EBASTION 20 Milligram Film Coated Tablet
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
21-05-2024
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Virkt innihaldsefni:
EBASTINE
Fáanlegur frá:
Lindopharm GmbH
INN (Alþjóðlegt nafn):
EBASTINE
Skammtar:
20 Milligram
Lyfjaform:
Film Coated Tablet
Gerð lyfseðils:
Product subject to prescription which may be renewed (B)
Leyfisstaða:
Withdrawn
Leyfisdagur:
0000-00-00
Vara einkenni
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 dose adjustment is necessary for treatment up to 5 days.
In patients with mild to moderate hepatic insufficiency, no dose adjustment is necessary for treatment up to 7 days.
Method of administration:
The film-coated tablets should be taken unchewed with liquid.
Ebastine can be taken at meal times or independently of meals.
Duration of use:
The physician decides on the duration of use.
For allergic rhinitis there is clinical experience of use for a duration of up to 1 year.
4.3 CONTRAINDICATIONS
Hypersensivity to the active substance or to any of the excipients.
Patients with
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