Desodene 5 mg. Tablets

DESODENE is indicated for the relief of symptoms associated with seasonal allergic rhinitis.

Adults and adolescents (>12 years of age): One tablet once a day regardless of mealtime, Improvement of symptoms associated with seasonal allergic rhinitis usually becomes noticeable within 1 - 2 hours after administration of DESODENE.

Hypersensitivity to the active substance or to any of the excipients.

In the case of severe renal insufficiency, DESODENE should be used with caution (see Pharmacokinetic properties). DESODENE 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 DESODENE treatment. Healthcare providers may consider discontinuing DESODENE in patients who experience a seizure while on treatment. DESODENE lacks significant sedative effects, however, some individuals may still experience the sedative effects. It is therefore advisable to determine individual response before driving or performing complicated tasks. Safety and efficacy of DESODENE in children under 12 years of age have not been established. Safety and efficacy of desloratadine have not been established for treatment periods in excess of 4 weeks. DESODENE tablets should not be taken by patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

DESODENE taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol. Co-administration of DESODENE with ketoconazole increases the maximum desloratadine concentration (C max) by 45 % and the area under the time concentration curve (AUC) by 37 %. Co-administration of DESODENE with erythromycin increased the C max of desloratadine by 24 % and the AUC by 14 %. Co-administration of DESODENE with azithromycin resulted in an increase of both C max (31 %) and AUC (12 %) of azithromycin. Co-administration of DESODENE with cimetidine did not significantly affect the pharmacokinetics of desloratadine. Co-administration of DESODENE with fluoxetine caused an increased in the C max of desloratadine by 15 %, and an increase of 13 % in AUC, and 17 % in the C max of 3-OH desloratadine respectively. The C max and AUC of fluoxetine were reduced by 9 % and 11 % respectively. The corresponding mean parameters of norfluoxetine increased by 23 % and 18 % respectively, with co-administration of DESODENE and fluoxetine. There is no effect of food and grapefruit juice on DESODENE.

Pregnancy: Safety in pregnancy and lactation has not been established. The use of DESODENE during pregnancy is therefore not recommended. Lactation: Desloratadine is excreted into breast milk, therefore the use of DESODENE is not recommended in breastfeeding women.

A few patients treated with non-sedating anti-histamines have experienced drowsiness. Therefore it is prudent to exercise caution before driving or operating machinery. The effect of a drug on a particular patient can be ascertained after the first few doses.

Metabolism and nutrition disorders: Frequency unknown: Increased appetite.
Psychiatric disorders: Less frequent: Hallucinations. Frequency unknown: Abnormal behaviour, aggression.
Nervous system disorders: Frequent: Headache. Less frequent: Dizziness, fatigue, somnolence, insomnia, seizures, psychomotor hyperactivity.
Cardiac disorders: Less frequent: Tachycardia, palpitations. Frequency unknown: QT prolongation.
Respiratory, thoracic and mediastinal disorders: Frequent: Pharyngitis.
Gastrointestinal disorders: Frequent: Dry mouth. Less frequent: Abdominal pain, nausea, vomiting, dyspepsia, diarrhoea.
Hepatobiliary disorders: Less frequent: Elevations of liver enzymes, increased bilirubin, hepatitis. Frequency unknown: Jaundice.
Skin and subcutaneous tissue disorders: Frequency unknown: Photosensitivity.
Musculoskeletal, connective tissue and bone disorders: Less frequent: Myalgia.
Reproductive system and breast disorders: Less frequent: Dysmenorrhoea.
General disorders and administration site conditions: Frequent: Fatigue. Less frequent: Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea, pruritis, rash and urticaria). Frequency unknown: Asthenia. Investigations: Frequency unknown: Weight increased.

In the event of overdose, consider standard measures to remove unabsorbed active substance. Symptomatic and supportive treatment is recommended. Desloratadine is not eliminated by haemodialysis; it is not known if it is eliminated by peritoneal dialysis.