CETAWAY Oral solution Ref.[115181] Active ingredients: Levocetirizine

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

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. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8.

Not applicable.