ZELARY Film-coated tablet Ref.[115280] Active ingredients: Cetirizine

• This medicine may lead to drowsiness and impaired concentration, which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressant agents.
• Porphyria: Use with Caution.
• Caution should be taken in patients with predisposition factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) as cetirizine may increase the risk of urinary retention.
• Caution is recommended in epileptic patients and patients at risk of convulsions.
• Response to allergy skin tests is inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them.
• Pruritus and/or urticaria may occur when cetirizine is stopped, even if those symptoms were not present before treatment initiation. In some cases, the symptoms may be intense and may require treatment to be restarted. The symptoms should resolve when the treatment is restarted.
• ZELARY 10 lacks significant sedative effects. Patients should be warned, however, that a small number of individuals may experience sedation. It is therefore advisable to determine individual response before driving or performing complicated tasks (see section 4.7). This effect may be compounded by the simultaneous intake of alcohol or other central nervous system depressants (see section 4.5).

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 cetirizine.

Excipient lactose

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

Concomitant use of alcohol and other sedating agents should be avoided.

There is no evidence of an interaction between cetirizine and cimetidine, ketoconazole, erythromycin, azithromycin, diazepam, glipizide, theophylline (400 mg/day) and pseudoephedrine.

The extent of absorption of cetirizine is not reduced with food, although the rate of absorption is decreased (see section 5.2).

Safety in pregnancy and lactation has not been established (see section 4.3).

Breastfeeding

Caution should be exercised when prescribing ZELARY 10 to lactating women. Cetirizine is excreted in human breast milk at concentrations representing 25% to 90% of those measured in plasma, depending on sampling time after administration.

Fertility

Limited data is available on human fertility, but no safety concern has been identified. Animal data show no safety concern for human reproduction.

The patient’s ability to perform hazardous activities requiring mental alertness or physical coordination such as driving or operating machinery may be impaired.

a) Summary of the safety profile

Clinical studies have shown that cetirizine at the recommended dosage has minor undesirable effects on the CNS, including somnolence, fatigue, dizziness and headache. In some cases, paradoxical CNS stimulation has been reported.

Although cetirizine is a selective antagonist of peripheral H₁-receptors and is relatively free of anticholinergic activity, isolated cases of micturition difficulty, eye accommodation disorders and dry mouth have been reported.

Instances of abnormal hepatic function with elevated hepatic enzymes accompanied by elevated bilirubin have been reported. Mostly these resolves upon discontinuation of the treatment with cetirizine dihydrochloride.

b) Tabulated list of adverse reactions

The table below shows all adverse drug reactions (ADRs) observed during clinical trials and postmarket spontaneous reports with cetirizine dihydrochloride.

c) Description of selected adverse reactions

After discontinuation of cetirizine, pruritus (intense itching) and/or urticaria have been reported.

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 professionals are asked to report any suspected adverse reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website.

Suspected adverse reactions can also be reported directly to the HCR via medsafety@austell.co.za.

Not applicable.