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

Renal function impairment

In the case of severe renal insufficiency, Aerius should be used with caution (see section 5.2).

Seizures

Desloratadine should be administered with caution in patients with medical or familial history of seizures, and mainly young children (see section 4.8), 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.

Aerius oral solution contains sorbitol (E420)

This medicinal product contains 150 mg sorbitol (E420) in each ml of oral solution.

The additive effect of concomitantly administered products containing sorbitol (E420) (or fructose) and dietary intake of sorbitol (E420) (or fructose) should be taken into account. The content of sorbitol (E420) in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.

Sorbitol is a source of fructose; patients with hereditary fructose intolerance (HFI) should not take this medicinal product.

Aerius oral solution contains propylene glycol (E1520)

This medicinal product contains 100.19 mg propylene glycol (E1520) in each ml of oral solution.

Aerius oral solution contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.

Aerius oral solution contains benzyl alcohol

This medicinal product contains 0.375 mg benzyl alcohol in each ml of oral solution.

Benzyl alcohol may cause anaphylactoid reactions.

Increased risk due to accumulation in young children. It is not recommended to be used for more than a week in young children (less than 3 years old).

High volumes should be used with caution and only if necessary, especially in subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis).

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 desloratadine and exhibit a higher exposure (see section 5.2). The safety of desloratadine 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 desloratadine in poor metabolisers <2 years of age have not been studied.

No clinically relevant interactions were observed in clinical trials with desloratadine tablets in which erythromycin or ketoconazole were co-administered (see section 5.1).

Paediatric population

Interaction studies have only been performed in adults.

In a clinical pharmacology trial, Aerius tablets taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol (see section 5.1). However, cases of alcohol intolerance and intoxication have been reported during post-marketing use. Therefore, caution is recommended if alcohol is taken concomitantly.

Pregnancy

A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicates no malformative nor foetal/neonatal toxicity of desloratadine. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Aerius during pregnancy.

Breast-feeding

Desloratadine has been identified in breastfed newborns/infants of treated women. The effect of desloratadine on newborns/infants is unknown. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Aerius therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Fertility

There are no data available on male and female fertility.

Aerius 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. Nevertheless, as there is individual variation in response to all medicinal products, it is recommended that patients are advised not to engage in activities requiring mental alertness, such as driving a car or using machines, until they have established their own response to the medicinal product.

Summary of the safety profile

Adults and adolescents

At the recommended dose, in clinical trials involving adults and adolescents in a range of indications including allergic rhinitis and chronic idiopathic urticaria, undesirable effects with Aerius were reported in 3% of patients in excess of those treated with placebo. The most frequent of adverse events reported in excess of placebo were fatigue (1.2%), dry mouth (0.8%) and headache (0.6%).

Tabulated list of adverse reactions

The frequency of the clinical trial adverse reactions reported in excess of placebo and other undesirable effects reported during the post-marketing period are listed in the following table. Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

^* Undesirable effects reported during the post-marketing period also in paediatric patients.

Paediatric population

Other undesirable effects reported during the post-marketing period in paediatric patients with an unknown frequency included arrhythmia and bradycardia.

In clinical trials in a paediatric population, the desloratadine syrup formulation was administered to a total of 246 children aged 6 months through 11 years. The overall incidence of adverse events in children 2 through 11 years of age was similar for the desloratadine and the placebo groups. In infants and toddlers aged 6 to 23 months, the most frequent adverse reactions reported in excess of placebo were diarrhoea (3.7%), fever (2.3%) and insomnia (2.3%). In an additional study, no adverse events were seen in subjects between 6 and 11 years of age following a single 2.5 mg dose of desloratadine oral solution.

In a clinical trial with 578 adolescent patients, 12 through 17 years of age, the most common adverse event was headache; this occurred in 5.9% of patients treated with desloratadine and 6.9% of patients receiving placebo.

A retrospective observational safety study indicated an increased incidence of new-onset seizure in patients 0 to 19 years of age when receiving desloratadine compared with periods not receiving desloratadine. Among children 0-4 years old, the adjusted absolute increase was 37.5 (95% Confidence Interval (CI) 10.5-64.5) per 100,000 person years (PY) with a background rate of new onset seizure of 80.3 per 100,000 PY. Among patients 5-19 years of age, the adjusted absolute increase was 11.3 (95% CI 2.3-20.2) per 100,000 PY with a background rate of 36.4 per 100,000 PY. (See section 4.4.)

Reporting of suspected adverse reactions

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 national reporting system listed in Appendix V.

Not applicable.