Zelary 10 mg FC tablets

ZELARY 10 is indicated for the symptomatic relief of allergic conditions such as allergic rhinitis, and allergic skin conditions such as urticaria.

Posology

Adults or children 12 years of age or older:
One 10 mg tablet daily.

Children 6 to 12 years old:
One 10 mg tablet once daily or 5 mg (half a tablet) twice daily.

Special populations

Elderly population
No dose adjustment is necessary in healthy elderly patients with normal renal function.

Dosage in Renal impairment
In patients with renal impairment, where the creatinine clearance is less than 40 mL/min, the recommended daily dose of cetirizine should be halved.

Hepatic impairment
In moderate to severe hepatic impairment half the recommended daily dose should be used.

Paediatric population
ZELARY 10 is contraindicated in children under the age of two years, as safety and efficacy have not been demonstrated (see section 4.3).

Method of administration
ZELARY 10 is for oral administration.

• Hypersensitivity to cetirizine, hydroxyzine, any piperazine derivatives or to any of the excipients listed in section 6.1.
• Patients with severe renal impairment at less than 30 mL/min creatinine clearance.
• Asthma, as it may cause airway obstruction in patients who have previously experienced adverse reactions to antihistamines.
• Lactating women, since the active ingredient is excreted in breast milk.
• Pregnancy, as safety has not been established.
• Children under the age of two years, as safety and efficacy have not been demonstrated.

• 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 patientu2019s 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 H 1 -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.

Symptoms
Drowsiness is an expected symptom of overdosage. Adverse events reported after an intake of at least 5 times the recommended daily dose is: somnolence, confusion, diarrhoea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, rash, restlessness or agitation, sedation, somnolence, stupor, tachycardia, tremor, and urinary retention.

Treatment
To date there is no specific antidote. Cetirizine is not effectively removed by dialysis. Further treatment is symptomatic and supportive.