EBASTEL Film-coated tablet Ref.[49512] Active ingredients: Ebastine

Administer with caution in patients with known cardiac risk such as prolonged QT interval, hypokaliaemia, concomitant treatment with compounds that increase the QT interval or that inhibit the CYP3A4 enzyme, such as antifungal azolic agents like ketoconazole and itraconazole and macrolid antibiotics, like erythromycin (see 4.5.).

Pharmacokinetic interactions can also occur under concomitant administration of ebastine with antituberculosis agents, like rifampicin (see section 4.5 Interactions with other medicinal products and other forms of interaction).

Ebastine should be used with caution in patients with severe hepatic insufficiency (see section 4.2).

Since ebastine achieves its therapeutic effect between 1 and 3 hours after administration, it must not be used in emergencies involving acute allergy.

Ebastel 10 mg film-coated tablets

Ebastel film-coated tablets contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

The interaction of ebastine in combination with ketoconazole or erythromycin (both compounds cause an increase in the QTc interval) has been studied. Both combinations evidenced a pharmacokinetic and pharmacodynamic interaction, causing an increase in plasma ebastine levels and to a lesser extent of carebastine which were, nevertheless, not associated with any clinically significant pharmacodynamic consequences. The increase in QTc was only approximately 10 ms above that observed with ketoconazole or erythromycin alone. However, as precautionary measure, caution should be taken when prescribing ebastine to patients receiving concomitant treatment with antimycotics of the imidazol type, like ketoconazole and itraconazole, or macrolid antibiotics, like erythromycin.

Pharmacokinetic interactions have been observed when ebastine is given with rifampin. These interactions could result in lower plasma concentrations and reduced antihistamine effects.

No interactions have been reported between ebastine and theophylline, warfarin, cimetidine, diazepam and alcohol.

When ebastine is administered with food, both the plasma levels and the AUC of the principal metabolite of ebastine increase between 1.5 and 2-fold. This increase does not modify the tmax. Administration of ebastine with food does not modify its clinical effect.

Ebastine could interfere with the results of cutaneous allergy tests, so these should not be performed until 5-7 days have elapsed after the interruption of treatment.

It could increase the effects of other antihistamines.

Fertility

There are no fertility data with ebastine in humans.

Pregnancy

There are limited amount of data from the use of ebastine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of ebastine during pregnancy.

Lactation

It is not known whether ebastine is excreted in human milk. High protein binding (>97%) of ebastine and its main metabolite, carebastine, suggest no excretion of drug into breast milk. As a precautionary measure, it is preferable to avoid the use of ebastine during lactation.

In humans, the psychomotor function has been investigated extensively and no effect was found. Ebastine at recommended therapeutic doses does not affect the ability to drive or operate machines. However, in sensitive subjects who react unusually to ebastine, it is advisable to know the individual reactions before a patient drives or carries out complicated activities: somnolence or dizziness may occur (see section 4.8).

In a pooled analysis of placebo-controlled clinical trials with 5.708 patients on ebastine, the most commonly reported adverse reactions were dry mouth and somnolence.

ADRs reported in clinical trials in children (n=460) were similar to those observed in adults

The table below lists the adverse reactions from clinical trials and post-marketing experience following the 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), not known (cannot be estimated from the available data).

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 via the national reporting system listed in Appendix V.

Not applicable.