SERC-16

Adults (including the elderly): initially two tablets three times daily taken preferably with meals. Maintenance doses are generally in the range 24-48 mg daily. 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 post-marketing experience no dose adjustment appears to be necessary.

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”. 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 Serc in bronchial asthma patients has been shown in a relatively few patients. These patients need to be carefully monitored during the therapy.

Phaeochromocytoma. Hypersensitivity to the active substance or to any of the excipients.