Delor

Delor is indicated in adults and adolescents aged 12 years and older for the relief of symptoms associated with:

- allergic rhinitis

- urticaria

Delor is indicated in adults, adolescents and children over the age of 1 year for the relief of symptoms associated with:

- allergic rhinitis

- urticaria.

Posology

Adults and adolescents (12 years of age and over)

The recommended dose of Delor is one tablet once a day.

Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or for less than 4 weeks) should be managed in accordance with the evaluation of patient's disease history and the treatment could be discontinued after symptoms are resolved and reinitiated upon their reappearance.

In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and for more than 4 weeks), continued treatment may be proposed to the patients during the allergen exposure periods.

Paediatric population

There is limited clinical trial efficacy experience with the use of desloratadine in adolescents 12 through 17 years of age.

The safety and efficacy of Delor 5 mg film-coated tablets in children below the age of 12 years have not been established. No data are available.

Method of administration

Oral use.

The dose can be taken with or without food.

Posology

Adults and adolescents 12 years of age and over.

The recommended dose of Delor oral solution is 10ml (5mg) oral solution once a day.

Paediatric Population

The prescriber should be aware that most cases of rhinitis below 2 years of age are of infectious origin and there are no data supporting the treatment of infectious rhinitis with Delor oral solution.

Children 1 through 5 years of age: 2.5 ml (1.25 mg) Delor oral solution once a day.

Children 6 through 11 years of age: 5 ml (2.5 mg) Delor oral solution once a day.

The safety and efficacy of Delor 0.5mg/ml oral solution in children below the age of 1 year have not been established. No data are available.

There is limited clinical trial efficacy experience with the use of Delor in children 1 through 11 years of age and adolescents 12 through 17 years of age.

Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or for less than 4 weeks) should be managed in accordance with the evaluation of patient's disease history and the treatment could be discontinued after symptoms are resolved and reinitiated upon their reappearance.

In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and for more than 4 weeks), continued treatment may be proposed to the patients during the allergen exposure periods.

Method of Administration

Oral use.

The dose can be taken with or without food.

In the case of severe renal insufficiency, Delor should be used with caution.

Desloratadine should be administered with caution in patients with medical or familial history of seizures, and mainly young children, being more susceptible to develop new seizures under desloratadine treatment. Healthcare providers may consider discontinuing desloratadine in patients who experience a seizure while on treatment.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Paediatric population

In children below 2 years of age, the diagnosis of allergic rhinitis is particularly difficult to distinguish from other forms of rhinitis. 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.

Approximately 6 % of adults and children 2- to 11-year old are phenotypic poor metabolisers of Delor and exhibit a higher exposure. The safety of Delor in children 2- to 11-years of age who are poor metabolisers is the same as in children who are normal metabolisers. The effects of Delor in poor metabolisers < 2 years of age have not been studied.

In the case of severe renal insufficiency, Delor oral solution should be used with caution.

This medicinal product contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.