VERTIMED Tablet Ref.[50388] Active ingredients: Betahistine

Patients with a history of bronchial asthma and peptic ulcer disease, should be carefully monitored during treatment.

Vertimed contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose – galactose malabsorption should not take this medicinal product.

In vivo interaction studies have not been conducted.

Based on the in vitro data, betahistine is not expected to inhibit the cytochrome P450 enzymes.

In vitro data indicate an inhibition of betahistine metabolism by drugs that inhibit monoaminooxidase (MAO) including MAO subtype B (eg., selegiline). Caution is recommended when using betahistine and MAO inhibitors (including MAO-B selective) concomitantly.

Betahistine is a histamine analogue, which is why betahistine and antihistamines concomitant administration can theoretically affect the effects of either drug.

Pregnancy

There are no adequate data from the use of betahistine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant therapeutic exposure (see section 5.3). As a precautionary measure, it is preferable to avoid the use of betahistine during pregnancy.

Lactation

It is not known whether betahistine is excreted in human milk.

Betahistine is excreted in rat milk. Effects seen post-partum in animal studies were limited to very high doses (see section 5.3). The importance of the drug to the mother should be weighed against the benefits of nursing and the potential risks for the child.

Fertility

Animal studies did not show effects on fertility in rats.

Betahistine is indicated for the symptomatic treatment of Meniére’s disease and vestibular vertigo. Both diseases can negatively affect the ability to drive and use machines.

Based on the clinical data, betahsitine has no or negligible influence on the ability to drive and use machines.

In placebo-controlled clinical trials, the following side effects were reported in patients taking betahistine, whose frequencies are defined as follows: 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), Not known (cannot be estimated from the available data).

Nervous system disorders

Common: headache.

Gastrointestinal disorders

Common: nausea and dyspepsia.

In addition, the following side effects have been reported in post-marketing clinical trials and the scientific literature. Frequency of these effects cannot be estimated from available data, which is why it has been classified as “not known”.

Immune system disorders

Not known: Hypersensitivity reactions such as anaphylaxis.

Gastrointestinal disorders

Not known: Mild gastrointestinal disturbances (eg., vomiting, abdominal pain, flatulence). They should be avoided by taking betahistine with or after a meal, or by reducing the dosage.

Skin and subcutaneous tissue disorders

Hypersensitivity reactions of the skin and subcutaneous tissue, especially angioneurotic edema, urticaria, 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 national reporting system to: (to be completed nationally).

Not applicable.