BETAHISTINE DIHYDROCHLORIDE Tablets Ref.[6460] Active ingredients: Betahistine

Betahistine dihydrochloride is considered to be unsafe in patients with porphyria.

Betahistine dihydrochloride should be administered with caution to patients with bronchial asthma (due to clinical intolerance) or a history of peptic ulcer.

Betahistine dihydrochloride is not recommended for use in children.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take this medicine.

No in-vivo interaction studies have been performed. Based on in-vitro data no in-vivo inhibition on Cytochrome P450 enzymes is expected.

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

Betahistine dihydrochloride should not be used concurrently with antihistamines (As betahistine is an analogue of histamine, interaction of betahistine with antihistamines may in theory affect the efficacy of one of these drugs).

Pregnancy

There are no adequate data from the use of betahistine in pregnant women.

Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition and postnatal development. The potential risk for humans is unknown. 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 post-partum in animal studies were limited to very high doses. 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.

Vertigo, tinnitus and hearing loss associated with Ménière’s syndrome can negatively affect the ability to drive and use machines. In clinical studies specifically designed to investigate the ability to drive and use machines betahistine had no or negligible effects.

The following undesirable effects have been experienced with the below indicated frequencies in betahistine dihydrochloride-treated patients in placebo-controlled clinical trials (very common (≥1/10); very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000))

Gastrointestinal disorders

Common: nausea and dyspepsia

Nervous systems 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 systems disorders

Hypersensitivity reactions, e.g. anaphylaxis have been reported

Gastrointestinal disorders

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

Skin and subcutaneous tissue disorders

Cutaneous and subcutaneous hypersensitivity reactions have been reported in particular angioneurotic oedema, 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 yellow card scheme at www.mhra.gov.uk/yellowcard. or search for MHRA Yellow Card in the Google Play or Apple App Store.

None known.