BETA-SYNTO Tablet Ref.[28144] Active ingredients: Betahistine

It is recommended to closely monitor patients with a history of peptic ulcers even though studies in healthy subjects showed no elevation of gastric acid secretion by betahistine dihydrochloride.

Caution should be exercised in patients with bronchial asthma. These patients need to be carefully monitored during the therapy.

This medicinal product contains lactose. 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.

Although an antagonism between betahistine and antihistamines could be expected on a theoretical basis, no such interactions have been reported.

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. Betahistine should not be used during pregnancy unless clearly necessary.

Breast-feeding

It is not known whether betahistine is excreted in human milk. There are no animal studies on the excretion of betahistine in milk. The importance of the drug to the mother should be weighed against the benefits of nursing and the potential risks for the child.

Betahistine is regarded to have no or negligible effects on the ability to drive and use machines as no effects potentially influencing this ability were found to be related to betahistine in clinical studies.

The following undesirable effects have been experienced with the below indicated frequencies in betahistine-treated patients in placebo-controlled clinical trials [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)].

Gastrointestinal disorders

Common: Nausea and dyspepsia

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

Hypersensitivity reactions, e.g. anaphylaxis have been reported.

Nervous System disorders

Headache

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 is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product. Any suspected adverse reactions should be reported to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs Fax: +357 22608649.

Not applicable.