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The measures include restricting use of hydroxyzine in patients at high risk of heart rhythm problems and using the medicine at the lowest effective dose for as short a time as possible. Hydroxyzine medicines are available in most EU countries. Their approved uses indications vary between countries and may include use to treat anxiety disorders, for relief of pruritus itching, as premedication before surgery, and treatment of sleep disorders. Recommendations for these new measures were originally made by EMA's Pharmacovigilance Risk Assessment Committee PRAC, which confirmed a previously known risk of QT interval prolongation and torsades de pointes, alterations in the electrical activity of the heart that can lead to abnormal heart rhythms and cardiac arrest stopping of the heart. The PRAC therefore recommended that the price of atarax be managed by restricting hydroxyzine use in those most at risk of heart rhythm problems and reducing exposure to the medicine. It was considered appropriate to restrict the maximum daily dose in adults, with corresponding changes in the paediatric and elderly populations based on pharmacokinetic data, in order to minimise exposure.

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