Source: Υπουργείο Υγείας (CY) Revision Year: 2020 Publisher: Almirall , S.A., General Mitre, 151, 08022 Barcelona, Spain
Ebastine is indicated in the symptomatic treatment of allergic rhinitis (seasonal and perennial) associated or otherwise with allergic conjunctivitis, idiopathic chronic urticaria and allergic dermatitis.
The tablets and the solution may be taken with or without food.
The usual dose is 1 tablet (10 mg) once daily.
There is no need to adjust the dose.
There is no need to adjust the dose in patients with mild, moderate or severe renal insufficiency.
There is no need to adjust the dose in patients with mild to moderate hepatic impairment. There is no experience with doses over 10 mg in patients with severe hepatic insufficiency, therefore. The maximum recommended dose must not be exceeded in patients with severe hepatic insufficiency (10 mg/day).
Treatment may be prolonged until symptoms disappear.
Studies carried out with high doses did not evidence clinically significant signs or symptoms at doses of up to 100 mg once daily. There is no specific antidote for ebastine. The following measures should be considered: stomach pump, monitoring of vital constants including ECG, and symptomatic treatment.
EBASTEL 10 mg Film-coated tablets: 3 years.
EBASTEL 10 mg Film-coated tablets: Store below 30ºC.
EBASTEL 10 mg Film-coated tablets: Package with 20 × 10 mg tablets.
EBASTEL 10 mg Film-coated tablets: None.
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