DESLORATADINE

Posology Adults and adolescents (12 years of age and over) The recommended dose of Desloratadine 5 mg 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. 1). The safety and efficacy of Desloratadine 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.

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 desloratadine 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) and not known (cannot be estimated from the available data). System organ class Frequency Adverse reactions Metabolism and nutrition disorders Not known Increased appetite Very rare Hallucinations Psychiatric disorders Not known Abnormal behaviour, aggression Common Headache Nervous system disorders Very rare Dizziness, somnolence, insomnia, psychomotor hyperactivity, seizures Very rare Tachycardia, palpitations Cardiac disorders Not known QT prolongation Common Dry mouth Gastrointestinal disorders Very rare Abdominal pain, nausea, vomiting, dyspepsia, diarrhoea Very rare Elevations of liver enzymes, increased bilirubin, hepatitisHepatobiliary 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, bradycardia, abnormal behaviour, and aggression.

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. Lactose Desloratadine 5mg film-coated tablets contain lactose.

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

1, or to loratadine.