Neoclarityn

Posology Adults and adolescents (12 years of age and over) The recommended dose of Neoclarityn 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 Neoclarityn 5 mg film-coated 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. 3

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 Neoclarityn 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). System Organ Class Frequency Adverse reactions seen with Neoclarityn Metabolism and nutrition disorders Not known Increased appetite Psychiatric disorders Very rare Not known Hallucinations Abnormal behaviour*, aggression*, depressed mood Nervous system disorders Common Very rare Headache Dizziness, somnolence, insomnia, psychomotor hyperactivity, seizures Eye disorders Not known Eye dryness Cardiac disorders Very rare Not known Tachycardia, palpitations QT prolongation* Gastrointestinal disorders Common Very rare Dry mouth Abdominal pain, nausea, vomiting, dyspepsia, diarrhoea Hepatobiliary disorders Very rare Not known Elevations of liver enzymes, increased bilirubin, hepatitis Jaundice Skin and subcutaneous tissue disorders Not known Photosensitivity Musculoskeletal and connective tissue disorders Very rare Myalgia General disorders and administration site conditions Common Very rare Not known Fatigue Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea, pruritus, rash, and urticaria) Asthenia Investigations Not known Weight increased * Undesirable effects reported during the post-marketing period also in paediatric patients.

Paediatric population Other undesirable effects reported during the post-marketing period in paediatric patients with an unknown frequency included arrhythmia and bradycardia. 9 % of patients receiving placebo. 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.

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. Neoclarityn tablet contains lactose Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose- galactose malabsorption should not take this medicinal product.

1, or to loratadine.