NEOCLARITYN

Posology Adults and adolescents (12 years of age and over) The recommended dose of Neoclarityn is 10 ml (5 mg) oral solution once a day. 4) and there are no data supporting the treatment of infectious rhinitis with Neoclarityn. 25 mg) Neoclarityn oral solution once a day.

5 mg) Neoclarityn oral solution once a day. 5 mg/ml oral solution in children below the age of 1 year have not been established. 1). 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. Method of administration Oral use.

The dose can be taken with or without food.

Summary of the safety profile Paediatric population In clinical trials in a paediatric population, the desloratadine syrup formulation was administered to a total of 246 children aged 6 months through 11 years. The overall incidence of adverse events in children 2 through 11 years of age was similar for the desloratadine and the placebo groups.

3 %). 5 mg dose of desloratadine oral solution. 9 % of patients receiving placebo. Adults and adolescents At the recommended dose, in clinical trials involving adults and adolescents in a range of indications including allergic rhinitis and chronic idiopathic urticaria, 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 Nervous system disorders Common Common (children less than 2 years) Very rare Headache Insomnia Dizziness, somnolence, insomnia, psychomotor hyperactivity, seizures Cardiac disorders Very rare Not known Tachycardia, palpitations QT prolongation Gastrointestinal disorders Common Common (children less than 2 years) Very rare Dry mouth Diarrhoea 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 System Organ Class Frequency Adverse reactions seen with Neoclarityn Musculoskeletal and connective tissue disorders Very rare Myalgia General disorders and administration site conditions Common Common (children less than 2 years) Very rare Not known Fatigue Fever Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea, pruritus, rash, and urticaria) 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.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 oral solution contains sorbitol (E420) This medicinal product contains 150 mg sorbitol (E420) in each ml of oral solution.

The additive effect of concomitantly administered products containing sorbitol (E420) (or fructose) and dietary intake of sorbitol (E420) (or fructose) should be taken into account. The content of sorbitol (E420) in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.

Sorbitol is a source of fructose; patients with hereditary fructose intolerance (HFI) should not take this medicinal product. 75 mg propylene glycol (E1520) in each ml of oral solution. Neoclarityn oral solution contains sodium This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

75 mg benzyl alcohol in each ml of oral solution. Benzyl alcohol may cause anaphylactoid reactions. Increased risk due to accumulation in young children. It is not recommended to be used for more than a week in young children (less than 3 years old).

High volumes should be used with caution and only if necessary, especially in subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis). Paediatric population In children below 2 years of age, the diagnosis of allergic rhinitis is particularly difficult to distinguish from other forms of rhinitis.

The absence of upper respiratory tract infection or structural abnormalities, as well as patient history, physical examinations, and appropriate laboratory and skin tests should be considered. 2). The safety of desloratadine in children 2- to 11-years of age who are poor metabolisers is the same as in children who are normal metabolisers.

The effects of desloratadine in poor metabolisers < 2 years of age have not been studied.

1, or to loratadine.