Levoway 0,5 Mg Oral Solution

LEVOWAY is indicated for the relief of symptoms associated with the following allergic conditions in adults and children:

• 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.

Children aged 6 - 12 years of age

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

Children aged 2 - 6 years of age

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

Children aged less than 2 years of age

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

Special populations

Elderly

Adjustment of the dose is recommended in elderly patients with moderate to severe renal impairment.

Renal impairment

Adults:

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) determination using the following formula:

Dosing adjustments for patients with impaired renal function:

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.

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.

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 LEVOWAY is currently available for a 6-month treatment period.

Method of administration

For oral use.

LEVOWAY is contraindicated in:

• Hypersensitivity to levocetirizine dihydrochloride, to any piperazine derivative or to any of the excipients listed in section 6.1.
• Infants and toddlers aged less than two years, as safety and efficacy have not been demonstrated.
• Pregnancy and lactation (see section 4.6).
• Patients with end stage renal disease, at less than 10 ml/min creatinine clearance.

Alcohol

Precaution is recommended with intake of alcohol (see section 4.5). LEVOWAY 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.)

Patients with epilepsy

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

Risk of urinary retention

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

Skin allergy tests

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

Discontinuation of treatment

Pruritus may occur when LEVOWAY 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 of age

Data are not sufficient to support administration of LEVOWAY to infants and toddlers aged less than 2 years of age. Therefore, administration of LEVOWAY to infants and toddlers aged less than 2 years of age is not recommended.

Children aged less than 6 years

LEVOWAY is recommended for use in children aged less than 6 years.

Excipients

Maltitol LEVOWAY contains maltitol. Patients with the rare hereditary condition of fructose intolerance should not take LEVOWAY.

Sodium benzoate

The presence of the preservative, sodium benzoate, may cause allergic reactions (see section 4.3).

No interaction studies have been performed with LEVOWAY (including CYP3A4 inducers). Studies with the racemate compound cetirizine demonstrated that there were no clinically relevant adverse interactions (with 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 approximately 40 % while the disposition of ritonavir was decreased by (-11 %).

Food

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

Alcohol

In sensitive patients the simultaneous administration of LEVOWAY 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 while using LEVOWAY.

Pregnancy

LEVOWAY is contraindicated during pregnancy.

Breastfeeding

LEVOWAY is contraindicated in women who are breastfeeding their babies.

Fertility

No fertility data is available for LEVOWAY.

Some patients could experience somnolence, fatigue and asthenia during therapy with LEVOWAY. Therefore, patients intending to drive, engage in potentially hazardous activities or operate machinery should take their response to LEVOWAY into account.

a. Tabulated summary of adverse reactions

b. Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

Symptoms of overdose may include drowsiness in adults. In children, agitation and restlessness may initially occur, followed by drowsiness. There is no known specific antidote to LEVOWAY. Should overdose occur, symptomatic or supportive treatment is recommended. Levocetirizine is not effectively removed by haemodialysis.