CLARITYNE Syrup / Tablet Ref.[51096] Active ingredients: Loratadine

Patients with severe liver impairment should be administered a lower initial dose of CLARITYNE because they may have a reduced clearance of loratadine; an initial dose of 5 ml (or 5 mg tablet) once daily, or 10 ml (or 10 mg tablet) every other day is recommended.

Efficacy of CLARITYNE Syrup has not yet been established in children younger than 2 years of age. However, the pharmacokinetic profile of loratadine in infants 1 to 2 years after the administration of a single 2.5 mg dose of CLARITYNE Syrup is similar to that in older children and adults.

When administered concomitantly with alcohol, loratadine has no potentiating effects as measured by psychomotor performance studies.

CLARITYNE contains sugar. Patients with rare hereditary problems of fructose or galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption or sucroseisomaltase insufficiency should not take CLARITYNE.

Weight gain has been reported with the use of loratadine, but the frequency is unknown.

Medicine/laboratory test interactions

The use of CLARITYNE should be discontinued approximately 48 hours prior to skin testing procedures since it may prevent or diminish otherwise positive reactions to dermal reactivity indicators.

An increase in plasma concentrations of loratadine have been reported after concomitant use with ketoconazole, erythromycin or cimetidine in controlled clinical trials, but without clinically significant changes (including electrocardiographic). Other medicines known to inhibit hepatic metabolism should be co-administered with caution together with CLARITYNE until definitive interaction studies can be completed or in the absence of formal interaction studies.

The safe use of CLARITYNE during pregnancy or lactation has not been established.

CLARITYNE lacks significant sedative effects. Patients should, however be warned that a small number of individuals may experience sedation. It is therefore advisable to determine individual response before driving or performing complicated tasks. This effect may be compounded by the simultaneous intake of alcohol or other central nervous system depressants.

In clinical trials involving adults and adolescents in a range of indications including allergic rhinitis and chronic iodiopathic urticaria, at the recommended dose of 10 mg daily, side effects with CLARITYNE Tablets were reported in 2% of patients in excess of those treated with placebo. The most frequent side effects reported in excess of placebo were somnolence (1.2%), headache (0.6%), increased appetite (0.5%) and insomnia (0.1%).

Other side effects reported during post-marketing period are listed in the following table.