CETIZAL Film-coated tablet Ref.[50452] Active ingredients: Levocetirizine

Alcohol

Precaution is recommended with intake of alcohol (see section 4.5). CETIZAL 5 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 (CNS) 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 CETIZAL 5 may increase the risk of urinary retention.

Lactose intolerance

CETIZAL 5 contains lactose. Patients with rare hereditary problems of galactose intolerance total lactase deficiency or glucose-galactose malabsorption should not take CETIZAL 5.

Paediatric population

Children aged less than 6 years

The use of CETIZAL 5 is not recommended in children aged 2 to 6 years since the film-coated tablet does not allow for appropriate dose adaption.

Infants and children under 2 years

Data are not sufficient to support the administration of CETIZAL 5 to infants and toddlers aged less than 2 years. CETIZAL 5 is contraindicated in infants and toddlers aged less than 2 years (see see section 4.3).

No interaction studies have been performed with CETIZAL 5 (including no studies with CYP3A4 inducers). Studies with the racemate compound cetirizine demonstrated that there were no clinically relevant adverse interactions with diazepam, glipizide, ketoconazole, erythromycin, azithromycin, cimetidine and pseudoephedrine.

Alcohol

In sensitive patients, the simultaneous administration of CETIZAL 5 and alcohol or other central nervous system depressants may have effects on the central nervous system. It is advisable to avoid excessive alcohol consumption.

Theophylline

A decrease in clearance of cetirizine (16%) was reported with theophylline (400 mg once a day), while the disposition of theophylline was not altered by concomitant cetirizine administration.

Ritonavir

It was reported, with 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 CETIZAL 5 is not reduced with food, although the rate of absorption is decreased.

Pregnancy

CETIZAL 5 is contraindicated in pregnancy as the safety has not been established.

Breastfeeding

Levocetirizine is excreted in breast milk; therefore, CETIZAL 5 is contraindicated in lactating women.

Patients should be warned that CETIZAL 5 may cause somnolence, fatigue and asthenia, and therefore it may interfere with the patient’s daytime activities. This effect may be compounded by the simultaneous intake of alcohol or other nervous system depressants. It is therefore advisable to determine individual response before driving, performing complicated tasks, engaging in potentially hazardous activities or operating machinery.

Clinical trial data

In therapeutic studies in women and men aged 12 to 71 years, 15,1% of the patients had at least one adverse reaction. In therapeutic trials, the dropout rate due to adverse events was 1,0%.

Clinical therapeutic trials with included 935 subjects exposed to the medicine at the recommended dose of 5 mg daily.

Tabulated list of adverse reactions:

^* Cannot be estimated from the available data.

Paediatric population

In paediatric patients less than 6 years, 159 subjects were exposed to at the dose of 1,25 mg daily for 2 weeks or 1,25 mg twice daily. The following incidence of adverse reactions were reported:

In children aged 6 to 12 years, double-blind placebo-controlled studies were performed where 243 children were exposed to 5 mg daily for variable periods ranging from less than 1 week to 13 weeks. The following incidence of adverse reactions were reported:

Post-marketing experience

In addition to the adverse reactions reported during clinical studies and listed above, the following adverse reactions have been reported in post-marketing experience, the frequency is unknown (cannot be estimated from the available data):

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 “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8.

Not applicable.