Levocetirizine 5 Mg Film-Coated Tablets

LEVOCETIRIZINE 5 MG AUSTELL 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 one 5 mg tablet.

Children

For children aged 2 - 6 years no adjusted dosage is possible with the film-coated tablet formulation.

Children aged 6 - 12 years: The daily recommended dose is one 5 mg tablet.

Special populations

Elderly

Adjustment of the dose is recommended in elderly patients with moderate to severe renal impairment (see u201cRenal impairmentu201d below).

Renal impairment

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 patient's creatinine clearance (Clcr) in mL/min is needed.

The Clcr (mL/min) may be estimated from serum creatinine (u03bcmol/L) determination using the following formula:

Clcr = [140 u2013 age (years)] x weight (kg) (x 0,85 for women)

Serum creatinine (u03bcmol/L)

Dosing adjustments for patients with impaired renal function:

Paediatric patients with 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 u201cRenal impairmentu201d above)

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.

Method of administration

The film-coated tablet must be taken orally, swallowed with liquid and may be taken with or without food. It is recommended to take the daily dose in one single intake.

LEVOCETIRIZINE 5 MG AUSTELL is contraindicated:

• in hypersensitivity to levocetirizine, to any piperazine derivative or to any of the excipients listed in section 6.1.
• in infants and toddlers aged less than two years, as safety and efficacy have not been demonstrated
• during breastfeeding of infants and while pregnant (see section 4.6)
• in patients with end stage renal disease, at less than 10 mL/min creatinine clearance.

Alcohol

Precaution is recommended with concurrent intake of alcohol. LEVOCETIRIZINE 5 MG AUSTELL 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 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.

Epilepsy and convulsion risk patients

Caution should be taken in patients with epilepsy and patients at risk of convulsion as 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.

Pruritus

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 (see section 4.8).

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.

Excipients: lactose intolerance

This medicine contains lactose: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

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

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.

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

LEVOCETIRIZINE 5 MG AUSTELL is contraindicated in pregnancy as safety has not been demonstrated (see section 4.3).

Lactation

LEVOCETIRIZINE 5 MG AUSTELL is contraindicated in breastfeeding (see section 4.3). Levocetirizine is excreted in human milk.

Fertility

No clinical data are available.

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 the medicine into account.

a) Tabulated list of adverse reactions

The table below shows all adverse drug reactions (ADRs) observed during post-market spontaneous reports with Levocetirizine dihydrochloride.

b) Description of selected adverse reactions

After levocetirizine discontinuation, pruritus has been reported (see section 4.4 above).

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 Reaction Reporting Formu201d, found online under S AHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

Symptoms

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

Management of overdoses

There is no known specific antidote to LEVOCETIRIZINE 5 MG AUSTELL. Should overdose occur, symptomatic or supportive treatment is recommended. Levocetirizine is not effectively removed by haemodialysis.