EBASTION Film Coated Tablet 20 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-03-2023
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Active ingredient:
EBASTINE
Available from:
Lindopharm GmbH
Dosage:
20 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2010-02-26
Summary of Product characteristics
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Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Ebastion 20 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ebastion 20 mg film-coated tablets:
1 film-coated tablet of Ebastion 20 mg contains: 20 mg ebastine
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Ebastion 20 mg film-coated tablets are white to off-white, round, bevelled film-coated tablets with a score line on one
side and a diameter of 9.2 mm.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
For the symptomatic treatment of seasonal and perennial allergic rhinitis with or without allergic conjunctivitis.
4.2 Posology and method of administration
The experience in children under the age of 12 years is limited.
For children 12 years and above and adults the following dosage recommendations apply: 1 film-coated tablet (20 mg
ebastine) once daily in cases of severe symptoms of allergic rhinitis. For patients with milder symptoms 1 film-coated
tablet of 10 mg ebastine once daily is recommended. For this dose, Ebastion10 mg film-coated tablets are available.
Special subject groups:
In patients with renal insufficiency, no&#
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