Cetaway 0.5mg/ml ORAL SOLUTION

CETAWAY SOLUTION is indicated for the relief of symptoms associated with the following allergic conditions:

• seasonal allergic rhinitis
• perennial allergic rhinitis
• chronic idiopathic urticaria.

Posology

Adults and adolescents 12 years of age and older

The daily recommended dose is 5 mg (10 ml) once daily.

Special populations

Elderly

Adjustment of the dose is recommended in elderly patients with moderate to severe renal impairment (see Patients with renal impairment below).

Adults with renal impairment

The dosing interval 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 patientu2019s creatinine clearance (Cl cr ) in ml/min is needed. The CL cr (ml/min) may be estimated from serum creatinine (u03bcmol/l) using the following formula:

CL cr = (140 - age) x body weight (kg) (x 0,85 for women) / serum creatinine (u03bcmol/l)

Dosing Adjustments for Patients with Impaired Renal Function

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/her 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).

Paediatric population

Children aged less than 2 years

The administration of CETAWAY SOLUTION to infants and toddlers aged less than 2 years is not recommended (see section 4.4).

Children aged 2 to 6 years

The daily recommended dose is 2,5 mg to be administered in 2 intakes of 1,25 mg (2,5 ml of solution twice daily).

Children aged 6 to 12 years

The daily recommended dose is 5 mg (10 ml) once daily.

Duration of use

Intermittent allergic rhinitis (symptoms 4 days/week or during more than 4 weeks), continuous therapy can be proposed to the patient during the period of exposure to allergens. Clinical experience with CETAWAY SOLUTION is currently available for a 6-month treatment period.

Method of administration

For oral administration.

CETAWAY SOLUTION is contraindicated:

• in hypersensitivity to levocetirizine, to any piperazine derivative or to any of the excipients of CETAWAY SOLUTION (see section 4.4)
• in infants and toddlers aged less than 2 years, as safety and efficacy have not been demonstrated
• during breastfeeding of infants and while pregnant (see section 4.6) and lactation
• in patients with end-stage renal disease, at less than 10 ml/min creatinine clearance.

Alcohol

Precaution is recommended with intake of alcohol. CETAWAY SOLUTION lacks significant sedative effects. Patients should, however be warned that a small number of individuals may experience sedation. This effect may be compounded by the simultaneous intake of alcohol or other central nervous system depressants (see section 4.5).

Risk of urinary retention

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

Risk of convulsion

Caution should be taken in patients with epilepsy and patients at risk of convulsion as CETAWAY SOLUTION may cause seizure aggravation.

Skin reactions

Pruritus may occur when levocetirizine, as in CETAWAY SOLUTION, 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.

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.

Information on excipients

CETAWAY SOLUTION contains maltitol and may have a laxative effect. Patients with the rare hereditary problems of fructose intolerance should not take CETAWAY SOLUTION.

Paediatric population

Infants and children under 2 years

The administration of CETAWAY SOLUTION to infants and toddlers aged less than 2 years is not recommended due to the lack of sufficient data in this age group (see sections 4.2 and 4.3).

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 antipyrine, ketoconazole, erythromycin, azithromycin, cimetidine, pseudoephedrine, glipizide and diazepam).

Theophylline

A 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 decreased (-11 %).

Food

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

Alcohol

In sensitive patients the simultaneous administration of CETAWAY SOLUTION and alcohol or other central nervous system (CNS) depressants may have effects on the central nervous system. It is advisable to avoid excessive alcohol consumption (see section 4.4).

Pregnancy

CETAWAY SOLUTION is contraindicated in pregnancy as safety has not been demonstrated (see section 4.3 and 5.3).

Breastfeeding

CETAWAY SOLUTION is contraindicated in women who are breastfeeding their babies, since the active ingredient is excreted in breast milk.

Fertility

No clinical data relating to levocetirizine effects on fertility is available.

CETAWAY SOLUTION lacks significant sedative effects. Nevertheless, some patients could experience somnolence, fatigue, and asthenia under therapy with CETAWAY SOLUTION. Therefore, patients intending to drive, engage in potentially hazardous activities or operate machinery should take their response to the CETAWAY SOLUTION into account.

a) Summary of the safety profile

Mild to moderate side effects most frequently experienced in adults include, headache, somnolence, dry mouth, fatigue, with asthenia or abdominal pain occurring less frequently.

b) Tabulated summary of adverse reactions

c) Description of selected adverse reactions

After levocetirizine discontinuation, pruritus has been reported.

d) Paediatric population

System Organ Class

Signs and symptoms

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

Management of overdose

There is no known specific antidote to CETAWAY SOLUTION. Should overdose occur, symptomatic or supportive treatment is recommended. Levocetirizine is not effectively removed by haemodialysis.