KESTINE Coated tablet Ref.[51035] Active ingredients: Ebastine

Since there is a pharmacokinetic interaction with antimycotics of the imidazol type like ketoconazole or macrolid antibiotics like erythromycin (see point 4.5, Interaction with other medicinal products and other forms of interaction), care should be taken when prescribing ebastine with medicines that contain such drugs.

Ebastine should be used with caution in patients with severe hepatic insufficiency.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.

There is no interaction of ebastine with theophylline, warfarin, cimetidine, diazepam or alcohol.

When ebastine is administered with food, there is a 1.5 to 2.0 fold increase in the plasma levels and the AUC of the main active acid metabolite of ebastine. This increase does not alter the Tmax. The administration of ebastine with food causes no modification in its clinical effect.

Pharmacokinetic interactions have been observed when ebastine is given with either ketoconazole or erythromycin (see section 5.2, Pharmacokinetic properties). These interactions resulted in increased plasma concentrations of ebastine and to a lesser extent of carebastine which were, nevertheless, not associated with any clinically significant pharmacodynamic consequences in limited data from clinical studies.

The safety of Kestine during human pregnancy has not been established. Studies in rats and rabbits do not indicate any direct or indirect harmful effects with respect to the development of the embryo or foetus, or the course of gestation and peri- and post-natal development. No teratogenic effects have been identified in animals. However, there are no wellcontrolled studies in pregnant women and reproductive studies are not always predictive of human response. Therefore, ebastine should be used during pregnancy only if clearly needed, category B1. Ebastine is not recommended for nursing women, because it is not known whether ebastine is excreted in human milk.

In man, psychomotor function has been investigated extensively and no effect was found at recommended therapeutic doses.

A study focused on car driving ability indicated that Kestine did not induce any driving impairment even at 30 mg. Based on these results, Kestine at recommended therapeutic doses does not affect the ability to drive or operate machines.

The adverse reactions reported in association with the use of ebastine presented according to system organ classes in a decreasing frequency, are listed below. According to frequency, reported adverse reactions have been classified in the category very rare (<1/10000).

Cardiac disorders: Palpitations, tachycardia.

Gastrointestinal disorders: Dry mouth, dyspepsia, abdominal pain, nausea, vomiting.

General disorders and administration site conditions: Asthenia, oedema.

Hepatobiliary disorders: Liver function test abnormal.

Infections and Infestations: Pharyngitis, rhinitis, sinusitis.

Nervous system disorder: Somnolence, headache, dizziness, dysaesthesia.

Psychiatric disorders: Insomnia, nervousness.

Reproductive system and breast disorders: Menstrual disorders.

Respiratory, thoracic and mediastinal disorders: Epistaxis.

Skin and subcutaneous tissue disorders: Rash, urticaria, dermatitis.

Not applicable.