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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/628776/2014

EMEA/H/C/000314

EPAR summary for the public

Neoclarityn

desloratadine

This is a summary of the European public assessment report (EPAR) for Neoclarityn. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Neoclarityn.

What is Neoclarityn?

Neoclarityn is a medicine containing the active substance desloratadine. It is available as a 5 mg tablet, 2.5 mg and 5 mg orodispersible tablets (tablets that dissolve in the mouth), a 0.5 mg/ml syrup and a 0.5 mg/ml oral solution.

What is Neoclarityn used for?

Neoclarityn is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, with symptoms including itching and hives).

The medicine can only be obtained with a prescription.

How is Neoclarityn used?

The recommended dose for adults and adolescents (12 years of age and over) is 5 mg once a day. The dose in children depends on their age. For children from one to five years of age, the dose is 1.25 mg once a day, taken as 2.5 ml syrup or oral solution. For children from six to 11 years of age, the dose is 2.5 mg once a day, taken either as 5 ml of the syrup or oral solution, or as one 2.5 mg orodispersible tablet. Adults and adolescents can use any form of the medicine.

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© European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged.

How does Neoclarityn work?

The active substance in Neoclarityn, desloratadine, is an antihistamine. It works by blocking the receptors to which histamine, a substance in the body that causes allergic symptoms, normally attaches itself. When the receptors are blocked, histamine cannot have its effect, and this leads to a decrease in the symptoms of allergy.

How has Neoclarityn been studied?

Neoclarityn has been studied in a total of eight studies involving about 4,800 adult and adolescent patients with allergic rhinitis (including four studies in seasonal allergic rhinitis, and two studies in patients who also had asthma). The effectiveness of Neoclarityn was measured by looking at the change in the symptoms (nasal discharge, itching, sneezing and congestion) before and after two or four weeks of treatment.

Neoclarityn has also been studied in 416 patients with urticaria. The effectiveness was measured by looking at the change in the symptoms (itching, number and size of hives, interference with sleep and daytime function) before and after six weeks of treatment.

In all studies, the effectiveness of Neoclarityn was compared with that of placebo (a dummy treatment).

Additional studies were presented to show that the syrup, oral solution and orodispersible tablets are treated by the body in the same way as the tablets, and to show that they can be used safely in children.

What benefit has Neoclarityn shown during the studies?

In allergic rhinitis, looking at the results of all studies taken together, two weeks of treatment with 5 mg Neoclarityn led to an average decrease in symptom score of 25 to 32%, compared with a decrease of 12 to 26% in the patients receiving placebo. In the two studies in urticaria, the decrease in symptom score after six weeks of treatment with Neoclarityn was 58 and 67%, compared with 40 and 33% in placebo-treated patients.

What is the risk associated with Neoclarityn?

In adults and adolescents, the most common side effects are fatigue (tiredness; 1.2%), dry mouth (0.8%) and headache (0.6%). The side effects seen in children are similar. In children less than two years of age, the most common side effects are diarrhoea (3.7%), fever (2.3%) and insomnia (difficulty sleeping; 2.3%). For the full list of all side effects reported with Neoclarityn, see the package leaflet.

Neoclarityn must not be used in people who are hypersensitive (allergic) to desloratadine, loratadine or any of the other ingredients.

Why has Neoclarityn been approved?

The CHMP decided that Neoclarityn's benefits are greater than its risks for the relief of symptoms associated with allergic rhinitis or urticaria and recommended that it be given marketing authorisation.

Neoclarityn

Other information about Neoclarityn

The European Commission granted a marketing authorisation valid throughout the European Union for Neoclarityn on 15 January 2001.

The full EPAR for Neoclarityn can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Neoclarityn, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 10-2014.

Neoclarityn

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