XYZAL

Posology Adults and adolescents 12 years and above:

The daily recommended dose is 5 mg (10 ml of solution). Elderly Adjustment of the dose is recommended in elderly patients with moderate to severe renal impairment (see Renal impairment below). Renal impairment The dosing intervals must be individualised according to renal function (eGFR – estimated Glomerular Filtration Rate).

Refer to the following table and adjust the dose as indicated.

Dosing adjustments for patients with impaired renal function:

Group eGFR (ml/min) Dosage and frequency Normal renal function ≥ 90 5 mg once daily Mildly decreased renal function 60 – < 90 5 mg once daily Moderately decreased renal function 30 – < 60 5 mg once every 2 days Severely decreased renal function 15 - < 30 (not requiring dialysis) 5 mg once every 3 days End-stage renal disease (ESRD) < 15 (requiring dialysis treatment) Contra-indicated In paediatric patients suffering from renal impairment, the dose will have to be adjusted on an individual basis taking into account the renal clearance of the patient and his body weight.

There are no specific data for children with renal impairment. Hepatic impairment No dose adjustment is needed in patients with solely hepatic impairment. In patients with hepatic impairment and renal impairment, adjustment of the dose is recommended (see Renal impairment above).

Paediatric population Children aged 6 to 12 years:

The daily recommended dose is 5 mg (10 ml of solution). 5 ml of solution twice daily). 4). Method of administration An oral syringe is included in the package. The appropriate volume of oral solution should be measured with the oral syringe, and poured in a spoon or in a glass of water.

The oral solution must be taken orally immediately after dilution, and may be taken with or without food.

Duration of use:

Intermittent allergic rhinitis (symptoms experienced for less than four days a week or for less than four weeks a year) has to be treated according to the disease and its history; it can be stopped once the symptoms have disappeared and can be restarted again when symptoms reappear.

3% in the placebo group. 6 % of these adverse drug reactions were mild to moderate. 8% (14/771) with placebo. Clinical therapeutic trials with levocetirizine included 935 subjects exposed to the medicinal product at the recommended dose of 5 mg daily.

5%) Further uncommon incidences of adverse reactions (uncommon ≥1/1,000 to <1/100) like asthenia or abdominal pain were observed. 1%). 25 mg twice daily respectively. The following incidence of adverse drug reactions was reported at rates of 1% or greater under levocetirizine or placebo.

3%) In children aged 6-12 years double blind placebo controlled studies were performed where 243 children were exposed to 5 mg levocetirizine daily for variable periods ranging from less than 1 week to 13 weeks. The following incidence of adverse drug reactions was reported at rates of 1% or greater under levocetirizine or placebo.

9%) Post-marketing experience Adverse reactions from post-marketing experience are per System Organ Class and per frequency. The frequency is defined as follows: 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), not known (cannot be estimated from the available data).

• Immune system disorders: Not known: hypersensitivity including anaphylaxis • Metabolism and nutrition disorders: Not known: increased appetite • Psychiatric disorders: Not known: aggression, agitation, hallucination, depression, insomnia, suicidal ideation, nightmare • Nervous system disorders: Not known: convulsion, paraesthesia, dizziness, syncope, tremor, dysgeusia • Ear and labyrinth disorders: Not known: vertigo • Eyes disorders: Not known: visual disturbances, blurred vision, oculogyration • Cardiac disorders: Not known: palpitations, tachycardia • Respiratory, thoracic and mediastinal disorders: Not known: dyspnoea • Gastrointestinal disorders: Not known: nausea, vomiting, diarrhoea • Hepatobiliary disorders: Not known: hepatitis • Renal and urinary disorders: Not known: dysuria, urinary retention • Skin and subcutaneous tissue disorders: Not known: angioneurotic oedema, fixed drug eruption, pruritus, rash, urticaria • Musculoskeletal, connective tissues, and bone disorders: Not known: myalgia, arthralgia • General disorders and administration site conditions: Not known: oedema • Investigations: Not known: weight increased, abnormal liver function tests Description of selected adverse reactions After levocetirizine discontinuation, pruritus has been reported.

5). Xyzal contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed). Caution should be taken in patients with epilepsy and patients at risk of convulsion as levocetirizine may cause seizure aggravation.

Xyzal contains maltitol liquid Patients with rare hereditary problems of fructose intolerance should not take this medicine. g. spinal cord lesion, prostatic hyperplasia) as levocetirizine may increase the risk of urinary retention. Response to allergy skin tests are inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them.

Pruritus may occur when levocetirizine is stopped even if those symptoms were not present before treatment initiation. The symptoms may resolve spontaneously. In some cases, the symptoms may be intense and may require treatment to be restarted.

The symptoms should resolve when the treatment is restarted. 2), these data are not sufficient to support the administration of levocetirizine to infants and toddlers aged less than 2 years. This medicine contains less than 1 mmol sodium (23 mg) per ml that is to say essentially ‘sodium-free’.

1. Patients with end stage renal disease with estimated Glomerular Filtration Rate (eGFR) below 15 ml/min (requiring dialysis treatment).