Aerius

HOS-084288 · has-adverse-reaction-information · PDF-Seite 11

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). 11  System Organ Class Frequency Adverse reactions seen with Aerius Metabolism and nutrition Not known Increased appetite disorders Psychiatric disorders Very rare Hallucinations Not known Abnormal behaviour*, aggression*, depressed mood Nervous system disorders Common Headache Common (children less Insomnia than 2 years) Very rare Dizziness, somnolence, insomnia, psychomotor hyperactivity, seizures Eye disorders Not known Eye dryness Cardiac disorders Very rare Tachycardia, palpitations Not known QT prolongation* Gastrointestinal disorders Common Dry mouth Common (children less Diarrhoea than 2 years) Very rare Abdominal pain, nausea, vomiting,

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HOS-084282 · has-adverse-reaction-information · PDF-Seite 4

Summary of the safety profile In clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg daily, undesirable effects with Aerius were reported in 3 % of patients in excess of those treated with placebo. The most frequent of adverse reactions 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). System Organ Class Frequency Adverse reactions seen with Aerius Metabolism and nutrition Not known Increased appetite disorders Psychiatric disorders Very rare Hallucinations Not known Abnormal behaviour*, aggression*, depressed mood Nervous system disorders Common Headache Very rare Dizziness, somnolence, insomnia, psychomotor hyperactivity, seizures Eye disorders Not known Eye dryness Cardiac disorders Very rare Tachycardia, palpitations Not known QT prolongation* Gastrointestinal disorders Common Dry mouth Very rare Abdominal pain, nausea, vomiting, dyspepsia, diarrhoea Hepatobiliary disorders Very rare Elevations of liver enzymes, increased bilirubin, hepatitis Not known J

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HOS-084278 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, or to loratadine.

HOS-084284 · has-contraindication-information · PDF-Seite 10

Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, or to loratadine.

HOS-084277 · has-indication-information · PDF-Seite 2

Aerius is indicated in adults and adolescents aged 12 years and older for the relief of symptoms associated with: - allergic rhinitis (see section 5.1) - urticaria (see section 5.1)

HOS-084283 · has-indication-information · PDF-Seite 9

Aerius is indicated in adults, adolescents and children over the age of 1 year for the relief of symptoms associated with: - allergic rhinitis (see section 5.1) - urticaria (see section 5.1)

HOS-084286 · has-interaction-information · PDF-Seite 11

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.

HOS-084280 · has-interaction-information · PDF-Seite 3

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.

HOS-084287 · has-pregnancy-information · PDF-Seite 11

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.

HOS-084281 · has-pregnancy-information · PDF-Seite 3

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.

HOS-084285 · has-warning-information · PDF-Seite 10

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-

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HOS-084279 · has-warning-information · PDF-Seite 3

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 tablet contains lactose Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.