GSL: General Sales Licence
This information is intended for use by health professionals
Adults and children over 12 years of age :10ml (10mg) of the syrup once daily.
Paediatric populationChildren 2 to 12 years of age are dosed by weight:Body weight more than 30kg : 10ml (10mg) of the syrup once daily.Body weight 30kg or less: 5ml (5mg) of the syrup once daily.The safety and efficacy of Clarityn Allergy Syrup in children under 2 years of age has not been established. No data are available.
Patients with hepatic impairmentPatients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine. An initial dose of 10mg every other day is recommended for adults and children weighing more than 30kg and for children weighing 30kg or less, 5ml (5mg) every other day is recommended.
Patients with renal impairmentNo dosage adjustments are required in patients with renal insufficiency.
ElderlyNo dosage adjustments are required in the elderly.
Method of administrationOral use. The syrup may be taken without regard to meal time.
Paediatric populationInteraction studies have only been performed in adults.
PregnancyA large amount of data on pregnant women (more than 1000 exposed outcomes) indicate no malformative nor feto/ neonatal toxicity of loratadine Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Clarityn Allergy Syrup during pregnancy.
Breast-feedingLoratadine is excreted in breast milk. Therefore, the use of Clarityn Allergy Syrup is not recommended in breast-feeding women.
FertilityThere are no data available on male and female fertility.
Summary of the safety profileIn clinical trials involving adults and adolescents in a range of indications including allergic rhinitis (AR) and chronic idiopathic urticarial (CIU), at the recommended dose of 10mg daily, adverse reactions with loratadine were reported in 2% of patients in excess of those treated with placebo. The most frequent adverse reactions reported in excess of placebo were somnolence (1.2%), headache (0.6%), increased appetite (0.5%) and insomnia (0.1%).
Tabulated list of adverse reactionsThe following adverse reactions reported during the post-marketing period are listed in the following table by System Organ Class. Frequencies are defined as 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) and not known (cannot be estimated from the available data).Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
|System Organ Class||Frequency||Adverse Experience Term|
|Immune System disorders||Very rare||Hypersensitivity reactions (including angioedema and anaphylaxis)|
|Nervous system disorders||Very rare||Dizziness, convulsion|
|Cardiac disorders||Very rare||Tachycardia, palpitation|
|Gastrointestinal disorders||Very rare||Nausea, dry mouth, gastritis|
|Hepatobiliary disorders||Very rare||Abnormal hepatic function|
|Skin and subcutaneous tissue disorders||Very rare||Rash, alopecia|
|General disorders and administration site conditions||Very rare||Fatigue|
Paediatric populationIn clinical trials in a paediatric population, children aged 2 through 12 years, common adverse reactions reported in excess of placebo were headache (2.7%), nervousness (2.3%), and fatigue (1%).
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, website www.mhra.gov.uk/yellowcard..
Mechanism of actionLoratadine, the active ingredient in Clarityn Allergy Syrup, is a tricyclic antihistamine with selective, peripheral H1-receptor activity.Pharmacodynamic effectsLoratadine has no clinically significant sedative or anticholinergic properties in the majority of the population and when used at the recommended dosage.During long-term treatment there were no clinically significant changes in vital signs, laboratory test values, physical examinations or electrocardiograms.Loratadine has no significant H2-receptor activity. It does not inhibit norepinephrine uptake and has practically no influence on cardiovascular function or on intrinsic cardiac pacemaker activity.Human histamine skin wheal studies following a single 10 mg dose has shown that the antihistamine effects are seen within 1-3 hours reaching a peak at 8-12 hours and lasting in excess of 24 hours. There was no evidence of tolerance to this effect after 28 days of dosing with loratadine.
Clinical efficacy and safetyOver 10,000 subjects (12 years and older) have been treated with loratadine 10 mg tablets in controlled clinical trials. Loratadine 10 mg tablets once daily was superior to placebo and similar to clemastine in improving the effects on nasal and non-nasal symptoms of AR. In these studies somnolence occurred less frequently with loratadine than with clemastine and about the same frequency as terfenadine and placebo. Among these subjects (12 years and older), 1000 subjects with CIU were enrolled in placebo controlled studies. A once daily 10 mg dose of loratadine was superior to placebo in the management of CIU as demonstrated by the reduction of associated itching, erythema and hives. In these studies the incidence of somnolence with loratadine was similar to placebo.
Paediatric populationApproximately 200 paediatric subjects (6 to 12 years of age) with seasonal allergic rhinitis received doses of loratadine syrup up to 10 mg once daily in controlled clinical trials. In another study, 60 paediatric subjects (2 to 5 years of age) received 5 mg of loratadine syrup once daily. No unexpected adverse events were observed.The paediatric efficacy was similar to the efficacy observed in adults.
AbsorptionLoratadine is rapidly and well-absorbed. Concomitant ingestion of food can delay slightly the absorption of loratadine but without influencing the clinical effect. The bioavailability parameters of loratadine and of the active metabolite are dose proportional.
DistributionLoratadine is highly bound (97% to 99%) and its active metabolite moderately bound (73% to 76%) to plasma proteins.In healthy subjects, plasma distribution half-lives of loratadine and its active metabolite are approximately 1 and 2 hours, respectively.
BiotransformationAfter oral administration, loratadine is rapidly and well absorbed and undergoes an extensive first pass metabolism, mainly by CYP3A4 and CYP2D6. The major metabolite-desloratadine (DL)- is pharmacologically active and responsible for a large part of the clinical effect. Loratadine and DL achieve maximum plasma concentrations (Tmax) between 11.5 hours and 1.53.7 hours after administration, respectively.
EliminationApproximately 40% of the dose is excreted in the urine and 42% in the faeces over a 10 day period and mainly in the form of conjugated metabolites. Approximately 27% of the dose is eliminated in the urine during the first 24 hours. Less than 1% of the active substance is excreted unchanged in active form, as loratadine or DL.The mean elimination half-lives in healthy adult subjects were 8.4 hours (range = 3 to 20 hours) for loratadine and 28 hours (range = 8.8 to 92 hours) for the major active metabolite.
Renal impairmentIn patients with chronic renal impairment, both the AUC and peak plasma levels (Cmax) increased for loratadine and its active metabolite as compared to the AUCs and peak plasma levels (Cmax) of patients with normal renal function. The mean elimination half-lives of loratadine and its active metabolite were not significantly different from that observed in normal subjects. Haemodialysis does not have an effect on the pharmacokinetics of loratadine or its active metabolite in subjects with chronic renal impairment.
Hepatic impairmentIn patients with chronic alcoholic liver disease, the AUC and peak plasma levels (Cmax) of loratadine were double while the pharmacokinetic profile of the active metabolite was not significantly changed from that in patients with normal liver function. The elimination half-lives for loratadine and its active metabolite were 24 hours and 37 hours, respectively, and increased with increasing severity of liver disease.
ElderlyThe pharmacokinetic profile of loratadine and its active metabolite is comparable in healthy adult volunteers and in healthy geriatric volunteers.