LORYTEC Tablet Ref.[28362] Active ingredients: Loratadine

Lorytec should be administered with caution in patients with severe liver impairment (see section 4.2).

This medicinal product contains lactose; thus patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

The administration of Lorytec should be discontinued at least 48 hours before skin tests since antihistamines may prevent or reduce otherwise positive reactions to dermal reactivity index.

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

Potential interaction may occur with all known inhibitors of CYP3A4 or CYP2D6 resulting in elevated levels of loratadine (see Section 5.2), which may cause an increase in adverse events.

Increase in plasma concentrations of loratadine has been reported after concomitant use with ketoconazole, erythromycin, and cimetidine in controlled trials, but without clinically significant changes (including electrocardiographic).

Paediatric population

Interaction studies have only been performed in adults.

Pregnancy

A 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 Lorytec during pregnancy.

Breast-feeding

Loratadine is excreted in breast milk. Therefore, the use of Lorytec is not recommended in breast-feeding women.

Fertility

There are no data available on male and female fertility.

In clinical studies that assessed driving ability, no impairment was observed in patients receiving loratadine. Loratadine has no or negligible influence on the ability to drive and use machines. However, patients should be informed that very rarely some people experience drowsiness, which may affect their ability to drive or use machines.

Summary of the safety profile

In clinical trials involving adults and adolescents in a range of indications including allergic rhinitis (AR) and chronic idiopathic urticaria (CIU), at the recommended dose of 10 mg 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 reactions

The 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.

Paediatric population

In 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 reactions

Reporting 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 to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Tel: +357 22608607, Fax: +357 22608669.

Not applicable.