Antiallergic activity of loratadine a non sedating antihistamine

A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no malformative nor foeto/ neonatal toxicity of desloratadine.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).

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.

Healthcare professionals are asked to report any suspected adverse reactions via the HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: 353 1 6764971, Fax: 353 1 6762517. Desloratadine has demonstrated antiallergic properties from in vitro studies.

These include inhibiting the release of proinflammatory cytokines such as IL-4, IL-6, IL-8, and IL-13 from human mast cells/basophils, as well as inhibition of the expression of the adhesion molecule P-selectin on endothelial cells.

Neoclarityn has no or negligible influence on the ability to drive and use machines based on clinical trials.

Patients should be informed that most people do not experience drowsiness.

The absence of upper respiratory tract infection or structural abnormalities, as well as patient history, physical examinations, and appropriate laboratory and skin tests should be considered.However, cases of alcohol intolerance and intoxication have been reported during post-marketing use.Therefore, caution is recommended if alcohol is taken concomitantly.Treatment was well tolerated as documented by clinical laboratory tests, vital signs, and ECG interval data, including QTc.When given at the recommended doses, the plasma concentrations of desloratadine (see section 5.2) were comparable in the paediatric and adult populations.

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