BETAHISTINE DIHYDROCHLORIDE

Posology Adults:

Initial oral treatment is 24-48mg daily divided over three equal doses, taken preferably with meals. For this purpose 8 and 16mg formulations are available. Maintenance doses are generally in the range 24 - 48mg daily. If a high daily maintenance dose is needed, the 24mg strength can be used 2 times a day (1 tablet in the morning and evening).

Daily dose should not exceed 48 mg. The dosage should be individually adapted according to the response. Renal impairment There are no specific clinical trials available in this patient group, but according to post-marketing experience no dose adjustment appears to be necessary.

Caution is recommended in this group of patients. Hepatic impairment There are no specific clinical trials available in this patient group, but according to post-marketing experience no dose adjustment appears to be necessary. Caution is recommended in this group of patients.

Elderly population Although there are limited data from clinical studies in this patient group, extensive post marketing experience suggests that no dose adjustment is necessary in this patient population.

Paediatric population:

Betahistine tablets are not recommended for use in children below 18 years due to insufficient data on safety and efficacy. Method of administration Preferably during meal, with some water. Duration of treatment Improvement can sometimes only be observed after a couple of weeks of treatment.

The best results are sometimes obtained after a few months. There are indications that treatment from the onset of the disease prevents the progression of the disease and/or the loss of hearing in later phases of the disease.

The frequency of undesirable effects [is described 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)]. Adverse reactions observed during clinical trials Gastrointestinal disorders Common: nausea and dyspepsia.

Disorders of the nervous system Common: headache. In addition to these events reported in clinical trials, the following adverse events have been reported spontaneously during post-marketing experience and published in the scientific literature.

Frequency cannot be determined from available data and is therefore classified as “frequency unknown”. g. g. vomiting, abdominal pain, flatulence). 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 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Patients with bronchial asthma need to be carefully monitored during the therapy. Patients with gastric or duodenal ulcer or a history of peptic ulceration need to be carefully monitored during the therapy, because of the occasional dyspepsia encountered in patients on Betahistine.

Caution is advised in prescribing betahistine to patients with either urticaria, rashes or allergic rhinitis, because of the possibility of aggravating these symptoms. Such patients should be carefully monitored for early signs of hypersensitivity reactions to Betahistine.

Caution is advised in patients with severe hypotension Betahistine dihydrochloride 24 mg tablets contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

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