agent classified among medications that act on vestibular function and microcirculation. The brand is registered in 10 countries, with a footprint spread across parts of Southern and Eastern Europe, the South Caucasus, and Latin America — a distribution pattern that places it in front of travellers and expatriates moving between fairly distinct regulatory environments.

Betahistine is used in the management of conditions linked to inner-ear and vestibular disturbance, including dizziness and lightheadedness, tinnitus, and certain forms of hearing impairment, and is also referenced in connection with nausea-type symptoms such as morning sickness. The structured indication list further down this page details the registered uses recognised in each of the markets where Microser is sold, and these can vary from one national regulator to another.

Markets where Microser is registered include Italy, Argentina, Russia, Romania, and Georgia. Outside this cluster, the brand itself is not widely encountered, but betahistine as an active ingredient is available in many additional countries under different brand names. A traveller who has been prescribed Microser at home will often find that an equivalent betahistine-containing product exists in the destination country, although packaging, prescription status, and product naming will not necessarily match.

Other medications acting on vestibular function or addressing dizziness through different mechanisms are also marketed internationally; they are not interchangeable with betahistine without medical input, since each works through a different pharmacological route. A pharmacist familiar with the local formulary can confirm what is available regionally, and any decision about starting, continuing, or substituting Microser should be taken together with a healthcare provider who knows the patient's history.

Countries
Argentina Chile Czech Republic Georgia Italy Lithuania Peru Poland Romania Russia
Diseases
Morning Sickness Lightheadedness,Dizzy Tinnitus Hearing loss
Ingredients
Betahistine
Drug Actions
Nootropic Other nervous system drugs Histamine-like Histaminergic Microcirculatory improver Normalizing vestibular function

Drugs with the same active ingredients

Betaserc Meniex Ronistina Travelmin (betahistine) Agihistine Betahistine stada Bestin Betahistin actavis Betahistin arcana Betahistin-ratiopharm Betahistine apotex Betahistine eg Betahistine mylan Betahistine sandoz Bétahistine teva Betahistin pharmas Urutal Urutal forte Labirin Acuver

Overdose

A few overdose cases have been reported. Some patients experienced mild to moderate symptoms with doses up to 640 mg (e.g. nausea, somnolence, abdominal pain).Other symptoms of Microser overdose are vomiting, dyspepsia, ataxia and seizures. More serious complications (convulsion, pulmonary or cardiac complications) were observed in cases of intentional overdose of Microser especially in combination with other overdosed drugs. No specific antidote. Gastric lavage and symptomatic treatment are recommended within one hour after intake.

Incompatibilities

Not applicable.

Undesirable effects

The following undesirable effects have been experienced with the below indicated frequencies in Microser-treated patients in placebo-controlled clinical trials and in post-marketing reports: very common (> 1/10); common (> 1/100 to <1/10); uncommon (> 1/1,000 to <1/100); rare ( >1/10,000 to <1/1,000); very rare (<1/10,000); and not known (frequency cannot be estimated from the available data).

Gastrointestinal disorders:

Common:

nausea & dyspepsia

Nervous system disorders:

Common:

headache

In addition to those events reported during clinical trials, the following undesirable effects have been reported spontaneously during post-marketing use and in scientific literature. A frequency cannot be estimated from the available data and is therefore classified as “not known”.

Immune system disorders:

Not known:

hypersensitivity reactions, e.g. anaphylaxis.

Gastrointestinal disorders:

Not known:

Mild gastric complaints (e.g. vomiting, gastrointestinal pain, abdominal distension and bloating). These can normally be dealt with by taking the dose during meals or by lowering the dose.

Skin and subcutaneous tissue disorders

Not known:

cutaneous and subcutaneous hypersensitivity reactions, in particular angioneurotic oedema, urticarial, rash, and pruritus

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Preclinical safety data

Repeated dose toxicity studies of six months duration in dogs and 18 months duration in albino rats revealed no clinically relevant harmful effects at dose levels in the range 2.5 to 120 mg. kg -1. Microser is devoid of mutagenic potential and there was no evidence of carcinogenicity in rats. Tests conducted on pregnant rabbits showed no evidence of teratological effects.

Pharmacotherapeutic group

2.7 Central Nervous System. Antiemetic and anti-vertigo

Pharmacodynamic properties

Pharmacotherapeutic group: 2.7 Central Nervous System. Antiemetic and anti-vertigo

ATC code: N07C A01

The mechanism of action of Microser is only partially understood.

There are several plausible hypotheses that are supported by animal studies and human data:

Microser affects the histaminergic system:

Microser acts both as a partial histamine H1-receptor agonist and histamine H3-receptor antagonist also in neuronal tissue, and has negligible H2-receptor activity.

Microser increases histamine turnover and release by blocking presynaptic H3-receptors and inducing H3-receptor downregulation.

Microser may increase blood flow to the cochlear region as well as to the whole brain:

Pharmacological testing in animals has shown that the blood circulation in the striae vascularis of the inner ear improves, probably by means of a relaxation of the precapillary sphincters of the microcirculation of the inner ear.

