DESLORATADINE

Posology Adults and adolescents (12 years of age and over) The recommended dose of Desloratadine 5 mg orodispersible tablets is one 5mg orodispersible tablets placed in the mouth 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. 1). The safety and efficacy of desloratadine 5 mg orodispersible tablets in children below the age of 12 years have not been established.

Method of administration Oral use. The dose can be taken with or without food. Immediately before use, the blister must be carefully peeled open and the dose of orodispersible tablet removed without crushing it. The dose of orodispersible tablet is placed in the mouth where it will disperse immediately.

Water or other liquid is not needed to swallow the dose. The dose must be taken as soon as the blister has been opened.

Summary of the safety profile In clinical trials, desloratadine in the syrup formulation was administered to a paediatric population. The overall incidence of adverse reactions was similar between the desloratadine syrup and the placebo groups and did not differ significantly than the safety profile seen in adult patients.

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 desloratadine tablets were reported in 3 % of patients in excess of those treated with placebo.

6 %). 9 % of patients receiving placebo. 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) not known (cannot be estimated from the available data) . System Organ Class Frequency Adverse reactions seen with desloratadine Metabolism and nutrition disorders Not known Increased appetite 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 Very rare Tachycardia, palpitationsCardiac disorders Not known QT prolongation Common Dry mouthGastrointestinal disorders Very rare Abdominal pain, nausea, vomiting, dyspepsia, diarrhoea Very rare Elevations of liver enzymes, increased bilirubin, hepatitis Hepatobiliary disorders Not known Jaundice Skin and subcutaneous tissue disorders Not known Photosensitivity Musculoskeletal and connective tissue disorders Very rare Myalgia Common Fatigue Very rare Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea, pruritus, rash, and urticaria) General disorders and administration site conditions Not known Asthenia Investigations Not known Weight increased Paediatric population Other undesirable effects reported during the post-marketing period in paediatric patients with an unknown frequency included QT prolongation, arrhythmia, abnormal behaviour (including anger, aggression and agitation) and bradycardia.

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. 3 per 100,000 PY. 4 per 100,000 PY.

) 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.

2). 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. This product contains phenylalanine.

Phenylalanine may be harmful for people with phenylketonuria. Important information regarding the ingredients of <invented name> Sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

1, or to loratadine.