DESLORATADINE

Posology:

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

5 mg) desloratadine oral solution once a day. 5mg/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 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 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). System Organ Class Frequency Adverse reactions seen with desloratadine Metabolism and nutrition disorders Not known Increased appetite Psychiatric disorders Very rare Not known Hallucinations Abnormal behaviour*, aggression*, depressed mood 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 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 Eye disorder Not known Eye dryness * Undesirable effects reported during the post-marketing period also in paediatric patients.

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.

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. Desloratadine 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 rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Desloratadine Oral Solution contains propylene glycol (E1520) This medicine contains 100 mg propylene glycol (E1520) in each ml of oral solution.

Desloratadine Oral Solution contains sodium This medicine contains less than 1mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

1.