Publisher: QualitecFarma, S.L., Ochandiano 10, Ed. 10, 28023 – Madrid, Spain
Ebastine 10 mg orodispersible tablet is indicated for the symptomatic treatment of:
The usual dose is one orodipsersible tablet (10 mg of ebastine) once a day.
The administration of this pharmaceutical form is not recommended in children less than 12 years old.
No dose adjustment is needed.
No dose adjustment is needed in patients with mild, moderate or severe renal insufficiency.
No dose adjustment is needed in patients with mild or severe hepatic insufficiency. A dosage of 10 mg should not be exceeded in patients with severe hepatic insufficiency, since no clinical studies have been developed with a higher dose than 10 mg.
Oral route.
Ebastine orodispersible tablets can be taken with or without food.
The dose of ebastine orodispersible tablet is placed on the tongue, where it disperses instantly. Water or other liquid is not needed to swallow the dose.
Immediately before use, the blister must be carefully peeled open with dry hands and the dose of orodispersible tablet removed without crushing it. The dose must be taken as soon as the blister has been opened.
Treatment may be prolonged until symptoms disappear.
In studies conducted at a high dosage, no clinically meaningful signs or symptoms were observed up to 100 mg given once-daily. There is no specific antidote for ebastine. Gastric lavage, monitoring of vital functions including ECG and symptomatic treatment should be carried out.
18 months.
No special precautions for storage.
Aluminium/PA/PVC-Aluminium blisters containing 10, 20, 30, 50 or 100 orodispersible tablets.
Not all pack sizes may be marketed.
No special requirements for disposal.
Any unused product or waste material should be disposed of in accordance with local requirements.
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