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PHARMACOTHERAPEUTIC GROUP

Antiallergic agent

THERAPEUTIC INDICATIONS

Levocetirizine is indicated for the symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and chronic idiopathic urticaria.

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.

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 compromised renal function (see Patients with renal impairment below).

Children aged 6 to 12 years:

The daily recommended dose is 5 mg (1 film-coated tablet). Far children aged less than 6 years no adjusted dosage is yet possible.

Patients with renal impairment:

The dosing intervals must be individualised 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 (CL_cr) in ml/min is needed. The CL_cr (ml/min) may be estimated from serum creatinine (mg/dl) determination using the following formula:

Dosing Adjustments for Patients with Impaired Renal Function:

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:

The duration of use depends an the type, duration and course of the complaints. Far hay fever 3-6 weeks, and in case of short-term pollen exposure as little as one week, is generally sufficient. Clinical experience with 5 mg levocetirizine as a film-coated tablet formulation is currently available far a 6-month treatment period. For chronic urticaria and chronic allergic rhinitis, up to one year's clinical experience is available far the racemate, and up to 18 months in patients with pruritus associated with atopic dermatitis.

CONTRA-INDICATIONS

History of hypersensitivity to levocetirizine or any of the other constituents of the formulation or to any piperazine derivatives.

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

SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE

The use of Xyzal is not recommended in children aged less than 6 years since the currently available film-coated tablets do not yet allow dose adaptation. Precaution is recommended with intake of alcohol (see Interactions). Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

No interaction studies have been performed with levocetirizine (including no studies with (CYP3A4 inducers); studies with the racemate compound cetirizine demonstrated that there were no clinically relevant adverse interactions (with pseudaephedrine, cimetidine, ketaconazole, erythromycin, azithramycin, glipizide and diazepam). A small decrease in the clearance of cetirizine (16%) was observed in a multiple dose study with theaphylline (400 mg once a day); while the disposition of theaphylline was not altered by concomitant cetirizine administration. The extent of absorption of levocetirizine is not reduced with food, although the rate of absorption is decreased. In sensitive patients the simultaneous administration of cetirizine or levocetirizine and alcohol or other CNS depressants may have effects an the central nervous system, although it has been shown that the racemate cetirizine does not potentiate the effect of alcohol.

PREGNANCY AND LACTATION

For levocetirizine no clinical data an exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. Caution should be exercised when prescribing to pregnant or lactating women.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

Comparative clinical trials have revealed no evidence that cetirizine, the racemate of levocetirizine, impairs mental alertness, reactivity or the ability to drive. This also applies to the use of this drug in the recommended doss. Nevertheless, patients intending to drive, engage in potentially hazardous activities or operate machinery should not exceed the recommended dose and should take their response to the medicinal product into account. In those sensitive patients, concurrent use with alcohol or other CNS depressants may cause additional reductions in alertness and impairment of performance.

UNDESIRABLE EFFECTS

From clinical studies, mainly mild to moderate side effects such as dry mouth, headache, fatigue and somnolence have been reported commonly (above 1%). Further uncommon incidences of adverse reactions like asthenia or abdominal pain were observed.

In addition to the adverse reactions reported during clinical studies and listed above, very rare cases of the following adverse drug reactions have been reported in past-marketing experience: hypersensitivity including anaphylaxis, dyspnoea, nausea, angioneurotic oedema, pruritus, rash, urticaria and weight increased.

OVERDOSE

a) Symptoms Symptoms of overdose may include drowsiness in adults and initially agitation and restlessness, followed by drowsiness in children.

b) Management of overdoses There is no known specific antidote to levocetirizine. Should overdose occur, symptomatic or supportive treatment is recommended. Gastric lavage should be considered following short-term ingestion. Levocetirizine is not effectively removed by haemodialysis.

INCOMPATIBILITIES

None known.

STORAGE CONDITIONS AND EXPIRY DATE

Stare below 30°C. Keep out of the reach and sight of children. Do not use after the expiry date stated an the carton box and blister.

NATURE AND CONTENTS OF CONTAINER

Xyzal film-coated tablets are packed in aluminium blisters placed into cardboard boxes containing 7,10, 50 and 500 film-coated tablets.

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