Vertran, 16 mg tablets 60 pcs

An agonist of H1-histamine receptors of the inner ear vessels and an antagonist of H3-histamine receptors of the vestibular nuclei of the central nervous system (CNS).

Indications

Meniere’s syndrome, characterized by the following main symptoms:
– dizziness (accompanied by nausea/vomiting)
– hearing loss
– tinnitus
Symptomatic treatment and prevention of vestibular dizziness (vertigo) of various etiologies.

Pharmacological effect

An agonist of H1-histamine receptors in the vessels of the inner ear and an antagonist of H3-histamine receptors of the vestibular nuclei of the central nervous system (CNS).

Special instructions

Impact on the ability to drive vehicles and machinery

Based on the results of clinical studies, it is believed that the effect of betahistine on the ability to drive a car and other mechanisms is absent or insignificant, since no effects potentially affecting this ability were detected.

Active ingredient

Betahistine

Composition

1 tablet contains:

active ingredient:

betahistine dihydrochloride – 16 mg;

excipients:

MCC – 303.619 mg;

mannitol – 108.081 mg;

citric acid monohydrate – 9.4 mg;

colloidal silicon dioxide – 9.4 mg;

talc – 23.5 mg

Contraindications

Hypersensitivity to any of the components of the drug. Due to insufficient data on effectiveness and safety: pregnancy and lactation; age up to 18 years.

Side Effects

From the gastrointestinal tract: often (from >1/100 to <1/10) - nausea and dyspepsia.
From the nervous system: often (from >1/100 to <1/10) - headache.In addition to these effects identified during clinical trials, the following side effects have been reported during post-marketing use and in the scientific literature (the available data are insufficient to estimate their frequency):From the gastrointestinal tract: moderate disorders such as vomiting, pain in the gastrointestinal tract, bloating. As a rule, these effects disappear if the drug is taken simultaneously with food or after a dose reduction.From the skin and subcutaneous fat: angioedema, urticaria, itching and rash.On the part of the immune system: hypersensitivity reaction, including anaphylactic reactions have been reported.

Interaction

In vivo studies aimed at studying interactions with other drugs have not been conducted. Based on in vitro data, it can be assumed that there is no inhibition of the activity of cytochrome P450 isoenzymes.

When used simultaneously with H1-histamine receptor blockers, the therapeutic effect of betahistine may be reduced.

Overdose

Symptoms: after taking the drug in doses up to 640 mg, mild to moderate symptoms (nausea, drowsiness, abdominal pain) may be observed. More serious complications (eg, seizures, cardiopulmonary complications) may occur when taking higher doses of betahistine, especially in combination with other drugs.

Treatment: symptomatic.
Patients with pheochromocytoma should use the drug under medical supervision.

Recommendations for use

Inside, during meals.

The dose of the drug is:
Tablets 16 mg: 1/2 – 1 tablet 3 times a day.
The maximum daily dose is 48 mg.

The dose and duration of treatment should be individualized depending on the patient’s response to treatment.
Improvement is usually noted at the beginning of therapy, but it can be gradual and appear even after several weeks of treatment. A stable therapeutic effect in some cases is achieved after several months of treatment.

Dose adjustment is not required in elderly patients, as well as in patients with renal and/or liver failure.

Storage conditions

At a temperature not exceeding 25 °C.

Shelf life

3 years.

Manufacturer

Belupo, medicines and cosmetics d.d., Croatia