BETAHISTINE HYDROCHLORIDE

Adults, including the elderly:

Initially 16 mg (two tablets) three times daily, taken preferably with meals. Maintenance doses are generally in the range 24 to 48 mg daily. Dosage should be altered according to clinical response. Paediatric population: not recommended for use in children below 18 years due to insufficient data on safety and efficacy.

Geriatric 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.

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.

Hepatic impairment:

There are no specific clinical trials available in this patient group, but according to postmarketing experience no dose adjustment appears to be necessary.

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 (≥ /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”. g. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Betahistine dihydrochloride is considered to be unsafe in patients with porphyria Betahistine dihydrochloride is not recommended for use in children. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Betahistine dihydrochloride should be administered with caution to patients with bronchial asthma (due to clinical intolerance) or a history of peptic ulcer. These patients need to be carefully monitored during the therapy.

Use in patients with hypersensitivity to betahistine dihydrochloride or any component of the tablet. Use in patients with phaeochromocytoma.