Posology and 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 < 4 days/week or for 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 > 4 days/week or for more than 4 weeks a year), continuous therapy can be proposed to the patient during 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 use of cetirizine (racemate) for up to one year.

Route of Administration

For oral use.

Adults and adolescents 12 years and above

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

Children

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

• Children aged 6 to 12 years

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

• 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 (see Section Special Warnings and Special Precautions for Use).

• Children aged less than 2 years

The administration of levocetirizine to infants and toddlers aged less than 2 years is not recommended (see Section Special Warnings and Special Precautions for Use).

Elderly

Adjustment of the dose is recommended in elderly patients with moderate to severe renal impairment (see Section Renal Impairment).

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. The CLCR (mL/min) may be estimated from serum creatinine (mg/dL) determination using the following formula: CLCR = [140-age (years)] x weight (kg) /72 x serum creatinine (mg/dL) Dosing adjustments for patients with impaired renal function:

Group Creatinine clearance Dosage and frequency

• Normal ≥ 80 (5 mg one tablet) once daily

• Mild 50 - 79 (5 mg one tablet) once daily

• Moderate 30 - 49 (5 mg one tablet) once every 2 days

• Severe < 30 (5 mg one tablet) once every 3 days

End-stage renal disease

Patients undergoing dialysis

< 10 Contraindicated

In pediatric 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/her 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).

Contraindications

Vozet is contraindicated in:

• Hypersensitivity to levocetirizine, to cetirizine, to hydroxyzine, to any piperazine derivatives or to any of the excipients (see Section Special Warnings and Special Precautions for use and List of excipents)

• Severe renal impairment at less than 10 mL/min creatinine clearance.

Special Warnings and Special Precautions for Use

Alcohol

Precaution is recommended with concurrent intake of alcohol (see Interactions with other Medicaments and other Forms of Interaction).

Risk of urinary retention

Caution should be taken in patients with predisposing factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) as levocetirizine may increase the risk of urinary retention.

Risk of seizure aggravation

Levocetirizine may cause seizure aggravation.

Allergy skin tests

Response to allergy skin tests are inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them.

Withdrawal syndrome

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.

Infants and children under 2 years

Even if some clinical data are available in children aged 6 months to 12 years (see Section Undesirable Effects; Pharmacodynamic Effects), these data are not sufficient to support the administration of levocetirizine to infants and toddlers aged less than 2 years. Therefore, the administration of levocetirizine to infants and toddlers aged less than 2 years is not recommended.

Children aged less than 6 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.

Lactose

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

Interactions with Other Medicaments and Other Forms of

Interaction

Theophylline

A small decrease in the clearance of cetirizine (16%) was observed in a multiple dose study with theophylline (400 mg once a day); while the disposition of theophylline was not altered by concomitant cetirizine administration.

Ritonavir

In a multiple dose study of ritonavir (600 mg twice daily) and cetirizine (10 mg daily), the extent of exposure to cetirizine was increased by about 40% while the disposition of ritonavir was slightly altered (-11%) further to concomitant cetirizine administration.

Food

The extent of absorption of levocetirizine is not reduced with food, although the rate of absorption is decreased.

Alcohol

In sensitive patients the concurrent administration of cetirizine or levocetirizine and alcohol or other CNS depressants may cause additional reductions in alertness and impairment of performance.

Pregnancy and Lactation

Fertility

There are no relevant data available.

Pregnancy

The use of levocetirizine may be considered during pregnancy, if necessary. There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of levocetirizine in pregnant women. However, for cetirizine, the racemate of levocetirizine, a large amount of data (more than 1000 pregnancy outcomes) on pregnant women indicates no malformative or feto/neonatal toxicity. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.

Lactation

Caution should be exercised when prescribing to lactating women. Cetirizine, the racemate of levocetirizine has been shown excreted in human. Therefore, the excretion of levocetirizine in human milk is likely. Adverse reactions associated with levocetirizine may be observed in breastfed infants.

Effects on Ability to Drive and Use Machines

Comparative clinical trials have revealed no evidence that levocetirizine at the recommended dose impairs mental alertness, reactivity or the ability to drive. Nevertheless, some patients could experience somnolence, fatigue and asthenia under therapy with levocetirizine. Therefore, patients intending to drive, engage in potentially hazardous activities or operate machinery should take their response to Vozet into account.