Publisher: QualitecFarma, S.L., Ochandiano 10, Ed. 10, 28023 – Madrid, Spain
Hypersensitivity to the active substance or to any of other excipients listed in section 6.1
As with other antihistamines, caution must be exercised when using ebastine in patients known to be at cardiac risk such as those with long QT syndrome, hypokalemia, treatment with any drug known to produce an increase in QT interval or inhibit CYP3A4 enzyme systems such as azole antifungals and macrolide antibiotics (see section 4.5 Interaction with other medicaments and other forms of interaction).
Pharmacokinetic interactions could be appear when ebastine is co-administered with rifampicin (see section 4.5 Interaction with other medicaments and other forms of interaction).
Since ebastine reaches its therapeutic effect between 1 and 3 hours after administration, it should not be used in emergency acute allergic problems.
Ebastine should be used with caution in patients with severe hepatic insufficiency (see section 4.2 Posology and method of administration, and section 5.2 Pharmacokinetic properties).
Ebastine orodispersible tablet contains 2.5 mg aspartame per dose. Aspartame is a source of phenylalanine, which may be harmful for people with phenylketonuria.
Ebastine orodispersible tablet contains lactose monohydrate and should not be administered in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Pharmacokinetic interactions have been observed when ebastine is given with ketoconazole or itraconazole and erythromycin. 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.
Pharmacokinetic interactions have been observed when ebastine is given with rifampicin. These interactions could result in lower plasma concentrations and reduced antihistamine effects.
No interactions have been reported between ebastine and 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 does not cause a modification in its clinical effect.
Ebastine may interfere results of skin allergy tests, so it is advisable not to perform them after 5-7 days after stopping treatment.
It can enhance the effects of other antihistamines.
There are limited amount of data from the use of ebastine in pregnant women. Animals studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferably to avoid the use of ebastine during pregnancy.
It is not known whether the active substance 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 preferably to avoid the use of ebastine during lactation.
There are no fertility data with ebastine in humans. Animal studies have not shown adverse effects on fertility.
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 joint analysis of placebo-controlled clinical trials conducted in 5,708 patients treated with ebastine, the adverse reactions most frequently reported were dry mouth and somnolence.
Adverse reactions reported in clinical trials in children (n=460) were similar to those observed in adults
The table below displays all ADRs that have been reported in clinical trials or from post marketing experience using the following 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).
Very rare: nervousness, insomnia.
Rare: somnolence.
Very rare: diziness, hypesthesia, headache.
Rare: dry mouth.
Very rare: vomiting, abdominal pain, nausea, dyspepsia.
Very rare: abnormal liver function test.
Very rare: urticaria, rash, dermatitis.
Very rare: menstrual disorders.
Very rare: oedema, asthenia.
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 [to be completed nationally].
Not applicable.
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