KESTINE Tablets 20mg Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
17-05-2024
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Active ingredient:
EBASTINE
Available from:
Almirall, S.A.
Dosage:
20mg Milligram
Pharmaceutical form:
Tablets
Authorization date:
2005-04-15
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Kestine 20 mg Film-Coated Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains ebastine 20 mg
For a list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Film-Coated tablet.
A round white film-coated tablet embossed with E20 on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Kestine is indicated for the symptomatic treatment of allergic rhinitis (seasonal and perennial) whether or not
associated with allergic conjunctivitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Allergic rhinitis:
Kestine at a dose of 10 mg once-a-day is efficacious in the relief of the symptoms of allergic rhinitis; in patients with
more severe symptoms including perennial allergic rhinitis, 20 mg once-a-day provides additional benefit.
Idiopathic chronic urticaria:
The adult dose is one 10 mg tablet once daily.
Kestine may be taken with or without food.
The safety and efficacy of Kestine in children less than 12 years has not been established.
4.3 CONTRAINDICATIONS
Patients with a known hypersensitivity to ebastine or any of the tablet ingredients.
Patients with severe liver insufficiency.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Since there is a pharmacokinetic interaction with antimycotics of the imidazol type like ketoconazole or macrolid
antibiotics like erythromycin (_see section 4.5, Interaction with other medicinal products and other forms of_
_interactions_) care should be taken when prescribing ebastine with medicines that contain such drugs.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 12/08/2008_
_CRN 2054294_
_page number: 1_
Ebastine should be used with caution in patients with renal insufficiency
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