LEVOCETIRIZINE DIHYDROCHLORIDE

Adults and adolescents 12 years and above:

The daily recommended dose is 5mg (1 film-coated tablet) Elderly: Adjustment of the dose is recommended in elderly patients with moderate to severe renal impairment (see Patients with renal impairment below) Children aged 6 to 12 years: The daily recommended dose is 5mg (1 film-coated tablet) For children aged 2 to 6 years no adjusted dosage is possible with the film-coated tablet formulation.

It is recommended to use a paediatric formulation of levocetirizine.

Patients with renal impairment:

The dosing intervals must be individualized according to renal function. Refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient’s creatinine clearance (CLcr) in ml/min is needed.

85 for woman) 72 x serum creatinine (mg/dl) Dosing adjustments for patients with impaired renal function: Group Creatinine clearance (ml/min) Dosage and frequency Normal > 90 1 tablet once daily Mildly decreased renal function 60 – < 90 1 tablet once daily Moderately decreased renal fuction 30 – 60 1 tablet once every 2 days Severely decreased renal function 15 – < 30 (not requiring dialysis) 1 tablet once every 3 days End – stage renal disease (ESRD) < 15 (requiring dialysis treatment) Contraindicated 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.

Patients with 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 Patients with renal impairment above) Duration of use: Intermittent allergic rhinitis (symptoms <4days/week or during less than 4 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.

In case of persistent allergic rhinitis (symptoms >4days/week and during more than 4 weeks a year), continuous therapy can be proposed to the patient during the period of exposure to allergens. Clinical experience with 5mg levocetirizine as a film-coated tablet formulation is currently available for a 6-month treatment period.

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 drug at the recommended dose of 5mg daily.

From this pooling, the following incidents of adverse drug reactions were reported at rates of 1% or greater (common: >1/100, <1/10) under levocetirizine 5mg or placebo. 5%) Further uncommon incidences of adverse reaction (uncommon >1/1000, <1/100) like asthenia or abdominal pain were observed.

1%). 25mg 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 5mg 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). Caution should be taken in patients with predisposing factors of urinary retention (eg spinal cord lesion, prostatic hyperplasia) as levocetirizine may increase the risk of urinary retention. Caution should be taken in patients with epilepsy and patients at risk of convulsion as levocetirizine may cause seizure aggravation.

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.

The use of the film-coated tablet formulation is not recommended in children aged less than 6 years since this formulation does not allow for appropriate dose adaptation. It is recommended to use a paediatric formulation of levocetirizine.

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

1. Patients with severe renal impairment at less than 10ml/min creatinine clearance.