Desloratadine Ratiopharm

Posology The recommended dose is one tablet once a day. Duration of treatment The duration of treatment depends on the type, duration and course of symptoms. If symptoms persist for more than 7 days or deteriorate, patients should seek medical advice in order to minimise the risk of masking an underlying disease.

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. For chronic idiopathic urticaria the symptoms may persist more than 6 weeks it is characterised by recurrent episodes and continued treatment may be necessary.

Paediatric population Desloratadine ratiopharm is not recommended for use in children and adolescents below 18 years of age. 1). 3 The safety and efficacy of Desloratadine ratiopharm 5 mg film-coated tablets in children below the age of 12 years have not been established.

1 but no recommendation on a posology can be made. Method of administration Oral use. The tablet 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 %). 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). 9 % of patients receiving placebo.

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. 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.

Chronic idiopathic urticaria Chronic idiopathic urticarial should initially be diagnosed by a physician. In case of symptom that indicate angioedema, the patient needs to seek medical help immediately. 8). 2). Seizures Desloratadine should be administered with caution in patients with medical or familial history of seizures, and mainly young children, 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. Excipients Lactose Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose- galactose malabsorption should not take this medicine.

Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

1.