Clinical studies: Adults and adolescents above 12 years of age: In therapeutic studies in women and men aged 12 to 71 years, 15.1% of the patients in the levocetirizine 5 mg group had at least one adverse drug reaction compared to 11.3% in the placebo group. 91.6% of these adverse drug reactions were mild to moderate.
In therapeutic trials, the dropout rate due to adverse events was 1.0% (9/935) with levocetirizine 5 mg and 1.8% (14/771) with placebo.
Clinical therapeutic trials with levocetirizine included 935 subjects exposed to the medicinal product at the recommended dose of 5 mg daily. From this pooling, following incidence of adverse drug reactions were reported at rates of 1% or greater (common: ≥1/100 to <1/10) under levocetirizine 5 mg or placebo: See Table 3.
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Further uncommon incidences of adverse reactions (uncommon ≥1/1,000 to <1/100) like asthenia or abdominal pain were observed.
The incidence of sedating adverse drug reactions such as somnolence, fatigue, and asthenia was altogether more common (8.1%) under levocetirizine 5 mg than under placebo (3.1%).
Paediatric population: In two placebo-controlled studies in paediatric patients aged 6-11 months and aged 1 year to less than 6 years, 159 subjects were exposed to levocetirizine at the dose of 1.25 mg daily for 2 weeks and 1.25 mg twice daily, respectively. The following incidence of adverse drug reactions was reported at rates of 1% or greater under levocetirizine or placebo. (See Table 4.)
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In children aged 6-12 years, double-blind placebo-controlled studies were performed where 243 children were exposed to 5 mg levocetirizine daily for variable periods ranging from less than 1 week to 13 weeks. The following incidence of adverse drug reactions was reported at rates of 1% or greater under levocetirizine or placebo. (See Table 5.)
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Oral drops: As stated in Dosage & Administration and Precautions, note that even if clinical data presented in this section are available in children aged 6 months to 12 years, there is no sufficient data to support the administration of the product to infants and toddlers aged less than 2 years.
Post-marketing experience: Adverse reactions from post-marketing experience are per System Organ Class and per frequency. The frequency is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Immune system disorders: Not known: hypersensitivity including anaphylaxis.
Metabolism and nutrition disorders: Not known: increased appetite.
Psychiatric disorders: Not known: aggression, agitation, hallucination, depression, insomnia, suicidal ideation, nightmare.
Nervous system disorders: Not known: convulsions, paraesthesia, dizziness, syncope, tremor, dysgeusia.
Eye disorders: Not known: visual disturbances, blurred vision, oculogyration.
Ear and labyrinth disorders: Not known: vertigo.
Cardiac disorders: Not known: palpitations, tachycardia.
Respiratory, thoracic and mediastinal disorders: Not known: dyspnoea.
Gastrointestinal disorders: Not known: nausea, vomiting, diarrhoea.
Hepatobiliary disorders: Not known: hepatitis.
Skin and subcutaneous tissue disorders: Not known: angioneurotic oedema, fixed drug eruption, pruritus, rash, urticaria.
Musculoskeletal, connective tissue, and bone disorders: Not known: myalgia, arthralgia.
Renal and urinary disorders: Not known: dysuria, urinary retention.
General disorders and administration site conditions: Not known: oedema.
Investigations: Not known: weight increased, abnormal liver function tests.
Oral drops: Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed).
Description of selected adverse reactions: After levocetirizine discontinuation, pruritus has been reported.