What is Desloratadine Sun?
Desloratadine Sun is a medicine containing the active substance desloratadine. It is available as tablets (5 mg).
Desloratadine Sun is a "generic medicine". This means that Desloratadine Sun is similar to a "reference medicine" already authorized in the European Union (EU) called Aerius. For more information on generic medicines, see the questions and answers by clicking here.
What is Desloratadine Sun used for?
Desloratadine Sun is used to get relief from the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, such as hay fever or allergy to dust mites) or urticaria (skin disease caused by an allergy, whose symptoms include itching and rash).
The medicine can only be obtained with a prescription.
How is Desloratadine Sun used?
The recommended dose for adults and adolescents (12 years of age and older) is 5 mg once a day.
How does Desloratadine Sun work?
The active substance in Desloratadine Sun, desloratadine, is an antihistamine. It works by blocking the receptors to which histamine, a substance in the body that causes allergic symptoms, normally attaches. Once the receptors are blocked, histamine fails to produce its effect and this leads to a decrease in allergy symptoms.
How has Desloratadine Sun been studied?
Because Desloratadine Sun is a generic medicine, studies in patients have been limited to tests to determine its bioequivalence to the reference medicine, Aerius. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.
What are the benefits and risks of Desloratadine Sun?
Because Desloratadine Sun is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.
Why has Desloratadine Sun been approved?
The CHMP concluded that, in accordance with EU requirements, Desloratadine Sun has been shown to have comparable quality and to be bioequivalent to Aerius. Therefore, the CHMP considered that, as in the case of Aerius, the benefits outweigh the identified risks and recommended the granting of the marketing authorization for Desloratadine Sun.
More information on Desloratadine Sun
On 13 January 2012, the European Commission issued a marketing authorization for Desloratadine Sun, valid throughout the European Union.
For more information about treatment with Desloratadine Sun, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 12-2011.
