LEVOCETIRIZINE

Posology Adults and adolescents 12 years and above:

The daily recommended dose is 5 mg (1 film-coated tablet).

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 1 tablet once daily Mildly decreased renal function 60 – < 90 1 tablet once daily Moderately decreased renal function 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) 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 (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. Method of administration The film-coated tablet must be taken orally, swallowed whole with liquid and may be taken with or without food.

It is recommended to take the daily dose in one single intake.

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.

In case of persistent allergic rhinitis (symptoms experienced more than four day a week or for more than four weeks a year), continuous therapy can be proposed to the patient throughout the period of exposure to allergens. There is clinical experience with the use of levocetirizine for treatment periods of at least 6 months.

In chronic urticaria and chronic allergic rhinitis, there is clinical experience of the use of cetirizine (racemate) for up to one year.

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 ≥1/1000, <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.

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.

5). g. 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. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

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. Paediatric population 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

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