Microser was also shown to increase cerebral blood flow in humans.

Microser facilitates vestibular compensation:

Microser accelerates the vestibular recovery after unilateral neurectomy in animals, by promoting and facilitating central vestibular compensation; this effect is characterised by an up-regulation of histamine turnover and release, is mediated via the H3 Receptor antagonism.

In human subjects, recovery time after vestibular neurectomy was also reduced when treated with Microser.

Microser alters neuronal firing in the vestibular nuclei:

Microser was also found to have a dose-dependent inhibiting effect on spike generation of neurons in lateral and medial vestibular nuclei.

The pharmacodynamic properties as demonstrated in animals may contribute to the therapeutic benefit of Microser in the vestibular system.

The efficacy of Microser was shown in studies in patients with vestibular vertigo and with Ménière's disease as was demonstrated by improvements in severity and frequency of vertigo attacks.

Pharmacokinetic properties

Absorption

Orally administered Microser is readily and almost completely absorbed from all parts of the gastro-intestinal tract. After absorption, the drug is rapidly and almost completely metabolized into 2-pyridylacetic acid. Plasma levels of Microser are very low. Pharmacokinetic analyses are therefore based on 2-PAA measurements in plasma and urine.

Under fed conditions Cmax is lower compared to fasted conditions. However, total absorption of Microser is similar under both conditions, indicating that food intake only slows down the absorption of Microser.

Distribution

The percentage of Microser that is bound by blood plasma proteins is less than 5 %.

Biotransformation

After absorption, Microser is rapidly and almost completely metabolised into 2-PAA (which has no pharmacological activity).

After oral administration of Microser the plasma (and urinary) concentration of 2-PAA reaches its maximum 1 hour after intake and declines with a half-life of about 3.5 hours.

Excretion:

2-PAA is readily excreted in the urine. In the dose range between 8 and 48 mg, about 85% of the original dose is recovered in the urine. Renal or fecal excretion of Microser itself is of minor importance.

Linearity:

Recovery rates are constant over the oral dose range of 8 - 48 mg indicating that the pharmacokinetics of Microser are linear, and suggesting that the involved metabolic pathway is not saturated.

Special warnings and precautions for use

Caution is advised in the treatment of patients with peptic ulcer or a history of peptic ulceration, because of the occasional dyspepsia encountered in patients on Microser.

Patients with bronchial asthma should be monitored carefully during the treatment with Microser.

Caution is advised in prescribing Microser to patients with either urticaria, rashes or allergic rhinitis, because of the possibility of aggravating these symptoms.

Caution is advised in patients with severe hypotension.

Effects on ability to drive and use machines

Microser is indicated for vertigo, tinnitus and hearing loss associated with Ménière's syndrome which can negatively affect the ability to drive and use machines. In clinical studies specifically designed to investigate the ability to drive and use machines, Microser had no or negligible effects.

Special precautions for disposal and other handling

No special requirements.

Frequently asked questions

What conditions does Microser treat?

Microser is prescribed in the management of symptoms associated with vestibular and inner-ear disturbance, including dizziness and lightheadedness, tinnitus, and certain forms of hearing impairment, and is also referenced in connection with nausea-related symptoms such as morning sickness. Its active ingredient belongs to the histamine-like category of medications that act on vestibular function. The structured indication block on this page lists each registered use in the markets where Microser is sold.

Which active substance is in Microser?

Microser contains betahistine, a histamine-like agent classified among medications that influence vestibular function and microcirculation. Betahistine is the same molecule whether sold as Microser or under other commercial names — internationally, the same active ingredient circulates under several brand names, particularly in markets where multiple manufacturers produce betahistine-containing products in parallel.

In how many countries is Microser available?

Microser is registered in 10 countries, with a footprint that spans parts of Southern and Eastern Europe, the South Caucasus, and Latin America. Examples include Italy, Argentina, Russia, Poland, Georgia, Chile, and Lithuania. If your country is not represented on this list, a local pharmacist can usually confirm whether betahistine is available in that market under a different brand name.

Are there other medications with the same active ingredient as Microser?

Betahistine is sold under several brand names worldwide, particularly in countries where multiple manufacturers produce betahistine products. Other medications addressing dizziness or vestibular symptoms through different mechanisms also exist internationally, although they are not interchangeable with betahistine without medical guidance. To identify a local betahistine-containing product, search the active ingredient on Pill2Trip or ask a pharmacist in your country.

Should I consult a doctor before taking Microser?

Yes. Microser is generally a prescription medication, and treatment for vestibular symptoms is calibrated to the underlying cause, the patient's broader medical history, and any concurrent medications. This matters particularly for travellers and expatriates, since prescription requirements, branded packaging, and available generics differ between regulatory regimes. Any decision to start, stop, switch, or substitute betahistine should be taken in consultation with a healthcare provider.

Microser

Available in 10 countries