AERIUS Oral solution Ref.[116343] Active ingredients: Desloratadine

Posology

Adults and adolescents (12 years of age and over)

The recommended dose of Aerius is 10 ml (5 mg) 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 (see section 4.4) and there are no data supporting the treatment of infectious rhinitis with Aerius.

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

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

The safety and efficacy of Aerius 0.5 mg/ml oral solution in children below the age of 1 year have not been established.

There is limited clinical trial efficacy experience with the use of desloratadine in children 1 through 11 years of age and adolescents 12 through 17 years of age (see sections 4.8 and 5.1).

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.

The adverse event profile associated with overdosage, as seen during post-marketing use, is similar to that seen with therapeutic doses, but the magnitude of the effects can be higher.

Treatment

In the event of overdose, consider standard measures to remove unabsorbed active substance. Symptomatic and supportive treatment is recommended.

Desloratadine is not eliminated by haemodialysis; it is not known if it is eliminated by peritoneal dialysis.

Symptoms

Based on a multiple dose clinical trial in adults and adolescents, in which up to 45 mg of desloratadine was administered (nine times the clinical dose), no clinically relevant effects were observed.

Paediatric population

The adverse event profile associated with overdosage, as seen during post-marketing use, is similar to that seen with therapeutic doses, but the magnitude of the effects can be higher.

2 years.

Do not freeze. Store in the original package.

Aerius oral solution, is supplied in 30, 50, 60, 100, 120, 150, 225 and 300 ml size Type III amber glass bottles closed with a plastic child resistant (C/R) screw closure having a multi-ply polyethylene-faced liner. All packages except the 150 ml package are supplied with a measuring spoon marked for doses of 2.5 ml and 5 ml. For the 150 ml package, a measuring spoon or an oral measuring syringe is provided, marked for doses of 2.5 ml and 5 ml.

Not all pack sizes may be marketed.

No special requirements.