BETAHISTINE DIHYDROCHLORIDE

Posology Adults (including the elderly): initially 16 mg three times daily taken preferably with meals. Maintenance doses are generally in the range 24-48 mg daily.

Paediatric population:

Betahistine should not be used in children aged below 18 years due to insufficient data on safety and efficacy.

Elderly:

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 post-marketing experience no dose adjustment appears to be necessary.

Method of administration:

Oral. Swallow the tablets with water. Preferably take the tablet with a meal.

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)].

Gastrointestinal disorders Common: nausea and dyspepsia Nervous System 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”.

Blood and lymphatic system disorders Not known:

Thrombocytopenia. g. anaphylaxis have been reported. 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.

Caution is advised in the treatment of patients with a history of peptic ulcer. Clinical intolerance to betahistine in bronchial asthma patients has been shown in a relatively few patients. These patients need to be carefully monitored during the therapy.

Caution is advised in prescribing betahistine to patients with either urticaria, rashes or allergic rhinitis, because of the possibility of aggravating these symptoms Caution is advised in patients with severe hypotension. Betahistine is not the appropriate treatment for the following pathologies: • Benign paroxysmal vertigo • Dizziness related to central nervous system disease Precautions for use Taking the drug in the middle of meals helps avoid gastralgia.

Phaeochromocytoma. 1. As betahistine is a synthetic analogue of histamine it may induce the release of catecholamines from the tumor resulting in severe hypertension.