Glemont L Adverse Reactions

The following listing of undesirable effects is based on data from a double blind controlled trial (279 patients) and from post-marketing surveillance study of individual components of the FDC with reporting rates classified as adverse reactions are ranked under heading of frequency, using the following convention: 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) including isolated cases.
In a double blind study conducted in 279 patients with seasonal allergic rhinitis, 93 patients were exposed to FDC of Montelukast and Levocetirizine for a mean duration of 13.28 days. Except for one adverse event (1.1%) of hypersomnia, all other adverse events were considered to be unrelated to FDC of Montelukast and Levocetirizine by the investigator. The adverse events reported during conduct of the study were mild to moderate in nature.
Following are the adverse drug reactions reported with the individual components of the fixed dose combination.
Montelukast: Montelukast has been evaluated in clinical studies as follows: 10 mg film-coated tablets in approximately 4000 adult asthmatic patients 15 years of age and older.
10 mg film-coated tablets in approximately 400 adult asthmatic patients with seasonal allergic rhinitis 15 years of age and older.
5 mg chewable tablets in approximately 1750 paediatric asthmatic patients 6 to 14 years of age. Following are the list of adverse reactions reported with montelukast both in clinical trials and post-marketing use, by System Organ Class and specific Adverse Experience Term, in the table as follows. Frequency Categories were estimated based on relevant clinical trials. The following drug-related adverse reactions in clinical studies were reported commonly (≥1/100 to <1/10) in asthmatic patients treated with montelukast and at a greater incidence than in patients treated with placebo: See Table 3.

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With prolonged treatment in clinical trials with a limited number of patients for up to 2 years for adults, and up to 12 months for paediatric patients 6 to 14 years of age, the safety profile did not change.
Post-marketing Experience: Adverse reactions reported in post-marketing use are listed, by System Organ Class and specific Adverse Experience Term, in the table as follows. Frequency Categories were estimated based on relevant clinical trials. (See Table 4.)

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Levocetirizine: 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 5.

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Further uncommon incidences of adverse reactions (uncommon ≥1/1000 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 6.)

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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.
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). (See Table 7).

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Description of selected adverse reactions: After levocetirizine discontinuation, pruritus has been reported.