Страна: Армения
Език: английски
Източник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ebastine
Industrias Farmaceuticas Almirall S.A.
R06AX22
ebastine
20mg
tablets film-coated
(10/1x10/) in blister
Prescription
Registered
2019-09-06
1/7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Kestine 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg of ebastine. EXCIPIENT WITH KNOWN EFFECT:_ _ Each film-coated tablet contains 177 mg of lactose. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. The film-coated tablets are white to almost white, round, engraved with “E20” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Kestine is indicated in the symptomatic treatment of: • allergic rhinitis (seasonal and perennial) associated or not with allergic conjunctivitis • urticaria of different etiology including idiopathic chronic urticaria 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology _ ADULTS AND CHILDREN OVER 12 YEARS OF AGE The recommended dose is 10 mg of ebastine once daily, but some patients may require a dose of 20 mg once daily. ELDERLY PATIENTS It is no necessary to adjust the dose. RENAL INSUFFICIENCY It is not necessary to adjust the dose in patients with mild, moderate or severe renal insufficiency. HEPATIC INSUFFICIENCY It is not necessary to adjust the dose in patients with mild or moderate hepatic impairment (Child-Pugh Classes A and B). There is no experience with doses over 10 mg in patients with severe hepatic insufficiency (Child-Pugh Class C); therefore, the dose of 10 mg of ebastine/day should not be exceeded in these patients. Treatment may be prolonged until symptoms disappear. 2/7 _Method of administration _ For oral use. The tablets may be taken with or without food and with a glass of water. 4.3 CONTRAINDICATIONS Known hypersensitivity to the active substance or to any excipient listed in section 6.1. Pregnancy, lactation period, children under 12 years of age, deficit of lactase, intolerance of lactose, malabsorption of glucose-galactose, severe hepatic failure (Child-Pugh classification, class C). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Administer with caution in patients with Прочетете целия документ