Neoclarityn 5 mg film-coated tablets Ref.[2727] Active ingredients: Desloratadine

Efficacy and safety of Neoclarityn tablets in children under 12 years of age have not been established.

In the case of severe renal insufficiency, Neoclarityn should be used with caution (see section 5.2).

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

No clinically relevant interactions were observed in clinical trials with desloratadine tablets in which erythromycin or ketoconazole were co-administered (see section 5.1).

In a clinical pharmacology trial Neoclarityn taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol (see section 5.1).

Desloratadine was not teratogenic in animal studies. The safe use of the medicinal product during pregnancy has not been established. The use of Neoclarityn during pregnancy is therefore not recommended.

Desloratadine is excreted into breast milk, therefore the use of Neoclarityn is not recommended in breast-feeding women.

In clinical trials that assessed the driving ability, no impairment occurred in patients receiving desloratadine. However, patients should be informed that very rarely some people experience drowsiness, which may affect their ability to drive or use machines.

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 Neoclarityn 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 %). In a clinical trial with 578 adolescent patients, 12 through 17 years of age, the most common adverse event was headache; this occurred in 5.9 % of patients treated with desloratadine and 6.9 % of patients receiving placebo. Other undesirable effects reported very rarely during the post-marketing period are listed in the following table.

Psychiatric disorders: Hallucinations

Nervous system disorders: Dizziness, somnolence, insomnia, psychomotor hyperactivity, seizures

Cardiac disorders: Tachycardia, palpitations

Gastrointestinal disorders: Abdominal pain, nausea, vomiting, dyspepsia, diarrhoea

Hepatobiliary disorders: Elevations of liver enzymes, increased bilirubin, hepatitis

Musculoskeletal and connective tissue disorders: Myalgia

General disorders: Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea, pruritus, rash, and urticaria)

Not applicable.